Syllabus relating

Title of the Course Assignments (Pharmaceutical Analysis)

Marks 50

Number of Hours per week 2

Total Hours 30

Class T. Y. B.Pharm.

Semester VI

Sr.No Topic

1. There will be several problem solving sessions where there will be discussions on

methodology and approaches to solve problems including discussions on how to gather

information from internet and literature. The problems will be given to the students as home

60

assignments where students can go through the literature and come out with solutions and

present it in the class. There shall be many assignments. No assignment shall be of more than

10 marks. The student shall submit the assignment in A4 size paper either hand written or

typed and pinned together. Marks will be awarded by the teacher and at the end of the

semester teacher will submit the marks along with the assignment copies of all the students

to the office.

Laboratory

Books Recommended: As recommended by the teacher

Title of the Course Pharmaceutical & Medicinal Chemistry Laboratory - I

Marks 50

Number of Hours per week 4

Total Hours 60

Class T.Y. B.Pharm.

Semester VI

Sr.No. Topic Hrs.

Functional group transformation: Minimum one exercise to be given for each of the preceding

types of transformations, if possible leading to synthesis of drugs or drug intermediates

1 Esterification (synthesis of acetyl salicylic acid) 8

2 Hydrolysis 4

3 Amide formation (acetylation, benzoylation), 8

4 Diazotization and coupling 4

5 Bromination 4

6 Nitration and Sulfonation in aromatic rings 8

7 Simple oxidation and reduction reactions 8

8 Synthesis of Heterocycles (e.g. Hydantoin, Benzimidazole ) 8

9 Aliphatic substitution reactions 4

10 Clasien / aldol condensation 4

Title of the course Pharmaceutics Laboratory - III

Marks 50

Number of hours per week 4

Total hours 60

Class T.Y. B.Pharm

Semester VI

Sr.No. Experiment

1 At least one representative example of each formulation type included in theory of

Pharmaceutics IV and V(Preparation and evaluation, with stress on official formulations)

61

Books Recommended

Sr.No. Title Author/Editor Edition Publisher

1 Vogel’s A Text book of

Practical Organic Chemistry

A. Vogel 3rd,

1962

Longman group limited,

London

2 Advanced Practical Organic

Chemistry

J. Leonard, trvor

P. Toube, B.

Lygo, G.

Proctor

2nd ,

1990

Stanley Thornes

3 Practical Organic Synthesis:

A Student's Guide

Reinhart Keese,

Martin P.

Brändle

Title of the Course Pharmaceutical Analysis Laboratory-II

Marks 50

Number of Hours per week 4

Total Hours 60

Class T.Y. B.Pharm.

Semester VI

Sr.No Experiment Hrs.

1 Atomic absorption spectroscopy (Alkali earth metal determinations) ** 4

2 Absorption spectroscopy (UV, Visible); ** 8

3 Fluorescence spectroscopy (Quinine salt), Quenching phenomenon. ** 4

4 Chromatography (PC, CC, TLC) application to reaction monitoring, purity

assessment of drugs, separation of the mixtures.

12

5 Medicaments in formulations**: Liquid oral, tablet, injectable, aerosol, capsule,

ointment, eye drops, suppositories, lozenges, etc. (one each);

16

6 Multi component analysis for drugs in combination**. eg: Using simultaneous

equation method, using iso absorption point method, Using solvent extraction

method, Using colorimetric and UV methods.

8

7 Refractometry**

Caibration of Abbe’s Refractometer, Estimation of refractive index of natural oils

and laboratory solvents , determination of the percentage of glycerin in the unknown

by calibration curve.

4

8 Polarimetry **

Instrument information, Optical rotation of dextrose solution, determination of

specific optical rotation of ethambutol,

4

**Applications may also include the compounds to which the techniques are applicable.

62

Title of the Course Pharmacognosy Laboratory-I

Marks 50

Number of Hours per Week 4

Total Hours 60

Class T.Y. B. Pharm.

Semester VI

Sr.No. Experiment

1 Study of simple and compound microscope, magnification, micrometry, and microscopical

drawing using camera lucida, Projection microscope. etc.

2 Studies on morphological features of leaves, roots and rhizomes, stem, flowers, fruits, seeds,

barks, woods, etc

3 Studies of plant tissues : palisade, epidermis, cork, parenchyma, collenchyma, sclerenchyma,

vascular tissues, secretary organs, spores, etc

4 Studies of stomata (diacytic, paracytic, animocytic , anisocytic, dumb-bell shaped stomata, etc.)

5 Studies of covering and glandular trichomes (minimum of 5 each type).

6 Studies of calcium oxalate crystals (acicular, prism, rosette, sandy, microneedles, crystal sheath,

etc.

7 Studies on starches (maize, wheat, rice, potato, etc.).

8 Determination of stomatal number and stomatal index

9 Determination of palisade ratio.

10 Determination of vein-islet and vein termination number

11 Quantitative microscopy using lycopodium spores.

12 Determination of total ash and acid insoluble ash

13 Determination of alcohol and water soluble extractive values

14 Development of thin layer chromatography for two drugs (alkaloids, volatile oils, glycoside, etc

15 Evaluation of volatile oil/fixed oil by R.I

16 Determination of swelling factor (isabgol seed or husk)

17 Determination of moisture content by (Karlfisher method, LOD, etc.)

Seminar:

Every student will be assigned a supervisor. The student will select a topic in consultation

with the supervisor. The seminar will be submitted in spiral bound form well in advance

of presentation. The seminar will be presented by the student as per the schedule put up.

63

Final Year B. Pharm.

SEMESTER VII

Title of the course Pharmaceutics -VI

Marks 50

Number of hours per week 2

Total hours 30

Class Final Year B. Pharm.

Semester VII

Sr.No. Topic Hrs

1. Sterile Products: Introduction to sterile dosage forms, parenteral preparationstypes,

general requirements,

1

2. Containers and closures(glass, plastic, rubber) for parenterals, evaluation and

selection,

2

3. Routes of parenteral administration, Formulation considerations in the

development of a small volume parenterals including solutions, suspensions,

emulsions, dry powders, water for injection (preparation and testing)

5

4. Manufacture of small volume parenterals in ampoules and vials, Freeze drying

of small volume parenterals

3

5. Sterilization methods and evaluation using biological indicators 1

6. Production facilities, layout of production facilities, Air systems, Filters, HEPA

filters,Class considerations, Environment control,

3

7. Quality control tests of small volume parenterals 3

8. Opthalmics: anatomy and physiology of eye, Factors affecting topical

ophthalmic delivery

1

9. Ophthalmic solutions, suspensions, ointments, gels, advantages and limitations,

Formulation considerations, manufacture and packaging, Quality control of

ophthalmics, preservative efficacy test

4

10. Contact lens solutions and their formulation and evaluation 1

11. Blood products and Plasma substitutes: collection and storage of blood, whole

human blood, and products obtained from it, methods used for these and

packaging employed for them, quality control of blood and its constituents;

Plasma substitutes their properties and quality control

2

12. Glandular products: Extraction and isolation of insulin from of pancreas, insulin

injections;

2

13. Sutures and ligatures 1

Books Recommended: As under Pharmaceutics IV

64

Title of the course Pharmacology - IV

Marks 50

Number of hours per week 2

Total hours 30

Class Final Year B. Pharm.

Semester VII

Sr. No. Topic Hrs.

1 CVS: Drugs used in the treatment of Hypertension Congestive cardiac

failure Arrhythmia Hyperlipidemia Angina Pectoris

6

2 Diuretics 4

3 Pharmacology of bronchial asthma and cough 3

4 Immunomodulators: immunostimulants/suppressants 6

5 Principle of toxicology: Heavy metal poisoning, Pesticides, Poisoning, opium

poisoning

4

6 Use of radioisotopes in medicine 3

7 Development of new drug: (Importance of preclinical and clinical studies, phases

of clinical trial and placebo)

4

Books Recommended

Sr.No. Title of the book Author/Editor Edition/Year Publisher

1-4 All Books under Pharmacology –II and

5 The Pharmacological

Basis of Therapeutics

Goodman and

Gilman,

11th 2006 McGraw –Hill Medical

Publishing

Title of the Course Pharmacognosy - II

Marks 50

Number of Hours per Week 2

Total Hours 30

Class Final Year B.Pharm.

Semester VII

Sr.No. Topic Hrs.

1 Carbohydrates – Agar, Alginic acid, Acacia, Aloe vera gel, Bael, Chitin, Dextrans,

Guar gum, Honey, Inulin, Irish moss, Ispaghula, Pectins, Starches, TKP, Tragacanth.

Biosynthesis of carbohydrates in brief

4

2 Acids - Citrus, Tamarind pulp, Garcinia, Amla 1

3 Fatty acids and their esters - Almond oil, Arachis, Castor, Chaulmoogra oil, Coconut

oil, Cotton seed oil, Croton, Linseed, Jajoba, Olive oil, Mustard oil, Neem, Sesame,

Wheatgerm oil, Fish liver oil, Cocoa butter, Kokum butter, Woolfat, Beeswax,

Carnauba wax, lecithin, Spermaceti. Biosynthesis of fatty acids and triglycerides.

4

65

4 Protein sand enzymes - Protein hydrolysate, Gelatin,; Pepsin, Renin, Trypsin,

Chymotrypsin, Thrombin, Papain, Ficin, Bromelain, Pancreatin, Hyaluronidase

2

5 Peptide toxins : Abrin, Botulinum toxin, Ricin, Bee venom, Snake venom, Scorpion

venom

1

6 Alkaloids: Derived from Ornithine: Belladonna*, Coca, Datura, Hyoscyamus,

Stramonium

Derived from Lysine :Black pepper*, Lobelia

Derived from Nicotinic acid: Areca, Tobacco

Derived from Phenylalanine: Ephedra

Derived from tyrosine and tyramine : Colchicum*, Opium*, Ipecac

Derived from tryptophan: Cathatharanthus, Cinchona*, Ergot*, Nuxvomica,

Rauwolfia

Derived from anthranilic acid : Vasaka

Derived from histidine : Pilocarpus

Purine alkaloids : Cocoa , Coffee, Cola, Tea

Terpenoid alkaloid : Aconite

Steroidal alkaloid : Kurchi, Solanum

20

7 Study of fibers (animal, vegetable, mineral, & synthetic) : Cotton, Jute, Flax,

Viscose, Cellulosics, Silk, Wool, Asbestos, Glasswool, Nylon, Terylene, Polythene

3

Books Recommended ; Will be recommended by the teacher

Title of the Course Pharmaceutical & Medicinal Chemistry-V

Marks 50

Number of Hours per week 2

Total Hours 30

Class Final Year B.Pharm.

Semester VII

Sr. No. Topic Hrs.

1 Antidiabetic agents:

a) Insulin

b) Sulfonylureas

c) PPAR-agonists and Misc.

1

2

1

2 Steroids:

a) Nomenclature and 3-D structure of steroids.

b) Biosynthesis and metabolism of steroids.

c) Corticosteroids – Glucocorticoids - systemic topical and inhaled,

Mineralocorticoids.

d) Male sex steroids and other related agents – Androgens and anabolic

steroids, Antiandrogens, androgen biosynthesis inhibitors, Drugs for

erectile dysfunction.

e) Estrogens- steroidal and non-steroidal, antiestrogens, SERMs. Aromatase

inhibitors.

Progestins & its inhibitors.

1

1

3

2

2

1

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3 Thyroid Agents:

a) Thyroid hormone and analogs.

b) Antithyroid agents

1

4 Introduction to eiconosides 1

5 Drugs for calcium homeostasis. 1

6 Vitamins and their involvement in metabolism :

a) Water soluble vitamins

b) Lipid soluble vitamins

c)

2

7 Introduction to pharmaceutical biotechnology: 1

8 Peptide and protein drugs 2

9 Introduction to antisense agents 1

10 Introduction to drug discovery:

a) Drug discovery from natural products.

b) Molecular modeling and drug design-ligand and structure based.

c) Enzymes and receptors in drug design.

Analog design and prodrugs

1

2

2

1

11 Emerging areas in medicinal chemistry. e.g. drugs based on PDEs and other

topics of current interest.

1

Books Recommended: As under Pharmaceutical Medicinal Chemistry –IV

Title of the Course Pharmaceutical Analysis-V

Marks 50

Number of Hours per week 2

Total Hours 30

Class Final Year B.Pharm.

Semester VII

Sr.No Topic Hrs.

1. Raw material analysis (RMA), Quality control of pharmaceutical excipient 5

2. Packaging material testing (PMT): Packaging material testing, permeability of

plastic, testing of foil, bottles, carrions, shipment.

6

3. Thermal analysis: Theory, introduction and applications of thermogravimetric

analysis (TGA), differential thermal analysis, DSC (Differential Scanning

Calorimetry), thermogravimetry – instruments available;

7

4. Atomic emission and atomic absorption spectrophotometry: Theory, introduction

and application;

5

5. Statistics and statistical quality control: Statistics in quality control – definition of

terms, normal distribution, T-test, F-test, linear regression, correlation coefficient,

statistical validation of analytical procedures – application to analysis; Methods of

statistical analysis as applied to sampling and interpretation of results, regression

regression lines – sampling procedures; Statistical quality control charts; Case

studies to be included.

7

Books Recommended: As under Pharmaceutical analysis –IV

67

Title of the course Biopharmaceutics And Pharmacokinetics

Marks 50

Number of hours per week 2

Total hours 30

Class Final Year B. Pharm.

Semester VII

Sr.No. Topic Hrs

1. Introduction: Definition: absorption, distribution, metabolism, excretion,

elimination, first pass effect, enterohepatic cycling, bioavailability,

biopharmaceutics, pharmacokinetics and pharmacodynamics

2

2. Pharmacokinetics parameters: biological half life, volume of distribution,

clearance: renal clearance, nonrenal clearance, additively of clearance, absolute

bioavailability relative bioavailability, bioequivalence, and other parameters

2

3. Concepts of compartment models: Pharmacokinetics of one compartment model,

mathematical treatment to pharmacokinetics upon i.v. bolus dosing, i.v. infusion

and first order extra vascular input; Methods of estimation of pharmacokinetic

parameters and parameters for bioavailability/ bioequivalence – including method

of residuals, excretion rate method, and sigma minus method of estimation of renal

clearance, renal clearance, mean residence time; Wagner Nelson method

8

4. Multicompartment models: Concepts and examples (excluding derivation or

mathematical treatment)

1

5. Plasma concentration and therapeutic response and introduction to

pharmacodynamics;

1

6. Non-linear pharmacokinetics: Non-linearities in absorption distribution,

metabolism and elimination, examples of drug showing nonlinear

pharmacokinetics

2

7. Dosage regimens: Factors affecting dosage regimens, individualization of dosage

regiments, therapeutic window, multiple dose pharmacokinetics, fluctuation,

accumulation index, steady state concept, time to reach steady state, loading dose,

maintenance dose, dose requiring individuation of dosage regimens

2

8. Drug absorption: Different mechanism of drug transport, passive transport and pH

partition theory, facilitated diffusion, active transport, blood and its drug binding

constituents as carriers of drugs in the body; Perfusion limitation and permeability

limitation and permeability limitation in drug transport; Physicochemical and

physiological factors affecting the absorption of drugs

4

9. Distribution: rate of distribution, perfusion limitation and permeability limitation,

extent of distribution , plasma and tissue binding of drugs, drugs with small,

intermediate and high volume of distribution and their relative plasma and tissue

binding

3

10. Elimination: Organ clearance concepts, hepatic clearance, hepatic extraction ratio,

blood flow limitation in hepatic clearance, first pas effect; Clinical application :

Effect of enzyme induction, enzyme inhibition, blood flow and protein binding on

hepatic clearance, bioavailability, steady state plasma concentration and dosage

3

68

regimens, renal clearance and mechanisms of renal excretion, estimation of renal

clearance, factors affecting renal elimination, clinical applications, biliary

clearance, enterohepatic circulation and other miscellaneous modes of drug

elimination

11. In vitro: in vivo Correlation: Official and unofficial methods of estimation of

dissolution / in – vitro release of drugs from dosage forms; In-vitro in-vivo

correlation and its significance.

2

Books Recommended

Title of the Course Pharmaceutical Biotechnology

Marks 50

Number of Hours per Week 2

Total Hours 30

Class Final Year B. Pharm.

Semester VII

Sr. No Topic Hrs.

1 Defintition of biotechnology, the different aspects of biotechnology,

pharmaceutical biotechnology and its role in producing therapeutics and

diagnostics and in health care

4

2 Therapeutic proteins, Nucleic acids (Antisense RNA technique).Animal and plant

cell culture: Brief introduction to cell culture with respect to the properties of

animal and plant cells, media requirements, typical media used, typical methods

for setting up primary culture, cell strains vs cell lines. Use of plant/animal cell

culture for production of pharmaceuticals. Recombinant DNA technology for

plant cell culture via use of Agrobacterium species.

6

Sr.No. Title Author/Editor Edition Publisher

1 Biopharmaceutics &

Pharmacokinetics-A

Treatise

D.M. Brahmankar,

Sunil B. Jaiswal

1st, 1995 Vallabh Prakashan

2 Biopharmaceutics &Clinical

Pharmacokinetics-An

Introduction

Robert E. Notari 4th, 1971 Marcel Dekker Inc.

3 Clinical Pharmcokinetics-

Concepts & Applications

Malcolm Rowland

Thomas N. Tozer

2nd, 1989 Lea &

Febiger,Philadelphia

4 Biopharmaceutics &Clinical

Pharmacokinetics

Milo Gibaldi 3rd, 1984 Lea & Febiger,

Philadelphia

5 Pharmacy Review Leon Shargel 1990 Wiley Medical

Publication

6 Principles & Applications of

Biopharmaceutics &

Pharmacokinetics

Dr.H.P.Tipnis

Dr.Amrita Bajaj

2004 Career Publication

69

3 Genomics in Clinical Diagnostics: Restriction fragment length polymorphism,

Gel electrophoresis techniques (PAGE, SDS-PAGE and agarose gel

electrophoresis), immunoblotting, Southern blotting, Northern blotting, Western

blotting, PCR and RT PCR, Sanger dideoxy method of sequencing.

3

4 Immunity, methods of immunization, principles of serology, antigen antibody

reactions, generation of immune response, polyvalent antibodies, hypersensitivity

responses. Preparation and characterization of immune sera, and allergenic

extracts. Monovalent antibodies or monoclonal antibodies, hybridoma

technology, humanization of monoclonal antibodies, application of monoclonals

in therapeutics and diagnostics RIA and ELISA diagnostic methods.

6

5 Vaccines: Preparation and standardization of vaccines. Discussion of different

types of vaccines, different approaches for vaccine preparation and their quality

control parameters

4

6 Pharmacogenomics 4

7 Tutorials 3

Books Recommended : Will be recommended by the teacher

Title of the Course Assignments (Medicinal Chemistry)

Marks 50

Number of Hours per week 2

Total Hours 30

Class Final Year B.Pharm.

Semester VIII

Sr. No. Topic

1. There will be several problem solving sessions where there will be discussions on

methodology and approaches to solve problems including discussions on how to gather

information from internet and literature. The problems will be given to the students as

home assignments where students can go through the literature and come out with

solutions and present it in the class. There shall be many assignments. No assignment

shall be of more than 10 marks. The student shall submit the assignment in A4 size paper

either hand written or typed and pinned together. Marks will be awarded by the teacher

and at the end of the semester teacher will submit the marks along with the assignment

copies of all the students to the office.

Title of the Course Assignments (Biopharmaceutics)

Marks 50

Number of Hours per week 2

Total Hours 30

Class Final Year B.Pharm.

Semester II

Sr.No Topic

1. There will be several problem solving sessions where there will be discussions on

methodology and approaches to solve problems including discussions on how to gather

information from internet and literature. The problems will be given to the students as

70

home assignments where students can go through the literature and come out with

solutions and present it in the class. There shall be many assignments. No assignment shall

be of more than 10 marks. The student shall submit the assignment in A4 size paper either

hand written or typed and pinned together. Marks will be awarded by the teacher and at

the end of the semester teacher will submit the marks along with the assignment copies of

all the students to the office.