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BP601T. MEDICINAL CHEMISTRY – III (Theory)

Unit-I

Antibiotics: Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of the
following classes.
β-Lactam antibiotics: Penicillin, Cephalosporin, β-Lactamase inhibitors,
Monobactams.
Aminoglycosides: Streptomycin, Neomycin, Kanamycin.
Tetracycline: Tetracycline, Oxytetracycline, Chlortetracycline, Minocycline, Doxycycline.

Unit-II

Antibiotics: Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of the
following classes.
Macrolide: Erythromycin Clarithromycin, Azithromycin.
BP606T. PHARMACEUTICAL QUALITY ASSURANCE (Theory)

Unit-I

Quality Assurance and Quality Management concepts: Definition and concept of
Quality control, Quality assurance and GMP.
Total Quality Management (TQM): Definition, elements, philosophies.
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of
QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines.
Quality by design (QbD): Definition, overview, elements of QbD program, tools.
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration.
NABL accreditation: Principles and procedures.

Unit-II

Organization and personnel: Personnel responsibilities, training, hygiene and personal
records. Premises: Design, construction and plant layout, maintenance, sanitation,
environmental control, utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications,
maintenance, purchase specifications and maintenance of stores for raw materials.

Unit-III

Quality Control: Quality control test for containers, rubber closures and secondary
packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a
Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities.

Unit-IV

Complaints: Complaints and evaluation of complaints, Handling of return good, recalling
and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master
Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
documents, distribution records.

Unit-V

Calibration and Validation: Introduction, definition and general principles of calibration,
qualification and validation, importance and scope of validation, types of validation, validation
master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management: Chloramphenicol*, Clindamycin.
Prodrugs: Basic concepts and application of prodrugs design.
Antimalarial: Etiology of malaria.
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine, Primaquine phosphate,
Pamaquine*, Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunate, Artemether, Atovaquone.

Unit-III

Anti-tubercular Agents:
Synthetic anti tubercular agents: Isoniazid*, Ethionamide, Ethambutol, Pyrazinamide,
Para amino salicylic acid.*
Ant-tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine, Streptomycin,
Capreomycin sulphate.
Urinary tract anti-infective agents:
Quinolones: SAR of quinolones, Nalidixic Acid, Norfloxacin, Enoxacin, Ciprofloxacin*,
Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin.
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Antiviral agents: Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine
trifluoride, Acyclovir*, Ganciclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine,
Loviride, Delavirdine, Ribavirin, Saquinavir, Indinavir, Ritonavir.

Unit-IV

Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole, Oxiconazole
Tioconazole, Miconazole*, Ketoconazole, Terconazole, Itraconazole, Fluconazole,
Naftifine hydrochloride, Tolnaftate.*
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide, Iodoquinol,
Pentamidine Isethionate, Atovaquone, Eflornithine.
Anthelmintic: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*, Albendazole,
Niclosamide, Oxamniquine, Praziquantel, Ivermectin.
Sulphonamides and Sulfones: Historical development, chemistry, classification and SAR
of Sulfonamides: Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*,
Sulphapyridine, Sulfamethoxazole*, Sulphadiazine, Mefenide acetate, Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.

Unit-V

Introduction to Drug Design
Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity relationship (QSAR)
such as partition coefficient, Hammett’s electronic parameter, Taft’s steric parameter and
Hansch analysis.
Pharmacophore modeling and docking techniques.
Combinatorial Chemistry: Concept and applications of combinatorial Chemistry: Solid
phase and solution phase synthesis.

BP602T. PHARMACOLOGY-III (Theory)

Unit-I

Pharmacology of drugs acting on Respiratory system:
Anti-asthmatic drugs.
Drugs used in the management of COPD.
Expectorants and antitussives.
Nasal decongestants.
Respiratory stimulants.
Pharmacology of drugs acting on the Gastrointestinal Tract:
Antiulcer agents.
Drugs for constipation and diarrhoea.
Appetite stimulants and suppressants.
Digestants and carminatives.
Emetics and anti-emetics.

Unit-II

Chemotherapy: General principles of chemotherapy.
Sulfonamides and Cotrimoxazole.
Antibiotics- Penicillins, cephalosporin, chloramphenicol, macrolides, quinolones and
fluoroquinolins, tetracycline and aminoglycosides.

Unit-III

Chemotherapy:
Antitubercular agents.
Antileprotic agents.
Antifungal agents.
Antiviral drugs.
Anthelmintics.
Antimalarial drugs.
Antiamoebic agents.

Unit-IV

Chemotherapy:
Urinary tract infections and sexually transmitted diseases.
Chemotherapy of malignancy.
Immunopharmacology:
Immunostimulants.
Immunosuppressant.
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars.

Unit-V

Principles of toxicology:
Definition and basic knowledge of acute, sub-acute and chronic toxicity.
Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and
mutagenicity.
General principles of treatment of poisoning.
Clinical symptoms and management of barbiturates, morphine, and organophosphosphorus
compound and lead, mercury and arsenic poisoning.
Chronopharmacology:
Definition of rhythm and cycles.
Biological clock and their significance leading to chronotherapy.

BP603T. HERBAL DRUG TECHNOLOGY (Theory)

Unit-I

Herbs as raw materials: 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: Basic principles involved in Ayurveda, Siddha, Unani and
Homeopathy. Preparation and standardization of Ayurvedic formulations viz. Aristas and
Asawas, Ghutika, Churna, Lehya and Bhasma.

Unit-II

Nutraceuticals
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: Alfa-alfa, 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.

Unit-III

Herbal Cosmetics: 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.
Herbal formulations: Conventional herbal formulations like syrups, mixtures and tablets
and Novel dosage forms like phytosomes.

Unit-IV

Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs. Stability
testing of herbal drugs.
Patenting and Regulatory requirements of natural products: Definition of the terms:
Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy.
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.

Unit-V

General Introduction to Herbal Industry: 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 – Good Manufacturing Practice of Indian systems of medicine:
Components of GMP (Schedule –T) and its objectives.
Infrastructural requirements working page, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.

BP604T. BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory)

Unit-I

Introduction to Biopharmaceutics:
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.

Unit-II

Elimination: Drug metabolism and basic understanding metabolic pathways 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.

Unit-III

Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment
models, Non compartment models, physiological models, One compartment open model.
Intravenous Injection (Bolus), Intravenous infusion and Extra vascular administrations.
Pharmacokinetics parameters – KE , t1/2,Vd, AUC, Ka, Clt and CLR- definitions, methods
of eliminations, understanding of their significance and application.

Unit-IV

Multicompartment models: Two compartment open model. IV bolus Kinetics of multiple
dosing, steady state drug levels, calculation of loading and maintenance doses and their
significance in clinical settings.

Unit-V

Nonlinear Pharmacokinetics: Introduction, Factors causing Non-linearity. MichaelisMenten method of estimating parameters, Explanation with example of drugs.

BP605T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)

Unit-I

Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.
Enzyme Biotechnology- Methods of enzyme immobilization and applications.
Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
Brief introduction to Protein Engineering.
Use of microbes in industry. Production of Enzymes- General consideration – Amylase,
Catalase, Peroxidase, Lipase, Protease, Penicillinase.
Basic principles of genetic engineering.

Unit-II

Study of cloning vectors, restriction endonucleases and DNA ligase.
Recombinant DNA technology. Application of genetic engineering in medicine.
Application of r DNA technology and genetic engineering in the production of:
i) Interferon
ii) Vaccines- hepatitis- B
iii) Hormones-Insulin.
Brief introduction to PCR.

Unit-III

Types of immunity- humoral immunity, cellular immunity.
Structure of Immunoglobulins.
Structure and Function of MHC.
Hypersensitivity reactions, Immune stimulation and Immune suppressions.
General method of the preparation of bacterial infections, toxoids, viral vaccine, antitoxins,
serum-immune blood derivatives and other products relative to immunity.
Storage conditions and stability of official vaccines.
Hybridoma technology- Production, Purification and Applications, Blood products and
Plasma Substitutes.

Unit-IV

Immuno-blotting techniques- ELISA, Western blotting, Southern blotting.
Genetic organization of Eukaryotes and Prokaryotes.
Microbial genetics including transformation, transduction, conjugation, plasmids and
transposons.
Introduction to Microbial biotransformation and applications.
Mutation: Types of mutation/mutants.

Unit-V

Fermentation methods and general requirements, study of media, equipments, sterilization
methods, aeration process, stirring.
Large scale production fermenter design and its various controls.
Study of the production of – Penicillins, citric acid, Vitamin B12, Glutamic acid,
Griseofulvin.
Blood Products: Collection, Processing and Storage of whole human blood, dried human
plasma, plasma Substitutes.

BP606T. PHARMACEUTICAL QUALITY ASSURANCE (Theory)

Unit-I

Quality Assurance and Quality Management concepts: Definition and concept of
Quality control, Quality assurance and GMP.
Total Quality Management (TQM): Definition, elements, philosophies.
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of
QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines.
Quality by design (QbD): Definition, overview, elements of QbD program, tools.
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration.
NABL accreditation: Principles and procedures.

Unit-II

Organization and personnel: Personnel responsibilities, training, hygiene and personal
records. Premises: Design, construction and plant layout, maintenance, sanitation,
environmental control, utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications,
maintenance, purchase specifications and maintenance of stores for raw materials.

Unit-III

Quality Control: Quality control test for containers, rubber closures and secondary
packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a
Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities.

Unit-IV

Complaints: Complaints and evaluation of complaints, Handling of return good, recalling
and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master
Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
documents, distribution records.

Unit-V

Calibration and Validation: Introduction, definition and general principles of calibration,
qualification and validation, importance and scope of validation, types of validation, validation
master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management