DEDICATION

I dedicate this report to the Almighty God for His love, mercy and protection over my life
and for seeing me through this Industrial Training as well as to my parents, ASP Ephriam
Hemen Nyidyu and Mr. & Mrs. Akor Nyidyu for their extraordinary support both
financially and otherwise, I pray that the ever sufficient God will bless them abundantly.
 ABSTRACT

The student industrial training program organized by ITF, aimed at equipping the student
with practical training of the theoretical knowledge already gained in school, giving the
student opportunity to be exposed to the usage and operational value of some facilities needed
in their chosen field later in life.

This report is a written statement of work done during my six months industrial training
which i underwent at Rico Pharmaceutical Industrial, limited Omagba phase ll Onitsha,
Anambra state. The establishment is sectioned into various departments, in which i was first
attached to Quality control department which comprises of two sections, namely: Chemistry
laboratory section and Microbiology laboratory section in which I was stationed to work in
chemistry laboratory section, then was later attached to production departments which
comprises of syrup section, tablet section and pure water/table water section.

This training exposed me to a lot of lessons and challenges and also gave me a big opportunity
to relate the theoretical aspect of biochemistry to its practical.
 TABLE OF CONTENTS

Dedication ……………………………………………………………………………. i

Acknowledgement …………………………………………………………………… ii

Abstract ……………………………………………………………………………… iii

CHAPTER ONE

Industrial Training Fund (I T F)……………………………………………………………....

Roles of Industrial Training Fund.……………………………………………….…
Introduction and Historical background of SIWES ………………………………………
Objectives of SIWES……………………………………………………………………….
Scope and Importance of a Pharmaceutical industry……………………………………
Brief History of Rico Pharmaceutical Industry…………………………………………….

CHAPTERTWO
Quality Control Section……………………………………………………………..…
Important and objectives of Q.C. Section………………………………………………
Equipments use in the Q.C. sections and their functions……………………………………..
GLP and SOP and their significance………………………………………….
FEFO and FIFO logistics……………………………………………………………….
Hvac system and Reference Standards…………………………………………………….
Strategic places outside the production premises …………………………………….
SOPs for receiving and sampling of raw materials………………………………………
Analyses done in Q.C. sections…………………………………………………………

CHAPTER THREE

Water Treatment Plant……………………………………………………………....…………

Water treatment processes………………………………………………………………........
Chemical &Physical analysis on production water……………………………………………..
Difference between, injection, portable and production water………....................................

CHAPTER FOUR

Drug department………………………………………………………………………..
Drug, it’s Components and examples ………………………………………………..
Importance of drugs …………….. ……………………………………………………….
GMP and CGMP ………………………………………………………………………….
Contamination and Cross-contamination………………………………...................................
Definition of relevant terms……………………………………….. ……………………
CHAPTER FIVE
Tablet Section………………………………………………………………………………
Production flow chart in tablet section………………………...
Room, machines and their significance found in tablet section………………………….
Chemical analyses and pharmacokinetics of some tablet drugs………………………

CHAPTER SIX
Oral liquid Section………………………………………………………………………….....
Production flow chart in syrup section………………………………………………………..
Room, machines and their
significance……………………………………………………………………………

Chemical analyses and pharmacokinetics of some syrups………………………………………….

CHAPTER SEVEN

Relevance of SIWES program…………………………………………………………………………………

Problems encountered during SIWES………………………………………………………………………….

Solution proffered………………………………………………………………………………………………….

CHAPTER EIGHT

General Appraisal of the program……………………………………………………………………….

Ways of improving the program………………………………………………………………………………

Advice for future participants……………………………………………………………………………

Advice for SIWES management………………………………………………………………………………

CHAPTER NINE

Conclusion……………………………………………………………………………………………………………

Recommendation………………………………………………………………………………………………….

Reference……………………………………………………………………………………………………………
 CHAPTER ONE
1.0 THE INDUSTRIAL TRAINING FUND (ITF)
It is an agency of the federal government of Nigeria, given the responsibility to
mediate and be a channel between the nation’s tertiary institutions and the industries, to
enable students, to enable students to participate in industrial activities prior to their
graduation. This participation in Industrial activities (training) is to ensure and prepare
students to fit well into the industrial system when they secure employment after graduation.
In some way bridging the gap between theories acquired in school and industrial work.
The SIWES apparently offers a veritable means of redressing the gaps, however many
problems include: increase in number of trainees and institutions, inadequate standard for
various facets of the scheme and inadequate compliance and adherence to these standards
where they exist. The emergence of global economy that is knowledge based was as a result
of such occasioned changes, which also implies that the SIWES administration must catch up
with the wind of reforms sweeping across the globe to avoid being left behind.

1.1 ROLE OF INDUSTRIAL TRAINING FUND (ITF)

 Formulate policies and guidelines on SIWES for distribution to all the SIWES
participating bodies, institution and companies.
 Regularly organize orientation programmes for students prior to their attachment.
 Supervise students on industrial Attachments.
 Disburse supervisory and students allowances.
 Provide insurance cover for students on attachment.

1.2 AN INTRODUCTION ABOUT SIWES

Experts are of the opinion that there is a yearning gap between the learning
acquired by graduates of Nigeria universities and the skills application required in the
workplace. Clearly, academic learning and theoretical knowledge alone would not usually
prepare an educated person for the world of work. It has been an open secret of discussion on
the general deterioration of graduates from Universities. Most employers are of the view that
the country’s graduate are of more theoretical sufficient but lack the practical skills, which
would have been a quality that would be productive and more efficient in various workplace,
this brings about versatility in the application of skills required to perform in a defined job.
The requirements are particular to graduates of the following fields(disciplines): Science,
Engineering, Medicine, Agriculture and Technology.
In most developed, advanced and progressing countries (nations), their development has
been primarily attributed to contributions from the above mentioned disciplines. They create
innovations which has helped drive the world today. Consequently the capacity of Nigerian
graduates to innovate and create, depends solely on the extent development. But, these
expectations cannot be made by graduates who lacking technical, practical or hand skills.

1.3 HISTORICAL BACKGROUND OF SIWES

Industrial training fund had a vision of providing an avenue for students to acquire
practical industrial exposure in their respective disciplines during the course of their studies,
which led to the inception and initiation of SIWES in 1973. This was to prepare students to fit
in, more readily into an industrial work environment after academics. The scheme offers
lecturers opportunity to evaluate training in industries.
Eleven institutions made part of the scheme at its commencement in 1974. And in
1978 it has already grown to (32) prior to this, the ITF narrowed the programme to just
Engineering, Science and Technology disciplines. In 1979, the federal ministry of
Education made it a compulsory for all students of Polytechnics and colleges of
Technology to undergo one year Industrial training. This led to a financial burden too
high for the ITF to shoulder, hence withdrawing its support from the Polytechnics and
colleges of Technology. The ITF withdrawal from financing was due to the increasing
number of Universities. Which led to the Federal Government finding the scheme
thought the NUC(National Universities commission) and the NTBE(National Board for
technical Education). The commissions helped managed the scheme for 5yrs (1979-
1984). Consequently, the federal Government handed over the administration of the
scheme to the ITF in Dec.1984.

Participating students increased on yearly basis just as institutions increased since it’s
inception of the scheme. In 1974, it was a total of 784 students. In 1978, 4,713 students
participated, between 1979-1984 during NUC/NBTE administration, there was no
compilation due to operational problems. But in 1985, 16912 students participated, and for
the next 10yrs institutions were about 141 and a total 57,443 students were involved.
The SIWES programme is part of included programmes in Nigeria universities. The programme helps
harmonize the extension theoretical background of tertiary education in Nigeria with the extensive
practical background of the industries. These helps expose students to equipment, machines,
infrastructure, work methods(indoor/field work) which may not be obtainable or available in their
institutions. The general approved duration for this exercise is 24 weeks equivalent to 6months.

1.4 OBJECTIVES OF SIWES

SIWES is an instrument for industrialization and economic development because it
has potential to induce scientific and technological productivity of students.
The scheme aims at promoting desired technological know-how for the advancement of the
nation, students who pass through SIWES scheme are fully prepared for the world of ‘work’.
Finally the scheme will surely develop the much needed highly skilled and articulated labor
force required to build an indigenous, self-reliant economy that is capable of meeting future
challenges of the Nation.

 To provide an avenue for Students in Nigeria Universities to acquire industrial skills

and experience in their course of study.
 To prepare Students for industrial work situation they are likely to meet after
graduation.
 To provide avenue for students to acquire industrial skills and experience in their in
their course of study.
 To expose Students to work methods and techniques in handling equipment and
machinery that may not be available in the Universities.
 Make the transition from the University to the world of work easier and thus enhance
Students contacts for later job placement.
 Provide Students with opportunity to apply their theoretical knowledge in real work
situation thereby bridging the gap between theory and practice.
 Enlist and strengthen employer’s involvement in the entire educational process of
preparing University graduates for employment in the industry
1.5 HISTORY AND SCOPE OF PHARMACEUTICAL INDUSTRIES
A pharmaceutical industry is a commercial industry that discovers, develops,
produces and markets drugs or pharmaceutical drugs for use as different types of medicine
and medications, and they market the drugs which have license to use as medicines.
Pharmaceutical companies may deal in generic or brand medications and medical devices.
They are subject to variety of laws and regulations that govern the patenting, testing, safety,
efficacy and marketing of drugs from its beginning, at the start of the 19th century, the
pharmaceutical industry is now one of the most profitable and influential in existence,
attracting practice and controversy. Most drugs are discovered by identifying the active
ingredients from traditional remedies or by serendipitous discovery i.e. unexpected discovery.
Before a drug can be approved, all the compounds used have to be tested and usually, only a
fraction is approved after heavy investment to determine the fety and efficacy of each
compound.

Drug discovery has been traced to its roots from two sources i.e. the traditional remedy
discussed above and discovery from plants. For example, morphine, an analgesic and sleep
inducing agent was isolated from OPIUM by Friedrich Sertijrner.

Drugs induce structural changes in patients and the science of pharmacology evaluates the biological
effects of these structural changes in patients. Drugs ranges from injectibles to tablets, capsules,
syrups, suspensions, antibiotics, vaccines and others.

In Nigeria, NAFDAC (National Agency For Drug Administration Commission) regulates advertising
of prescription of drugs and to establish Good Manufacturing Practices (GMP). “The law was that
all drugs introduced had to be effective” sometimes it seems like there are more medicines than there
are disease. Some can be bought over the counter at pharmacies or other stores, others requires a
doctor’s prescription, only a few medicine are available in the hospital.

1.5 IMPORTANCE OF PHARMACEUTICAL INDUSTRIES

 Pharmaceutical products help to treat various types of diseases.

 Drugs are released into the market after studies and clinical testing.
 Pharmaceuticals can be classified as prescription drugs and over the counter drugs.
 Prescription drugs will be available from the drug store only with a prescription from a
medical practitioner or health care provider.
 The products of pharmaceutical companies saves life, improve the quality of life of
people and also help in preventing diseases.

1.6 BRIEF HISTORY OF RICO PHARMACEUTICAL INDUSTRY

 Rico pharmaceutical industry limited was incorporated in the year 1992 and fully
commences business in 1933. It’s a 100% private owned pharmaceutical industry engaged in the
business of manufacturing drugs of liquids, tablets and oral powder products. Currently the
company has about 45 products dully approved by NAFDAC.

Branch network of the company across different places within Nigeria includes,

ONITSHA LAGOS ILORIN JOS

ENUGU KANO MUBI SOKOTO

CALABAR MAIDUGURI GOMBE ASABA

WARRI YOLA MINNA

The staff strength in Rico pharmaceutical industry is currently above 250 personnels.The
company is a registered member of [P.M.G.-MAN] Pharmaceutical Manufacturing Group of
Pharrmaceutical Manufacturing Association of Nigeria.

1.7 THE VISION STATEMENT

To become a standard indigenous health and pharmaceutical industry, working through a

professional and competent team to provide globally acceptable good pharmaceuticals always

1.8 COMPANY MISSION STATEMENT

To be manufacturers of good pharmaceuticals consistently complying with the exact
standards of the international current good manufacturing practices (CGMP) of World Health
Organisation (WHO).
1.9 THE COMPANY’S CORE VALUE
A dogged focus on consistently delivering sustainable health care solutions. A professional integrity
of all manufacturing process for the delivery of top notch- quality products. A dedication and
commitment to enriching the lives of customers and market associates so as to foster meaningful
and mutually rewarding partnerships on an ongoing basis.
2.1 DEPARTMENTS AND PRODUCTON SECTIONS IN THE COMPANY
 Quality Control Section [QC] Oral liquid section (syrups & suspension)
 Water Treatment Plant. Powder section
 Tablet Section.
RICO PHARMACEUTICAL INDUSTRY NIGERIA LIMITED

ORGANIZATIONAL ORGANOGRAM
 CHAPTER TWO

2.1.1 QUALITY CONTROL SECTION

The term quality control refers to the sum of all procedures undertaken to ensure the
identity, purity and efficacy of a particular product .it also emphasis on standards and industry
requirements and check the quality level of products.

Quality control is also essential to building a successful business that delivers products that meet or
exceed customers’ expectations; it also forms the basis of an efficient business that minimizes waste
and operates at high levels of productivity. Quality control is also concerned with controlling negative
variances which ultimately affect the excellence of a manufacturer in producing products.

ROLES AND OBJECTIVES OF QUALITY CONTROL

 To evaluate the methods and processes of production and suggest further
improvements in their functioning.
 To establish the desired quality standards which are acceptable to the customers.
 To analysed in detail the causes responsible for such deviation.
 To undertake such steps which are helpful in achieving the desired quality of the
product.
 To study and determine the extent of quality deviation in a product during the
manufacturing process.

In Rico pharmaceutical industry, quality control section is divided into laboratories,

which are;

 Chemistry Laboratory.
 Microbiology Laboratory.
STRATEGIC ROLES OF CHEMISTRY LABORATORY

 Conduct the necessary Quality Control to ensure that measurement systems are in
control and operating correctly.
 Properly document results of the analyses.
 Properly document measurement system evaluation of the analysis specific Q.C.
including corrective actions.
 STRATEGIC ROLES OF MICROBIOLOGY LABORATORY

Microbiologists capture samples, incubate them for a period of time, then read and record
results, then if samples are out of specification, the lab performs an investigation and root
cause analysis as part of good manufacturing practices.

NB: Both labs are essential because it’s there that different tests are being done which provides a
considerable benefit to manufacturing and the organization by uncovering potential contamination
quickly, the labs allows the business to respond proactively, protecting customers, patients and the
community.

EQIUPMENTS USE IN THE QUALITY CONTROL SECTION

Chemistry Laboratory:
EQUIPMENTS USES
PH Meter PH Meter is the electric device used to measure the amount of
acidity or alkalinity in the raw material.

Moisture Analyzer Moisture analyzer determines the moisture content of a sample with
the loss on drying method and consists of a weighing and heating
unit (infrared).

Friability Test Apparatus This apparatus is used for determination of durability of tablets at the
time of production.

Disintegration Test Apparatus This apparatus/tester is used to test how a drug in pellet form will
disintegrate in solution.

Conductivity Apparatus The apparatus determines the amount of dissolved ions present in a
water sample, which serves as a measure of water quality.

Spectrophotometer Spectrophotometer is a technique used to measure the

concentration of solutes in solution by measuring the amount of
light that is absorbed by the solution in a corvette placed in the
Spec.

Melting Point Apparatus This is use to check the melting point of a substance.
Dissolution Test Apparatus This is a device use to check the rate at which an active
ingredient is released in the body over a given period of time.

Hardness Tester This is device use to determine the hardness of tablet drug.

Weighing Balance This is an electronic device use to measure the weight of

samples and tablet drugs during analyses.
MICROBIOLOGY LABORATORY
EQUIPMENT
Fugal Growth Incubator
Bacteria Incubator
USES
Fungal growth incubator are used for the growth and storage of
bacterial cultures.
Bacteria Incubator is basically the laboratory equipment which is used
for the incubation of biological product under controlled conditions.

Microscope Microscopes are used to identify and visualize some tricky samples
including bacteria, algae and fungi.

Autoclave Autoclave is used to decontaminate certain biological waste and sterilize

media, instrument and lab ware.

Colony Counter Colony counter are used to estimate a liquid culture’s density of
microorganisms by counting individual colonies of an agar plate, slide
and Petri-dish.

Water Bath Water bath is a device used to incubate samples in water, maintained at
a constant temperature.

Quality Assurance: Quality assurance makes sure the process being taken is correct i.e. doing the
right thing in the right way with the help of GMP.

Difference Between Quality Assurance And Quality Control

QUALITY ASSURANCE QUALITY CONTROL

Focus is on the process of product creation. Focus is on the end product.

Proactive approach. Reactive approach.

Errors can be avoided through proper planning Spotting errors made easy by following the
and documentation. planned activity precisely.
Emphasis on customer requirements. Emphasis on standard and industry
requirements.

Can be use to verify quality level of the Validation for quality level of the product.
products.

 Quality Control: Quality control makes sure what has being done reproduces what was
expected, making sure requirements are matched.

 Summary: The difference is that Q.A. is process oriented and Q.C. is product oriented.

GOOD LABORATORY PRACTICE (GLP)

Good Laboratory Practice (GLP) refers to a quality system of management controls for research
laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality and
integrity of chemical (including pharmaceuticals) nonclinical safety test; from physiochemical properties
through acute to chronic toxicity tests.

IMPORTANCE OF GOOD LABORATORY PRACTICE

 It helps maintain 100% safety and quality of the drug.

 It controls what scientists do and how they carry out their safety/quality testing of
chemical and biochemical products as well as in development pharmaceuticals.
 It also ensures that no safety and quality data has been manipulated or changed in one
way or another.

GLP(S) OBSERVED IN THE LABORATORY

 Cloaking well with your lab coat, safety boot or slippers.

 keep all reagents safe and always run a control sample.
 Differentiating there agents bottles by labeling on them with their names, concentration
and factor to avoid mix-up.
 Always calibrate your equipment properly before using to ensure accurate result.
  Avoid eating and making noise in the laboratory.
 All acids must be stored in glass transparent containers.
 Fire extinguishers should be mounted in strategic places to control any case of fire outbreak.
 Always check the integrity and quality of your sample.
 Wash/rinse the glassware used after preparation(s) or practical and keep safe in the
proper place.

 STANDARD OPERATING PROCEDURES (SOP)

Standard Operating Procedures (SOP) is a written procedure for any process or system that is
followed during the operation of any system or production machine. SOPs provide standard
working tools that can be used to document routine quality system management and technical
activities. The development and use of SOPs are an integral part of a successful quality system as
it provides individuals with the information to perform a job and facilitates consistency in the
quality and integrity of a product or end-result.

FEFO AND FIFO LOGISTICS

FEFO is an acronym for “First Expired, First Out”. This term is used in logistics and inventory
management to describe a way of dealing with perishable products with a specified expiry date,
the product with the deadline for the intake will be the first to be served or removed from stock.

In pharmaceutical certain, FEFO is applicable in approved raw material store and approved
finished product store respectively but most specifically the approved raw material store,
where raw materials with the nearest expiry date are been remove from the store for
production irrespective of when they are bought or brought into the store for storage.

While FIFO is an acronym for “First In, First Out”.It is an asset-management and valuation
method n which the assets produce or acquired first are sold, used or disposed of first and may
be used by an individual or cooperation. However in a pharmaceutical certain FIFO is only
applicable in an approved finished product store, where products that comes in the store first,
are first to be dispense for market and vice versa.NB: FEFO is applicable in both raw material
and finish product store, while FIFO is only use in approved finished product store.
CONTAMINATION AND CROSS-CONTAMINATION

Contamination is defined as the undesired introduction of impurities of a chemical, microbial

nature or foreign matter into a starting material or intermediate during production, sampling,
packaging, storage or transportation.

While cross-contamination is the contamination of a starting material, intermediate product

or finished product with another starting material, intermediate product or finished product.

SOURCES OF CONTAMINATION

 People
 Processes
 Objects

HVAC SYSTEM IN A PHARMACEUTICAL CERTAIN

HVAC system is a basic requirement of a pharmaceutical facility, It is an acronym for Heating,

Ventilation, and Air Conditioning. It is a system that is used to control the air temperature by
controlling the air filtration and the moisture in the air. These help to maintain the required
temperature and humidity in the manufacturing and storage area of the pharmaceutical facility.

REFERENCE STANDARDS

A pharmaceutical reference standard is a substance prepared for use as the standard in an

assay suitable to test the identity, strength, quality and purity of substances for pharmaceutical
use and laboratory analyses. A reference standard is a prerequisite to measuring potency. To
measure potency, a sample of unknown potency must be compared to a standard of known
potency, so that the potency ratio can be calculated. There two types of reference standard, namely,
primary and secondary reference standards.

 Primary Reference Standard: This is a chemical substance or a raw material that have
been analysed and of good purity and is use to standardize other raw materials.
 Secondary reference standard: This is the standard that the purity level has been
standardize and are used for analyses.
STRATEGIC PLACES IN A PHARMACEUTICAL PREMISES OUTSIDE THE PRODUCTION AREA

 RECEIVING BAY: Receiving bay in a pharmaceutical industry is a place or an area within

the company premises where pharmaceutical raw materials are first received, checked,
sampled and sorted before taking it to the quarantine raw material store.
 QUARANTINE RAW MATERIAL STORE: This is a store set aside outside the production
area where raw materials are kept and lebelled yellow to indicate that the raw material
is still undergoing test and analysis.
 APPROVED RAW MATERIAL STORE: This is where the raw materials are kept after it
must have been tested and proven beyond reasonable doubt that it is pure and identify
to be that particular material they are keeping. In this store the raw materials are labeled
green indicating that it is of standard or being approved for production. FEFO logistic is
use in this store to prevent raw materials that are getting closer to expiration date from
expiring before others.
 REJECTION STORE: This store is where raw material that are under quarantine are
kept after they might have fail all the necessary test ( including identification test ) are
kept.

SOP FOR RECEIVING RAW MATERIALS

 Ensure the raw material is received in good packaging condition and stated quantity
under the receiving bay.
 Ensure the check of name of the raw material, batch number, manufacturing date,
expiry date written on the bags.
 Send raw material to the quarantine store.
 The Quality control department is notified of the arrival of raw materials with
notification form from the stores department.
 The Quality control personal will place a well filled yellow label on the raw material
and thereafter collect sample for analyses with the request form.
  If the raw material passes quality control analyses, it is then taken to approved raw
material store and labelled green, which indicate that the raw material is save for
production.
 From here, raw material is issued out for production based on “First expire, first out
(FEFO)”

 But if the raw material fail critical test, it is taken to the raw material reject store, where it
is labelled red.
 The raw material should be returned to the supplier.

SAMPLING OF RAW MATERIALS.

Due to bulky supply of the raw materials, it therefore becomes cumbersome for the QC
personnels to sample all the bags of the raw materials. scientist has therefore derived a very
efficient and reliable formular for sampling of raw materials, thus is below:
Formula for sampling raw material = √n + 1

For instance if there are 25 bags of ascorbic acid for sampling, the QC personnels can not
go ahead to sample all the 25 bags individually but use the above formular for fast and
efficient result.

n = Number of containers e.g. 25 bag of ascorbic acid

√n + 1 = √25 + 1 (using the formula)

=5+1

=6

Therefore, 6 (six) bags of the ascorbic acid pure sample will be picked at random and
sampled.

TYPES OF ANALYSES DONE IN THE QUALITY CONTROL SECTION

Chemistry Laboratory

Hardness Test: Hardness test is a test analyses done only on tablet drugs, by the use of a
device called hardness tester (manual or automatic). It is done to test the breaking point
and the structural integrity of the tablets under condition of handling during blistering,
coating, packaging, storage and transportation before reaching the final consumer. The
tablet is not expected to be too hard (to ensure easy disintegration) or too soft (to
withstand the vigorous process of packaging and transportation).

Below is an analyses of a
hardness test carried out on paracetamol tablets in the QC laboratory:

Apparatus Used

 Petri dish
 Hardness tester
 Weighing balance

Procedure

 Using 4 tablets of paracetamol.

 Place each tablet into the hardness tester, starting from point 46.8km/cm while screw
tight the tablet.
 Record the value at which the tablet breaks.
  Perform the same procedure for the remaining tablets and get average of the records

Results

Take the average of the value gotten as the tablet hardness tester breaks each tablet.

First tablet at 4kg/cm Breaks At 6.8kg/cm

Second tablet at 4kg/cm Breaks At 5kg/cm

Third tablet at 4kg/cm Breaks At 3.2kg/cm

Fourth tablet at 4kg/cm Breaks At 4.9kg/cm

Average = 6.8 + 5 + 3.2 +4.9 = 4.9kg/cm

4
Specification => 38kg/cm

NB: The harder the tablets the longer the friability and disintegration and vice versa.

Friability Test: Friability test is done using a friability test apparatus. This is to determine the durability of
tablet at the time of production, and how fragile the tablet can withstand the vigorous processes ranging
from blistering, coating, packaging and transportation before reaching the final consumers.

Below is a friability analyses on paracetamol tablets:

 Apparatus Used
 Double drum friability tester
 Cotton wool(for cleaning the double drum)
 Weighing balance
 Petri dish
 Procedure
 Weigh 20 tablets in a Petri-dish and record the initial weight = (11.5).
 Remove the moisture (if any) from the double drum by cleaning with cotton wool.
 Set the friability machine to 100 or 105revolution.
 Transfer the tablets inside the double drum friability tester.
 Revolve till it gets to 0.00.
 Observe if there‘s some capping or if it’s being crushed.
 Record the final weight = (11.01).

Result
Initial weight of the tablet = 11.5
Final weight of the tablet = 11.01

Loss in weight = Initial weight - Final weight

11.5 - 11.01 = 0.49 (Ans)

Friability % = Loss in weight × 100

 original weight

0.49 × 100

11.5 = 4.26%

Specification=>1 - 5%

Disintegration Test: Tablet disintegration tester is used to test how long drug will
disintegrate in solution and also the rate at which tablet disintegrate in the body.

NB: Disintegration time for uncoated tablet should not be more than 15 minutes, while for coated
tablets should not be more than 30 minutes.

Moisture Test Analyses: Moisture test analyzer is used to determine the moisture content of the sample
with the loss on drying method.
 Apparatus Used

 Moisture analyzer
 Petri dish

Procedure

 Weigh empty Petri-dish and record the result.

 Weigh the sample and the Petri-dish and record.
 Weigh the granules and record the result.

Calculation
Weight of empty Petri dish = 34.0g
Weight of the sample = 52.0g
Weight of the granules = 18g
Weight of the sample after being placed in the moisture analyzer = 51.4g
Weight of the sample – Weight of empty Petri-dish

52.0 – 34.0 = 18.0g (Initial weight)

Weight of the sample placed in moisture analyzer – Weight of empty Petri-dish

51.4 – 34.0 = 17.4g (Final weight)

Loss in weight of moisture = Initial weight – Final weight

= 18.0 – 17.4

= 0.6g

Percentage moisture = Loss in weight × 100

Original weight

Loss in weight of moisture = 0.6g

Original weight of the granules = 18

% = 0.6 × 100

18

% moisture = 3.3%

Percentage of total solid = Final weight × 100

Original weight

= 17.4 × 100

18 = 96.66%

NB: Percentage of solid + Percentage moisture must be up to 100%.

Therefore 96.66 + 3.3 = 99.96 % (approximately 100%)

Assay: This is a quantitative analyses of drugs. Assay is done to check the percentage content of an
active ingredient of a particular drug. There are three types of assay, thus are as follows:

 Spectrometric method.

 Titration method.

 Chromatographic method (HPLC).

Spectrometric Method
The working principle of the uv-visible spectrometer is based on two laws: Beer’s law and
Lambert’s law, which combine to give Beer-Lambert’s law. This law states that the intensity of
monochromatic light transmitted through a solution decreases exponentially with increase in
concentration of the compound (absorbing species) in the solution and increase in the path length
of the cuvette or thickness of the solution. It is mathematically expressed as:
Where A is the measured absorbance, IO is the intensity of the incident light at a given
wavelength, I is the intensity of the transmitted light, L the pathlength of the cell, c the
concentration of the absorbing species, E is a constant known as molar absorptivity or molar
extinction coefficient, which is the fundamental property in a given solvent, at a particular
temperature and pressure.

Every API has its absorption maximum, which is defined as the wavelength at which the
molecules of the API will absorb the most or have the highest absorbance. Therefore, the
concentration of the API can be ascertained given its absorption maximum. Quantitative
determination of a drug’s active by spectrometric technique consists of sample preparation and
operation of the uv-visible spectrometer to obtain the absorbance value, followed by computation
of the active content by formula and, hence, the percentage active content of the drug. Below is an
assay carried out on paracetamol tablet using spectrometric method

Preparation of sample solution

 Weigh 5 paracetamol tablets and crushed them in a mortal

 Weigh out the average of paracetamol tablets in 500ml of volumetric flask, dissolve with 10ml
of methanol, dilute it with water to the mask and shake to mixed

 Filter some quantity and take about 2ml of the filtrate powder into 100ml of volumetric flask and
mixed with water to mask.

 1st tablet 0.56g

 2nd tablet 0.55g

 3rd tablet 0.55g

 4th tablet 0.55g

 5th tablet 0.55g

Average weight = 0.56+0.55+0.55+0.55+0.55 =0.552

 5

Therefore 0.552g of the powder will be use to prepare the sample solution.

Preparation of standard solution

 Weigh 500mg pure standard paracetamol powder and pour into 500ml volumetric flask.

 Dissolve with 10ml of methanol and add water to mask

 Then pipette 2ml into 100ml volumetric flask add water to volume.

Determination of absorbance using spectrophotometer

Procedures

 Determine the absorbance at 244nm with a stable spectrophotometer

 Put the uv-spectrophotometer on and allow it to self-test, Then set the wavelength at 244nm

 Using the quartz curvettes put the solvent use in preparing the sample and standard solutions
(methanol) in the cuvettes insert it in the spectrophotometer and blank.

 Put the sample solution in another curvette, insert in the spectrophometer,pull gently and take
your absorbance.

 Blank for the second time, insert your standard solution and take your absorbance.

Results

Absorbance of sample =0.094

Absorbance of standard =0.095

Calculations

% Absorbance = absorbance of sample X 100

 absorbance of standard

% = 0.094 X 100 =98.95%

0.095

Content = 98.95 X 500mg

100

Content = 494.75

Specification: USP 90% - 110% B.P. 95% - 105%

Conclusion: the drug is within the U.S.P. and B.P. specification, therefore is considered satisfactory for
consumption.

PH test: This test is carried out using an electric PH meter to determine the acidity and alkalinity of a
particular drug.

Dissolution Test Analyses : This is to check the rate at which active is released in the body
over a given period: This test is done to determine the rate at which drugs dissolve or turn
into solution in the body, the use of a dissolution test apparatus. of time. This is achieved
by dissolving the sample and analysing it and concurrently analysing the standard that
would have the concentration equal to the one declared. It is expected that the sample
should be able to release not less than 75% of
its active .

.
Weighing Balance: It is an electronic device use for weighing samples and drugs.

OTHER ANALYSES

Determination of weight per ml Test.

Below is a weight per ml analysis on metronidazole syrup.

 Apparatus
 Measuring cylinder
 Weighing balance
 Test tubes
 Procedures
 Weigh an empty measuring cylinder
 Weigh the sample in the measuring cylinder
 Caculations
 Weight of empty measuring cylinder = 19.98g
 Weight of sample in measuring cylinder = 30.80g
  Weight of sample = weight of empty cylinder—weight of sample in measuring
cylinder
 Weight of sample = 30.80—19.98 =10.82
 Wt/Ml = weight of sample

Weight of capacity of cylinder

= 10.82

10 =1.082g/ml

U.S.P. Specification (1.00- 2.00g/ml)

Preparation of 0.1M HCL Acid

Aim: To prepare 0.1M hydrochloric Acid

Materials: Concentrated HCL with 38% w/w and about 11.5m in strength, volumetric
flask, distilled water, measuring cylinder.

Procedures: 8.13ml of concentrated HCL was measured and diluted in 1000ml volumetric
flask with diluted water.

Precaution: Acid was added to water not water to acid

The relation below was used to calculate the volume of concentrated HCL to be measured in
order to prepare 1.0M HCL solution in a required amount.

𝑴𝑪𝑽
𝑽𝟏=
𝟏𝟎𝑷𝑫

Where;
M= Molar Mass of HCL = 36.46g/mol

C= Concentration of HCL to be prepared (Known) =1.0M

V= Volume of HCL to be prepared (Known) =1000ml

P= Percentage Purity or Assay (Usually found on the container’s label) =38.0%

D= Density of H2SO4 (Usually found on the container’s label) = 1.18g/cm3

𝟑𝟔. 𝟒𝟔 × 𝟎. 𝟏 × 𝟏𝟎𝟎𝟎
𝑽𝟏=
𝟏𝟎 × 𝟑𝟖. 𝟎 × 𝟏. 𝟏𝟖

𝟑𝟔𝟒𝟔
𝑽𝟏=
𝟒𝟒𝟖. 𝟒

V1= 8.13ml

This is the method used to determine the volume of a stock solution required to prepare a given
volume of known concentration of the solution.

Identification test of pure thiamine powder

Thiamine is an active ingredient use in the production of vitamin B-Complex.

Procedures

 Weigh out small quantity of thiamine pure powder and dissolve in distilled water
 Add small quantity of AgNO3 solution
 Add drops of nitric acid
 It will give a white precipitate as the refrence.
 NB: If a white precipitate is not formed it shows that is not pure thiamine sample
 Microbiology Laboratory

In microbiology laboratory the QC officers which are the microbiologist run a qualitative
analyses (purity) on raw materials and finished product by checking the growth of micro-
organisms on the raw materials and finished products respectively.

Types Of Media Use, And Their Functions

 Maconkay Agar: Use for checking bacterial growth

 Nutrients Agar: Use for checking both bacteria and fungi growth.
 Sabouraud dextrose Agar: use for checking fungi growth
 Lactose broth: Use for bacterial and fungi for water analysis.

SOPs FOR PREPARING A MEDIA

 Weigh each of the media as stated by the compendia and put in a conical flask and label
accordingly.
 Add 100ml of water to each of the media and shake properly to mix
 Heat for some minutes to dissolve and obtain homogeneity
 Sterilize in an autocleave at 1200c for about 15 minutes, then allow it to cool
 Pour each media in a well labeled petri dishes.
 Sterilize a wire loop on a bursen burner
 Using the wire loop make streak on the media, cover it
 Incubate it for 48 hours and check result.
Some analyses done in microbiology laboratory

Analyses on paracetamol syrup

AIM: To qualitatively check the growth and presence of micro-organism on the paracetamol
syrup using pour plate method.

MATERIALS: sterilized bottles, sterilized petri-dishes, sterilized pipettes, molten agar,

incubator.

PROCEDURES
 Collect sample of the paracetamol into sterilized bottles
 Assemble sterilized petri-dishes and pipettes
 Using sterilized pipette, transfer 1.00ml of the sample into petri-dishes asceptically.
 Molten agar was poured into the petri-dishes containing the samples
 The plates were labeled to avoid mix-ups
 negative controls were set up by pouring the molten agar into empty sterilized petri-
dishes and allow to gel
 It was then incubated for 24- 72 hours (350c and 250c)

NB: Incubation for bacterial is at 350c , while for fungal is 250c

MICROBIOLOGY WATER ANALYSIS

Using Most Probable Method

Materials: cornical flask, test tubes, test tubes rack, pipette, lactose broth, cotton wool,
durhams tubes,

Aim: To determine the presence and growth of micro-organism in water

Procedures

Presumptive stage

 Samples of water were collected into sterilized conical flask

 Sterilized test tubes were assembled on a test tube rack
 Using sterilized pipette, 9ml of lactose broth was introduced into the test tubes
 The test tubes were covered with sterilized cotton wool
 1ml of the water sample was transferred into the test tube containing the lactose broth
using sterilized pipette
 Negative controls were set up by only transferring the 9ml of the lactose broth into
test tubes without introducing the samples
 With the help of the sterilized forcept durhams tubes were introduced into the test
tubes in inverted position.
 The test tubes were incubated for 24-72 hours.
NB: Analysis may stop here when there is no displacement of the durham tubes at the end of
the incubation.

Confirmed Stage

 From the positive presumptive stage, the test tube that shows displacement
 Using sterilized wire loop and bursen burner inoculate the eosine methyline blue agar,
incubate for another 48 hours.

Completed stage

 From the positive confirmed stage

 Assemble another set of sterilized test tubes
 Introduce 9ml of lactose broth into the test tubes and cover with cotton wool
 Arrange the agar slants tubes
 With a wire loop and bursen burner a colony was transferred into each of the tubes
using sterilized forcept, durhams tubes were introduced into the cultured tubes in
inverted positions.
 Also the EMBA slants were inoculated and incubated for another 48 hours
 CHAPTER THREE

WATER UNIT

Water Treatment Plant

Water is a transparent, tasteless, odourless and colourless chemical substance that is the
main constituent of earth’s streams, lakes and oceans and the fluids of most living
organisms.

In pharmaceutical industry water plays a vital role in the product itself, in the production
process and for cleaning purposes, water is widely used as a raw material, ingredient and
solvent in the processing, formulation and manufacture of pharmaceutical products, active
pharmaceutical ingredients (API) and intermediate and analytical reagents. There are two
types of water treatment process and they are:

 Primary treatment
 Secondary treatment

Primary Treatment: Here, the source of water which is borehole. Water is being
generated with the help of sumo to the overhead tank where the water is left for some time
for the water particles to settle at the bottom of the tank before the water is release to the
sand bed which has chambers arranged according to size of the sand particles to remove
particles from water, then the water enters the activated carbon bed which removes tastes,
odour and colour from the water before going to deionizer which has two resins (anions
and cations), which helps to remove heavy metals in the water, converting the heavy
metals to re-metallic ions converting the re-metallic ions to water ions for production
water, it has to pass through deionizer to remove those ions like Mg, Cl, Ca, and lead to
prevent this metals from reacting with the drugs during and after production.

NB: Portable water for drinking don’t go through the deionizer because it tend to removed
some essential compounds in the water which are important in the body, such as Mg, Cl
and Ca ions which are required in the body. Therefore portable water pass through the
activated carbon straight to the water factory for further processings.

Secondary Treatment: Secondary treatment for production water moves from the
deionizer which removes some ions to prevent them from reacting with the production
water, the water now goes to the storage tank (reservoir), inside the production area, then
the water is allowed to fall gravitationally from the storage tank to activated carbon
chambers arranged in descending order from 5.0 micron filters – 1.0 micron filters – 0.5
micron filters respectively to remove any available particle, taste, odour and colour. Then
the water finally enters the U.V (ultraviolet) sterilizer which eliminates micro-organism in
the water, from now the water is free and save for production.

NB: For sachet and table water, it doesn’t go through deionizer, it moves from activated
carbon chain to the activated carbon chambers used to remove colour and odour, through
the micron filters (5-1.0-0.5), then finally to the UV water sterilizer and ozonizer for
sterility of the water to make it portable for drinking.
The parameters being determined in water unit are as follows:
1. Sensory parameters
 Appearance
 Odour
 Taste
SENSORY PARAMETERS
The analyses carried out under this parameter are done with the aid of functional sensory organs
such as the tongue, eyes and nose of the analyst.

Portable water for consumption by convention is expected to be colorless, odorless and tasteless
as such, any water sample without these characteristics is not considered fit for drinking.

Test For Water Appearance: Test for water appearance provides an answer based upon the
visual sighting of the water sample. It pertains to the colouration of the water sample.
Pure and uncontaminated water is expected to be colourless. Any water sample that is coloured
fails the appearance test and is, therefore, not accepted based on appearance. The eyes are used
for this test. It requires an experienced analyst with good eyes; therefore it is usually carried out
by the Head of the Unit.
Test For Water Taste: Good suitable water for consumption is expected to be tasteless. Water
taste arises as a result of the presence of mineral elements in the form of dissolved ions. This test
helps to ascertain the level of water purification or good manufacturing and purification practices
employed by the industry of factory. The tongue is used for this test. This is carried by an
experienced analyst, usually the Head of the Unit.
Test For Water Odour: Pure water is expected to be odourless, water odour arises from water
pollution by microbial metabolic activities, poor sewage management, and/or poor industrial
procedures. The nose is used for this test by well-trained personnel with good olfactory qualities;
hence it is usually carried out by the Head of the unit.
CHEMICAL PARAMETERS
Conductivity Test: Conductivity test determines the amount of ions such as (chlorides,
sulphides carbonate compounds in the water, this test is done with conductivity meter.

Procedure:
  Set the temperature to 30 degree Celsius
 Push the range to the lowest (200) point
 Rinse the electrode with water
 Drag the controller to check the standard of the conductivity meter to 1.0v
 Check the cell content, then insert the electrode inside the water
 Set to conductivity and read the value

NB: Any value gotten should be divided by 10

Result:

Value gotten = 26.5

Constant value = 10 Therefore, 26.5 / 10 = 2.65ppm

Specification = < 5

Chloride Test: Chloride test is done to detect the presence of chloride ions and the
simplest method for detecting chlorides ions is by the use of silver nitrate (AgNO3) which
reacts with the chloride to form a cloudy white precipitate.

NB: Chlorine in water helps to destroy the bacteria and viruses that can enter a water
system in many different ways. Although chlorine can react with organic material in water
to create low level contaminants, that’s why treated water should have a detectable level of
chlorine to prevent contamination.

Procedure:

 100ml of water sample in a measuring cylinder

 Transfer the water in a conical flask
 Add 2 drops of potassium dichromate (K2CrO7)
 Titrate with 0.1ml of AgNO3 with the use of pipette

Result:
Initial value = 0.0

Final value = 1.26

Titre value (end point) = 1.26

Volume of sample used = 100

Formula = Titre values x 200

Volume of sample used

Therefore, 1,26 x 200

100

= 2.52ppm

Specification/range = 0.0 – 500 ppm

Colour change = Yellow cloudy - white precipitate (ppt)

 Oxidizable Substance Test: This test is done to test for dissolved organics in
pharmaceutical grade water by using acidified potassium permanganate.

Procedure:

 10ml of water sample in a measuring cylinder

 Add 1ml of 1mol sulphuric acid (H2SO4)
 Also add slight quantity of potassium permanganate solution
 Then boil for 5 minutes.

NB: If the colour doesn’t discharge, there’s no presence of Fe3 but if it discharges, there’s
presence of Fe3

Result:

The colour discharged (disappeared), so the test was gotten and there’s presence of Fe3
  Hardness Test: Hardness test is being carried out to measure the amount of
calcium and magnesium ions present in water.

Procedure:

 50ml of water sample

 10ml of ammonia solution in a conical flask where the 50ml of water is being
transferred
 2 drops of mordant black 2 indicator
 Titrate with 0.02ml of EDTA

Calculations

Titre value = Initial value – Final value

= 2.0 - 4.3

= 2.3

Formula = Titre value x 1000

Volume of sample

Titre value = 2.3

Volume of sample = 50

Therefore, 2.3 x 1000 = 46 ppm

50

Specification/range = 0 - 250ppm

 Acidity Test: Acidity test is done to check the amount of hydroxyl ion dissolved in
water.

Procedure:

 100ml of water sample in a measuring cylinder

  Transfer the water sample into a conical flask
 2 drops of methyl orange indicator
 Titrate with 0.1 molar sulphuric acid (H2SO4).

Result:

Titre value = 1.13

Volume of water sample = 100

Formula = Titre value x 1000

Volume of water used

= 1.13 x 1000

100

= 11.3 ppm

Specification = 0.0 - 500ppm

Colour change = Orange - Pink

 Alkalinity Test: Alkalinity test is usually done to check the amount of hydrogen
dissolved in water.

Procedure:

 100ml of water
 2 drops of phenolphthalein indicator.
1. Titrate with 0.1 mol of sodium hydroxide solution (NaOH)

Result:

Titre value = 1.7 ppm

Volume of water sample = 100

Formula = Titre value x 1000

100

= 1.7 x 1000

100

= 17 ppm

Specification/range = 0.0 - 500ppm

Colour change = Colourless - Purple.

 Test For Iron in H2O.

Fe2+ + O2 ___________Fe
3+

Procedure

 Measure 10ml of water

 Put 1ml of 1M H2SO4 in the water
 Add slight quantity of 0.05% w/v of potassium /maganate solution to give a light
pink colour
 Heat it under the water bath for 5 minute
NB: If the colour does not disappear there is no present of iron

CHAPTER FOUR

DRUGS DEPARTMENT

This is a department in the company where drugs are produce in tablet, syrup, suspension
and powdered form.
What is a drug?

A drug can be define as a chemical substance of known structure, other than a nutrient or
an essential dietary ingredient, which when administered to a living organism, produces a
biological effect.

Components of drug

Drugs are made up of two components, namely

 Active Pharmaceutical ingredients (API)

 Excipients (non API)

Active Pharmaceutical Ingredients (API)

This is the main pure sample, active pharmaceutical ingredients or raw material which are
required in a particular dosage or amount to yield a proper biological effect or perform a
therapeutic function in the body when ingested by a patient. Examples of APIs are,
ibuprofen pure sample, paracetamol pure sample, sabutanol and theopyline pure samples,
ascorbic acid, caffeine anhydrous, etc.

Excipients (non APIs)

This is the non-active ingredient of a drug, it is intentionally added to drug for purposes
other than the therapeutic or diagnostic effect at the intended dosage. It acts as a vehicle
and as a binder for the active pharmaceutical ingredient. (B.P. 2007). The true role of
excipients will be to produce a stable, uniform product of high quality and in some cases to
influence the delivery of a drug to a desired location at the desired rate. Excipients have a
major impact on the field of biopharmaceutics, reason for which is necessary to ensure that
they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy
of the active ingredient. Degradation of an excipient can negatively affect the drugs physical
or microbiological stability. Therefore a good excipient must be inert so as not to react with
the API and must be able to dissolve in a physiological medium. Excipient can be categories
into different types, via:
  Antiadherents agents: Antiadherents reduces the adhesion between the powder
(granules) and the punch faces and thus prevent sticking to tablet punches by
offering a non-stick surface. They are also used to help protect tablets from sticking.
The most commonly used is magnesium stearate.
 Binding agents: Binders hold the ingredients in a tablet together. Binders ensure
that tablets and granules can be formed with required mechanical strength, and give
volume to low active tablets. Binders are classified according to their application:
I. Solution Binders—Are dissolved in a solvent (for example water or alcohol can be
used in wet granulation processes). Examples include gelatine, cellulose, cellulose
derivatives, polyvinylpyrrolidone, starch, sucrose and polyethylene glycol.
II. Dry Binders--- Are added to the powder blend, either after a wet granulation step, or
as part of a direct power compression. Examples include cellulose, methyl cellulose,
polyethylene glycol.
 Colourants: Colours are added to improve the appearance of a formulation, colour
consistency is important as it allow easy identification of a medication.
Furthermore, colours often improve the aesthetic look and feel of medications.
Small amounts colouring agent are easily processed by the body, although rare
reactions are known, notably to tartrazine. Commonly, titanium oxide is used as a
colouring agent to produce the popular opaque colours along with azo dyes for
other colours.
 Disintegrants: Disintegrants expand and dissolve when wet causing the tablet to
break apart in the digestive tract, or in specific segments of the digestion process,
releasing the active ingredients for absorption. They ensure that when the tablet is
in contact with water, it rapidly breaks down into smaller fragments, facilitating
dissolution. Examples of disintegrants include: crosslinked sodium carboxymethyl,
sodium starch glycolate.
 Flavours: Flavours can be used to mask unpleasant tasting active ingredients and
improve the acceptance that the patient will complete a course of medication.
Flavourings may be natural (e.g. fruit extract) or artificial. For example, to improve a
bitter product (mint, cherry or anise may be used) a salty product (peach, apricot or
 liquorice) a sour product (raspberry or liquorice) an excessively sweet product
(vanilla)
 Glidants: Glidants are used to promote powder flow by reducing interparticles
friction and cohesion. They have no ability to reduce die wall friction. Examples
include silica gel, fumed silica,talc and magnesium carbonate.
 Lubricants: Lubricants prevents ingredients from clumping together and from
sticking to the tablets punches or capsules filling machine. Lubricants also ensure
that tablet formation and ejection can occur with low friction between the solid and
die wall. Common minerals like tacl or silica and fats, e.g. vegetable stearin,
magnesium stearate or steric acid are the most frequently used lubricants.
 Preservatives: Preservatives are use to preserve the active ingredient for a period
of time without altering any negative effect on the drug. Some typical preservatives
used in pharmaceutical formulations are: Antioxidants like vitamin A, vitamin B,
vitamin C, and selenium). The amino acids cysteine and methionine). Citric acid and
sodium citrate). Synthetic preservatives like the parabens: methyl paraben and
propyl paraben.
 Sorbents: Sorbents are used for tablet and capsule moisture-proofing by limited
fluid sorbing (taking up of a liquid or a gas either by absorption) in a dry state. For
example desiccants absorb water.
 Sweeteners: Sweeteners are added to make the ingredient more palatable,
especially in chewable tablets such as antacid or liquids like cough syrup. Sugar cab
be used to mask unpleasant tastes or smells, but artificial sweeteners tend to be
preferred, as natural ones tends to cause tooth decay.
 Vehicles: In liquid and gel formulations, the bulk excipient that serves as a medium
for conveying the active ingredient is usually called the vehicle. Petrolatum,
dimethyl sulfoxide and mineral oil are common vehicle.
 Emulsifying agents: Emulsifying agents are mostly use for syrup for mixing sugar
phase and thickeners together. Examples are emulsifying wax, sodium stearate
powder, sodium lauryl sulphate.

Importance of drugs
  Drugs are important to mankind because it’s a chemical or compound used to cure, halt or
prevent disease, ease symptoms, or help in the diagnosis of illness.
 Drugs acts as supplements to replenish lost nutrients.
 Drugs treat disease symptoms and relieve pains.
 Drugs help control hypertension or high cholesterol.

GOOD MANUFACTURING PRACTICES (GMP)

Good according to quality standards. It is designed to minimize the risks manufacturing practice
(GMP) is a system for ensuring that products are consistently produced and controlled involved
in any pharmaceutical production that cannot be eliminate through testing the final products.
Good manufacturing practices are prescribed by regulatory agencies from around the world, the
FDA (Food and drug agency) being among them.

Components Good Manufacturing Practices

 Quality management
 Quality assurance
 Self-inspection, quality audits & approval
 Personal training and personal hygiene
 Quality control
 Sanitation and hygiene
 Documentation
 Hygiene of equipment, materials and distribution.

Examples Of Good Manufacturing Practices

 Ensure adequate and proper cloaking before going into the production area.
 Avoid eating and drinking in the production area.
 Avoid taking of cell phones and jewelries in the production area.
 Maintain adequate quietism during production.
 Machines and containers should be properly identified and cleaned before and after use
 to avoid contamination and cross-contamination.

NB: The GLP regulations are intended to ensure the quality and integrity of “open-ended”
research studies of product safety, while the GMP regulations are intended to ensure the quality
and safety of individual batches of regulated medical products through manufacturing and
testing in accordance with pre-defined processes.

CURRENT GOOD MANUFACTURING PRACTICES (CGMP)

Current Good Manufacturing Practices (CGMP) is regulation enforced by the FDA to provide for
systems that assure proper design, monitoring and control of manufacturing processes and
facilities. Adherence to the CGMP regulations assures the identity, strength, quality, purity and
efficacy of drugs products by requiring that manufacturers of pharmaceuticals adequately
control manufacturing operations. This includes establishing robust operating procedures,
detecting and investigating product quality deviations and maintaining reliable testing
laboratories. This formal system of controls at a pharmaceutical company, if adequately put into
practice help to prevent instances of contamination, mix-ups, deviations, failures and errors.
This assures that drugs products meet their quality standards.

The CGMP requirements were established to be flexible in order to allow each manufacturer
to decide individually how to best implement the necessary controls by using scientifically
sound design, processing methods and testing procedures. The flexibility in these regulations
allows companies to use modern technologies and innovative approaches to achieve higher
quality through continual improvement. Accordingly, the “C” in CGMP stands for “Current”
requiring companies to use technologies and systems that are up-to-date in order to comply
with the regulations. Systems and equipment that may have been “top-the-line” to prevent
contamination, mix-ups and errors 10 or 20 years ago may be less than adequate by today
standards.

DEFINITION OF TERMS
 Pharmacopeia: It is a book published usually under the jurisdiction of the government
and containing a list of drugs, their formulas, methods of making medicinal preparations,
 requirements and tests for their strength, purity, efficacy and other related information.
There are two main types of pharmacopeia frequently consulted in pharmaceuticals via:
 British Pharmacopeia (B.P).
 United State Pharmacopeia (U.S.P).

 Pharmacokinetics: this is a branch of pharmacology that deals with the absorption,

distribution, metabolism and excretion of drugs.
 Pharmacodynamics: this is a branch of pharmacology that deals with the molecular,
biochemical and physiological effects of drugs, including drug mechanism of action in the
body.
 Line Clearance: Line clearance is a process that provides a high degree of confidence and
assurance that the production area or all the production vessels and machines are free
from any unwanted residue or left over of previous processing before proceeding to
another production.

In Rico pharmaceutical drug unit is divided into different sections via:

1. Tablet section
2. Oral liquid section (syrup and suspensions)
3. Powder section (ORS)
4. Antibiotics section (B- Lactant line)

CHAPTER FIVE
TABLET SECTION
This is a section where drugs are produce in a tablet form, tablets are solid
dosage forms containing one or more active ingredients. They are obtained by single
or multiple compressions and may be coated or uncoated. They are circular in shape
and their surfaces are flat or convex and they should be sufficiently hard to withstand
packaging, storage and transportation without breaking. Tablets may contain
excipients such as binders, diluents, disintegration agents, substance capable of
modifying the behavior of the dosage forms and the active ingredients in the
gastrointestinal tracts, colouring matter etc. tablets can either be coated or uncoated.

 Coated Tablet: they are tablets covered with one or more layers of mixtures of substances
such as natural or synthetic resins, polymers, sugars, waxes etc. the tablets are coated for
a variety of reasons such as protection of the active ingredients from air, moisture, or
light and masking of unpleasant taste and odours. Coated tablets are further groups into
three main categories such as sugar-coated, film-coated and enteric-coated tablets.
 Uncoated Tablet: The majority of uncoated tablets are made in such a way that the
release of active ingredients is unmodified. A broken section, when examined under a
lens, shows either a relatively uniform texture (single-layer tablets) or a stratified texture
(multi-layer tablets). Uncoated tablets are also classified into three groups such as soluble
tablets, effervescent tablets and tablets for use in the mouth.

CAPSULES: capsules are solid dosages forms with hard or soft shells. They are of various
shapes and sizes, and contain a single dose of one or more active ingredients. The different
categories of capsules that exist include hard, soft and modified release capsules. Capsules shells
are made of gelatin or other substances which may be modified by the addition of substances
such as glycerol and sorbitol.

Capsules shells and contents may contain excipients such as diluents, solvents, anti-microbial
agents, sweeteners, colouring matter, flavouring substances etc. the contents should not cause
deterioration of the shell.

Some Tablet Drugs Produced In Rico Pharmaceutical Industry

Ricomol Paracetamol 500mg

Ridrex Paracetamol and caffeine anhydrous
Rico cold Paracetamol500mg,chloropheniramine meleate
 B.P.2mg and phenylephrine Hcl 2.5mg
Sodamints Sodium bicarbonate 300mg
Riclox Ampicillin and amoxillin
Ricotrin Sulphametoxazole B.P.400mg, trimethoprin
B.P 80mg
BKB Ibuprofen

Below is the production flow chart, significance and the activities carried out in the various
production rooms in tablet section.
Cloak Room: This is a room where personal protective equipments are kept, Before going
into the production area everyone should ensure adequate and proper cloaking before
starting work in requirements to GMP regulations.
  Weighing Room: In this room, approved raw materials are weighed according to
international standard or pharmacopeia specifications with the use of a measuring
scale.

MEASURING SCALE

 Mixing Room: This is where raw

material that have been measured are
properly mixed to obtain a
homogeneous dose, with the use of a
mixing machine. Thus after the mixing
the QC personnels collect samples of
granules from the four conners and
the center of the mixing machine to
conduct test for homogeneity or
uniformity of dose.
 Drying Room: After mixing the
drugs are dried to facilitate the
easy flow of granules at the
 compression machine. During drying, water is been removed in form of vapour.
There are two types of driers via: Oven drier and the fluid bed drier.
 NB: Vitamins drugs like vitamin c, are been dried with domine granules to prevent
the vitamins from degrading from the heat during drying. However the active
ingredients are added after the drying. Furthermore the drying temperature should
not be too higher or too low but moderate to avoid brittleness and capping during
compression.
 Crushing Room: After drying the granules are taken to the crushing room to crush
and sieve the lumps into fine granules, with the help of a crushing machine.

CRUSHING MACHINE
 Quarantine Granules Room: This is a room where granules that have undergone drying
 and crushing and are waiting for final mixing and compression are kept. this is to avoid
contamination and cross contamination.
 Final Mixing Room: This is a room where the final mixing is done, in this room excipient
are added to the granules also for vitamins drugs, is in this room that the APIs is added.
 Compression Room: This is a room where granules are compressed into various sizes and
shape of tablet with the use of a compression machine. Although during compression there
are some factors that causes high friability, brittleness and capping of tablets, thus are
below:

 COMPRESSION MACHINE.

 Factors that causes friability of tablets

  Over drying of granules.
 The granules size distribution.
 The lubricant concentration.
 The compression force.
 Factors that causes brittleness in tablets
 Density of the granules
 Compression force
 Compression speed
 Moisture content of the granules
 Tablet dimension.
Factors that causes capping of tablets
Capping of tablets is cause either by formulation or by the machine.
By Formulation
 Large amount of fines in the granulation.
 Low moisture content.
 Over drying of granules.
 Insufficient or improper lubricants.
 Insufficient amount of binders or improper binder.
 Granular mass too cold to compress firm.
By The Machine
 Poorly finished dies.
 Deep concave punches or beveled-edge faces of punches.
 Incorrect adjustment of sweep off blade
 High turrest speed.
 NB: During compression of granules into tablets the QC Personnels collect some tablets at
the interval of every 15 minutes to check the weight, friability, disintegration, dissolution
and the hardness of the tablets.
 In-process Room: As the name implies during the process of compression, some tablet are
collected at a given interval to check the weight, hardness, disintegration, friability,
dissolution, test. From her the tablets are taken to the quarantine finished product room,
which shows that the tablets are ready for coating, blistering and packaging.
 Coating Room: This is a room where tablets are coated to delay the release of the APIs
before reaching the alimentary canal, also tablets are coated to mask unpleasant taste and
 smell. Coating is divided into 3 types via: Sugar coating, Film coating and Enteric coating.
However in Rico pharmaceutical industry, sugar coating is use, thus:
 Sugar Coating: Sugar coating may be visualized as the traditional method of coating
tablet, It involves successive application of sucrose based solution to tablets. Sugar
coating is divided in the following steps:
 Sealing of the tablet
 Sub coating
 Smoothing
 Colouring
 Polishing

Sealing: Sugar coating is an aqueous process during which the tablet cores are thoroughly
wetted by syrup application. A tablet sealant is therefore applied to protect the tablet cores
during this initial susceptible period from the action of the water e.g. acetate phthalate.

Sub-coating: Sugar coating tablets have a complete smooth profile with no visible edge
remaining from the original tablet core.

Two Method of Sub-Coating:

1. Application of a gum and sucrose solution

2. Dusting with powder and the drying.

 Smoothing: After the correct profile has been attained, the sub-coating tablet will
almost certainly have a rather rough surface. They are made perfectly smooth by
successive application of dilute syrup. The tablets are subjected to drying after each
application.
 Colouring: Nearly all sugar coated tablets are coloured. colours used are those
colours permitted in the national legislative of the countries where the product will
be sold.
 Two Types of Colouring:
I. Water soluble colouring.
II. Water insoluble pigments.
 Polishing: After colour coating, the tablet will require a separate polishing step for
them to achieve an attractive appearance. The step is carried out in a clean pan; the
tablets receive one or two application of wax dissolved in an organic solvent using
bee wax.

COATING MACHINE

 Blistering Machine: In this room tablets are blistered to form sachets in other to be
presentable for packaging. Blistering machine is been powered by electricity and
mechanized by the air compression. Tablets are been poured into the feeder with
 the help of electric motor, then the tablet are placed at the opening of the forming
polyvenical polydon (pvp) and after which a sealing foil will sealed the tablets with
the help of the sealing heater to produce a reasonable sizes.

BLISTERING MACHINE

 Packaging Hall: In this room finished products are package for proper storage,
distribution and marketing in accordance to GMP regulations to avoid
contamination and cross contamination or mix-ups. There are five important
informations that must be found on a packet of a finished product via:
 The name of the product
  Content of the product (in ml or in dose)
 Batch number
 Manufacturing date
 Expiry date

Types of Packaging

 Primary packaging.
 Secondary packaging.
 Tertiary packaging.
 Primary Packaging: This is a type of packaging that prevent direct contact with the
tablet, it also prevent the tablets from aging. Blistering is a very good example of a
primary packaging.
 Secondary Packaging: This type of packaging prevents the drug from the
packaging vessel against sunlight and harsh temperature. Packets are examples of
secondary packaging.
 Tertiary Packaging: This type of packaging house the primary packaging to
prevent external or physical damage. Cottons are good examples of tertiary
packaging.
 Approved Raw Finished Product Store: After series of packaging the drug is taken
to the approved finished product store and labelled green meaning the drugs are
ready and safe for consumption or market. FEFO and FIFO is use in this store for the
dispensing of finished products.
 CHEMICAL ANALYSES AND PHARMACOKINETICS OF SOME TABLET DRUGS.
 Analyses And Pharmacokinetics On BKB Tablet
 Generic Name: Ibuprofen
 Brand Name: BKB
 IUPAC Name: (RS)-2-(4-(2-Methylpropyl)propanoic acid.
 Molecular formular: C13H18O2.
 Metabolism: liver
 Molar mass: 206.29g/mol
  Molecular structure:

 AIM: To quantitatively determine (p- isobutylphenyl) propionic acid in ibuprofen

tablets.
 Materials: UV-Visible spectrometer, analytical balance, spatula, dropper, separating
funnel, 100-ml beaker, 100-ml volumetric flask, 5-ml volumetric flask, measuring
cylinder, 0.1M NaOH solution, phenolphthalein solution.
 Procedures
 Weigh 5 (five) tablets in the weighing balance and take their average
 Crushed the tablets in a mortal and weigh out the average
 Add 0.4 ml of phenolphthalein solution
 Titrate with 0.1m of sodium hydroxide (NAOH) until a red colour is obtained
 Carry out a blank titration

NB: 1ml of 0.1m NAOH is equivalent to 20.63mg of C13H18O2

Calculation

 First tablet = 0.22

 Second tablet = 0.25
 Third tablet = 0.25
 Fourth tablet = 0.20
 Fifth tablet = 0.20
Average weight = 0.22 + 0.25 + 0.25 + 0.20 + 0.20 = 0.224g

Titration:

Initial value = 15.0

Final value = 28.5

End point =13.5

Colour change = colourless to red

Equivalent factor = 20.63 mg

Volumetric factor of 0.1M of NAOH = 0.7107

Label claim = 200mg

Content = End point x Equivalent factor x Volumetric factor

= 13.5 × 20.63 × 0.7107

= 197.93mg

% Content = Content × 100

Label claim

= 197.93 × 100

200

= 98.965%

Specification: (BP = 95 - 105 %)

{USP = 90 - 110%}

Conclusion
The percentage content of (RS)-2-(4-(2-Methylpropyl)propanoic acid in ibuprofen is
98.965% which means it is between the B.P. and U.S.P specification respectively, therefore
the drug is potent and satisfactory.

Pharmacokinetics of Ibuprofen

Ibuprofen is absorbed from the gastrointestinal tract after oral administration, peak serum
concentration is reached after 1-2 hours and up to 99% of the drug is bound to plasma
proteins. The majority of ibuprofen is metabolised and eliminated within 24 hours in the
urine, however 1% of the unchanged drug is removed through biliary excretion. It is
rapidly excreted in the urine mainly as metabolites and their conjugates. About 1% is
excreted in urine as unchanged ibuprofen and about 14% as conjugated ibuprofen. There
appears to be little if any distribution into breast milk. The above figures refer to racemic
ibuprofen. However, ibuprofen’s disposition is stereo selective and there is some metabolic
conversion of the inactive R-(-)-enantiomer to the active S-(+)-enantiomer, dexibuprofen.

Adverse Effects, Administration, Overdose and uses of Ibuprofen

 Effect on breast feeding: No adverse effects have been seen in breast-fed infants
whose mothers were receiving ibuprofen, and the American Academy of paediatrics
considers that it is therefore usually compatible with breast feeding. It also
considers the amount of ibuprofen distributed into breast milk to be too small to be
harmful to a breast-fed infant. A study estimated that a breast-fed infants would
ingest about 0.0008% of the maternal dose. However, licensed product information
for some preparations, including some topical preparations, recommends that
breast feeding should be avoided during ibuprofen treatment.
 Effect on the blood: Blood disorders including agranulocytosis, aplastic anaemia,
pure white-cell aplasia, and thrombocytopenia have been reported in patients
taking ibuprofen. Fatal haemolytic anaemia occurred in man taking ibuprofen.
 Effect on the eyes: Reversible amblyopia has been reported in patients receiving
ibuprofen.
  Effect on the gastrointestinal tract: Ibuprofen may be association with a lower risk
of upper gastrointestinal effects than some other drugs, but nevertheless it can
cause dyspepsia, nausea and vomiting, gastrointestinal bleeding and peptic ulcers
and perforation.
 Effects on the kidney: Reports of adverse renal effects with ibuprofen include an
increase in serum creatinine concentration, acute renal failure, and nephorotic
syndrome. Cystitis, heamaturia and interstitial nephritis may occur. Accute flank
pain and reversible renal dysfunction has been reported in some patients treated
with ibuprofen.
 Effect on the liver: Raised liver transaminase values were noted in 3 patients with
chronic hepatitis C infection after taking ibuprofen. Values returned to normal on
stopping the drug; the effect recurred in one patient who was re-exposed. Other
hepatic adverse effect reported with ibuprofen include hepatitis and liver failure.
 Effect on the skin: Skin rashes may occur during hypersensitivity reactions
although serious dermatological effects attributed to ibuprofen are rare. Reports of
more serious effects have included stevens-johnson syndrome.
Administration of ibuprofen in children
 1 to 3 months: 5mg/kg 3 or 4 times daily
 3 to 6 months: 50mg 3 times daily
 6 to 12 months: 50mg 3 or 4 times daily
 1 to 4 years: 100mg 3 times daily
 4 to 7 years: 150mg 3 times daily
 7 to 10 years: 200mg 3 times daily
 10 to 12 years: 300mg 3 times daily
 12 to 18 years: 200 to 400mg 3 or 4 times daily increased, if necessary, to a
maximum of 2.4g daily.
 In severe conditions in children aged between 3 month and 12 years, a dose
of 30mg/kg daily in 3 or 4 divided doses may be given.

Effects Associated With Overdose Of Ibuprofen

  A syndrome of coma, hyperkalaemia with cardiac arrhythmias
 Metabolic acidosis
 Pyrexia
 Respiratory and renal failure

Uses Of Ibuprofen

 Ibuprofen helps in treating body pain, dental pain, musculoskeletal and joint
disorders such as ankylosing spondylitis and osteoarthritis.
 It is also use to reduce fever
 Ibuprofen is also use as an alternative to indometacin in treatment of patent ductus
arteriosus.
 Ibuprofen is applied topically as a 5% cream, foam, gel, or spray solution; a 10% gel
is also available. It is also used topically as a dressing containing 500
micrograms/cm2 of ibuprofen for the management of ulcers and superficial wounds.
 Assay And Pharmacokinetics On Ricogyl Tablets
 Generic Name: metronidazole
 Brand Name: Ricogyl
 IUPAC Name: 2-(2-methyl-5-nitroimidazol-1-yl)ethanol
 Molecular formular: C6H9N3O3
 Molecular weight: 171.15g/mol
 Molecular structure:
Aim: To quantitatively determine metronidazole in Ricogyl tablets

Materials: weighing balance, mortal, filter papers, volumetric flask, petri dish, funnel,0.1m
Hcl, spectrophotometer.

PROCEDURES

Preparation of a sample soluton

 Weigh 5 Ricogyl tablets and take their average weight

 Crush the tablets in a mortal and measure out the average you got
 Put in a 250ml volumetric flask and add 0.1m HCL and shake vigorously mask to
volume
 Filter it using the funnel and filter paper
 Take 5ml of the filtrate and put in 100ml volumetric and add 0.1m to mask, shake
vigorously.

Preparation of standard solution

 Take the standard sample of pure metronidazole powder and weigh out 0.20g
 Put it in 100ml volumetric flask and add 0.1m HCL to mask and shake vigorously

Determination of absorbance using a spectrophotometer

 Take both your sample and standard solution to the spectrophotometer, put it on
and set the required wavelength
 Blank it using the solvent use (0.1m HCL)
 Put your sample solution in a cuvette either quartz or glass depending on the
wavelength
 Insert your sample pull the spectrophotometer half way and take your absorbance
 Blank again, insert your standard solution and take your reading.

Calculations
  1st tablet 0.34g
 2nd tablet 0.34g
 3rd tablet 0.35g
 4th tablet 0.34g
 5th tablet 0.36g
 Average weight = 0.34+0.34+0.35+0.34+0.36

5 = 0.35g

Therefore 0.35g of the powder will be weighed out to prepare the sample solution.

Determining the absorbance using the spectrophotometer as thus below;

Absorbance of sample solution = 0.269 A

Absorbance of standard solution = 0.264 A

%Content = Absorbance of sample X 100

Absorbance of standard 1

= 0.269 x 100

0.264 = 101.8%

Label claim= 200mg/tablet

Content = 101.8 x 200mg label claim = 203.6mg

100

Specification ( U.S.P = 90-110%) (B.P. = 95-105%)

Conclusion

Therefore the drug is within the U.S.P. Specification and is consider potent and satisfactory
for consumption.
Pharmacokinetics of Metronidazole

Metronidazole is readily and almost completely absorbed after oral doses. Peak plasma
concentrations of about 6 and 12 mg/ml are achieved, usually within 1-2 hours, after single
dose of 250 and 500mg respectively. Absorption may be delayed, but is not reduced overall
by food. Metronidazole benzoate given orally is hydroiysed in the gastrointestinal tract to
released metronidazole, which in turn is then absorbed.

Metronidazole is widely distributed. It is appears in most body tissues and fluids

including bile, bone, breast milk, cerebral abscesses, liver and liver abscesses, saliva,
seminal fluid, and viginal secretions, It also crosses the placenta and enters the fetal
circulation.

Metronidazole is metabolised in the liver by side-chain oxidation and glucuronide

formation, the principal oxidative metabolites are 1-(2-hydroxyethyl)-2-hydroxymethyl-5-
nitroimidazole(the hydroxyl metabolite), which has antibacterial activity and is detected in
plasma and urine, and 2-methyl-5-nitroimidazole-1-acetic acid ( the acid metabolite) which
has no antibacterial activity and is often detected in plasma but is excreted in urine. The
majority of a dose of metronidazole is excreted in the urine as metabolites; a small amount
appears in the feaces.

Adverse Effects, Administration, Overdose and uses of Metronidazole

Adverse effect of metronidazole are generally dose-related, the most common are
gastrointestinal disturbances, especially nausea and and an unpleasant metallic taste.
Vomiting, diarrhoea or constipation may also occur. Weakness, dizziness, headache,
drowsiness, insomnia and changes in mood or mental cases such as depression or
confusion have also been reported.

Temporary moderate leucopenia and thrombocytopenia may occur in some patients

receiving metronidazole. Skin rashes, urethral discomfort and darkening of urine, raised
liver enzyme values, cholestatic hepatitis and jaundice have occasionally been reported.
  Effect on breast feeding: Metronidazole is distributed into breast milk giving it a
bitter taste which may impair feeding. The American Academy of Pediatrics
considers that although the effects of metronidazole on breast-fed infants are
unknown they maybe of concern. It recommends that breast feeding should be
stopped for 12- 24 hours when single dose therapy is used, no specific
recommendations are given for long term treatment.
 Effect on the ears: Mypia which develop in a patient after 11 days of oral
metronidazole for trichomoniasis had resolved 4 days after withdrawal of
treatment, but recurred when she resumed treatment.
Uses of metronidazole
 Metronidazole is used in the treatment of susceptible protozoal infections such as
amoebiasis, balantidiasis, giardiasis and trichomoniasis.
 Metronidazole is also used in the treatment and prophylaxis of anaerobic bacterial
infections such as, bacterial vaginosis, acute necrotising ulcerative gingivitis, pelvic
inflammatory disease.
 Metronidazole is use to eradicate helicobacter pylori in peptic ulcer disease, it is also
use in the treatment of rosacea and of dracunculiasis ( guinea worm infection).
Assay Of Sodamints Tablet
 Generic Name: Sodium Bicarbonate
 Brand Name: Sodamints
 IUPAC Name: Sodium hydrogen carbonate
 Molecular formular: NaHCO3
 Molecular weight: 84.007g/mol
 Molecular structure:

Aim: To quantitatively determine sodium bicarbonate in sodamint tablet

Materials: weighing balance,1M HCL

Procedures.

 Weigh 5 tablets of sodamint and take the average weight

 Dissolve a 100ml of water add methyl red
 Titrate with 1M of HCL
 Each ml of 1M of hydrochloric acid is equivalent to 84.01mg

Calculations

1st tablet = 0.40g

2nd tablet = 0.40g
3rd tablet = 0.39g
4th tablet = 0.35g
5th tablet = 0.38g

Average = 0.4+0.40+0.39+0.35+0.38 =1.92 =0.38g

5 5

Titration
Initial = 16.00
Final = 20.30
Final –initial = 20.30-16.00
=4.30ml
Content = titre value x equivalent weight x factor
= 4.30 x 84.01 x 0.968 = 349.680mg
Percentage % = content x 100
Content of each table
Percentage (%) = 349.68 x 100
300
= 116.56%
 Specification ( 95- 105% B.P.)

Conclusion: Therefore the drug is within the B.P. Specification and is therefore considered
potent and satisfactory for consumption.
 CHAPTER SIX

ORAL LIQUID SECTION

This is a section of drug department where drugs are produce in syrup and suspension.

SYRUP: A syrup is a liquid viscous drug made up of an aqueous concentrated solution

containing sugar, such as sucrose in water combined with other active ingredients and
excipients use for medication.

SUSPENSION: A suspension is heterogeneous mixture in which the solute particles do not

dissolve completely, but get suspended throughout the bulk of the solvent, let floating
around freely in the medium.

Some syrup and suspension drugs produce in rico pharmaceutical industry.

SYRUP APIs

Paracetamol syrup Paracetamol liquid preparations.

Pedilix cough syrup Diphenhydramine trisodium citrate, menthol.
Chest and lungs cough syrup Ammonium chloride,liquid liquoria
extract.
Chloroquine syrup Chloroquine sulphate liquid.
Vitamin C syrup Vitamin C liquid preparation.
Multi vitamin syrup Vitamin B series Vit. A1, Vit. B1, Vit. B2,
Vit. B6, Vit. C, Nicotinamide.

Ricolyn cough syrup Diphenhydramine, Hcl, NH4CL.

B Complex syrup Vitamin combined series; Vit. B1,Vit. B2,
Vit. B6, Nicotinammide.

Promethazine Hcl syrup Promethazine Hcl.

SUSPENSIONS
Ricogyl suspension Metronidazole.
Ricotrin (paediatric suspension) Trimethoprine and Sulphamethaoxazole

Definition Of Relevant Terms

Batch size: Batch size is the quantity of a particular product produce at a particular given
time. i.e. the total quantity of ingredients ( APIs and Expcipients) formulated in the mixing
tank at a particular time.

Production Flow In Oral-Liquid Section

 Cloak Room
 Approved Raw Material Room
 Weighing Room
 Mixing Room
 Filling and Corking Room
 Quarantine Finished Product Room
 Packaging Room
 Approved Finished Product Room
 Approved Raw Material Room: This room is scientifically fit and ventilated
enough for the storage of raw materials used in the production of syrups and
suspensions.
 Weighing Room: In this room, the pharmacist weighs the required quantity of raw
materials for the production of syrup and suspensions according to their
formulation.
 Mixing Room: Mixing room is where various drugs are being mixed together with
their active ingredients, water and other excipients to form syrup or suspension in
 different millilitres of stainless tanks e.g. 500ml, 1000ml, 2000ml etc.

 Filling and Corking Room: Filling and corking room is where syrup / suspension is
being filled into the amber bottle of either 50ml, 60ml, 100ml using manual or
automatic filling machine after which a corking machine is used to cork the bottle
covers tightly to avoid contamination.
 Quarantine Finished Product Room: This is where all the finished products are
kept for thorough analysis, as the quality control personnel passes test on the drugs
both physical and chemical test before packaging.
 Packaging Room: In this room, various drugs are being packaged for effective
market value.
 Approved Finished Product Room/Store: This room is scientifically fit and
ventilated enough for the storage of finished products like syrups and suspensions.
CHEMICAL ANALYSES AND PHARMACOKINETICS OF SOME ORAL LIQUID
DRUGS
Assay and pharmacokinetics of Rico vitamin-C
 structure Generic Name: Ascorbic acid
 Brand Name: Rico vitamin-C
 IUPAC Name: (5R)-{(1S)-1,2- Dihydroxyethyl}-3,4-dihydroxyfuran-2(5H)-one
 Molecular formular: C6H8O6 or HC6H7O6
 Molecular weight: 176.12g/mol
Molecular Structure:
 Ascorbic Acid

AIM: To quantitatively determine the percentage content of ascorbic acid in Rico vitamin-C
syrup.

MATERIALS: Conical flask, distilled water, 0.1M sulphuric acid, ferrion solution, 0.1M
ammonium cerium (IV) sulphate.

Procedure:
 Pour 5ml of the sample into a conical flask
 Add 30ml of water and shake
 Add 20ml of 1mol sulphuric acid and shake
 Add 2 drops of ferroin indicator solution
 Then titrate with 0.1mol of ammonium cerium (IV) sulphate
 Colour Change; Mild red to light green

Result:

Record of the titration done

Initial value = 0.0

Final value = 4.6

Titre value/end point =4.6

Equivalent weight = 8.806

Factor of 1mol of ammonium cerium (IV) sulphate = 0.965

Formula for content = Titre value x Factor x Equivalent value

Content = 4.6 x 0.965 x 8.806

= 39 mg

% Content = 39 × 100

40

= 97.5 %

NB: Each 5ml contains 40 milligram of ascorbic acid.

Specification/range = 90 - 110% (according to USP)

Conclusion: Therefore the drug is within the U.S.P. Specification and is therefore
considered potent and satisfactory for consumption.

PHARMACOKINETICS OF VITAMIN C (ASCORBIC ACID)

Ascorbic acid is readily absorbed from gastrointestinal tract and is widely distributed in
the body tissues. Plasma concentrations of ascorbic acid rise as the dose ingested are
increased until a plateau is reached with doses of about 90 to 150mg daily. Body stores of
ascorbic acid in health are about 1.5g although more may be stored at intakes above 200mg
daily. The concentration is higher in leucocytes and platelets than in erythrocytes and
plasma. In deficiency states the concentration in leucocytes declines later and at a slower
rate, and has been considered to be a better criterion for the evaluation of deficiency than
the concentration in plasma.

Ascorbic acid is reversibly oxidised to dehydro ascorbic acid; some is metabolised to

ascorbate 2 sulfate which is inactive, and oxalic acid which are excreted in the urine.
Ascorbic acid in excess of the body’s needs is also rapidly eliminated unchanged in the
urine,this generally occurs with intakes exceeding 100mg daily. Ascorbic acid crosses the
placenta and is distributed into breast milk. It is removed by haemodialysis.

USES OF VITAMIN C (ASCORBIC ACID)

 It helps to treat scurvy

  It’s used in poor wound healing
 It helps in development of cartilage and bones
 Also used as supplements with other drugs for the treatment of cold, influenza and
stress.

DEFICIENCY

Scurvy is the deficiency of vitamin C

Assay And Pharmacokinetics Of Ricotrin Syrup

 Generic Name: Co-trimoxazole (trimethoprim and sulfamethoxazole)

 Brand Name: Ricotrin
 Molecular formular: C24H29N7O6S
 Molecular structure:

Trimethoprim and sulfamethoxazole

AIM: To quantitatively determine the percentage content of Co-trimoxazole (trimethoprim

and sulfamethoxazole) in Ricotrin syrup.

MATERIALS: Conical flasks, weighing balance, distilled water,Hydrochloric acid, potassium

bromide, 0.1M sodium nitrate solution.

Analysis on the First Active Ingredient (Sulfamethoxazole)

PROCEDURES

 Get 2 (two) conical flask (sample A & sample B)

 Weigh 5ml of the sample and pour into each conical flask.
 Add 50ml of water to each conical flask.
 Add 10ml of HCL (to dissolve solution)
 Add 3g of potassium bromide to each samples, shake and freeze for 5 minutes.
 Titrate with 1ml of 0.1 molar sodium nitrate which is equivalent to 27.83mg.

CACULATIONS

Titration data for sample A

 Initial value = 5
 Final value = 11.4
 Titre value = 6.4

Titration data for sample B

 Initial value = 12
 Final value = 20.5
 Titre value = 8.5

Take the average of the titre value of sample A & B = 6.4 + 8.5 = 7.45

 Titre value = 7.45

 Volumetric factor = 1.063
 Equivalent weight = 27.83
 Label claim = 200

Content = Titre value x volumetric factor x equivalent weight

= 7.45 × 1.063 × 27.83

 = 220.395

% Content = Content × 100

Label claim

= 220.395 × 100

200

= 110.19 %

Specification/range = {Bp = 95 - 105%}

= {Usp = 90 - 110 %}

Analysis for the Second Active Ingredients

PROCEDURE

 Measure 5ml of Ricotrin

 Add 30ml of 0.1 NaOH
 Add 50ml of chloroform to form two layers, extract 4 times by adding 50ml of
chloroform at each extraction.
 Add 5g of anhydrous sodium sulphate to serve as a drying agent.
 Dry with Bunsen burner
 Add 50ml of galatia acid to the sample
 Add 3 drops of napthol benzene indicator
 Titrate with 0.1m perchloric acid

CALCULATION

 Initial value = 9
 Final value = 10.4
 Titre value = 1.4
 Equivalent weight = 29.03
 Volumetric factor = 0.9239
  Label claim = 40

Content = Titre value x equivalent weight x volumetric factor

= 1.4 x 29.03 x 0.9239

= 37.549

% Content = Content x 100

Label claim

= 37.549 x 100

40

= 93.87 %

Specification/range = {USP = 90 – 110 %}

{BP = 95 105 %}

Conclusion: Therefore the drug is within the U.S.P. Specification and is therefore
considered potent and satisfactory for consumption.

PHARMACOKINETICS OF RICOTRIN (CO-TRIMOXAZOLE)

As for sulfamethoxazole and trimethoprim, when co-trimoxazole is given orally,plasma

concentrations of trimethoprim and sulfamethoxazole are generally around the optimal
ratio of 1:20, although they may vary from 1:2 to 1:3 or more. The ratio of the two drugs is
usually much lower in the tissues (often around 1:2 - 1:5) since trimethoprim, the more
lipophilic drug, penetrates many tissues better than sulfamethoxazole and has a much
larger volume of distribution. In urine the ratio may vary from 1:1 to 1:5 depending on the
PH.
USES OF CO-TRIMOXAZOLE

 It is an antibiotics used to treat a variety of bacterial infections

 It is used for urinary tract infections,

Assay and pharmacokinetics of Rico chloroquine syrup

 structure Generic Name: Chloroquine sulphate

 Brand Name: Rico chloroquine syrup
 Molecular formular: C18H26CIN3
 Molecular weight: 319.872g/mol
 Metabolism: liver
 Molecular structure:

Chloroquine sulphate.

AIM: To quantitatively determine the percentage content of chloroquine sulphate in Rico

chloroquine syrup.

MATERIALS: Seperation funnels, 20ml of NaOH, Chloroform solution, distilled water,

beakers, bursen burner, 40ml of glacial acetic acid, crystal violet indicator, 0.1M perchloric
acid.

PROCEDURES

 Measure 5ml of chloroqine syrup in a separating funnel

 Add 20ml of NaOH solution (it will form a double layer, aquaeous layer and non
aquaeous layer)
 Shake carefully to avoid explosion
  Measure 25ml of chloroform for every extraction
 Then extract the chloroquine
 Repeat the extraction process up to 3-5 times to get the pure chloroquine sulphate
 Pour the chloroquine sulphate extracted in a separating funnel
 Add 10ml of water to help remove the remaining colour
 Then shake vigorously
 Pour it in a beaker and heat to form powder
 Add 40ml of glacial acetic acid
 Add 1 drop of crystal violet indicator
 Titrate with 0.1M perchloric acid
Data Of Titration
Initial = 38
Final = 41.0
Titre value = final – initial
41.0 – 38 = 3.0
Content = Titre value x Equivalent weight x factor
Content = 3.0 x 25.79 x 0.9521
= 73.66mg/5ml
% Content = content x 100
Label claim
% Content = 73.66 x 100
80
= 92.07%
U.S.P. Specification = (92.5 – 107.5% )

Conclusion: Therefore the drug is within the U.S.P. Specification and is therefore
considered potent and satisfactory for consumption.

 Pharmacokinetics of chloroquine sulphate

 Chloroquine is rapidly and almost completely absorbed from the gastrointestinal tract
when given orally. Absorption is also rapid after intramuscular or subcutaneous use. It is
widely distributed into body tissues and has a large apparent volume of distribution. It
accumulate in high concentration in some tissues, like the kidney, liver, lungs and spleen
and is strongly bound in melanin containing cells such as those in the eyes and the skin.
Chloroquine is eliminated very slowly from the body and it may persist in tissues for
months and years.

Chloroquine is extensively metabolised in the liver, mainly to monodesethylchloroquine

with smaller amount of bisedesethylchloroquine and other metabolites been formed.
Chloroquine and its metabolites are excreted in the urine, with about half of a dose
appearing as unchanged drug and about 10% as the monodesethyl metabolite. Chloroquine
an its monodesethyl metabolites are both distributed into breast milk.

 Effect on the skin: Pruritus is common in patients given chloroquine for treatment
of malaria and it may become so severe as to compromise treatment. Itching starts a
few hours after use but usually remits spontaneously within 72 hours. The incidence
of pruritus is purported to be higher in black patients. The aetiology of this reaction
is unknown, but this apparent high incidence has prompted suggestions that it may
have a genetic baisis or related to affinity of chloroquine for melanin.
 Effect on the eyes: The main adverse effects of chloroquine on the eyes are
keratopathy and retinopathy.
 Effect on the heart: Studies in patients with malaria and in healthy subjects indicate
that the acute cardiovascular toxicity that may be associated with parenteral use of
chloroquine is related to transiently high plasma concentrations produced during
the early part of distribution phase; this findings appear to confirm that the dosage
rate is a major determinants of this toxicity. Cardiac conduction abnormalities,
includes heart block.

Uses of Chloroquine sulphate

 Chloroquine is used in the treatment and prophylaxis of malaria

  It is also use in the treatment of hepatic amoebiasis.

CHAPTER SEVEN

POWDER SECTION

This is a section of production where drugs are produced in powdered form

 CHAPTER EIGHT
RELEVANCE OF THE PROGRAM
 SIWES provide an avenue for students in Nigerian Universities to acquire industrial skills
and experience in their course of study.
 Prepare students for industrial work situation they are likely to meet after graduation.
 Expose students to work method and technique in handling equipments and machineries
that may not be available in the Universities.
 Make the transition from the university to the world of work easier and thus enhance
students’ contacts for later job placement.It provides students with opportunity to apply
their theoretical knowledge in real work situation thereby bridging the gap between
theory and practice.
 To enlist and strengthen employers involvement in the entire educational process of
preparing University graduates for employment in industries.

PROBLEMS ENCOUNTERED DURING SIWES

 Problems encountered during the SIWES program include the following:
 Restriction to some units and some divisions in the Institute.
 Restriction on the use of certain equipment by some laboratory Scientist and Technicians.
 Lack of financial and infrastructural (accommodation) obligation on the part of the
institute which should have alleviated the hardship face.

SOLUTIONS PROFFERED
 The private sector, cooperate bodies, Industries and establishment should try to alleviate
the financial hardship faced by students by giving certain allowances.
 Funds allocated to students after SIWES should instead be given during the attachment
period to assist the student during the program.
 SIWES National Identification (I.D) card should be provided by ITF so as to grant
students on I.T legal permission to Laboratories or their place(s) of attachment without
any restrictions.
 CHAPTER NINE

GENERAL APPRAISAL OF THE PROGRAM

The Students work experience scheme (SIWES) program gives students the opportunity to be
part of an actual work situation outside the classroom. It is a very good initiative of the Federal
Ministry of education.
SIWES is a skill training program which forms part of the approval for a minimum academic
standard in between theory and practical. It is a program required to be undertaken by
students of tertiary institution in Nigeria.
The students industrial work experience scheme (SIWES) is a planned and supervised
training intervention program which is based on well stated learning objectives which is geared
towards developing occupational competence of participants (students).

WAYS OF IMPROVING THE PROGRAM

 SIWES allowances from ITF should be reviewed upward and be should be given to
Students during the periods of their attachment.
 The private sector, cooperate bodies, Industries and establishment where SIWES students
are attached should alleviate the financial hardship faced by students during the periods
of their attachment by a means of stipend.
 SIWES Identification (I.D) card should be provided by either ITF or the place of I.T, to
enable students on I.T gain access to Laboratories in their place(s) of attachment without
any restriction.
 Supervision of students on SIWES by the ITF should be on a regular basis.
 SIWES allowances from ITF should be reviewed upward and be should be given to
Students during the periods of their attachment.

ADVICE FOR FUTURE PARTICIPANTS

 Intending SIWES Students should do their training in places relevant to their field of
study.
 Students should be willing, punctual, obedient and dedicated to learn in the places
assigned to them irrespective of the supervisor’s presence.
  Students should always ask questions in gray areas before taking any action whether in
the laboratory or in the course of their training.

ADVICE FOR THE SIWES MANAGERS

In view of the importance and contribution of the Students Industrial Work Experience
Scheme (SIWES), the ITF and Universities should ensure that students do their training in places
relevant to their field of study; as this will expose them to practical work relating to their field of
study as they were taught in class. SIWES managers should encourage and liaise with, industries,
institutions and organizations to grant students seeking SIWES placement(s) acc
 CHAPTER TEN

CONCLUSION
The Industrial Training Fund (ITF) and the SIWES is truly a training and experience program
for Students. Indeed, the experience has been worth it. So many theories and principles that were
abstract and difficult to understand in the four corners of the class room were made simpler and
clearer. As a potential chemist this industrial training gave me a lot of experience and confidence
in doing practical work effectively. Also, during the period, several analyses were carried out on
drugs and water, etc. samples which exposed me to the use of sophisticated equipments in
chemical analyses.
RECOMMENDATION
To encourage proper participation of students in the program, they should be placed on
monthly allowance to ease the financial challenges usually experienced during the program.
It is also important that students be visited more regularly rather than at the beginning and end of
the programme to ensure adequate participation.
The relevant authorities should ensure that organizations do not reject students who approach
them for a place during the programme. Also, they should ensure that SIWES stipends be paid as
and when due.

REFERENCE
B.P and U.S.P pharmacopeia (2007)