Forth Year B. Pharm [ Syllabus, Saurashtra University, Rajkot ]
SR.
NO.
SUBJECT
MARKS*
Theory
Practical
1
Biotechnologyand Biological Pharmaceuticals
100
100
2
Pharmaceutical
Technology
100
100
3
Pharmaceutical
Dosage Form Design
100
100
4
Biopharmaceutics
and Pharmacokinetics
100
---
5
Medicinal
Chemistry II
100
100
6
Pharmaceutical
Analysis (Instrumental Analysis)
100
100
7
Pharmacognosy
IV
100
100
8
Pharmacology
III
100
100
* 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,
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….
9.
Gene diagnosis, gene therapy and genetic delivery systems.
10.
Bioinformatics and Healthcare
11.
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.
2.
Tutorial Pharmacy-Carter.
3.
Surgical Dressings, Ligatures and Sutures – Fish and Dawson.
4.
SAQ 10 + Kin,, W.A. Orenteinetal Vaccine 3,e 1999
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.
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
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
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.]
Classification, general chemistry and structural formulas of vitamins including in IP, detailed chemistry of Vit-A, B1, B2
NOTE : - Biochemical approaches in drug desgining wherever applicable should be iscussed.
PRACTICALS
3 HOURS / WEEK
1.
Synthesis of selected drug from the course content involving two or more steps, Spectralanalysis of drugs synthesized.
2.
Establishing the pharmacopoeial standards of the drugs synthesized
3.
Organic spotting of binary mixtures with derivative preparations and TLC.
4.
Excersises based on QSAR: Hansch and free-Wilson methods.
5.
Determination of Partition Coefficient, Dissociation constant and Molar refractivity of compounds for QSAR analysis.
6.
Experiments designed on drug metabilism.
BOOKS RECOMMENDED
1.
Wilson and Gisvold`s Text Book of Organic Medicinal and Pharmaceutical Chemistry. Edited by J.N. Delgado and William A. Remers , J.B. Lippincott Company Philadelphia.
2.
Principles of Medicinal Chemistry by W.C. Foye, Lea and Febiger Philadelphia.
3.
Bergers Medicinal Chemistry – H.E. Wolf , Jhon Wiley and Sons New YorkOxford Univwrsity Press, Oxford.
4.
The Organic Chemistry of Drug Synthesis Volume 1-6 by Deniel Lednocer , John Wiley and sons, Inc. New York.
5.
Pharmaceutical Substances Synthesis (two parts) ,patents, applications by A. Kleemann, J.Engel by Thieme Stuttgart New York.
Principles of Medicinal Chemistry by Dr. S. S. Kadam, K.G. Bothara , Nirali Prakashan Pune .
8.
Medicinal and Pharmaceutical Chemistry by Harkishan Singh, V.K.Kapoor by Vallabh Prakashan New Delhi.
9.
Fundamentals of Drug Metabolism and Disposition by H.N. Ladu, H. G. Mandal and E.L. Way Williams and Wi;kins Co. Baltimore.
10.
Vogale`s Text Book of Practical Organic Chemistry , ELBS / Longman , London.
11.
Practical Organic Chemistry BY Mann and Saunder. Orient Longman, UK.
12.
The Systematic Identification of Organic Compounds byshriner, Hermann,Morrill, Curtin & Fuson, John Wiley and sons , USA.
13.
An Introduction To The Chemistry Of heterocyclic Compounds by R.M. Acheson Wiley Eastern Ltd. New Delhi.
14
Spectrometric identification Of Organic Compounds by R. M. Silverstein, G. Claytorn Bassel`s. T.C. Mivvill. John wiley & sons USA.
15.
Organic spectropscopy by William Kemp .ELBS, London.
Pharmaceutical Analysis (Instrumental)
1.
Introduction :
Scope of instrumental methods of analysis in pharmacy .
2.
Liquid chromatography :
High performance liquid chromatography ; Theory , instrumentation and pharmaceutical application.
3.
Gas chromatography :
Theory , instrumentation and pharmaceutical applications.
4.
Electronic absorption spectroscopy in near ultraviolet and visible :
Theory ; Introduction, molecular electronic structure and the absorption of radiation by molecule. Instrument components and configuration. Quantitative analysis ; General principle and specific techniques. Application of pharmaceutical interest
5.
Infra red spectroscopy :
Theory, instrumentation, preparation of sample, interpretation of IR-spectra and pharmaceutical application.
6.
Fluorescence spectroscopy :
Origin of fluorescence, structural requirement of fluorophore, relationship between concentration and fluorescence intensity, analytical factors, instrumentation and pharmaceutical application.
7.
Radio chemical techniques :
Fundamental of radioactivity, properties of radio active rays, radiation protection, measurement of radioactivity, radio chemical laboratories, sample preparation , radio pharmaceuticals and its quality control, radiochemical methods in analysis, radio immunoassay and related immunoassay.
8.
Atomic emission spectroscopy :
Theory instrumentation and application flame photometry.
9.
Magnetic resonance spectroscopy :
Introduction and theory, instrumentation and sample handling, chemical shift, spin-spin coupling, application.
10.
Mass spectrometry :
Introduction, instrumentation, mass spectrum, fragmentation, rearrangement and pharmaceutical application.
11.
Introduction to miscellaneous techniques:
-
Conductometric and potentiometric titration.
-
X-ray methods
-
Thermal analysis
-
Electrophoresis
-
Atomic absorption spectroscopy
-
Validation of instrument and analytical methods
Pharmaceutical Analysis (Instrumental)
Fourth B Pharm - Practical
Exercise for the practical are to be selected whenever possible from IP,BP, USP , NF etc. sufficient practice must be given for the analysis of dosage forms and raw materials based on following techniques :
-
Colorimetry, UV- spectrophotometry, fluorimetry, IR spectroscopy, Flame photometry.
-
Potentiometry, polarography,
-
Gas chromatography, HPLC, TLC, Column chromatography.
-
Solvent extraction
-
Determination of Water in Pharmaceuticals.
BOOKS RECOMMENDED
1.
Instrumental method of analysis- Willard, Merrit, Dean, Settle - CBS
2.
Practical Pharmaceutical Chemistry, part-II – Beckett and Stenlake
3.
Instrumental methods of chemical analysis – Ewing
4.
A text book of Pharmaceutical analyasis – Kenneth A. Connor
5.
Pharmaceutical analysis – James W. Munson Part-A and B
6.
Spectrometric identification of Organic compounds – Silverstein, Bassler and Morrill – Wiley
7.
Vogel’s text book of quantitative analysis.
8.
Principle of Instrumental analysis – D.A. Skoog and D.M. West - CBS
9.
Quality assurance principle for analytical laboratory – Garfield
10.
Quantitative analysis of drugs in Pharmaceutical formulation – P.D. Shethi
11.
Modern methods of Pharmaceutical analysis – Roger E. Schinger – CRC
12.
IP, BP, USP, BPC, NF
Pharmacognosy - IV
THEORY
1.
world – wide trade in medicinal plants and derived products with special reference to diosgenin (doscorea) , taxol (Taxus spp.) ditialis, tropane alkaloid containing plants papain cinchona, Ipecac, iquorice, gingers, aloe, valerian, cauwolfia and plants containing laxatives, artemisia, camptothesia;
2.
A brief account of plant based industries and institution involved in work on medicinal and aromatic plants in india. Utilization and production of phytoconstituents such as quinine, calcium sennosides, podophyllotoxin, diosgenin. Solasodine and tropane alkaloids.
3.
Utilization of aromatic plants and derived products with special reference to sandalwood oil. Mentha oil, lemon grass oil, vetiver oil, geranium oil and eucalyptus oil.
4.
Historial development of plant tissue culture, type of cultures, nutritional requirements, growth and their maintenance. Applicatins of plant tissued culture in pharmacognosy, Plant cell immobilization.
5.
Chemotaxonomy of medicinal plants.
6.
Marine pharmacognosy, novel medicinal agents from marine sources.
7.
Natural allergens and photosensitizing agents andn fungal toxins. (b) perticider of natural origine.
8.
Herbs as health food
9.
Herbal cosmetics on commercial scale.
10.
Introduction, classification and study of different chromatographic methods and their applications in evaluation of lherbal drugs.
11.
Studies of traditional drugs, common vernaculor names,botanjical sources, morphology (1) Chemical nature of chief constituents (2) pharmacology, categories and common uses and market3ed formulations of following indigenous drugs:
Clinical pathology (Urine analysis, examination of body fluids, semen analysis, stool examination)
-
Interpretation of laboratory findings in haematology
13.
Multi Drug Resistance
14.
Patient Counseling
-
Introduction
-
Factors associated with non-compliance
-
Consequences of non-compliance
-
The pharmacist and patient compliance
15.
Drug therapy in Pediatric patients
-
Introduction
-
Pharmacokinetic considerations and therapeutic monitering
-
Drugs in antenatal period (during pregnancy)
-
Adverse drug reactions and toxicity
-
Drug therapy during lactation
-
Immunization
16.
Pharmacogenetics
17.
Development of new drugs
-
Evolution of a drug
-
Pre clinical evaluation(animal studies)
-
Clinical evaluation(Human studies)
-
Phases of clinical trial (Phase I, II, III & IV )
18.
Radio pharmaceuticals
19.
Rheumatism
20.
Screening and Evaluation of Drugs
-
Screening and testing of some specific classes of drugs.
-
Screening of antifertility drugs, Hepatoprotective activity, Anti inflammatory drugs, CVS drugs, Anti diabetic drugs, Neuropharmacological agents.
-
Screening techniques in ocular pharmacology.
21.
Toxicology, Types of toxicity, Toxicity testing
-
Heavy metals and antagonists
-
General principles of treatment of acute poisoning and
-
environmental and occupational toxicology
22.
Virology
-
Structure ans characteristics of viruses
-
Viral diseases
-
Management of viral disesases
-
Pharmacology of antiviral drugs
BOOKS RECOMMENDED
1.
Clinical Pharmacokinetics /3rd Edition/Rowland and Tibzer/Williams & Wilkins
2.
Clinical Pharmacokinetics - Pocket Reference, 2nd Edition/Murphy/American Society of Health-System Pharmacists
3.
Drug Interaction Facts/Facts and Comparisons/up-dated quarterly
4.
Drug Facts and Comparisons/Covington, et al/Facts and Comparisons/updated monthly
5.
Pharmacology/4th Edition/H. Rang/Harcourt Health Sciences Group
6.
Pharmacotherapy: A Physiologic Approach/3rd Edition/Appleton & Lange
7.
Principles of Clinical Toxicoldgy Edition/Oossel & Bricker/lippincott-Raven
8.
Textbook of Therapeutics: Drug and Disease Manage-inentf7th Edition/Herfindal and Oouriey/lippincott Williams and Wilkins
9.
Goodman and Gillman’s The Pharmacological Basis of Therapeutics Edition/ Hardroan, et al/McGraw Hill
10.
Ebadi
11.
Laurence
12.
Crossland
B.Pharm R. 29 :
To pass an examination, candidate must obtain atleast 40% marks in theory (including sessional) and practical (including sessional) seperately of each subject and must obtain at least 50 % of the total marks assigned to the whole Fourth B.Pharm Examination.
Successful candidates shall be awarded classes on the basis of total of percentage of marks obtained by them (including sessional) at the Second B. Pharm, Third B. Pharm and Fourth B. Pharm examinations
Those obtaining 70% of the total and above
:
Distinction
Those obtaining 60% and above but below 70% of total
:
First Class
Those obtaining 50% and above but below 60% of the total
:
Second Class
B.Pharm R. 30 :
A candidate who has secured 50 % of the total marks in any subject (including sessional) at the Fourth B. Pharm examination, at his option be exempted from appearing in that subject at subsequent examination provided he has passed all the heads of passing in that subject.
Candidate will be declared to have passed the Fourth B. Pharm examination when he has passed in all the remaining subjects and has obtained the aggregate 50 % marks in all the subjects.
Candidate passing the fourth B. Pharm examination in this manner by compartments, shall not be eligible for a prize or scholarship to be awarded at the examination.
