School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore A. … plan_fourth sem.pdf · ·...

1

School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore

A. Subject Specification [1]. Subject title and code: Dosage Form Design(401T) [2]. Program(s) in which the Subject is offered: B. Pharm [3]. Name of faculty member responsible for the Subject : Ms. Apeksha Saraf [4]. Level/year at which this Subject is offered : Second Year

B. Objectives

[1]. Objective of the Subject: To understand the various phases in development of pharmaceutical products. And also the quantitation of various physicochemical properties of a drug moiety that will assist in developing a stable, safe and effective formulation with maximum bioavailability.

C. Subject Description [1]. Subject Detail S. No. Topic No. of Classes

1. Preformulation studies: Study of physical properties of drug like

physical form, particle size, shape, density, wetting, dielectric

constant, solubility, dissolution and organoleptic property and

their effect on formulation, stability and bioavailability, study of

chemical properties of drugs like hydrolysis, oxidation, reduction,

racemization, polymerization etc. and their influence on

formulation and stability of products, biopharmaceutical

consideration in the formulation stages of dosage form

development.

13

2. Study of different types of formulation additives e.g., diluents,

binders, disintegrants, lubricants, vehicles, anti-oxidants,

preservatives, coloring, flavoring, sweetening, suspending and

emulsifying agents and drug-excipient interactions.

06

3. Stability studies: Determination of shelf life (expiry date) and

overage calculations, stabilization and stability testing protocol for

various pharmaceutical products.

04

2

4. Polymers: Classification, synthesis, properties, characterization

and evaluation of polymers including biodegradable polymers,

mechanism of biodegradation in body, pharmaceutical

applications of polymers.

06

5. Dissolution technology: Types of various dissolution apparatus as

per pharmaceutical compendia, dissolution media, factors

affecting dissolution, dissolution testing of different types of

dosage formulations, data interpretation, similarity and difference

factors.

06

6. Solubilization: Theory of solubilization, factors affecting

solubilization, methods of solubility enhancement.

05

Total Classes 40

[2]. Subject Components (total contact hours):

Lecture: 4 hrs. per week Practical: 6 hrs. per week Other: -

[3]. Development of Learning Outcomes in Domains of Learning

i. Description of the knowledge to be acquired: Preformulation studies for dosage form designing

Various additives used for formulation designing

Stability studies of various pharmaceutical products

Dissolution technology used for evaluation of dosage forms and apparatus used

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Overhead projector, Group discussion, Assignments.

3

D. Learning Resources

i. Essential References, Required Text(s), Electronic Materials, Web Sites, Other learning material such as computer-based programs/CD, professional standards/regulations:

Lachman, L., Lieberman, H.A. and Kanig, J.L., The Theory and Practice of Industrial Pharmacy, Varghese Publishing House, Mumbai.

Banker, G.S. and Rhodes C.T., Modern Pharmaceutics, Marcell Decker Inc., New York. Gennaro, A.R., Remington’s: The Science and practice of Pharmacy, Lippincott,

Williams & Wilkins, Philadelphia. Rawlins, E.A. (Ed.), Bentley’s Textbook of Pharmaceutics, Bailliere Tindall, London. Pharmacopoeia of India, Ministry of Health and Family Welfare, Govt. of India, New

Delhi. E. Facilities Required

F. Subject Evaluation and Improvement Processes

G. List of Assignments: [1]. To prepare a protocol of preformulation studies required to develop a parenteral dosage

form. [2]. To list out various types dissolution apparatus as per pharmacopeia(I.P, U.S.P, B.P) [3]. To prepare chart of various additives used in formulation of dosage forms.

Indicate requirements for the Subject including size of classrooms and laboratories (i.e number of seats in classrooms and laboratories, extent of computer access etc.)

[1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room and 1 laboratory [2]. Computing resources: -- [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list): -

[1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching: Feedbacks from the students are taken twice in a semester. [2]. Other Strategies for Evaluation of Teaching The system exists for class test followed by 2 sessional examinations per semester for evaluation of teaching.

4


DETAILED COURSE PLAN

A. Subject Specification

[1]. Subject title and code: PHARMACEUTICAL ANALYSIS-II:402T [2]. Program(s) in which the Subject is offered: B. Pharm.

(If general elective available in many programs indicate this rather than list programs) [3]. Name of faculty member responsible for the Subject : Jitendra Sainy [4]. Level/year at which this Subject is offered : IInd Year(IVth semester)

B. Objectives

Objective: The intent of the course is to build upon basic understanding of working and principle of different types of analytical equipments such as potentiometers, Amperometer, Electrochemical cell, Conductometer, pH meters etc. The course develops an insight towards various methods of analytical techniques.

C. Subject Description S.NO Unit/Topics Teaching Hours

Required 402T: PHARMACEUTICAL ANALYSIS-II

01 Conductometry: Ohm’s law and ionic conductivities, instrumentation, conductometric titration curves, applications of conductometry in acid-base, redox, precipitation and complexometric titrations with suitable examples.

05

02 Potentiometry: Theory and principles, reference electrodes, indicator electrodes, instrumentation for potentiometric titrations, location of end point in potentiometry, application of potentiometry in acid-base, redox, precipitation and complexometric titrations with suitable examples.

05

03 Polarography: Principle, polarographic wave, Illkovic equation and factors affecting it, dropping mercury electrode, instrumentation, polarographic methods of analysis, pharmaceutical applications.

05

04 Amperometry: Principle, amperometric titration curves, applications.

05

05 Coulometry: Principle, apparatus, pharmaceutical applications. 03

5

06 Radioimmunoassay: Principle, procedure, pharmaceutical applications.

03

07 Thermal methods of analysis: Principle, instrumentation, pharmaceutical applications of differential scanning calorimetry, thermogravimetric analysis and differential thermal analysis.

06

08 X-ray diffraction: Principle, Bragg’s Law, instrumentation, pharmaceutical applications.

03

09 Miscellaneous methods of analysis: Karl-Fischer titrations, Diazotization titrations, gasometry, Kjeldahl’s method of nitrogen estimation and oxygen flask combustion.

05

Total 40




Description of the knowledge to be acquired: (i) Learning Outcomes:

Experimental determination of potentials of electrochemical cells. Working of an electrochemical cell. Application of conductometery in acid base titration. General principles and working of potentiometer. Assays of various drug compounds and their applications to Pharmacy. X-ray diffraction technology for the structure elucidation of compounds. Knowledge of Thermal methods of analysis. Methods for determination of water and nitrogen. ii. Teaching strategies to be used to develop that knowledge:

Black board teaching, General discussion about newly launched drugs, Interactive classes, Learning through internet, Group discussion, Assignments.


i. Essential References, Required Text(s), Electronic Materials, Web Sites, Other learning material such as computer-based programs/CD, professional standards/regulations: Beckett, A.H. and Stenlake, J.B., Practical Pharmaceutical Chemistry, Vol.

6

I and II,CBS Publishers and Distributors, New Delhi, India. Bassett, R.C., Denney, G.H., Mendham, J., Vogel’s Textbook of

Quantitative Inorganic Analysis, The ELBS and Longman, London. Atherden, L.M., Bentley and Driver’s Text Book of Pharmaceutical

Chemistry, McGrawHill Company, New York. Pharmacopoeia of India, Govt. of India, Ministry of Health and Family

Welfare, New Delhi. Willard, H.H., Merritt, L.L and Dean, J.A., Instrumental Methods of

Analysis, Van Nostrand Reinbold, New York. Connors, K.A., A Textbook of Pharmaceutical Analysis, John Wiley and

Sons, New York. Higuchi, T., Brochmann, E., Hanssen, H., Hanssen, H., Pharmaceutical

Analysis, CBS Publishers and Distributors, New Delhi, India. Munson, J.W., Pharmaceutical Analysis-Modern Methods, Part A and B,

International Medical Book Distributors, Mumbai. www.google.com www.journals.elsevier.com/journal-of-pharmaceutical-analysis.

E. Facilities Required



requirements or attach list): Karl-Fischer’s apparatus, Amperometer, Conductometer, pH meter.



G. List of Assignments: [1]. Coulometry [2]. Gasometry [3]. Oxygen flask combustion

7




[1]. Subject title and code: Pharmaceutical Chemistry-IV (Biochemistry) (403T) [2]. Program(s) in which the Subject is offered: B. Pharm.

(If general elective available in many programs indicate this rather than list programs) [3]. Name of faculty member responsible for the Subject : Dr. Love Kumar Soni [4]. Level/year at which this Subject is offered : Fourth Semester

B. Objectives

[1]. Objective of the Subject:

The objectives of this course are to provide students the basic understanding and knowledge of the biochemical process of the body.

At the end of the course, the student shall have acquired the knowledge of basic metabolic pathway and their regulation.

C. Subject Description [1]. Subject Detail

S. No. Topic No. of Classes

1. Enzymes: Nomenclature and classification, structure of enzymes, mechanism of enzyme action, mode of enzyme action, factors affecting enzyme action, enzyme inhibition, regulation of enzyme activity, allosteric enzymes and pharmaceutical application.

06

2. Co-enzymes: Metals and vitamins as coenzymes and their significance.

01

3. Carbohydrates metabolism: Glycolysis, gluconeogenesis and glycogenolysis, citric acid cycle, pentosephosphate, pathway, uronic acid pathway, metabolism of galactose and galactosemia.

08

4. Lipid metabolism: Transportation and absorption of fats, role of liver in fat metabolism, oxidation of fatty acids, ketosis, biosynthesis of saturated and unsaturated fatty acids, control of lipid metabolism, essential fatty acids and eicosanoids, metabolism of cholesterol.

08

8

5. Biological oxidation: Redox potential, enzymes and co-enzymes involved in oxidation reduction and its control, the respiratory chain, its role in energy capture and its control, energetic of oxidative phosphorylation, inhibitors of respiratory chain and oxidative phosphyrlation, mechanism of oxidative phosphorylation.

06

6. Metabolism of ammonia and nitrogen containing monomers: Nitrogen balance, biosynthesis of amino acids, catabolism of amino acids, conversion of amino acids to specialized products, assimilation of ammonia, urea cycle, metabolic disorders of urea cycle, metabolism of sulfur containing amino acids, porphyrin biosynthesis, formation of bile pigment, hyperbilirubinemia, purine biosynthesis, purine nucleotide interconversion, pyrimidine biosynthesis, and formation of deoxyribonucleotides.

12

7. Genetic code and protein synthesis: Genetic code, components of protein synthesis and inhibition synthesis.

02

Total No. of Classes 43


Lecture: 4 hrs. per week Practical: 6 hrs. per week Other:


i. Description of the knowledge to be acquired: Knowledge of Enzyme mechanism and role of enzyme in biochemical process of the

body. Knowledge of basic metabolic pathway, their mechanism and regulation. Concept in bioenergetics. Concept in Genetic code and protein synthesis.

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Power point presentation, Group discussion, Assignments.


i. Essential References, Required Text(s), Electronic Materials, Web Sites, Other learning material such as computer-based programs/CD, professional

9

standards/regulations: Harrison, A guide to Biochemistry, University Press, Cambridge. Theorpe W.V., Biochemistry for medical students, J & A Churchill, London. Rao, R., Text book of Biochemistry, Prentice Hall India Limited, New Delhi. Murray, R.K., Granner, M.D., Redwell, V.W., Harper’s Review of Biochemistry,

Lange Medical Publications McGraw Hill, New Delhi. West E.S. and Todd W.R., Text Book of Biochemistry, Oxford and IBH Publishing

Co. Pvt. Ltd., New Delhi. Mazur, A. and Horrow, B., Textbook of Biochemistry, Saunders, Philadelphia. Lehninger, A.L., Principles of Biochemistry, Worth Publishers, New York. Satyanarayan, U., Biochemistry, Books & Allied Ltd., Kolkata. Stryer, L.,Biochemistry, Freeman & Co. New York. Rama Rao, A.V.S.S., Suryalakshmi A., A Text Book of Biochemistry, UBS Publishers

and Distributors, New Delhi. Plummer, D.T., An Introduction to Practical Biochemistry, Tata McGraw Hill, New

Delhi. Jayaraman, J., Laboratory manual in Biochemistry, New Age International, Publishers,

New Delhi.



[1]. Accommodation (Lecture rooms, laboratories, etc.): 1 Lecture room and 1 laboratory

[2]. Computing resources: -- [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list):. Basic Biochemistry Laboratory facilities are needed for practicals. UV Spectrophotometer, Electrophoresis apparatus

F. Subject Evaluation and Improvement Processes [1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching: Feedbacks from the students are taken. [2]. Other Strategies for Evaluation of Teaching The system exists for class test followed by 2 Sessional examinations per semester for evaluation of teaching.

G. List of Assignments: [1]. Selected metabolic pathways and their regulation.

10



A. Subject Specification [1]. Subject title and code: Pharmacognosy (404T) [2]. Program(s) in which the Subject is offered: B. Pharm

(If general elective available in many programs indicate this rather than list programs) [3]. Name of faculty member responsible for the Subject : Dr. G.P.Choudhary [4]. Level/year at which this Subject is offered : Second Year

B. Objectives

[1]. Objective of the Subject: The objective is to study of plant Classification, cultivation, collection, commercial

varieties, chemical constituents, substitutes, diagnostic macroscopic and microscopic features and specific chemical tests of drugs containing glycosides, volatile oils & plant drugs used in Indian Traditional system.

C. Subject Description S.No. Name of Topic No. of classes required1. Classification, cultivation, collection, commercial varieties,

chemical constituents, substitutes, diagnostic macroscopic

and microscopic features and specific chemical tests of

following groups of drugs containing glycosides:

a) Saponins - Liquorice, Ginseng, Dioscorea, and

Senega.

4

2. Cardio active sterols-Digitalis, Squill, Strophanthus and

Thevetia.

4

3. Anthraquinone cathartics - Aloe, Senna, Rhubarb and

Cascara.

4

4. Others - Psoralea, Ammi majus, Ammi visnaga, Gentian,

Saffron, Chirata, and Quassia.

4

5. Volatile oils: General method of obtaining volatile oils from plants. Study of following volatile oil containing drugs as Mentha, Coriander, Cinnamon, Cassia, Lemon grass, Citronella, Caraway, Dill, Clove, Fennel, Nutmeg,

8

11

Eucalyptus, Chenopodium, Cardamom, Musk, Palmrosa, Gultheria, Sandal wood.

6. Plant bitters and sweeteners. 2 7. Studies of following drugs: Amla, Shatavari, Tyllophora,

Bhilwa, Bach, Punarnava, Chitrak, Apamarga, Gokhru, Shankhpusphi, Brahmi, Adusa, Arjuna, Ashoka, Methi, Lahsun, Palash, Guggal, Gynmema, and Shilajit.

9

8. Biological sources, preparation, identification tests and uses

of the following enzymes Diastase, Papain, Pepsin, Trypsin

and Pancreatin

5

Total No. of classes 40




i. Description of the knowledge to be acquired: Study of saponin,cardioactive , anthraquinone glycosidal drugs & the therapeutic value of drug. Study of Biological source, distribution, classification, chemical composition & allied species of drugs. Study of volatile oil containing drugs. Study of Plant bitters and sweeteners. Studies of following drugs: Amla, Shatavari, Tyllophora, Bhilwa, Bach, Punarnava, Chitrak, Apamarga, Gokhru, Shankhpusphi, Brahmi, Adusa, Arjuna, Ashoka, Methi, Lahsun, Palash, Guggal, Gynmema, and Shilajit. Study of enzymes such as Diastase, Papain, Pepsin, Trypsin and Pancreatin

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Overhead projector, Group discussion, Assignments.



12

Kokate C.K., Purohit A.P., Gokhale S.B.In; Pharmacognosy,;Nirali Prakashan; Pune

Wallis, T.E., Text Book of Pharmacognosy, J and A Churchill Limited,

London.

Trease, G.D. and Evans, W.C.,In; Pharmacgnosy, Harcourt Brace and company.

Indian Pharmacopoeia, Ministry of Health and Family Welfare, Govt. of India, New Delhi. Nadkarni K.M. Indian Materia Medica, , Vol I & II, Popular Prakashan Pvt. Ltd. Mumbai.

Brain,K.R. and Turner,T.D. The practical evaluation of phytopharmaceutical,Write scientechnica, Bristal.

Harborne,J.B., Phytochemical Methods,Chapman and Hall, London.




requirements or attach list): Soxhlet extractor etc.



G. List of Assignments:Nil

13



[1]. Subject title and code: Pharmaceutical Jurisprudence and Ethics (405T) [2]. Program(s) in which the Subject is offered: B. Pharm

(If general elective available in many programs indicate this rather than list programs) [3]. Name of faculty member responsible for the Subject : Mr. Devashish Rathore [4]. Level/year at which this Subject is offered : Second Year

B. Objectives

[1]. Objective of the Subject: The objective is to provide the knowledge in sufficient details, about the law relating to

drugs and pharmaceuticals and the profession of Pharmacy. At the end of the course, the student shall acquire the key of applying pharmaceutical

knowledge to legal problems.


S. No. Topic No. of Classes

1. A brief review- Pharmaceutical Legislations, Drugs and pharmaceutical industry with special reference to India and Code of pharmaceutical ethics

3

2. Pharmacy Act 1948. 2 3. Drugs and Cosmetics Act 1940 and Rules 1945 8 4. Medicinal & Toilet Preparations (excise duties) Act 1955 3 5. Narcotic Drugs & Psychotropic Substances Act 1985 & Rules 4 6. Drugs Price Control Order 1995 1 7. Drug Policy 2002 1 8. Poisons Act 1919 1 9. Drugs and Magic Remedies (objectionable advertisements) Act 1954 1 10. Medical Termination of Pregnancy Act 1970 & Rules 1975 1 11. Prevention of Cruelty to Animals Act 1960 1 12. States Shops & Establishments Act & Rules 1 13. Insecticides Act 1968 1 14. AICTE Act 1987 1 15. Factories Act 1948 2

14

16. Minimum Wages Act 1948 1 17. Introduction to Intellectual Property Rights and Indian Patent Act 1970

with patents rules 1972 4

18. A brief study of the various marketed pharmaceutical products from the following categories: (i) Antibiotics (ii) Vitamins (iii) Antihypertensive (iv) Anti-diabetics(v) NSAIDs

4

Total No. of Classes 40


Lecture: 4 hrs. per week Practical: - Other: -

[2].Development of Learning Outcomes in Domains of Learning

Description of the knowledge to be acquired: Study of all fundamental legal principles related to pharmacy profession. Study of history of drug legislation. Study of constitutions and functions of various regulatory bodies. Study of guidelines related to import, registration, manufacture and sale of drugs.

Teaching strategies to be used to develop that knowledge: Black board teaching, Power point presentation, Overhead projector, Group discussion, Assignments.



Jain, N.K.; A Textbook of Forensic Pharmacy, Vallabh Prakashan, New Delhi. Agarwal, S.P., Khanna, R.; Pharmaceutical Jurisprudence and Ethics, Birla Publication

Pvt. Ltd., Delhi. Kuchekar, B.S., Khadatare A.M.; Forensic Pharmacy, Nirali Prakashan, Pune. www.google.com www.pci.nic.in www.aicte-india.org www.ipindia.nic.in www.fda.gov

15

E. Facilities Required Indicate requirements for the Subject including size of classrooms and laboratories (i.e number of seats in classrooms and laboratories, extent of computer access etc.)

[1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room [2]. Computing resources: -- [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list): --



G. List of Assignments: [1]. Regulatory study of the various marketed pharmaceutical products [2]. Detail study of patents through Internet.

16



[1]. Subject title and code: Communication skills and personality development(406P) [2]. Program(s) in which the Subject is offered: B. Pharm [3]. Name of faculty member responsible for the Subject : Ms. Apeksha Saraf [4]. Level/year at which this Subject is offered : Second Year

B. Objectives

[1]. Objective of the Subject: A technical report’s purpose is to communicate information gained through a process of technical or experimental work. The objective of this subject is to provide basics of technical writing, report writing, its format and style.


S. No. Topic No. of Classes 1. Technical writing: Purpose and characteristics of technical writing,

technical writing process, technical writing style, formatting

technical documents for function and effectiveness, some forms of

technical writing: Technical descriptions, summaries, instructions,

technical proposals, user manuals.

06

2. Communicating through reports: Essentials of good report writing,

classification of reports, planning, organizing, and writing the

report, report formats, formal and informal (short and long),

structure and formatting of short informal reports and memo

reports

06

17

3. Technical reports: structures of a technical report, techniques that

help the process of writing technical reports, editing and revising

technical reports for style and usage, for grammar and

punctuation, some common informal technical reports, progress

reports, lab reports, feasibility reports, incident reports, problem-

solving reports and reports identifying cause-and-effect

relationship.

08

Total Classes 20


Lecture: 2 hrs. per week Practical: - Other: -


i. Description of the knowledge to be acquired: Characteristics of technical writing, its process and its style.

Essentials of good report writing.

Technical report writing.

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Group discussion, Assignments.



Rutherford, A.J. Basic Communication Skills for Technology, Pearson Education Asia, Hong Kong.

Gerson, S.J. and Gerson, S.M., Technical Writing, Pearson Education Asia, Hong Kong. Murphy, H.A., Hildebrandt, H.W., Thomas, J.P., Effective Business Communication,

The McGraw-Hill Companies. Chaturvedi, P.D., Chaturvedi, M., Business Communication, concepts, cases and

applications, Pearson. Rizvi, M.A., Effective Technical Communication, McGraw Hill.

18



G. List of Assignments: [1]. To prepare a incident report. [2]. To prepare a report identifying cause-and-effect relationship. [3]. To prepare a problem-solving report


[1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room [2]. Computing resources: -- [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list): -

[1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching: Feedbacks from the students are taken twice in a semester. [2]. Other Strategies for Evaluation of Teaching - Assignments

School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore A. … plan_fourth sem.pdf · ·...

Documents

Transcript of School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore A. … plan_fourth sem.pdf · ·...