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JSS UNIVERSITY

SRI SHIVARATHREESHWARA NAGAR

MYSORE 570 015

REGULATIONS AND SYLLABUS

Revised Regulations - 2012

BACHELOR OF PHARMACY (B.PHARM) COURSE

March- 2012

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0

JSS University

Sri Shivarathreeshwara Nagar Mysore 570 015

Bachelor of Pharmacy (B.Pharm) course

REGULATIONS

These regulations shall be called as ―The Regulations for the B. Pharmacy Degree course of the J.S.S. University, Mysore‖.

They shall come into force from the Academic Year 2012 - 2013.

The regulations framed are subject to modifications from time to time by the authorities of the university

Minimum qualification for admission to the course

1. Candidates who have passed two year P.U.C./P.D.C/H.S.C (10+2) examination or an equivalent examination of any approved Board or university with not less than 40% marks in any

combination comprising Physics, Chemistry and Mathematics (PCM) or Physics, Chemistry and Biology (PCB) or Physics, chemistry, mathematics and Biology (PCMB)

Note: In respect of candidates who have taken P.C.M.B. Combination the aggregate of P.C.M. or P.C.B. whichever is higher shall be considered for the purpose of admission.

2. In case of students belonging to SC/ST/or Category-I, the minimum percentage of marks for admission to B. Pharm Course shall be not less than 35% in P.D.C. any combination comprising Physics, Chemistry and Mathematics (PCM) or Physics. Chemistry and Biology (PCB) or Physics, chemistry, mathematics and Biology (PCMB).

3. Candidates who have passed D.Pharm course with not less than 50% aggregate, from an institution, approved by Pharmacy Council of India shall be eligible to this course and shall be admitted directly to II B. Pharm course.

Duration of the course The course of study for B.Pharm shall extend over a period of four academic years and three academic years for those admitted to second B. Pharm directly. The curricula and syllabi for the course shall be prescribed from time to time.

Medium of Instruction and Examinations Medium of Instruction and Examination shall be English.

Working days in the academic year Each academic year shall consist of not less than 200 working days.

Attendance and Progress A candidate is required to put in at least 80% attendance in theory and practical subjects separately.

The candidate shall complete the prescribed course satisfactorily to be eligible to appear for the respective

examinations.

Course of study The course of study for B.Pharm I, II, III and IV year shall include the respective Theory & Practical subjects as given in Table - I, II, III and IV respectively. The number of hours to be devoted to each

theory and practical subject in an academic year shall not be less than that shown in Table - I, II, III and

IV.

Academic Work A regular record of attendance both in Theory and Practical shall be maintained by the teaching staff of respective subjects.

Internal Assessment Marks:

Theory: Three sessional examinations evenly spread during the academic year shall be conducted by the constituent colleges. The average marks of the best two examinations shall be computed out of a maximum of 30 marks and shall constitute the sessional award in theory. Provided further the colleges may conduct one special theory sessional examination towards the end of the academic session for those who might have missed any one of the regular sessional examination on genuine grounds.

Practical: Students are expected to perform the experiment listed in the respective syllabus. The number of experiments is also listed. Marks shall be awarded out of a maximum of 10 to each of the practical exercise and an average of those shall be computed out of maximum of 10 marks. In addition, three practical examinations evenly spread during each academic year shall be conducted. The average marks

of the best of two practical examinations shall be computed out of a maximum of 20 marks. A total of 30 marks shall constitute the sessional award in practical. While awarding the sessional marks for practical experiments, the following considerations should be taken into account.

1. Preparation of the candidate.

2. Manipulative skills.

3. Results of the experiment.

4. Knowledge of the experiment

5. Viva voce pertaining to the experiments only.

The college shall maintain the sessional books of the students and the record of sessional award of the students. A regular record of both theory and practical class work and sessional examinations conducted in an institution imparting the course shall be maintained for each student in the institution. Marks shall be awarded as per the schemes given in Tables - V, VI, VII and VIII.

Conditions under which candidates are permitted to appear for annual university examination The candidates are required to score a minimum of 50% marks in each of the subjects (Theory and practicals separately) in the sessional examination to be eligible to appear for annual university examination in the respective subject.

University Examinations

1. Every year there shall be an examination to examine the students.

2. Each examination will be held twice every year. The first examination in a year shall be the annual examination and the second examination shall be supplementary examination.

3. The examinations shall be of written and practical (including oral nature) carrying maximum marks for each part of a subject as indicated in Tables - V, VI, VII and VIII.

Question Pattern

Long

Essay 2/3

= 2 x 15

= 30 marks

Short Essay 6/8

= 6 x

5

= 30 marks

Short Answers 5/7

= 5 x

2

= 10 marks

Criteria for pass

-----------------------

Total

70 marks

-----------------------

a) Candidates who have secured a minimum of 50% marks in the Theory (including sessionals) and Practical (including sessionals) separately in any subject or subjects shall be declared to have passed in that subject/s and exempted from appearing in that subject/s at subsequent examination.

b) Theory and Practical of a particular subject are considered as individual subjects for the purpose of pass criteria.

c) Those candidates who fail in one or more subjects shall have to appear only in the subject so failed, in the subsequent examinations.

Conditions under which candidates are permitted to proceed to next higher class:

a) Candidates of I B.Pharm are permitted to carry not more than any two subjects (Two Theory/ Two Practicals/ One theory & one practical of same or different subjects), to II B. Pharm and appear for II B.Pharm examination concurrently along with failed subjects of I B.Pharm. However, these candidates have to pass all the failed subjects of I B.Pharm to become eligible to proceed to III B.Pharm.

b) Similarly, candidates of II B.Pharm who have completely passed all the subjects of I B.Pharm but have failed in II B.Pharm are permitted to carry not more than any two subjects (Two Theory/ Two Practicals/ One theory & one practical of same or different subjects), of II B.Pharm to III B.Pharm and appear for III B.Pharm concurrently along with failed subjects of II B.Pharm. However, these candidates have to pass all the failed subjects of II B.Pharm to become eligible to proceed to IV B.Pharm.

c) Candidates of III B.Pharm who have completely passed all the subjects of II B.Pharm but have failed in III B.Pharm are permitted to carry not more than any two subjects (Two Theory/ Two Practicals/ One theory & one practical of same or different subjects), to III B.Pharm and appear for IV B.Pharm examination concurrently along with failed subjects of III B.Pharm and he/she has satisfactorily completed the project in the IV B. Pharm.

Declaration of class Class shall be awarded at the end of I, II, III and final year of B.Pharm examination as shown below:

1) Distinction 2) First Class 3) Second class

75% and above 60% and above and less than 75% 50% and above and less than 60%

The result of the successful candidate shall be classified at the end of the final year examination on the basis of the aggregate of all subjects, theory and practicals, secured by the candidate in the I to IV year examinations and completes the course in four years, as indicated below.

I Class

: 60% and above

II Class

: 50%-59%

Candidate securing aggregate of 75% or above marks and have passed in all the subjects in a year in first attempt shall be declared to have obtained Distinction.

Project Work All the students must submit a short report on a project study undertaken in any of the following

subjects:-

i. Pharmaceutics

ii. Pharmaceutical Chemistry

iii. Pharmacognosy

iv. Pharmacology

v. Pharmacy Practice

The project shall be carried out under the guidance of a teacher in the College. The project shall be carried out either individually or in groups not exceeding 5 in number. The project report shall be submitted in triplicate (typed copy not exceeding 25 pages). The project will be evaluated by the examiner at the time of the Practical examination ( Final Year) appointed by the University. The projects shall be evaluated by qualitative grading as Excellent / Good / Average. The evaluation of the project report shall not be considered for the purpose of pass/class/rank, but grading shall be included in the Mark Sheet of the Final B. Pharm Course.

Industrial Tour Candidates studying in final year of the course shall visit several Pharmaceutical manufacturing houses as a supplement to their academic training and submit a report to the satisfaction of the Head of the institution where he/she has studied.

Practice School and Industrial training During III B Pharm and IV B Pharm course, every candidate shall be exposed to Pharmaceutical Manufacturing operation / research activities for a period of not less than 300 hrs. As a part of this training, candidates during the III B Pharm course shall be exposed to unit operations in the college/industry by the industrial experts for a period of 150 hrs and the remaining 150 hrs in pharmaceutical manufacturing units/ research laboratories during IV B Pharm.

Award of Ranks Ranks and Medals shall be awarded on the basis of aggregate of all the four university examinations. However, candidates who fail in one or more subjects during the B.Pharm courses shall not be eligible for award of ranks. Moreover, the candidates should have completed the B. Pharm course in minimum prescribed number of years, (four years) for the award of Ranks.

Award of degree Candidates who fulfill the requirements mentioned above will be eligible for award of degree during the ensuing convocation.

Duration for completion of the course of study The duration for the completion of the course shall be fixed as double the actual duration of the course and the students have to pass within the said period, otherwise they have to get fresh Registration.

Revaluation I Retotalling of answer papers There is no provision for revaluation of the answer papers of failed candidates in any examination. However, the failed candidates can apply for retotalling.

Re-admission after break of study Candidate who seeks re-admission to the course after break of study has to get the approval from the university by paying a condonation fee.

No condonation is allowed for the candidate who has more than 2 years of break up period and he/she has to rejoin the course by paying the required fees.

Courses of study for B. Pharm

Table I: First year B. Pharm

Sl No

Subjects

Theory hours / week

Practical hours / week

1.1

Human Anatomy & Physiology

3

3

1.2

Pharmaceutical Chemistry I

3

3

1.3

Physical Pharmaceutics

3

3

1.4

Biochemistry

3

3

1.5

Pharmacognosy

3

3

 

Total number of Working hours

15

15

 

Grand Total

30 hours

 

Table II: Second year B. Pharm

 

Sl No

Subjects

Theory

Practical

hours / week

hours / week

2.1

Pharmaceutics

3

3

2.2

Pharmaceutical Chemistry II

3

3

2.3

Industrial Pharmacognosy

3

3

2.4

Biostatistics & Computer applications

3

3

2.5

Social Pharmacy and Behavioral Science

3

---

2.6

Pharmaceutical Jurisprudence

3

---

 

Total number of Working hours

18

12

 

Grand Total

30 hours

Table III: Third year B. Pharm

Sl No

Subjects

Theory

Practical

hours / week

hours / week

3.1

Medicinal Chemistry -I

3

3

3.2

Pharmacology I

3

3

3.3

Pharmaceutical Engineering

3

3

3.4

Pharmaceutical Biotechnology

3

3

3.5

Pharmaceutical Quality Assurance

3

--

3.6

Biopharmaceutics & Pharmacokinetics

3

--

 

Total number of Working hours

18

12

 

Grand Total

30 hours

Table IV: Fourth year B. Pharm

Sl No

Subjects

Theory

Practical

hours / week

hours / week

4.1

Medicinal Chemistry -II

3

3

4.2

Pharmacology II

3

3

4.3

Formulative and Industrial Pharmacy

3

3

4.4

Instrumental Methods of Analysis

3

3

4.5

Pharmacy Practice

3

--

4.6

Pharmaceutical Marketing and Management

3

--

 

Total number of Working hours

18

12

 

Grand Total

30 hours

Scheme of Study and Examination

Table V: First year B. Pharm course

Sl.

Subject

 

Theory Examination

   

Practical Examination

   

No.

Sessional

 

Annual

 

Sessional

 

Annual

Duration

Marks

Duration

Marks

Total

Duration

Marks

Duration

Marks

Total

(Hrs)

(Hrs)

Marks

(Hrs)

(Hrs)

Marks

1.1

Human Anatomy &

1.5

30

03

70

100

03

30

04

70

100

Physiology

1.2

Pharmaceutical Chemistry -I

1.5

30

03

70

100

03

30

04

70

100

1.3

Physical Pharmaceutics

1.5

30

03

70

100

03

30

04

70

100

1.4

Biochemistry

1.5

30

03

70

100

03

30

04

70

100

1.5

Pharmacognosy

1.5

30

03

70

100

03

30

04

70

100

 

Total

       

500

       

500

 

Grand Total

                 

1000

 

Table VI: Second year B. Pharm course

 

Sl.

Subject

Theory Examination

     

Practical Examination

 

No.

 

Sessional

 

Annual

 

Sessional

 

Annual

 

Duration

 

Marks

 

Duration

 

Marks

 

Total

 

Duration

 

Marks

 

Duration

 

Marks

Total

(Hrs)

 

(Hrs)

 

Marks

(Hrs)

 

(Hrs)

 

Marks

2.1

Pharmaceutics

1.5

 

30

 

03

 

70

 

100

 

03

 

30

 

04

 

70

100

2.2

Pharmaceutical Chemistry

1.5

 

30

 

03

 

70

 

100

 

03

 

30

 

04

 

70

100

II

               

2.3

Industrial Pharmacognosy

1.5

 

30

 

03

 

70

 

100

 

03

 

30

 

04

 

70

100

2.4

Biostatistics & Computer

1.5

 

30

 

03

 

70

 

100

 

03

 

30

 

04

 

70

100

applications

               

2.5

Social Pharmacy and Behavioral Science

1.5

 

30

 

03

 

70

 

100

 

No Practical

 

2.6

Pharmaceutical

1.5

 

30

 

03

 

70

 

100

 

No Practical

 

Jurisprudence

         
 

Total

       

600

       

400

 

Grand Total

               

1000

Table VII: Third year B. Pharm course

Sl.

Subject

Theory Examination

     

Practical Examination

 

No.

 

Sessional

 

Annual

 

Sessional

 

Annual

 

Duration

 

Marks

Duration

 

Marks

Total

 

Duration

 

Marks

 

Duration

 

Marks

Total

(Hrs)

   

(Hrs)

 

Marks

(Hrs)

 

(Hrs)

 

Marks

3.1

Medicinal Chemistry I

1.5

 

30

 

03

 

70

100

 

03

 

30

 

04

 

70

100

3.2

Pharmacology I

1.5

 

30

 

03

 

70

100

 

03

 

30

 

04

 

70

100

3.3

Pharmaceutical Engineering

1.5

 

30

 

03

 

70

100

 

03

 

30

 

04

 

70

100

3.4

Pharmaceutical

1.5

 

30

 

03

 

70

100

 

03

 

30

 

04

 

70

100

Biotechnology

             

3.5

Pharmaceutical Quality Assurance

1.5

 

30

 

03

 

70

100

 

No Practical

 

3.6

Biopharmaceutics & Pharmacokinetics

1.5

 

30

 

03

 

70

100

 

No Practical

 
 

Total

     

600

       

400

 

Grand Total

               

1000

 

Table VIII: Fourth year B. Pharm course

 

Sl.

Subject

 

Theory Examination

   

Practical Examination

   

No.

Sessional

 

Annual

Sessional

 

Annual

Duration

Marks

Duration

Marks

Total

Duration

Marks

Duration

Marks

Total

(Hrs)

(Hrs)

Marks

(Hrs)

(Hrs)

Marks

4.1

Medicinal Chemistry II

1.5

30

03

70

100

03

30

04

70

100

4.2

Pharmacology II

1.5

30

03

70

100

03

30

04

70

100

4.3

Formulative and Industrial Pharmacy

1.5

30

03

70

100

03

30

04

70

100

4.4

Instrumental Methods of Analysis

1.5

30

03

70

100

03

30

04

70

100

4.5

Pharmacy Practice

1.5

30

03

70

100

 

No Practical

   

4.6

Pharmaceutical Marketing and Management

1.5

30

03

70

100

 
 

Total

       

600

       

400

 

Grand Total

                 

1000

COURSE CONTENTS

First year B. Pharm

Sl.

 

Theory hours / week

Practical hours / week

No.

Subjects

1.1

Human Anatomy & Physiology

3

3

1.2

Pharmaceutical Chemistry I

3

3

1.3

Physical Pharmaceutics

3

3

1.4

Biochemistry

3

3

1.5

Pharmacognosy

3

3

 

Total number of Working hours

15

15

 

Grand Total

30 hours

THEORY

1.1 Human Anatomy and Physiology

75 Hrs (3Hrs/Week)

Scope: This subject is designed to impart fundamental knowledge on the structure and functions of the various systems of the human body. It also helps in understanding both homeostatic mechanisms and homeostatic imbalances of various systems of the body. Since a medicament, which is produced by the pharmacist, is used in various disease conditions to correct the abnormal functioning of the body systems, the basic knowledge of this subject is must for a student to understand how drugs act on various systems/organs in correcting the disease state of organs/systems. Thus it becomes a prerequisite subject for the pharmacy course.

Objectives: Upon completion of the course the student shall be able to Understand the gross morphology, structure and functions of various organs of the human body. Understand the various homeostatic mechanisms and their imbalances. Identify the various tissues and organs of different systems of human body. Perform the hematological tests like blood cell counts, haemoglobin estimation, bleeding/clotting time etc and also record blood pressure, ECG, heart rate, pulse and respiratory volume. Appreciate coordinated working pattern of different organs of each system Appreciate the interlinked mechanisms in the maintenance of normal functioning (homeostasis) of human body.

of normal functioning (homeostasis) of human body. Lecture wise programme: Topic Hrs 1. Introduction
of normal functioning (homeostasis) of human body. Lecture wise programme: Topic Hrs 1. Introduction
of normal functioning (homeostasis) of human body. Lecture wise programme: Topic Hrs 1. Introduction
of normal functioning (homeostasis) of human body. Lecture wise programme: Topic Hrs 1. Introduction
of normal functioning (homeostasis) of human body. Lecture wise programme: Topic Hrs 1. Introduction
of normal functioning (homeostasis) of human body. Lecture wise programme: Topic Hrs 1. Introduction

Lecture wise programme:

Topic

Hrs

1. Introduction Definition, scope of anatomy and physiology, description of body and basic terminologies.

1

2. General anatomy and physiology Cell, cell junctions, transport mechanisms, homeostasis, ion channels, cell communication and signaling pathways.

4

3. Tissues Definition, classification of tissues, their location, characteristics and Functions.

4

4. Human skeleton Structure, composition, classification and function of bones. Identification and few salient features of important bones of axial and appendicular skeleton. Classification of joints, types of movements.

2

5. Body fluids and blood Body fluids, composition and functions of blood, haemopoiesis, mechanism of coagulation, bleeding and clotting disorders, blood grouping and its significance, blood transfusion, lymphatic system and reticuloendothelial system. Definitions of Anemia, Hemophilia, leukemia and lymphoma.

7

6. Cardio Vascular system Anatomy and physiology of heart, blood circulation, cardiac output, cardiac cycle, heart rate, blood pressure, electrocardiogram, heart sounds. Definitions of

8

hypertension, hypotension, atherosclerosis, arteriosclerosis, angina, myocardial infarction, congestive heart failure, cardiac arrhythmia.

7. Digestive system Gross anatomy of G.I. Tract and its physiology with special reference to liver, pancreas and stomach, digestion, absorption, movements of intestine. Definitions

7

of peptic ulcer, colorectal cancer, hepatitis.

8. Respiratory system Anatomy of respiratory tract, mechanism of respiration, regulation of respiration lung volumes and capacities, transport of oxygen and carbondioxide, artificial respiration, resuscitation methods. Definitions of hypoxia, asphysia, bronchial asthma. COPD.

6

9. Urinary system Structure and functions of kidney and urinary tract, physiology of urine formation, micturition reflex and acid base balance. Definitions of renal calculi, urinary tract infection, nephrotic syndrome, renal failure, nephritis.

4

10. Reproductive system Structure and function of male and female reproductive system, sex hormones, physiology and menstruation, coitus, fertilization, spermatogenesis, oogenesis, pregnancy and parturition.

7

11. Endocrinology Introduction, chemistry and action of hormones, basic anatomy and physiology of pituitary, thyroid, parathyroid, adrenal and pancreas, local hormones. Definitions of disorders of these glands.

7

12. Nervous system

11

a. Definition and classification nervous system.

b. Neurons and properties of nerve fibers, neuroglia.

c. Synapses, neurotransmitters its receptors and neurohumoral transmission.

d. Meninges, ventricles of the brain and CSF.

e. Anatomy and functions of cerebrum, cerebellum, brain stem (pons, medulla and mid brain), hypothalamus, thalamus, basal ganglia.

f. Spinal cord- structure and reflexes.

g. Cranial nerves- names and their functions.

h. Definitions of stroke, Alzheimer’s disease, brain tumor, epilepsy,

 

Parkinson’s disease, psychosis, anxiety, depression.

i.

Autonomic nervous system-Anatomy and functions of sympathetic and parasympathetic nervous system. Definitions of Raynaud’s phenomenon, autonomic dysreflexia.

13. Sense organs Introduction to special senses. Anatomy and physiology of eye, ear, skin, nose and tongue. Disorders related to sense organs. Definitions of cataract, glaucoma, sight disorder, deafness, Otitis media, vertigo.

5

14. Skeletal muscle Physiology of muscle contraction, definition of myasthenia gravis.

2

1.1 Human Anatomy and Physiology (Practical)

Practical: 3 Hrs/week

Title of the experiment

Experiments

1. Study of compound microscope.

1

2. Microscopic study of different tissues.

1

3. Identification of bones

1

4. Study of nervous, digestive, respiratory, cardiovascular, urinary, reproductive systems and special senses with the help of models, charts and specimens.

7

5. Blood experiments:

8

a. General blood collection techniques

b. Study of appliances used in hematological experiments

c. Determination of total Red Blood Corpuscles (RBC) count

d. Determination of White Blood Corpuscles (WBC) count

e. Determination of platelet count

f. Estimation of hemoglobin

g. Estimation of Differential Leukocyte Count (DLC)

h. Estimation of Erythrocyte Sedimentation Rate (ESR)

i. Determination of Blood groups.

j. Determination of Bleeding and Clotting time

k. Demonstration/Determination of different hematological parameters by using analytical instruments.

6. To record human heart rate, pulse rate and ECG

1

7. To study the effect of posture and exercise on blood pressure

1

8. Recording of human body temperature and Body Mass Index (BMI).

1

9. Determination of tidal volume & vital capacity.

1

10. Study of pregnancy diagnosis test

1

11. Experiments on electrophysiology of nerve and heart using computer assisted models

2

Recommended Books

1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam.

2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson.

3. Physiological basis of Medical Practice-Best and Tailor.

4. Text book of Medical Physiology-Guyton and Hall.

5. Principles of Anatomy and Physiology by Tortora Grabowski.

6. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje

7. Textbook of Human Histology by Inderbir Singh

8. Textbook of Practical Physiology by C.L. Ghai

9. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma.

THEORY

1.2 Pharmaceutical Chemistry -I

75 Hrs (3Hrs/Week)

Scope: This subject consists of two sections. The organic chemistry section deals with classification and nomenclature of organic compounds, structural isomerism, intermediates forming in reactions, important physical properties, reactions and methods of preparation of compounds. The syllabus also emphasizes on mechanisms and orientation of reactions. The analytical chemistry section designed to enable the students to have fundamental knowledge of volumetric analysis and determination of impurities in Pharmaceuticals.

Objectives: Upon completion of the course the student shall be able to write the structure, name, type of isomerism of the organic compound write the reaction, name the reaction and understand orientation of reactions account for reactivity/stability of compounds, identify/confirm the organic compound know the principle of volumetric analysis of drugs.

compound know the principle of volumetric analysis of drugs. Lecture wise programme: Section A: Organic Chemistry
compound know the principle of volumetric analysis of drugs. Lecture wise programme: Section A: Organic Chemistry
compound know the principle of volumetric analysis of drugs. Lecture wise programme: Section A: Organic Chemistry
compound know the principle of volumetric analysis of drugs. Lecture wise programme: Section A: Organic Chemistry
compound know the principle of volumetric analysis of drugs. Lecture wise programme: Section A: Organic Chemistry

Lecture wise programme:

Section A: Organic Chemistry

General methods of preparation, General reactions of compounds marked* to be explained.drugs. Lecture wise programme: Section A: Organic Chemistry To emphasize on definition, types/ classification,

To emphasize on definition, types/ classification, mechanisms, uses/applications, examples, differencesGeneral reactions of compounds marked* to be explained. 45 hrs   Topics Hrs 1 Classification

45 hrs

 

Topics

Hrs

1 Classification /Nomenclature/ Isomerism

10

a. Classification of organic Compounds

b. Common and IUPAC systems of Nomenclature of organic compounds

c. Structural Isomerisms in organic compounds

2 Alkanes*/Alkenes*/ Conjugated dienes*

12

a. SP 3 hybridization in alkanes, Halogenation of alkanes.

b. Stabilities of alkenes, SP 2 hybridization in alkenes,

i.

ii.

E 1 and E 2 reactions kinetics, order of reactivity of alkyl halides, rearrangement of carbocations, Saytzeffs orientation, evidences. E 1 verses E 2 reactions, Factors affecting E 1 and E 2 reactions.

iii.

Ozonolysis, electrophilic addition reactions of- alkenes,

Markownikoff’s orientation, free radical addition reactions of alkenes, Anti Markownikoff’s orientation.

c. Stability of conjugated dienes, Diel-Alder, electrophilic addition, free radical addition reactions of conjugated dienes, allylic rearrangement

 

3 Cyclo alkanes* Stabilities – Baeyer’s strain theory, limitation of Baeyer’s strain theory, Coulson and Moffitt’s modification, Sachse Mohr’s theory (Theory of strainless rings)

3

4

Alkyl halides*

5

a. SN 1 and SN 2 reactions-kinetics, order of reactivity of alkyl halides, stereochemistry and rearrangement of carbocations.SN 1 versus SN 2 reactions, Factors affecting SN 1 and SN 2 reactions

b. Nucleophilic substitution versus elimination reactions

5 Alcohols*

3

6 Carbonyl compounds* (Aldehydes and ketones) Electromeric effect, aldol condensation, crossed aldol condensation, cannizaro reaction, crossed cannizaro reaction, benzoin condensation, perkin condensation, Knoevenagel reaction, reformatsky reaction.

6

7 a) Carboxylic acids* Acidity of carboxylic acids, effect of substituents on acidity, inductive effect b) Carboxylic acid derivatives*

6

Section B: Analytical Chemistry

30 Hrs

8 Errors:

2

Sources of errors, types of errors, methods of minimisizing errors, accuracy, precision and significant figures.

9 Impurities:

6

Source and effect of impurities in pharmacopoeial substances, importance of limit test, general principle and procedures for limit test, limit test for chloride, sulphate, Iron, Arsenic, Lead and heavy metals.

10 Fundamentals of volumetric analysis:

4

Theories of Acid-Base indicators and methods of expressing concentrations. Primary and secondary standard. Preparation and standardization of various molar/normal solutions like oxalic acid, sodium hydroxide, hydrochloric acid, sodium thiosulphate, sulpuric acid, potassium permanganate, iodine and ceric ammonium sulphate solution.

11 Acid base titration:

2

Classification, estimation of strong, weak, very weak Acids and Bases

12 Non-aqueous titration:

3

Introduction, solvents, classification with examples

13 Principles of redox titrations:

4

Concept of oxidation and reduction. Redox reactions, strength and equivalent weights of oxidizing and reducing agents, theory of redox titrations, cerimetry, Iodimetry, Iodometry, bromometry.

14 Complexometric titrations:

3

Classification with examples, Metal ion indicator, mechanism.

15 Principles of precipitation titrations:

3

Different methods- Mohr's, Modified Mohr's, Volhard's, Modified Volhard's, Fajans methods with example.

16 Gravimetry: Introduction and steps involved in gravimetric methods of analysis 3

1.2 Pharmaceutical Chemistry -I (Practical)

Practical: 3 Hrs/week

Title of the experiment

Experiments

1 Systematic qualitative analysis of unknown organic compound/s for preliminary tests

1

2 Systematic qualitative analysis of unknown organic compound/s for preliminary and Lassaigns tests.

2

3 Systematic qualitative analysis of unknown organic compound/s for functional group (for preliminary / Lassaigns / solubility / functional group tests ) Following classes of compounds may be analysed Phenols, amide/ urea, carbohydrate, amine, carboxylic acid, aldehyde, ketone, alcohol, carboxylic acid ester, hydrocarbon, halohydrocarbon, nitrocompound, anilide

7

4 Determination of melting and boiling points of organic compounds 1

5 Systematic qualitative analysis of unknown organic compound for functional group and identification of the organic compound

6 Preparation of suitable solid derivatives from organic compounds 1

1

7 Systematic qualitative analysis of unknown organic compound for Functional group, its identification and confirmation of identification

1

8 Introduction to the use of molecular models Students to prepare the ball and stick molecular models using lugs , tubes, plastic sticks, balls etc individually and to explain the formation of bonds , bond angles, hybridization (example- Methane, Ethane, Ethene, Acetylene, Benzene etc )

1

9 Limit tests:

5

Chloride, Sulfate, Iron, Heavy metals and Arsenic

10 Assay of the following compounds:

7

a. Ammonium chloride-acid base titration (Formal titration)

b. Ferrous sulphate- Redox titration- Cerimetry

c. Copper sulphate- Redox titration - Iodometry

d. Calcium gluconate-complexometry

e. Hydrogen peroxide- Redox titration -Permanganometry.

f. Sodium benzoate-nonaqueous titration

g. Sodium chloride-Modified Volhard's method

Recommended Books

1. Organic Chemistry by Morrison and Boyd

2. Organic Chemistry by I.L. Finar , Volume-I

3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.

4. Organic Chemistry by P.L.Soni

5. A.H.Beckett & J.B. Stenlake's -Practical Pharmaceutical Chemistry Vol I & II, Stahlone Press of University of London, 4th edition.

6. Text Book of Quantitative Inorganic analysis by Vogel

7. Bentely and Driver's Textbook of Pharmaceutical chemistry

8. Analytical chemistry principles by John H. Kennedy.

9. I.P.1985 ,1996, 2008 Govt. of India, Ministry of Health

10. Practical Organic Chemistry by Mann and Saunders.

11. Vogel’s text book of Practical Organic Chemistry

12. Advanced Practical organic chemistry by N.K.Vishnoi.

13. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.

THEORY

1.3 Physical Pharmaceutics

75 Hrs (3Hrs/Week)

Scope: The course deals with the various physical, physicochemical properties and principle involved in formulations of dosage forms. Theory and practical components of the subject help the student to get a better insight in to various areas of formulation research and development and stabilit y studies of pharmaceuticals.

Objectives: Upon the completion of the course student shall be able to Understand various physicochemical properties of drug molecules in the designing the dosage form Know the principles of chemical kinetics & to use them in assigning expiry date for formulation Demonstrate use of physicochemical properties in evaluation of dosage forms. Appreciate physicochemical properties of drug molecules in formulation research and development

of drug molecules in formulation research and development Lecture wise programme:   Topic Hrs 1 .
of drug molecules in formulation research and development Lecture wise programme:   Topic Hrs 1 .
of drug molecules in formulation research and development Lecture wise programme:   Topic Hrs 1 .
of drug molecules in formulation research and development Lecture wise programme:   Topic Hrs 1 .

Lecture wise programme:

 

Topic

Hrs

1. Physicochemical properties of drug molecules: Refractive index, optical rotation, dielectric constant, dipole moment, dissociation constant, determinations and applications

6

2. Solubility of drugs Solubility expressions, mechanisms of solute solvent interactions, ideal solubility & Scatchard-Hildebrand equation, solubility parameters, solvation & association, quantitative approach to the factors influencing solubility of drugs, Dissolution & drug release, diffusion principles in biological systems. Solubility of gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions) Raoult’s law, real solutions, azeotropic mixtures, fractional distillation. Partially miscible liquids, Critical solution temperature, and applications

10

3 pH, buffers and Isotonic solutions: Sorensen’s pH scale, pH

6

 

determination(electrometric and calorimetric), applications of buffers, buffer equation, buffer capacity, buffers in pharmaceutical and biological systems, buffered isotonic solutions

3.

Surface and interfacial phenomenon Liquid interface, surface & interfacial tensions, surface free energy, measurement of surface & interfacial tensions, spreading coefficient, adsorption at liquid interfaces, surface active agents, HLB classification, solubilisation, detergency adsorption at solid interface.

6

4. Micromeretics Particle size and distribution, average particle size, number and weight distribution, particle number, methods for determining particle size, optical microscopy, sieving, sedimentation measurement, particle shape, specific surface, methods for determining surface area, permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities, bulkiness & flow properties.

7

5. Rheology Newtonian systems, law of flow, kinematic viscosity, effect of temperature on viscosity, Non-Newtonian systems- plastic, pseudoplastic and dilatants systems. Thixotropy, thixotropy in formulation, determination of viscosity, capillary, falling ball, rotational viscometers.

6

6. Drug stability Reaction kinetics: zero, pseudo-zero, first & second order, units of basic rate constants, determination of reaction order. Physical and chemical factors influencing the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength, dielectric constant, specific & general acid base catalysis, light. Simple numerical problems. Stabilization of medicinal agents against common reactions like hydrolysis & oxidation. Accelerated stability testing in dating of pharmaceutical dosage forms.

10

7. Colloidal dispersions Classification of dispersed systems & their general characteristics, size & shapes of colloidal particles, classification of colloids & comparative account of their general properties. Optical, kinetic & electrical properties. Effect of electrolytes on colloids, coacervation, peptization & protective action.

8

8. Coarse dispersion Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of suspensions, emulsions and theories of emulsification. Physical stability of emulsions, preservation of emulsions, rheological properties of emulsions, phase equilibria and emulsion formulation, special emulsion systems, semisolids and gels.

10

9. Complexation and protein binding Metal complexes, organic molecular complexes, inclusion compounds, methods of analysis, protein binding, complexation and drug action, crystalline structures of complexes and thermodynamic treatment of stability constants.

6

1.3 Physical Pharmaceutics (Practical)

Practical: 3 Hrs/week

Title of the Experiments

Experiments

1. Determination of dissociation and P ka values. 1

2. Determination of % composition of sodium chloride in the given unknown solution by CST

1

3. Determination of partition coefficient of iodine distributed between carbon tetrachloride and water

1

4. Determination of partition coefficient of benzoic acid distributed between benzene and water

1

5. To determine the solubility of drug at room temperature and express the solubility in different concentration expressions

1

6. Determination of surface of given liquids by drop count and drop weight method

1

7. Determination of surface of given liquids by capillary rise method 1

8. Determination of HLB value of ester surfactant by saponification method

9. Determination of critical micellar concentration of surfactants 1

1

10. Determination of Freundlich and Langmuir’s constants for adsorption of acetic acid on charcoal.

1

11. Determination of particle size, particle size distribution using microscopic method.

1

12. Determination of particle size, particle size distribution using sieving method

1

13. Determination of derived properties of powders like bulk density, true density and porosity, compressibility of powders.

1

14. To determine the angle of repose and flow rate of granules. 1

15. Determination of viscosity of liquid using ostwalds viscometer 1

16. Determination of viscosity of liquid using falling sphere viscometer 1

17. Determination of half life, rate constant

1

18. Determination of half life, rate constant in second order reaction(a=b) 1

19. To study the influence of temperature on the rate of reaction. 1

20. To Study of different types of colloids and their properties. 1

21. Preparation of various types of suspensions and determination of their sedimentation parameters.

22. Preparation and stability studies of emulsions. 1

1

in first order reaction.

23. To determine the stability constant and donor acceptor ratio by solubility method.

1

24. To determine the stability constant and donor acceptor ratio by distribution method.

1

25. To determine the stability constant and donor acceptor ratio by pH titration method.

1

Recommended Books

1.

Physical pharmacy by Alfred Martin

2.

Experimental pharmaceutics by Eugene, Parott.

3.

Tutorial pharmacy by Cooper and Gunn.

4.

Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.

5.

Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3, Marcel Dekkar Inc.

6.

Liberman H.A, Lachman C, Pharmaceutical dosage forms disperse systems, volume 1, 2, 3. Marcel Dekkar Inc.

7.

Laboratory manual of physical pharmaceutics, C.V.S.Subramanyam, J. Thimma setty

THEORY

1.4 Biochemistry

75 Hrs (3Hrs/Week)

Scope: Biochemistry deals with complete understanding of the molecular levels of the chemical process associated with living cells. The scope of the present course is providing biochemical facts and the principles to understand metabolism of nutrient molecules in physiological and pathological conditions, which can help to understand the mechanism of drug action and fundamental changes occur in diseases.

Objectives:

Upon completion of course student shell able to Understand the catalytic role of enzymes, importance of enzyme inhibitors in design of new drugs, therapeutic and diagnostic applications of enzymes. Understand the metabolism of nutrient molecules in physiological and pathological conditions. Understand the genetic organization of mammalian genome, functions of DNA and RNA in protein synthesis. Understand the principles of organ functions tests and their clinical significances

of organ functions tests and their clinical significances Lecture wise programme: Topics 1 Introduction to
of organ functions tests and their clinical significances Lecture wise programme: Topics 1 Introduction to
of organ functions tests and their clinical significances Lecture wise programme: Topics 1 Introduction to
of organ functions tests and their clinical significances Lecture wise programme: Topics 1 Introduction to

Lecture wise programme:

Topics

1 Introduction to biochemistry:

a. Cell organelles and its biochemical functions

b. Transport process across the cell membranes

2 Bioenergetics:

a. Concept of free energy: determination of free energy from equilibrium constant; Redox potential.

b. Energy rich compounds; Definition, classification and Production and biological significance of ATP and cyclic AMP

3 Enzymes

Hrs

03

04

13

a. Definition; Nomenclature; IUB classification

b. Properties of enzymes

c. Factor affecting enzyme activity

d. Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)

e. Enzyme inhibitors with examples

f. Mechanism of enzyme action and theories of enzyme action

g. Allosteric enzymes, Enzyme induction and repression

h. Isoenzymes and their diagnostic applications

i. Therapeutic and diagnostic applications of enzymes

j. Coenzymes Structure and biochemical role

4

Biological oxidation

04

a. Enzymes and co-enzymes involved in Biological oxidation.

b. Electron transport chain (its mechanism and role).

c. Oxidative phosphorylation (its mechanism) and substrate level phosphorylation

d. Inhibitors ETC and Uncouplers or inhibition of oxidative phosphorylation

5 Carbohydrate metabolism

12

a. Definition, classification, chemistry and biological role of carbohydrates

b. Glycolysis energetics and significance

c. Citric acid cycle- energetics, amphibolic nature, anaplerosis and significance

d. HMP shunt and its significance

e. Glycogen metabolism ( Glycogenolysis and glycogenesis) and its regulation

f. Gluconeogenesis and its significance

g. Various shuttle systems and its significance: glycerol phosphate & malate - aspertate

h. Uronic acid pathway and its significance

i. Hormonal regulation of carbohydrate metabolism

j.

Disorders of Carbohydrate metabolism: Diabetes mellitus, glycogen storage diseases

6 Lipid metabolism

10

a. Definition, classification, chemistry and biological role of lipids

b. β-Oxidation of saturated (Palmitic acid) and unsaturated fatty acids(linolinic acid)

c. Ketone bodies metabolism (Ketogenesis and ketolysis) ketosis and ketoacidosis

d. De novo Biosynthesis of fatty acids (Palmitic acid)

e. Metabolism of cholesterol (Biosynthesis and degradation)

f. Biosynthesis and significance of Phospholipids

g. Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis and fatty liver

7 Amino acid metabolism

11

a. Definition, classification and biological role of amino acids

b. General reactions of amino acid metabolism: Transamination, deamination & decarboxylation.

c. Urea cycle and its metabolic disorders

d. Metabolism of sulfur containing amino acids their metabolic disorders

e. Catabolism of tyrosine, tryptophan, phenylalanine and their metabolic disorders

f. Synthesis and significance of biological substances; creatine, histamine, 5-hydroxy Tryptophan (5-HT), dopamine, noradrenaline, adrenaline

g. Metabolism of Heme and its disorders Porphyriaas, hyperbilirubinemia and jaundice

8 Nucleic acid metabolism

04

a. Definition, chemistry and biological role of nucleosides, nucleotides

b. Biosynthesis of purine and pyrimidine nucleotides

a. Catabolism of purine and pyrimidine nucleotides

b. Disorders of nucleotide metabolism: Gout disease

9

Replication and Protein synthesis

08

a.

Organization of mammalian genome

b.

Structure of DNA and significance as genetic material

e.

RNA, structure, types and significance in protein synthesis

f.

DNA replication, types and details on semi conservative model

g.

Mutation and consequences of mutation

h.

DNA Damage and repair mechanism

i.

Transcription or RNA synthesis

j.

Genetic code

k.

Translation or Protein synthesis and its regulation and inhibition

10 Clinical biochemistry

05

a. Role of the kidney: routine performed Laboratory tests (serum creatinine, creatinine clearance, serum urea and serum uric acid )

b. Liver functions: Metabolic, synthetic, excretion & detoxification. Tests to evaluate the liver functions

c. Composition and significance of lipoproteins; Lipid profile tests

1.4 Biochemistry (Practical)

Practical: 3 Hrs/Week

Title of Experiment

Experiments

I

Qualitative tests for biomolecules

6

1. Qualitative analysis of carbohydrates

2. Qualitative analysis of Proteins

II

Liver functions tests

4

1. Determination of Serum Glutamate Oxoloacetate Transaminase

2. Determination of Serum Glutamate Pyrvuate Transaminase

3. Determination of blood and urine sugar to asses metabolic function

4. Determination of serum calcium

II

Kidney functions tests

6

1. Qualitative analysis of urine for normal constituents

2. Qualitative analysis of urine for abnormal constituents

3. Determination of serum total proteins

4. Determination of blood creatine

5. Determination of urine creatinine

6. Determination of blood urea

IV

Lipid profile tests

2

1. Determination of serum cholesterol

2. Determination of serum triglycerides

V

Determination of enzyme activity and study the factors effect of enzyme activity

4

1. Determination of Salivary amylase activity

2. Study the effect of pH on salivary amylase activity.

3. Study the effect of Temperature on Salivary amylase activity.

4. Study the effect of substrate concentration on salivary amylase

activity.

VI

Demo experiment on determination of biochemical parameter in blood using auto analyzer

1

Recommended Books

1. Principles of Biochemistry by Lehninger.

2. Harper’s Biochemistry by Robert K. Murry, Daryl K. Granner and Victor W. Rodwell.

3. Biochemistry by Stryer.

4. Biochemistry by D. Satyanarayan and U.Chakrapani

5. Textbook of Biochemistry by Rama Rao.

6. Textbook of Biochemistry by Deb.

7. Outlines of Biochemistry by Conn and Stumpf

8. Practical Biochemistry by R.C. Gupta and S. Bhargavan.

9. Introduction of Practical Biochemistry by David T. Plummer. (3rd Edition)

10. Practical Biochemistry for Medical students by Rajagopal and Ramakrishna.

11. Practical Biochemistry by Harold Varley.

12. Laboratory manual of Biochemistry by Pattabiraman and Sitaram Acharya

THEORY

1.5 Pharmacognosy

75 Hrs (3Hrs/Week)

Scope: To learn and understand the cultivation and production of crude drugs and their usefulness.

Objectives: Upon completion of the course, the student shall be able to

Know the advances in the cultivation and production of drugsUpon completion of the course, the student shall be able to Know the evaluation techniques for

Know the evaluation techniques for the herbal drugs.Know the advances in the cultivation and production of drugs Lecture wise programme:   Topic Hrs

Lecture wise programme:

 

Topic

Hrs

1. Definition,

History,

present

status,

future

scope

&

Development

of

2

Pharmacognosy

 

2. Classification of crude drugs: Alphabetical, Morphological, chemical, taxonomical, pharmacological and chemotaxonomy

5

3. Cultivation, collection, processing & storage of crude drugs

 

10

• General principle of cultivation & collection of crude drugs

 

• Advantages & disadvantages of cultivation.

 

• Factors influencing cultivation of medicinal plants

 

• Soil & soil fertility

 

• Plant hormones & their applications.

 

• Processing, storage & preservation of crude drugs.

 

4. Quality Control of Crude Drugs: Different method of Adulteration of crude drugs and their evaluation. Using various methods like Organoleptic, Microscopic, Physical, Chemical, Biological and Quantitative microscopy

4

5. Conservation of medicinal plants

 

2

6. Detailed study of the following crude drugs with specific emphasis on source, cultivation, collection, preparation, storage, diagnostic characters applicable, constituents, chemical tests, substitutes, adulterants and uses.

35

a. Carbohydrates: Agar, Gum Acacia, Gum tragacanth, Honey, Isapghol, Bael

b. Tannins: Black Catechu, Myrobalan, Pale catechu and Arjuna.

c. Lipids: Castor oil, Wool fat, Bees wax, Cod liver oil, Olive oil, Sesame oil and Chaulmoogra oil

d. Proteins: Gelatin and spirulina

e. Volatile oils: Mentha, Coriander, Cinnamon, Clove, Fennel,Cardamom, Lemon grass oil, Sandal wood, Lehsun

f. Saponins: Dioscorea, Gokhru, Liquorice, Ginseng, Centella

g. Cardio active sterols: Digitalis, Squill, Stropanthus

h. Anthraquinones: Aloes, Senna, and Rhubarb,

i. Alkaloids: Areca, Lobelia, Belladonna, Berberis, Datura, Opium, Ergot, Rauwolfia, Adathoda, Pilocarpus,Kurchi, Punarnava, Sankupusphi, Ephedra.

j. Resins: Guggul, Garcinia,Balsam of Tolu, Benzoin, Balsum of Peru, Asafoetida, Turmeric and Ginger, Shellac

7. Tumor inhibitors: Taxol, Vinca and Podophyllum

5

8. Anti hepatotoxic and oral hypoglycemic agents: Phyllanthus, Gymnema

4

9. Plant fibers used as surgical dressings: Cotton, Jute, Flax, silk, wool and rayon. Sutures surgical catguts and ligatures.

5

10. Pharmaceutical aids: Talc, Bentonite, Kaolin, Kieselguhr

3

1.5 Pharmacognosy (Practical)

Practical: 3Hrs/Week

Title of Experiments

Experiments

1 Microscopical and powder microscopical characters of the following drugs:

12

Cinchona, Cinnamon, Senna, Digitalis, Rauwolfia, Liquorice, Ipecac,Clove, Ephedra, Kurchi, Fennel and Coriander

2 Study of Morphology of drugs:

5

Strophanthus, Squill, Rhubarb, Cascara, Liquorice, Senna, Cinchona, Ipecac, Rauwolfia, Nuxvomica, Vinca, Aconite, Kurchi, Ephedra, Fennel, clove

3 Analysis of crude drugs by chemical tests:

5

i) Asafoetida (ii) Benzoin (iii) Acacia (iv)Agar (v) Gelatin (vi) Aloes vii) Honey vii)Shark liver oil viii) Castor oil

4 Distillation of volatile oils

1

5 Determination of foaming index

1

6 Determination of moisture content of crude drugs

1

Recommended Books

1. Pharmacognosy: V.E.Tyler. Lynn. R. Brady, James E. Robgers.

2. Text book of Pharmacognosy by T.E.Wallis.

3. Study of crude drugs by Iyenger.

4. Powder crude drugs by Iyenger

5. Chemistry of organic natural products vol. I and II by O.P. Agarwal.

6. Practical pharmaceutical chemistry by Backett and Stanlake

7. Indian herbal pharmacopoeia and British herbal pharmacopoeia

8. Anatomy of crude drugs by M.A. Iyengar

9. Text book of Pharmacognosy Ed.3-C.K. Kokate.

10. Pharmacognosy Pharmacobiotechnology- James Bobbers, Marilyn K, Speedice & V E.Tylor.

Second year B. Pharm

Sl.

 

Theory hours / week

Practical hours / week

No.

Subjects

2.1

Pharmaceutics

3

3

2.2

Pharmaceutical Chemistry II

3

3

2.3

Industrial Pharmacognosy

3

3

2.4

Biostatistics & Computer applications

3

3

2.5

Social and Behavioral Science

3

--

2.6

Pharmaceutical Jurisprudence

3

--

 

Total number of Working hours

18

12

 

Grand Total

30 hours

THEORY

2.1 Pharmaceutics

75 Hrs (3Hrs/Week)

Scope: This course is designed to impart a fundamental knowledge on the art and science of formulating different dosage forms. It prepares the students for most basics of the applied field of pharmacy.

Objectives: Upon the completion of the course the student should be able to:

Know the formulation aspects of different dosage formsthe completion of the course the student should be able to: Do different pharmaceutical calculation involved

Do different pharmaceutical calculation involved in formulationto: Know the formulation aspects of different dosage forms Formulate different types of dosage forms Appreciate

Formulate different types of dosage formsdifferent pharmaceutical calculation involved in formulation Appreciate the importance of good formulation for

Appreciate the importance of good formulation for effectivenessin formulation Formulate different types of dosage forms Lecture wise programme: Topic Hrs 1 Historical back

Lecture wise programme:

Topic

Hrs

1 Historical back ground and development of profession of pharmacy History of profession of Pharmacy in India in relation to pharmacy education, industry and organization, Pharmacy as a career, Pharmacopoeias: Introduction to IP, BP, USP and extra pharmacopoeia. Salient features of Indian Pharmacopoeia.

05

2 Dosage forms Introduction to dosage forms, classification and definitions Prescription: Definition, significance, parts and handling of Prescription. Posology: Definition, Factors affecting dose selection. Calculation of doses for infants & children based on age, body weight and body surface area.

05

3 Pharmaceutical Calculations: Weights and measures Imperial & Metric system, Calculations involving percentage solutions, alligation, proof spirit and isotonic solutions.

06

4 Powders and Granules: Definition, classification, advantages and disadvantages,

04

Particle size analysis, Flow characteristics, quality control tests, simple & compound powders official preparations, insufflations, dusting powders, eutectic mixtures, effervescent powders and effervescent granules. Granules: definition, methods of granulation (wet, dry, spray drying, RMG, roller compaction, high shear mixer granulators), granulation process validation, scaleup

04

considerations (dissolution testing requirement; size, equipment and process change; reporting requirements), regulatory issues in granulation processes, Pellets: Definition; rationale for pelletization; manufacturing considerations- equipments and methods used (coating pan, FBP, extrusion spheronisation); formulation variables.

04

5 Liquid Dosage forms: Classification, Advantages & Disadvantages. General formulation aspects including adjuvants like Vehicles, Organoleptic additives & Stabilizers.

02

Monophasic Dosage forms:

03

 

Study of Monophasic liquids - Definition, formulation and official examples of gargles, mouthwashes, Throat paint, Eardrops, Nasal drops, Liniments and lotions, Enemas, collodions, Syrups, Elixirs and solutions. Biphasic dosage forms:

06

Suspensions: Definition; advantages and disadvantages; classification; Diffusible and indiffusible suspensions; Formulation & official examples; Flocculated and Deflocculated suspension; Surfactants employed (anionic, non-ionic, cat ionic and additional surfactants); nano suspensions; reconstitutional suspensions; parenteral suspensions; aerosol suspensions; rheology of suspensions and emulsions. Emulsions: Definition, classification, test for the identification of type of emulsion, emulsifying agents, Methods of preparation & stability problems cracking, creaming and phase inversion; self emulsifying drug delivery systems; emulsions for ocular delivery of drugs, multiple emulsions.

06

6

Semisolid dosage form: Definition, types, mechanism and factors affecting drug penetration, General formulation of ointments, creams, pastes and gels, their evaluation and packing, ophthalmic ointments and gels; in situ gels

05

7

Suppositories: Definition, types, advantages and disadvantages, types of bases, method of preparation, Displacement value & its calculations, packaging and evaluation.

05

8

Extraction: Definition, study of different extraction processes - Expression, Infusion, Decoction, Maceration, Percolation & Soxhelation. Examples of tinctures and extracts.

06

9.

Surgical aids Surgical dressings, sutures, ligatures and preparation of surgical catgut.

04

10

Incompatibilities: Definition, Physical, Chemical and Therapeutic incompatibilities, reasons and correction of incompatibilities.

04

11.

Introduction to novel dosage forms and drug delivery technologies Ocular drug delivery, transdermal drug delivery, nasopulmonary drug delivery, colon specific drug delivery, bioadhesive and mucoadhesive systems, gastroretentive systems, microspheres, microparticles, iontophoresis, osmotic pumps, oral inhalations, IUD’s, ophthalmic inserts, liposomes, implants, autoinjection systems

06

2.1 Pharmaceutics (Practical)

Practical: 3Hrs/week

Title of the Experiments

No of classes

1. Syrups

2

a) Simple syrup

b) Chlorpheniramine maleate syrup

2. Elixirs

2

a) Piperazine citrate elixir

b) Paracetamol paediatric elixir

3. Solutions

2

a) Strong solution of ammonium acetate

b) Cresol with soap solution

4. Suspensions

2

a) Calamine lotion

b) Magnesium hydroxide mixture

5. Emulsions

2

a) Castor oil emulsion

b) Liquid paraffin emulsion

6. Powders and Granules

5

a) Eutectic powder

b) Effervescent granules

c) Granule preparation-Wet granulation

d) Granule preparation-dry granulation

e) Pellets preparation-extruder spherinizer/ FBP

7. Suppositories

1

a)

Boric acid suppository

8. Semisolids

5

a) Sulphur ointment

b) Cold cream

c) Vanishing cream

d) Bentonite Gel

e) In situ gel preparation

9. Gargles and Mouth Washes

2

a) Potassium chlorate gargle

b) Any antiseptic mouth washes

10. Tinctures

2

a) Orange tincture

b) Compound Benzoin tincture

Recommended Books

1. H.C. Ansel et al, Pharmaceutical Dosage form and Drug delivery system, Lippincott Williams and Walkins, New Delhi, 7th Edition, 2000.

2. Carter S.J., Cooper and Gunn’s-Dispensing for Pharmaceutical students, CBS publishers, New Delhi 12th Edition. 2000.

3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone, Edinburgh, 2nd Edition, 2002.

4. Indian pharmacopoeia and British pharmacopoeia.

5. Theory and practice of Industrial pharmacy by Lachmann.

6. Alfonso R. Gennaro Remington: The science and practice of pharmacy, Vol I and Vol II, Lipponcott Williams, 20th edition, 2000.

7. Carter S.J., Cooper and Gunn’s-Tutorial pharmacy, CBS Publications, New Delhi, 6th edition,

2000.

8. E.A. Rawlins, Bentley’s text book of Pharmaceutics, English language Book Society, 8th edition,

1997.

9. Isaac Ghebre Sellassie: Pharmaceutical; Pelletization Technology, Marcel Dekker, INC, New York, 1989.

10. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel Dekker, INC, New York, 1997.

11. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and Suspensions, Marcel Dekker, INC, New York, 2000.

THEORY

2.2 Pharmaceutical Chemistry - II

75 Hrs (3Hrs/Week)

Scope: The subject deals with structure, stability and reactivity of organic compounds. It emphasizes on mechanisms and orientation of reactions. The syllabus includes physical properties of organic compounds and named reactions. This course also deals with stereo chemical aspects of organic compounds and stereo chemical reactions.

Objectives: Upon completion of the course the student shall be able to write the structure, name, the type of isomerism of the organic compound write the reaction, name the reaction and understand orientation of reactions understand the stereo chemical aspects of organic compounds and reactions know and account for stability/reactivity/orientation

know and account for stability/reactivity/orientation Lecture wise programme: Topics Hrs Note: To emphasize on
know and account for stability/reactivity/orientation Lecture wise programme: Topics Hrs Note: To emphasize on
know and account for stability/reactivity/orientation Lecture wise programme: Topics Hrs Note: To emphasize on
know and account for stability/reactivity/orientation Lecture wise programme: Topics Hrs Note: To emphasize on

Lecture wise programme:

Topics

Hrs

Note: To emphasize on definition, types/ classification, mechanisms, examples, uses/ applications, differences.

1 Benzene and its derivatives

18

a. Analytical/ synthetic/ other evidences in the derivation of structure of benzene. Orbital picture, resonance in benzene, aromatic characters, Huckel’s rule Reactions of benzene nitration, sulphonation, halogenation- reactivity, friedel crafts alkylation- reactivity, limitations, friedel crafts acylation. Substituents,effect of substituents on reactivity and orientation of mono substituted benzene compounds towards electrophilic substitution reactions.

b. Aryl halides Nomenclature,General methods of preparation, General reactions of - Aryl halides,Nucleophilic aromatic substitution reactions (Bimolecular nucleophilic substitution and Benzyne- mechanisms), effect of substituents on reactivity towards nucleophilic aromatic substitution reactions

c. Phenols - Nomenclature,General methods of preparation, General reactions, Acidity of - phenols, effect of substituents on acidity

d. Amines Nomenclature,General methods of preparation, General reactions, Basicity of - aromatic amines, effect of substituents on basicity, comparision with aliphatic saturated amines, synthetic uses of diazonium salts

2 Polynuclear hydrocarbons:

8

Synthesis , reactions and medicinal uses of of following compounds/ derivatives - Naphthalene, Phenanthrene, Anthracene. Diphenylmethane and Triphenylmethane.

3 Reactions of synthetic importance

8

a. Catalytic hydrogenation, metal hydride reduction, Clemmensen reduction, Meerwein Pondorff Verley reduction, Birch reduction, Wolff kishner reduction.

b.

Oppenauer-oxidation, Dakin reaction.

 

c.

Beckmanns rearrangement, Schmidt rearrangement.

d.

Claisen-Schmidt Condensation

4 Stereo isomerism:

18

a. Optical isomerism

 

i. Optical activity, enantiomerism, diastereoisomerism, meso compounds ii. Elements of symmetry, chiral, achiral- molecules iii. DL system of nomenclature of optical isomers, sequence rules, RS system of nomenclature of optical isomers

iv.

Reactions of chiral molecules

v. Racemic modification, resolution of racemic mixture.

 

vi.

Asymmetric synthesis- partial, absolute

b. Geometrical isomerism

 
 

i. Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)

ii. Methods of determination of configuration of geometrical isomers.

c. Conformational isomerism in alkanes, Cyclopentane, Cyclohexane.

d. Stereo isomerism in biphenyl compounds (Atropisomerism) - conditions for optical

 

activity.

e. Stereospecific and stereoselective reactions

 

5 Heterocyclic compounds:

15

a.

Nomenclature.

b.

Synthesis ,reactions and medicinal uses of following compounds /derivatives

 

i. Pyrrole/Furan/Thiophene - Relative aromaticity, reactivity, Basicity of pyrrole,

 

ii. Pyrazole/ Imidazole/ Oxazole/ Thiazole.

 

iii. Pyridine/ Quinoline/ Isoquinoline/ Acridine/ Indole. Basicity of pyridine

c.

Synthesis and medicinal uses of following compounds / derivatives - Pyrimidine/

 

Purine.

6 Fats and Oils.

a. Fatty acids- Reactions

 

b. Hydrolysis, hydrogenation, saponification and rancidity- of oils, drying oils.

8

c. Analytical constants Acid value, saponification value, ester value, iodine value,

acetyl value, Reichert Meissl (RM) value significance and principle involved in the

determination.

Pharmaceutical Chemistry II (Practical)

Practical: 3 Hours/Week

Title of the experiment

Experiments

I Quantitative determination of following classes of organic compounds ( including standardization of reagents)

7

1.

Alcohol by acetylation method.

2.

Carbonyl compound by hydroxyl amine hydro chloride method.

3.

Carboxylic acid by acid base method.

4.

Ester by hydrolysis method.

5.

Amino acid by formal titration method

6.

Aldehyde by sodium sulfite sulphuric acid method.

7.

Acetone by Sodium hypo iodite method.

8.

Phenol by bromination method.

(

Students to carry out Minimum of seven Quantitative

determination experiments)

 

II Determination of following oil values (including standardization of reagents)

3

 

1. Acid value.

2. Saponification value.

 

3. Iodine value by pyridine bromide method.

4. Iodine value by iodine mono chloride method.

( Students to carry out Minimum of three determination of oil value experiments)

III Preparation of homocyclic compounds. ( Students to prepare Minimum of six homocyclic compounds listed below )

1. Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol /Aniline by acylation reaction.

2. 2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/ Acetanilide by halogenation (Bromination) reaction.

3. 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid / Nitro benzene by nitration reaction.

6

4. Benzoic acid from benzyl chloride by oxidation reaction.

5. Benzoic acid/Salicylic acid from alkyl benzoate/ alkyl salicylate by hydrolysis reaction.

6. 1- Phenyl azo -2- napthol from aniline by diazotization and

coupling reactions.

IV Preparation of heterocyclic compounds. (Students to prepare Minimum of Five heterocyclic compounds listed below or any other heterocyclic compounds)

1. Benzimidazole from ortho phenylene diamine.

5

2. 2,3diphenyl quinoxaline from benzil

3. Benzotriazole from ortho phenylene diamine by diazotization.

4. 2-phenyl indole from acetophenone.

5. 3-methyl 1-phenyl pyrazol-5-one from ethylacetoacetate

V Separation of binary mixture of organic compounds 2

VI Stereo modeling of enantiomers, diastereoisomers, anomers, epimers meso compounds, geometrical isomers, conformational isomers (chair, boat, twist conformers of cyclohexane and substituted cyclohexane), biphenyl compounds etc.

2

Recommended Books

1. Organic chemistry by I. L. Finar, Volume-I & II.

2. A text book of organic chemistry Arun Bahl , B.S.Bahl.

3. Heterocyclic Chemistry by Raj K. Bansal

4. Organic Chemistry by Morrison and Boyd

5. Heterocyclic Chemistry by T.L.Gilchrist

6. Elementary Practical Organic Chemistry by AI Vogel, Part- III, Quantitative Organic Analysis.

7. Practical Organic Chemistry by Mann and Saunders.

8. Practical Pharmaceutical Chemistry, Volume- I & II by Beckett and J. B.Stanlake

9. Indian Pharmacopoeia

10. Vogel’s text book of Practical Organic Chemistry

11. Advanced Practical Organic Chemistry by N. K. Vishnoi

THEORY

2.3 Industrial Pharmacognosy

75 Hrs (3Hrs/Week)

Scope: To learn and understand the techniques involved in the herbal drug, cosmetic preparation and their standardization

Objectives: Upon completion of the course, the student shall be able to

know the modern extraction techniques, characterization and identification of the herbal drugsUpon completion of the course, the student shall be able to understand the preparation and development

understand the preparation and development of herbal drugs as per GMP guidelinescharacterization and identification of the herbal drugs Lecture wise programme: Topics Hrs 1 Modern methods

Lecture wise programme:

Topics

Hrs

1 Modern methods of extraction, application of latest techniques like Spectroscopy, chromatography and electrophoresis in the isolation, purification and identification of crude drugs.

11

2 Introduction to plant biochemistry with special reference to basic metabolic pathways.

a)

08

b)

Introduction to biogenesis of secondary metabolites like Atropine, Ergotamine, Morphine and Steroidal glycosides.

c)

Study of utilization of radioactive isotopes in the investigation of

Biogenetic studies.

3 A brief account of plant based industries and institutions involved in work on

02

medicinal and aromatic plants in India.

4 Industrial production and estimation of the following phytoconstituents:

10

Forskolin, Sennoside, Artemisinin, Diosgenin,, Tropane alkaloids., Curcumin,Rutin, Phyllanthin, Asiaticoside, Andrographolides and Gymnemic acid

5 Herbal formulation development and standardization

10

a) Preparation, stability testing of Herbal extracts and formulations

b) Role of Herbs in Cosmetics Hair care preparation - Henna, Amla, Hibiscus Skin Care preparation Aloe vera, Turmeric, Sandal wood

c) Neutraceuticals

6 WHO Guidelines for the assessment of Herbal Medicine and Cosmetics

02

7 Basic principles involved in the alternative system of medicine viz. Ayurveda, Siddha, Unani and Homeopathy

a)

07

b)

Preparation and standardization of Ayurvedic formulations i.e.

Aristas, Asawas, Ghutika,Churna, Leha and Bhasma.

8 Plant Toxins and adverse drug reactions:

06

Natural allergens, Hallucinogens, Teratogens.

9 Plant tissue culture:

07

Historical development, nutritional requirements, growth and their maintenance, applications of plant tissue culture and types of cultures related to cell suspension culture, callus culture, hairy root culture and protoplast culture

10

Enzyme Biotechnology Introduction, general methods of isolation, purification and application of immobilized enzymes. Biological sources, methods of preparation, chemical nature and uses of:

07

a. Papain b. Pepsin c. Trypsin d. Pancreatin e. Asparaginase, urokinase

11

a) Herb-Drug interaction

b) Edible Vaccine

02

2.3: Industrial Pharmacognosy (Practical)

Practical: 3 Hours/Week

Title of the experiment

Experiments

1 Exercise involving isolation of active principles

08

a. Caffeine - from tea dust.

b. Curcumin from turmeric

c. Berberine from Berberis

d. Andrographolide from Kalmegh

e. Diosgenin from Dioscorea

f. Phyllanthin from Phyllanthus neruri

g. Piperine from Pepper

h. Hespiridin from orange peel

2 Separation of amino acids by Paper chromatography

1

3 TLC analysis of extracts

1

4 Determination of

4

a. Moisture content (Loss on drying)

b. Extractive values

c. Ash values

d. Swelling factors

5 Preparation and standardization of Ayurvedic formulations

1

6 Preparation of herbal cosmetics

1

7 Demonstration of experiments in column chromatography

1

8 Demonstration of experiments in plant tissue culture.

1

Recommended Books

1. Pharmacognosy by Trease and Evans 14th and 15th edition.

2. Pharmacognosy Pharmacobiotechnology- James Bobbers, Marilyn K, Speedice & V.E. Tylor.

3. Herbal Drug Industry R.D.Chowdary.

4. The formulation and preparation of cosmetic, fragrances and flavours.

5. Remington’s Pharmaceutical sciences.

6. WHO Guidelines website http:/www/who.int/druginformation

7. Standardization of botanicals.

8. Quality Control Herbal Drugs - Pulok K.Mukherjee.

9. Pharmacognosy and Phytochemistry I edition, vol- l &II by Vinod. D. Rangari

10. Practical Pharmacognosy, III edition, C.K. Kokate.

2.4 Biostatistics and Computer applications

THEORY

75 Hrs (3Hrs/Week)

Scope: This subject deals with the introduction to computers, M.S. Word, M.S. Excel, Computer graphics, operating system, softwares, Net-work, Internet, Computer application in clinical studies. Biostatistics deals with the Frequency distribution, Graphics, Measures of central tendency, Correlation, Regression, Probability theory, Sampling technique, Sample, Parameter, Statistics, Students t-test and Pharmaceutical examples.

Objectives: Upon completion of the course the student shall be able to know the operation of M.S. Word, M.S. Excel, M.S. Access know the various application of computers in pharmacy know the various statistical technique to solve statistical problems solve statistical problems by using Excel appreciate various applications of software packages in Pharmacy Appreciate statistical techniques in solving the problems.

Appreciate statistical techniques in solving the problems. Lecture wise programme: Topics Section A: Biostatistics
Appreciate statistical techniques in solving the problems. Lecture wise programme: Topics Section A: Biostatistics
Appreciate statistical techniques in solving the problems. Lecture wise programme: Topics Section A: Biostatistics
Appreciate statistical techniques in solving the problems. Lecture wise programme: Topics Section A: Biostatistics
Appreciate statistical techniques in solving the problems. Lecture wise programme: Topics Section A: Biostatistics
Appreciate statistical techniques in solving the problems. Lecture wise programme: Topics Section A: Biostatistics

Lecture wise programme:

Topics Section A: Biostatistics

Hrs

01 Frequency distribution: Definition, Types of frequency distribution, Cumulative frequency Graphical Representation: Histogram, frequency polygon, frequency curve, Semi logarithmic graph, ogive.

06

02 Measures of central tendency : Average, Types of averages - Mean, Median, Mode, Harmonic mean, Geometric mean, Quartile, deciles, percentile - Pharmaceutical examples

08

03 Measures of dispersion : Dispersion, Range, quartile deviation, mean deviation, standard deviation, Variance, coefficient of variation, application of coefficient of variation in pharmacy, skewness, Kurtosis, coefficient of skewness, Pharmaceutical problems

08

04 Correlation : Definition, Types of correlation, Karl Pearson’s coefficient of correlation, Rank difference method, Correction of tied ranks, Multiple correlation - Pharmaceuticals examples

05

05 Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x = a + by, fitting the curve y = ab x , fitting exponential curve, Multiple regression, standard error of regression, difference between regression and correlation Pharmaceutical Examples

05

06 Probability : Trial, event, sure event, random event, Sample space, Definition of probability, mutually exclusive events, Independent event, Law’s of Probability - simple problems, Binomial distribution, Normal distribution, Poisson’s distribution, properties - problems

06

07

Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical examples

05

08 T- distribution : t-test between the means of Population and sample, Pooled t-test, student’s t-test, Pharmaceutical examples

Section B: Computer Science

09 Number system: Binary number system, Decimal number system, Octal

number system, conversion decimal to binary, binary to decimal, octal to binary etc, binary addition, binary subtraction First complement, second complement method, binary multiplication, binary division

04

05

10 Over view of computers, Generation of computers, Types of computers Mini, Micro, Super computer, digital, analog and hybrid computers, input devices, output devices, input/output devices Floppy disk, CD-ROM, Pen drive, Monitor, Printers, types of printers-Impact and Non impact printers,

11 Algorithm and flow chart Pharmaceutical problems 02

12 Hardware, software , types of software’s – System, application, Custom

02

08

software

13 Operating system, Types of Operating systems

02

14 Computer Network LAN, WAN, MAN, Internet, Intranet, WWW 02

15 Programming languages Machine language, Assembly language, High level languages

01

16 Introduction to M.S. Office M.S. Excel, M.S. Access-operators and Expression

03

17 Application of computers in Pharmacy Drug information storage and retrieval, Pharmacokinetics, Drug design, Crude drug identification, Hospital and Clinical Pharmacy, Pharmaceutical analysis

03

2.4: Biostatistics and Computer applications (Practical)

Practical: 3 Hrs/week

Title of the Experiments

Experiments

1. Introduction to M.S. Word, Mail Merge, Table Handling 2

2. Introduction to Excel - Graphs Histogram, Bar, Line, Pie etc

1

3. Introduction to mathematical functions and Statistical functions - Sum, Average, Exponential, Logarithm, Round, Power , If and Else - logical function

2

4. Calculation of Averages using excel - Mean - Individual, discrete and continuous series

1

5. Calculation of Median and Mode using Excel - Discrete and continuous series

1

6. Calculation of Geometric mean, Harmonic mean using Excel - Individual, Discrete and continuous series

1

7. Calculation of mean deviation by direct and shortcut method using Excel - Individual, Discrete and continuous series

1

8. Calculation of Standard deviation and coefficient of variation by direct method using Excel - Individual, Discrete and continuous series

1

9. Calculation of Standard deviation and Coefficient of variation by shortcut method using Excel - Individual, Discrete and continuous series

1

10. Calculation of coefficient of correlation by direct , shortcut method and Rank difference method using Excel

1

11. Multiple correlation problem

1

12. Calculation of coefficient of Skewness using Excel 1

13. Calculation of Kurtosis using excel

1

14. Formation of linear regression equation calculation of predicted values

1

15. Binomial distribution , Poisson’s distribution problems – Using excel 1

16. t-test Problem to know the significance difference between population and sample mean Using excel

1

17. Pooled t-test Problem to know the significance difference between means of two Samples Using excel

1

18. Student’s t-test Problem to know the significance difference between means of Control and treatment group Using excel

1

19. Student t-test from correlation coefficient and regression coefficient

1

20. Introduction to Access - Creating database, Creating table, designing table creating forms

1

21. Writing programme to generate labels of different formulation using access

1

22. Operating statistical software

1

23. Introduction to Power point Slides Preparations 1

Books Recommended

1. Pharmaceutical Statistics - By Sanford Bolton Third/Fourth Edition

2. Comdex Computer Course Kit -

3. Fundamental of Statistics - S.C.Guptha

4. Practical Problems in Statistics D.N.Elhance and Veen Elhance

5. Microsoft Office Access 2003 - Cary N.Prague, Michael R.Irwin

6.

7. Fundamental of Statistics -

8. Methods in Biostatistics B.K.Mahajan

Vikas Guptha

Statistics -

Kapoor

S.N.Guptha