.:: Fourth Year B. Pharm ::.
Syllabus, Saurashtra University, Rajkot

* Marks includes sessional marks, 20% in each theory and practical)

Biotechnology  and Biological Pharmaceuticals

1.         Biological obtained by fermentation

Fermentation-general requirements-culture-strain development media-equipments sterilization-fermentation process-controls-extraction, etc. Detailed production of selected antibiotics, vitamins, Organic  acid, specially following,

Antibiotics-Penicillin, Erythromycin, Bacitracin, Streptomycin

Vitamins-Cynocobalamine, Riboflavin OR Vitamin C

Organic Acid- Citric Acid, Lactic Acid, Glutamic Acid

Solvents-Butanol, Ethanol, Glycerol

Enzymes and Immobilized drugs, Enzymes.

Preparation of growth hormones, Insulin, Hepatitis-B vaccine, Interferon’s, staumonals penditide etc.

Study of microbiological transformations of steroids and others reactions and    Ch . transformation.

2.         Gene Cloning, Hybridoma technology and monoclonal antibody preparation techniques and its applications.

3.         Surgical dressings, sutures and ligatures

Definitions, primary would dressings, absorbents surgical cotton, surgical gauzesetc. bandages,            Adhesive tape, protective, cellulose hemostats, official dressings, absorbable sutures – catgut and others, nonnabosorbable sutures, and others.

4.         Immunological and prophylactic preparations

Immunology of vaccination Antigens, Immune systems- humoral immunity –cellular immunity, privileged graft sites, graft-host reaction,  tolerance, immunogenetics, Immunity-natural-acquired            Hypersensitivity and other reactions, active immunization products- bacterial vaccines- toxoids-             Viral vaccines rickettsial vaccines; passive immunization products-antitoxins-antivenins-immune             serums-immune blood derivatives and other products related  to immunity, diagnostic biological,           

            Gen immunization practice storage and control of products.

5.         Glandular Products

Preparation of extracts of isolation  of pure substances for the preparation of dosage forms from :Pituitary, adrenal pancreas, thyroid parathyroid ovary, liver, stomach etc.

6.         Cruds drug extracts

Principles and methods of preparation of dry-soft-liquid extracts of the I.P. fresh  or dry plant drugs.

7.         Allergenic extracts                

Types of allergens, preparation of extracts, testing and standardization of extracts, general Preparations                                                                                                           

8.         Blood products and plasma substitutes-                                                                   Collection, processing and storage of: whole human blood, blood components, concentrated human R.B.C. dried human plasma, human plasma protein fraction, dried human serum, human fibrinogen ,human thrombin, human normal immunoglobulins human fibrin foam: plasma substitutes- ideal requirements PVP-Dextran etc. control of blood products as per I….

8.         Gene diagnosis, gene therapy and genetic delivery systems.

9.         Bioinformatics and Healthcare

10.       Study of new biotechnology -Healthcare products

Biological Pharmaceutical Practical

Experiments designed in the preparation and standardization of surgical dressings, sutures ligatures, different immunological products, preparation, extraction and standardization of different products of fermentation, preparation and testing of glandular product Allergenic extracts and crude drugs extracts and other experiments to illustrate the covered in theory.

                                                            BOOKS RECOMMENDED                                            

1.         Remington’s   Pharmaceutical Sciences-hoover.

1.                  Tutorial  Pharmacy-Carter.

2.                  Surgical Dressings, Ligatures and Sutures – Fish and Dawson.

3.                  SAQ 10 + Kin,, W.A. Orenteinetal Vaccine 3,e 1999

4                                                                     

PHARMACEUTICAL TECHNOLOGY

4.1       Pharmaceutical Plant, location, layout:

Plant location and lay out of an industry

Various factors affecting locational aspects of chemical and pharmaceutical plants. Layout of plant building and importance of flow sheet,  difference  between scientific process and technological process, layout of various departments  , equipments, product lay out v/s process layout..

4.2       Powders:

Advantages and limitations as dosage form, manufacturing procedure and equipments, special care and problems in manufacturing powders, powders of IP, effervescent granules and salts.

4.3       Capsules:

Hard gelatin capsules, shell formulation and manufacturing sizes, storage, painting, filing, cleaning, binding, general formulation of contents, evaluation, soft gelatin capsules, shell formulation, content formulation, filing, micro encapsulation, advantages, coating material, methods of application of coating materials, I.P. formulations.

4.4       Tablets:

types, ideal requirement, classification, granulation methods, general formulation, compression machines, difficulties in preparation, evaluation, sugar coating, compression coating, film coating, IP formulations.

4.5       Parenterals- product requiring sterile packaging

Definition, types advantages and limitations, general formulation, vehicles, production procedure, production facilities, controls, tests, selected IP, injections, sterile powders, implants, emulsions,  suspensions.

4.6       Suspensions:

Formulation of deflocculated and flocculated suspension, manufacturing procedure, evaluation methods, IP suspensions.

4.7       Emulsions:     

Types, emulsifying agents, general formulation, manufacturing procedure, evaluation methods, IP emulsions.

4.8       Suppositories:

Ideal requirements, bases, manufacturing procedure, evaluation methods, IP products.

4.9       Semisolids:

Definitions, bases, general formulation, manufacturing procedure, evaluation methods, IP products.

4.10    Liquids(solutions, syrups, elixirs, spirits, aromatic water, liquid for external uses)

            Definition, general formulation, manufacturing procedure, evaluation methods, IP products.

4.11    Pharmaceutical aerosols:

            Definition, propellants, general formulation, manufacturing and packaging methods, pharmaceutical applications.

4.12    Radio Pharmaceuticals:

            Therapeutic uses, diagnostic uses, facilities and work area, preparation of radio pharmaceuticals, radio pharmaceuticals used in medicines.

4.13    Ophthalmic preparations

Requirement, formulation, methods of preparation, containers, evaluation, IP products.

4.14    Cosmetic formulations:

Formulation and preparation of dentifrices, hair creams, lipsticks, face powders, shaving  preparations, skin creams, shampoos, hair dyes, depilatories, manicure preparations etc.

Pharmaceutical Technology Practical

IP and other pharmaceutical products to be selected to illustrate the preparation, stabilization and physical evaluation of:

Powders

Capsules

Tablets

Parenterals

Suspensions,

Emulsions

Semisolids,

Liquids

Ophthalmic etc.

Preparation and evaluation of cosmetics preparations mentioned in syllabus

Books recommended

1.               Remington’s pharmaceutical science

2.               American Pharmacy_ Sprowls and Boal

3.               Induatrial Pharmacy-Lachman and others

4.               Physical Pharmaceutics- Shotton and Ridgway

5.               Bentley’s Text Book of Pharmaceutics- Rawlins

Pharmaceutical Dosage Form Design:

1          Reformulations:

Consideration of Importance, physical properties, physical forms, particle size, crystal forms, bulk control, solubility, wetting, flow cohesiveness, compressibility, organoleptic properties and its effect on final product.

Consideration of Chemical properties, hydrolysis, oxidation, recemization, polymerization, isomerization, decaboxylation, enzymatic decomposition, formulation additives, stabilizers, suspending and dispersing agents, dyes, solid excipients etc. and its effect on quality of finished product.

2.         Dosage Form Necessities and Additives:

Antioxidants, preservatives, coloring agents, flavoring agents and diluting agents, emulsifying agents, suspending agents, ointment bases, solvents, and others.

3.         Stability of formulated products

Requirements, drug regulatory aspects, pharmaceutical products stability, self life, overages, containers, closures

4.         Kinetic Principles and Stability Testing:

Reaction rate and order, acid base catalysts, decomposition reactions, methods of stabilization and stability testing.

5.         Prolonged Action Pharmaceuticals:

Benefits, limitations, oral  products, terminology, drug elimination rate, types and construction of implants products, products evaluation, parenteral products, absorption and evaluation.

6.         Novel Drug delivery system:

Critical fluid technology, transdermal drug delivery system, controlled drug delivery system, multiple emulsion, neon particles, targeted drug delivery system, aerosols, inhalation  & new products reported etc.

 Pharmaceutical Dosage Form Design Practicals

 Experiments devised to study the formulation of dosage forms, stability testing, formulated dosage forms, evaluation of stable dosage forms, evaluation of dosage form, necessity in manufacturing of dosage forms, evaluation of prolonged action dosage form, bioavailability testing, and others to illustrate the topics mentioned in theory.

 Books recommended

1.               Remington’s Pharmaceutical Science

2.               Theory and Practice of Industrial Pharmacy-Lachman and others

3.               Bentley’s Text Book of Pharmaceutics_ Rawlins

BIOPHARMACEUTICS & CLINICAL  PHARMACOKINETICS

INTRODUTION (Pharmacokinetics)

Biopharmaceutics:

 Fate of drug after drug absorption, drug concentration in blood, biological factors in drug absorption, physicochemical factors, dosage form consideration for gastrointestinal absorption, drug distribution site seeking drugs, drug elimination.

   1.                  Introduction to Pharmacokinetics

2.                  Compartmental and Noncompartmental Pharmacokinetics

3.                  Gastrointestinal  Abspr[topm-Biologic Considerations

4.                  Gastrointestinal Absorption-Physicochemical Considerations

5.                  Gastrointestinal Absorption-Role of the Dosage Form

6.                  Nonoral Medication

7.                  Prolonged Release Medication

8.                  Bioavailability

9.                  Drug Concentration and Clinical Response

10.             Drug Diposition-Distribution

11.             Drug Diposition-Elimination

12.             Pharmacokinetic Variability-Body Weight, Age, Sex and Genetic Factors

13.             Pharmacokinetic Variability-Disease

14.             Pharmacokinetic Variability-Drug Interactions

15.             Individualization and Optimization of Drug Dosing Regiments

 Drug  Development Regulatory Requirements , (I) cGMP , (II) Process Validation, (III) International Conference on Harmonization (ICH) and Its benefits and implication in drug development. IV ,Guide lines for Biomedical 

 Research on human Subjects ,ICMR guideline . ICMR CODES ,Schedule –Y- of D & C ACT 1940 etc

BIO-AVAILABILITY & BIO EQUIVALANCE

Quality parameters of dosage forms Assay methods & its validation

Physico - chemical properties of drugs & added substances and its effect on preparations and biological availability of dosage forms.

Pharmaceutical properties of  dosage forms , disintegration ,dissolution rate

Biological , pharmacological effects of dosage  forms

Factors affecting Bio availability , Determination of  bioavailability

 Design & implementation of Bioequivalance   studies

Statistical analysis of  bioequivalence  studies

 Development, scale  up & post approval changes[ SUPAC]

& in vitro [ Dissolution] in vivo [ plasma concentration profile] correlation or IV / IV  correlation

Multi stage - Bioequivalence studies

Therapeutic   equivalence

Titration design for clinical rationales

New Drug Application  [ NDA]

CLINICAL TRIAL

A, PHASE  1    Clinical Trial

Introduction ,various methods , consideration of ethnic factors

B,PHASE 11- CLINICAL TRIAL

Various approach ,

Sequential[crossover] design

Multistage design

C,PHASE 111- CLINICAL TRIAL

Unstratified & stratified design

Phase 111-with multi experimental arms

Climical  end point

Mutiple end point

Surrogate end point

BIO PHARMACEUTICAL STATISTICS

Post Maketing Surveillance

 Process Validation

Books Recommended

1.                  Milo Gibaldi, Bio Pharmaceutics and Clinical Pharmacokinetics 4/e, Lea and Bebiger

2.                  Gordon L Amidon, Ping 1-Lec and Elizabeth M Topp, Transport Processes in Pharmaceutical System, Vol 102 by Marcel Dekker Inc. USA

3.                  Welling and TSE, Pharmacokinetics Regulatory, Industrial and Academic Prospectives 2/e Vol 57, Dekker

4.                  Willing and TSE, Pharmaceutical Bioequivalence, Vol 48, Dekker

5.                  Willing and Stoker, Good Manufacturing Practice, Vol 78, Dekker

6.                  M. R. Hamrel, Clinical Audit in Pharmaceutical Development, Vol-104, Dekker

7.                  Willing, Good Manufacturing Practice In Pharmaceuticals, Vol 109, Dekker

8.                  Leon Shargel, Comprehensive Review of Pharmacy, 3rd Edition.

9.                  Raymond J. M. Niesink and John de Vries, Toxicology Principles and Applications

10.             Shein-Chung Chow --Ecly Biopharmaceutical statistics 2000 Dekker

MEDICINAL CHEMISTRY – II                                    

THEORY - 3  Lectures/ WEEK

1.      Drug metabolism and concepts of prodrug.

2.      Principles of drug design [Theoretical aspects ] Quantitative structure

activity relationship (QSAR), mechanism based approaches. Introduction to graph theory, applications of quantum mechanics, Computer aided drug designing(CADD) molecular modeling.

3.   Synthetic procedure of selected drug, mode of action (mechanism of action), uses structure activity relationship including physico chemical properties of following classes of drug.

A.      Drugs acting on Cardiovascular system:

Cardio tonic drugs,Antihypertensive agents,Antianginal drugs,Antiarrhthmic drugs,Antihyperlipidemic agents,Antiplatelates,Thrombolytic drugs,Coagulants and anticoagulants.

B.      Diuretics.

C.      Steroids and related drugs.

Steroidal nomenclature and stereo chemistry, Androgens and anabolic agents, Estrogens and progesterones,Adrenocorticoids,Oral contraceptives.

D.     Chemotherapy:

General principle of chemotherapy, Sulphonamides and sulphones, Antibiotics, Tuberculostatic angents,Antifungal agents,Antival including anti-HIV agents, Antineoplastic agents,Drug used in protozoal parasitic and other infection,Antimalarial agents,Antiamoebic drugs.

E.      Immunosuppressives and immunostimulants.

F.      Amino acids, peptide,nucleotides and related drugs.

(i)               Thyroid and antithyroid drugs.

(ii)             Insulin and oral hypoglycaemic agents

(iii)           Peptidomimetics and nucleotidomimetics.

(iv)           Oxytocics [including oxytocin, ergot alkaloids and prostaglandins.]

G.     Drug used in Hyper acidity and  Peptic Ulcer.

H-₂ receptor antagonist, Proton-pup inhiitor, Antacids.

      H. Vitamins

Classification, general chemistry and structural formulas of vitamins including in IP, detailed chemistry of Vit-A, B1, B 2

NOTE :-    Biochemical approaches in drug desgining wherever applicable  should

be  iscussed.

PRACTICALS                                                                    3HOURS / WEEK