GTU B Pharm Sem 6 Full Syllabus
GTU B Pharm Sem 6 Full Syllabus
GTU B Pharm Sem 6 Full Syllabus
Bachelor of Pharmacy
Subject Code: BP601TP
SEMESTER: VI
Subject Name: Medicinal Chemistry III
Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and
therapeutic value of drugs. The subject emphasis on modern techniques of rational drug design like
quantitative structure activity relationship (QSAR), Prodrug concept, combinatorial chemistry and
Computer aided drug design (CADD). The subject also emphasizes on the chemistry, mechanism of action,
metabolism, adverse effects, Structure Activity Relationships (SAR), therapeutic uses and synthesis of
important drugs.
Sr No Topics %
weightage
1. Antibiotics 10
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of the
following classes
β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors,
Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline,Oxytetracycline, Chlortetracycline, Minocycline,
Doxycycline
2. Antibiotics 10
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of the
following classes
Macrolide: Erythromycin Clarithromycin, Azithromycin
Miscellaneous: Chloramphenicol*, Clindamycin
Prodrugs: Basic concepts and application of prodrugs design.
Antimalarials: Etiology of malaria
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,
Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.
3. Anti-tubercular Agents 10
Synthetic anti tubercular agents: Isoniozid*, Ethionamide, Ethambutol,
Pyrazinamide, Para amino salicylic acid.*
Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine
Streptomycine, Capreomycin sulphate
Urinary tract anti-infective agents
Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin,
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP601TP
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin,
Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine
Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine
trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine,
Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir, Ritonavir.
Antifungal agents: 8
4. Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole,
Oxiconazole Tioconozole, Miconazole*, Ketoconazole, Terconazole,
Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*.
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide,
Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.
Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*,
Albendazole, Niclosamide, Oxamniquine, Praziquantal, Ivermectin.
Sulphonamides and Sulfones
Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*,
Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate,
Sulfasalazine
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole
Sulfones: Dapsone*.
5. Introduction to Drug Design 7
Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity relationship
(QSAR) such as partition coefficient, Hammet’s electronic parameter, Tafts
steric parameter and Hansch analysis
Pharmacophore modeling and docking techniques.
Combinatorial Chemistry: Concept and applications of Combinational
chemistry: solid phase and solution phase synthesis.
Study of the development of the following classes of drugs, Classification, mechanism of action, uses of
drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the
course and synthesis of drugs superscripted by (*)
Practical
I Preparation of drugs and intermediates
1. 1 Sulphanilamide
2. 2 7-Hydroxy, 4-methyl coumarin
3. 3 Chlorobutanol
4. 4 Triphenyl imidazole
5. 5 Tolbutamide
6. 6 Hexamine
II Assay of drugs
1. 1 Isonicotinic acid hydrazide
2. 2 Chloroquine
3. 3 Metronidazole
4. 4 Dapsone
5. 5 Chlorpheniramine maleate
6. 6 Benzyl penicillin
III Preparation of medicinally important compounds or intermediates byMicrowave irradiation technique
IV Drawing structures and reactions using chem draw®
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP601TP
V Determination of physicochemical properties such as logP, clogP, MR, Molecular weight, Hydrogen
bond donors and acceptors for class of drugs course content using drug design software Drug likeliness
screening (Lipinskies RO5)
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP602TP
SEMESTER: VI
Subject Name: Pharmacology III
Scope: This subject is intended to impart the fundamental knowledge on various aspects (classification,
mechanism of action, therapeutic effects, clinical uses, side effects and contraindications) of drugs acting
on respiratory and gastrointestinal system, infectious diseases, immuno-pharmacology and in
addition,emphasis on the principles of toxicology and chronopharmacology.
Objectives: Upon completion of this course the student should be able to:
1. understand the mechanism of drug action and its relevance in the treatment of different infectious
diseases
2. comprehend the principles of toxicology and treatment of various poisoningsand
3. appreciate correlation of pharmacology with related medical sciences.
Sr No Topics %
weightage
1. Pharmacology of drugs acting on Respiratory system 10
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
d. Nasal decongestants
e. Respiratory stimulants
2. Pharmacology of drugs acting on the Gastrointestinal Tract
a. Antiulcer agents.
b. Drugs for constipation and diarrhoea.
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.
3. Chemotherapy 10
a. General principles of chemotherapy.
b. Sulfonamides and cotrimoxazole.
c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides,
quinolones and fluoroquinolins, tetracycline and aminoglycosides
Chemotherapy 10
4. a. Antitubercular agents
b. Antileprotic agents
c. Antifungal agents
d. Antiviral drugs
e.Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents
5. Chemotherapy 8
l. Urinary tract infections and sexually transmitted diseases.
m. Chemotherapy of malignancy
Immunopharmacology
a. Immunostimulants
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP602TP
b. Immunosuppressant
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars
6 Principles of toxicology 7
a. Definition and basic knowledge of acute, subacute and chronic toxicity.
b. Definition and basic knowledge of genotoxicity, carcinogenicity,
teratogenicity
and mutagenicity
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine,
organophosphosphorus compound and lead, mercury and arsenic poisoning
7 Chronopharmacology
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy.
Practical
1. Dose calculation in pharmacological experiments
2. Antiallergic activity by mast cell stabilization assay
3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and
NSAIDS induced ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi- autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens ( rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon Signed Rank test)
*Experiments are demonstrated by simulated experiments/videos
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP603TP
SEMESTER: VI
Subject Name: Herbal Drug Technology
Scope: This subject gives the student the knowledge of basic understanding of herbal drug
industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics,
natural sweeteners, nutraceutical etc. The subject also emphasizes on Good Manufacturing
Practices (GMP), patenting and regulatory issues of herbal drugs
Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .
Sr No Topics %
weightage
1. Herbs as raw materials 11
Definition of herb, herbal medicine, herbal medicinal product, herbal drug
preparation Source of Herbs Selection, identification and authentication of
herbal materials Processing of herbal raw material
Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic
farming. Pest and Pest management in medicinal plants:
Biopesticides/Bioinsecticides.
Indian Systems of Medicine
a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz Aristas and
Asawas, Ghutika,Churna, Lehya and Bhasma.
2. Nutraceuticals 7
General aspects, Market, growth, scope and types of products available in the
market. Health benefits and role of Nutraceuticals in ailments like Diabetes,
CVS diseases, Cancer, Irritable bowel syndrome and various Gastro intestinal
diseases. Study of following herbs as health food: Alfaalfa, Chicory, Ginger,
Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina
Herbal-Drug and Herb-Food Interactions: General introduction to
interaction and classification. Study of following drugs and their possible side
effects and interactions: Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic,
Pepper & Ephedra.
3. Herbal Cosmetics 10
Sources and description of raw materials of herbal origin used via, fixed oils,
waxes, gums colours, perfumes, protective agents, bleaching agents,
antioxidants in products such as skin care, hair care and oral hygiene products.
Herbal excipients:
Herbal Excipients – Significance of substances of natural origin as excipients –
colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors
& perfumes.
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP603TP
Herbal formulations :
Conventional herbal formulations like syrups, mixtures and tablets and Novel
dosage forms like phytosomes
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs 10
4. Stability testing of herbal drugs.
Patenting and Regulatory requirements of natural products:
a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right,
Bioprospecting and Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study
of Curcuma & Neem.
Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation
of manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU
drugs
5. General Introduction to Herbal Industry 7
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on
medicinal and aromatic plants in India.
Schedule T – GoodManufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives Infrastructural
requirements, working space, storage area, machinery and equipments, standard
operating procedures, health and hygiene, documentation and records.
Practical
1. To perform preliminary phytochemical screening of crude drugs.
2. Determination of the alcohol content of Asava and Arista
3. Evaluation of excipients of natural origin
4. Incorporation of prepared and standardized extract in cosmetic formulations like creams, lotions
and shampoos and their evaluation.
5. Incorporation of prepared and standardized extract in formulations like syrups, mixtures and
tablets and their evaluation as per Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP604TT
SEMESTER: VI
Subject Name: Biopharmaceutics and Pharmacokintetics
Scope: This subject is designed to impart knowledge and skills of Biopharmaceutics and pharmacokinetics
and their applications in pharmaceutical development, design of dose and dosage regimen and in solving
the problems arised therein
Sr No Topics %
weightage
1. Introduction 10
Biopharmaceutics To Absorption; Mechanisms of drug absorption through
GIT, factors influencing drug absorption though GIT, absorption of drug from
Non per oral extra-vascular routes,
Distribution Tissue permeability of drugs, binding of drugs, apparent, volume
of drug distribution, plasma and tissue protein binding of drugs, factors affecting
protein-drug binding. Kinetics of protein binding, Clinical significance of
protein binding of drugs
2. Elimination: Drug metabolism and basic understanding metabolic pathways 10
renal excretion of drugs, factors affecting renal excretion of drugs, renal
clearance, Non renal routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of
bioavailability, absolute and relative bioavailability, measurement of
bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations,
bioequivalence studies, methods to enhance the dissolution rates and
bioavailability of poorly soluble drugs.
3. Pharmacokinetics: Definition and introduction to Pharmacokinetics, 10
Compartment models, Non compartment models, physiological models, One
compartment open model. (a). Intravenous Injection (Bolus) (b). Intravenous
infusion and (c) Extra vascular administrations. Pharmacokinetics parameters -
KE ,t1/2,Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations,
understanding of their significance and Application
Multicompartment models: Two compartment open model. IV bolus Kinetics 8
4. of multiple dosing, steady state drug levels, calculation of loading and
mainetnance doses and their significance in clinical settins
5. Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non- 7
linearity. c. Michaelis-menton method of estimating parameters, Explanation
with example of drugs.
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP604TT
Recommended Books (Latest Editions)
1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th
edition,Prentice-Hall Inernational edition.USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
5. Pharmacokinetics: ByMilo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, ByMilo Gibaldi and Laurie Prescott by ADIS Health
Science Press.
7. Biopharmaceutics; By Swarbrick
8. Clinical Pharmacokinetics, Concepts and Applications: ByMalcolm Rowland and
9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing
Company,Pennsylvania 1989.
11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and
expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
12. Remington’s Pharmaceutical Sciences, ByMack Publishing Company, Pennsylvnia
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP605TP
SEMESTER: VI
Subject Name: Industrial Pharmacy I
Scope: Course enables the student to understand and appreciate the influence of pharmaceutical
additives and various pharmaceutical dosage forms on the performance of the drug product.
Objectives: Upon completion of this course the student should be able to:
1. Know the various pharmaceutical dosage forms and their manufacturing Techniques
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality.
Sr No Topics %
weightage
1. Preformulation Studies: Introduction to preformulation, goals and objectives, 7
study of physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size,
shape, flow properties, solubility profile (pKa, pH, partition coefficient),
polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation,
polymerization BCS classification of drugs & its significant.
Application of preformulation considerations in the development of solid, liquid
oral and parenteral dosage forms and its impact on stability of dosage forms.
2. Tablets: 10
a. Introduction, ideal characteristics of tablets, classification of tablets.
Excipients, Formulation of tablets, granulation methods, compression and
processing problems. Equipments and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests
Liquid orals: Formulation and manufacturing consideration of syrups and
elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid
orals official in pharmacopoeia
3. Capsules: 8
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule
shells. Size of capsules, Filling, finishing and special techniques of formulation
of hard gelatin capsules, manufacturing defects. In process and final product
quality control tests for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules,
importance of base adsorption and minim/gram factors, production, in process
and final product quality control tests. Packing, storage and stability testing of
soft gelatin capsules and their applications.
Pellets: Introduction, formulation requirements, pelletization process,
equipments for manufacture of pellets
Parenteral Products: 10
4. a. Definition, types, advantages and limitations. Preformulation factors and
essential requirements, vehicles, additives, importance of isotonicity
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GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP605TP
b. Production procedure, production facilities and controls, aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and
infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations;
formulation of eye drops, eye ointments and eye lotions; methods of preparation;
labeling, containers; evaluation of ophthalmic preparations
5. Cosmetics: Formulation and preparation of the following cosmetic 10
preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes,
hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of
aerosol systems; formulation and manufacture of aerosols; Evaluation of
aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical
products, factors influencing choice of containers, legal and official
requirements for containers, stability aspects of packaging materials, quality
control tests.
Practical
1. Preformulation studies on paracetamol/asparin/or any other drug
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets- film coating of tables/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Qulaity control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/ and Eye ointments
10. Preparation of Creams (cold / vanishing cream)
11. Evaluation of Glass containers (as per IP)
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