DEPARTMENT OF TECHNICAL EDUCATION ANDRA PRADESH

Name of the Staff Designation : Y.Venkat Reddy : Sr. Lecturer

Branch
Institute Subject Subject Code Topic Sub topic Duration Teaching Aid

: Packaging Technology
: J.N.G.P.Ramanthapur,Hyd : Drug & Pharmaceutical Packaging : PKG.503 : Introduction to Drug Packaging : Basic concept of Drug & its terminology : 100 minutes : PPT, Animations & Photographs
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Recap

In the last class we have learnt about

The Concept of Drug and its related Terminology

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Objectives:
On the completion of the topic the student will able to understand

The Concept Classification of Pharmaceuticals.

Preparation of Tablets.

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Classification
The pharmaceuticals can be classified under two broad categories viz. 1. Sterile and

2.

Non- sterile

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 The

former

includes

parenteral

preparations

and

ophthalmic preparations

and under the latter comes orals, products for external

use such as ointments, lotions, liniments and

suppositories.

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From the view point of packaging , the drugs could be broadly divided into following categories Solids Tablets, Granules, Capsules Liquid Orals Syrups, Suspensions

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 Skin ointments, cream and lotions

Eye ointments , lotions and creams Parenteral preparations (injections)

Sterile powders, solutions/ suspensions,

Sterilized surgical catguts and sutures

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The pharmaceuticals can also be classified into two broad categories Orals Injectables

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The 'Oral' form of pharmaceuticals comprises of

1. Powders and granules 2. Tablets (coated and uncoated)

3. Soft and hard gelatin capsules and lozenges

4. Syrups / drops / liquids

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The Injectable form of pharmaceuticals comprises of

Powder form injectables
Liquid form injectables

Intravenous (I.V) Fluids

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selection of the new drug's most effective route of administration: oral parenteral (i.e. injection into body cavity) transdermal (i.e., through skin) rectal

vaginal

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Available dosage forms

1. SOLID
i. powder ii. capsules iii. tablets

2. LIQUID
i. solution ii. suspension iii. emulsion
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3. SEMI-SOLID
i. ointments

ii. creams

4. MISCELLANEOUS
i. inhalants

ii. aerosols

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Powders
Powder preparation involves two processes the isolation of coarse, aggregated substances and the reduction of particle size.

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Microencapsulated Powders
Micro encapsulation, the coating of very small solid particles or liquid droplets, is done Sterile Powders for Injection Some pharmaceuticals for injection are supplied as powders because of instability in solution. These are dissolved in water just prior to use.

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Tablets
Tablets are made in a variety of shapes.

Sizes
depends

and

weights
on the

amount of drug in the

dose and the mode of

administration.

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 They are prepared by compression or molding. Compressed Tablet

Compressed tablets are made by compaction of powdered
or granular substances.

Un-coated Immediate Release

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Layered
Tablet Within a Tablet
Two Part Three Layer

Compression Coated Function as Film/Sugar

Coated

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Film Coated

Solvent Based
Aqueous Based Alternative to Sugar Coated

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INGREDIENTS Active Drug Substance

Non-Active Diluents Binders Lubricants Disintegrants Coloring Flavoring Antiadherents

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Pharmaceutical solutions:
One of more solvent to dissolve the drug Preservatives to prevent microbial growth Stabilizers to prevent drug decomposition

Colorants and flavorants to enhance product appeal

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Drug Substance
Fully Characterized Physical Specifications (Including Particle size distribution, density, isomerism

and Morphology)

Chemical

Specifications

(Including

Impurity

and

Degradation Profile)

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DILUENTS:

Diluents or filler to increase the bulk of the formulation.

Lactose Starch

Mannitol
Calcium Sulfate Sorbitol

Dicalcium Phosphate
Kaolin Sodium Chloride Powdered Sugar Microcrystalline Cellulose
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DISINTEGRANTS
Disintegrating agents to promote tablet break up after

administration
Starch Micro-crystaline Cellulose Alginic Acid Gums Crospovidone
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Binders
Binders to cause the adhesion of the powdered drug and inactive ingredients

Starch Paste Glucose Gelatin Solution Acacia

Sucrose
Sodium Alginate
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LUBRICANTS
Antiadherents or lubricants to assist the smooth tableting process Magnesium Stearate Calcium Stearate

Talc
Stearic Acid

Sodium Lauryl Sulfate

Sodium Acetate
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The manufacturing process consists of two basic steps

mixing of ingredients,

and compaction into a tablet.

The most widely used mixing methodwet granulation

the active drug and additives are first blended in large

scale blenders such as twin-shell rotary blenders, stirred

vessels, and fluidized beds.

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GRANULATING

Wet Granulation
Direct Compression Dry Granulation Slugging Roll Compaction

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Wet Granulation
Advantages Improved Compressibility

Improved uniformity
Decreased segregation Flexibility Process complexity Cost

Disadvantages

Possible affect on drug

substance
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Dry Granulation
Useful when ingredients are sensitive to moisture or heat.
Blended ingredients are either compressed into slugs or
roll compacted into sticks or sheets

Slugs or sticks are screened/milled

Granulation is blended with lubricant an disintegrants then

compressed

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Direct Compression

Ingredients are milled and/or screened, then mixed, then

compressed into tablets.

Few Manufacturing steps

Greater potential for segregation

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High speed Rotary Press

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Tablets making by compression

a) Fill

b) Corrected fill

c) Compression
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d) Ejection
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Molded Tablets

Molded tablets are

prepared to achieve rapid

dissolution in water.

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Mixers & Blenders

Pony/Planetary Mixer High Shear Mixer Ribbon Blender Screw Blender Tumble Blenders Twin Shell Double Cone Drums Other

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COATING
Protect drug from the environment Mask taste Improve appearance Separate ingredients Provide multiple release profiles

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COATING Equipment

Standard coating pan

Perforated coating pan Fluidized bed

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Standard Pans

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Tablet bed Pan coater with immersion tube

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Drum coater for Tablets

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Standard Pans

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Perforated Pans

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Fluid Bed

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Fluidized bed coater

Air
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Film Coating Materials

Polymers - Hydroxypropyl methylcellulos Povidone Polyethyleneglycol Enteric Materials - Cellulose acetate phthalate Sugar Coating Materials Sealant - Shellac Sugar - Syrup and color
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Summary
PREFERABLE DOSAGE FORMS:
When the medication is intended for systemic use and oral administration is desired: *tablet *capsules *oral solutions or suspensions

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 When the medications intended for infants and children under 5 years of age: *liquid preparations when immediate therapeutic action is desired:

* injections

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Quiz
1.

Which of the following does not belongs to

solid form medication

a) Powder

b)
c)

capsules
emulsion

d)

tablets
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Quiz
2. When immediate therapeutic action is desired we use
a) Tablet b) capsules c) injections d) creams
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Frequently Asked Questions

1. How the pharmaceutical products are classified on the basis of Dosage forms ? 2. What are the different types of Tablet shapes ?

3.
4.

What are the basic ingredients of a Drug?

How the different types of pharmaceutical products are

manufactured ?
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