B Pharm 6th Semester Syllabus Pdf Download

B Pharm 6th Semester latest Syllabus Pdf

Medicinal Chemistry-III Syllabus

Theory (PT- 613)

Unit 1

Antibiotics

Antibiotics’ Historical Background, Stereochemistry, Nomenclature, Structure-Activity Relationship (SAR), Classification of chemical degradation, and Important Products.

• Lactam Antibiotics: Cephalosporins, Lactamase Inhibitors, Monobactams, Penicillin.

• Aminoglycosides: Kanamycin, Neomycin, Streptomycin.

• Tetracyclines: Chlortetracycline, Doxycycline, Minocycline, Oxytetracycline, Tetracycline.

Unit 2

• Macrolide: Azithromycin, Clarithromycin, Erythromycin.

• Miscellaneous: Clindamycin, Chloramphenicol.

• Prodrugs: Prodrugs’ basic concepts, applications, and design.

• Antimalarials: Malarial Etiology

• Quinolines: SAR of Quinolines, Amodiaquine, Chloroquine, Mefloquine, Pamaquine, Primaquine Phosphate, Quinacrine Hydrochloride, Quinine Sulphate.

• Biguanides & dihydro triazines: Proguanil, Cycloguanil pamoate.

• Miscellaneous: Artesunate, Atoviquone, Artemether, Pyrimethamine.

Unit 3

Anti-tuber Agents

• Synthetic antitubercular agents: Ethionamide, Ethambutol, Isoniazid, Para aminosalicylic acid, Pyrazinamide.

• Anti-tubercular antibiotics: Cycloserine, Capreomycin Sulphate, Rifabutin, Rifampicin, Streptomycin.

Urinary tract anti-infective agents

• Quinolines: Quinolines SAR, Ciprofloxacin, Enoxacin, Gatifloxacin, Lomefloxacin, Moxifloxacin, Norfloxacin, Nalidixic Acid, Ofloxacin, Sparfloxacin.

• Miscellaneous: Furazolidone, Methanamine, Nitrofurantoin.

• Anti-viral Agents: Acyclovir, Amantadine Hydrochloride, Delavirding, Didanosine, Idoxuridine trifluoride, Indinavir, Gancyclovir, Loviride, Lamivudine, Rimantadine Hydrochloride, Ribavirin, Ritonavir, Saquinavir.

Unit 4

Antifungal Agents

• Antifungal agents: Amphotericin-B, Griseofulvin, Natamycin, Nystatin.

• Synthetic Antifungal agents: Butoconazole, Clotrimazole, Econazole, Fluconazole, Itraconazole, Ketoconazole, Oxiconazole, miconazole, Naftifine Hydrochloride, Tolnaftate, Tioconozole, Terconazole.

• Anti-protozoal agents: Atovaquone, Eflornithine, Diloxanide, Iodoquinol, Metronidazole, Pentamidine Isethionate, Ornidazole, Tinidazole.

• Anthelmintics: Albendazole, Diethylcarbamazine citrate, Ivermectin, Mebendazole, Niclosamide, Oxamniquine, Praziquantel, Thiabendazole.

Sulphonamide and sulfones

Historical Development, Classification, SAR of sulfonamides and sulfones, Mefenide acetate, Sulphadiazine, Sulfamethoxazole, Sulphamethizole, Sulfasalazine, Sulfisoxazole, Sulfacetamide, Sulphamethizine, Sulphapyridine.

• Folate Reductase Inhibitors: Cotrimoxazole, Trimethoprim.

• Sulfones: Dapsone

Unit 5

• Introducing the design of the drug

Drug design various approaches, Physiochemical parameters used in QSAR (Quantitative Structure-Activity Relationship), Hammet’s electronic parameters, Taft’s steric parameters, Partition Coefficient, and Hansch Analysis.

Docking techniques and Pharmacophore modeling.

• Combinatorial Chemistry

Application and Concepts of combinatorial chemistry, Solid-phase, and solution-phase chemistry.

Practical (PT- 693)

1. Preparation of the drugs

1. 7-Hydroxy, 4-methyl coumarin
2. Chlorobutanol
3. Chlorobutanol
4. Hexamine
5. Sulphanilamide
6. Tolbutamide

2. Assay of the Drugs

1. Benzyl Penicillin
2. Chloroquine
3. Chlorpheniramine
4. Dapsone
5. Isonicotinic Acid Hydrazide
6. Metronidazole

3. By Microwave irradiation techniques preparation of medicinally important compounds.

4. Using chem draw drawing structures and reactions.

5. Determination of the Physicochemical properties like MR, Clogs, logP, Hydrogen bond, and Molecular weight for the class of drugs using drug design software.

Pharmaceutical Quality Assurance Syllabus

Theory (PT- 611)

Unit 1

• Quality Assurance and Quality Management Concepts: Introduction, Definitions, Concepts of quality control, quality assurance, and GMP.

• Total Quality Management (TQM): Introduction, Definitions, Elements, and Philosophies.

• Guidelines of ICH: Introduction, Definitions, Purpose, Short overview of QSEM, Process of harmonization, with special emphasis on the Q-series guidelines, ICH stability testing guidelines criteria.

• Quality by design (QbD): Introduction, Definitions, Overview, Tools, Elements of QbD program.

• ISO 9000 and ISO 14000 Details: Introduction, Definitions, Overview, Advantages, Elements, Steps for the registration.

• NABL Accreditation: Principles, Definitions, and Procedures of the NABL accreditation.

Unit 2

• Organization and Personnel: Organisation and personnel responsibilities, training, hygiene, and personal records.

• Premises: Design, Construction and plant layout, maintenance, environmental control, sanitation, utilities and maintenance of sterile areas, and control of contamination.

• equipment and raw materials: Equipment selection, maintenance, purchase specifications, of stores for raw materials.

Unit 3

• Quality Control: Test for Containers, Secondary packaging materials, and rubber closures.

• Good Laboratory Practices: Facilities, General provisions, Organisation and Personnel, Equipment, Testing facilities operations, Protocol for the conduct of a nonclinical laboratory study, test and control articles, Records and report, Disqualification of testing facilities.

Unit 4

• Different Complaints: Evaluation of the complaints, Handling of returned goods, Recalling and waste disposal materials.

• Document Maintenance in the Pharmaceutical Industry: Batch formula records, Master formula records, Quality audit, SOP, Reports and documents, Quality review and quality documentation, and Distribution records.

Unit 5

• Calibration and Validation Process: Definitions, General principles of calibration, Importance, and scope of validation, Qualifications and validation, Types of validation, Validation master plans, Qualifications of UV- Visible spectrophotometer, General principles of Analytical method validation.

• Warehousing: Materials management and Good warehousing practice.

Pharmacology-III Syllabus

Theory (PT- 618)

Unit 1

Pharmacology of the Drugs Acting on the Respiratory System of the Body

1. Anti-asthmatic drugs.
2. Expectorants and antitussives.
3. Drugs used in the management of COPD disease.
4. Nasal decongestants.
5. Respiratory Stimulants.

Pharmacology of the Drugs Acting on Gastrointestinal Tract (GI Tract)

1. Appetite stimulants and suppressants.
2. Antiulcer agents.
3. Emetics and anti-emetics.
4. Drugs for constipation and diarrhea.
5. Digestants and carminatives.

Unit 2

Chemotherapy

1. Antibiotics- Cephalosporins, Chloramphenicol, Penicillins, Macrolides.
2. General Principles of Chemotherapy.
3. Sulfonamides and cotrimoxazole.

Unit 3

Chemotherapy

1. Antileprotic agents
2. Antitubercular agents
3. Antifungal agents
4. Antiviral drugs
5. Antimalarial drugs
6. Anthelmintics
7. Antiamoebic agents

Unit 4

• Chemotherapy: Urinary Tract Infections (UTI), Sexually Transmitted Diseases (STD), and Chemotherapy of malignancy.

• Immunopharmacology

1. Immunostimulants
2. Immunosuppressants

Monoclonal antibodies, Protein drugs, target drugs to antigens, and biosimilars.

Unit 5

• Principles of Toxicology

1. Basic knowledge and definitions of acute, subacute, and chronic toxicity.
2. Basic knowledge and definitions of carcinogenicity, genotoxicity, teratogenicity, and mutagenicity.
3. General principles of treatment of the poisoning.
4. Clinical symptoms, management of barbiturates, morphine, organophosphorus compounds, mercury, and arsenic poisoning.

• Chrono Pharmacology

1. Introduction and definitions of Rhythm and Cycles.
2. Biological clock and their significance of chronotherapy.

Practical (PT- 698)

I. Anti-allergic activity of the mast cell by the stabilization assay methods.

II. Calculation of dose in pharmacological experiments.

III. Study of anti-ulcer activity of a drug-using pylorus ligand rat model and NSAIDS-induced ulcer model.

IV. Study of the effect of the drugs on gastrointestinal tract motility in animals.

V. Effect of antagonists and agonists on guinea-pig ileum.

VI. Estimation of the serum biochemical parameters by the use of a semi-autoanalyzer.

VII. Determination of the effect of the saline purgatives on the frog intestine.

VIII. Hypoglycemic effects of insulin in rabbits.

IX. Test for pyrogens or Rabbit method test.

X. Determination of the acute oral toxicity (LD50) of a drug.

XI. Determination of the acute skin irritations or corrosion of a test substance.

XII. Determination of the acute eye irradiation or corrosion of a test substance.

XIII. Pharmacokinetics parameters calculation from the given data.

XIV. Experimental pharmacology in biostatistics methods student’s test and ANOVA.

XV. Experimental pharmacology in biostatistics methods Chi-square test, and Wilcoxon signed-rank test.

Herbal Drug Technology Syllabus

Theory (PT- 612)

Unit 1

• Herbs as raw materials

Herb definition, herbal medicine, and medicinal products, preparation, sources of herbs, Selection, identification, and authentication of the herbal drugs materials, Processing of the herbal raw drug materials.

• Biodynamic Agriculture

Good agricultural practices in the cultivation of medicinal plants organic farming, and pest management in the medicinal plants like Bioinsectisides or Biopesticides.

• Indian System of Medicine

Basic principles of the Siddha, Ayurveda, Unani, and Homeopathy systems of medicine, Preparation and standardization method of the Ayurvedic formulation like Aristas, Asavas, Ghutika, Lehya, Churna, and Bhasma.

Unit 2

• Neurmtraceuticals

Nutraceuticals general aspects, Scope, Growth, Market, and types of products available in the market, Health advantages and role of the nutraceuticals in the animal if various disease CVS diseases, Cancer, Diabetes, Irritable bowel syndrome, and various gastrointestinal (GI) diseases.

Study of the herbs Alfalfa, Amla, Ashwagandha, Chicory, Fenugreek, Ginseng, Garlic, Honey, Spirulina.

• Herbal Drug and Herbal Food Interactions

General introduction to the interaction between herbal and drugs, and herb and food, Study of drugs with side effects and interactions like Ginkobiloba, Garlic, Hypericum, Kava-kava, Pepper, and Ephedra.

Unit 3

• Herbal Cosmetics

Sources and distribution of raw materials of herbal origin used fixed oils, waxes, gums colors, perfumes, protective agents, antioxidants, and bleaching agents in products such as skin care, oral hygiene, and hair care products.

• Herbal Excipients

Significance of substances of natural origin as excipients, colorants, binders, diluents, disintegrates, sweeteners, viscosity builders, flavors, and perfumes.

• Herbal Formulation

Conventional herbal formulations like tablets, syrups, and novel dosage forms like phytosomes.

Unit 4

• Evaluation of drugs

WHO and ICH guidelines for the assessment of herbal drugs, and their stability testing.

• Patenting and Natural Products Regulatory Requirements

Definitions of the terms: Breeder’s right, Patent, IPR, Bioprospecting, Farmer’s right, and Biopiracy.

Traditional knowledge and natural products of patenting aspects, Case study of the Curcuma and neem.

• Regulatory Issues

Regulatory Issues in India (ASU DCC, ASU DtAB), ASU drugs regulations of manufacture-; schedule Z or T of drugs and Cosmetics Act for the ASU drugs.

Unit 5

• General Introduction to the Herbal Industry

Present scope and prospects, a brief account of plant-based industries and institutions involved in working on the medicinal field and aromatic plants in India.

• Schedule T – Good Manufacturing Practice of the Indian System of Medicines

GMP components (Schedule-T), and its objectives, infrastructural requirements, storage area, Working space, Machinery and Equipment, Health and hygiene, Standard operating procedures, documentation, and records.

Practical (PT- 692)

I. To perform primary phytochemical screening of crude drugs.

II. Determine the alcohol content of the Asavas and Arista plants.

III. Evaluations of excipients used from the natural origin.

IV. Incorporation of the prepared and standardized extract in cosmetics formulations like creams, shampoos, lotions, and their evaluation.

V. Incorporation of the prepared and standardized extract in formulations like mixtures, syrups, tablets, and their evaluation.

VI. Monograph analysis of the herbal drugs from the latest pharmacopeias.

VII. Determination of the Aldehyde content.

VIII. Determination of the Phenol content.

IX. Determination of the total alkaloid content.

Biopharmaceutics and Pharmacokinetics Syllabus

Theory (PT- 616)

Unit 1

Introduction to the Biopharmaceutics

• Absorption: Mechanism of the absorption of the drug through the GIT, Factors influencing absorption through GIT, Absorption of drug from non-per oral extra-vascular routes.

• Distribution: Tissue permeability, Binding of drugs, apparent volume of drug distribution, factors affecting protein-drug binding, Plasma and tissue protein binding of drugs, Kinetics of protein binding, Clinical significance of protein binding of drugs.

Unit 2

• Elimination: Drug metabolism and basic understanding of the metabolic pathways renal experience excretion of drugs, Factors affecting the excretion of drugs, renal and non-renal clearance with the routes of drug excretion.

• Bioavailability and Bioequivalence: Objectives and Definitions of Bioavailability, Absolute and relative bioavailability, Measurements of bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations, Methods to increase the dissolution rates and bioavailability of poorly soluble drugs, Bioequivalence studies.

Unit 3

• Pharmacokinetics: Pharmacokinetics definitions and introduction, Compartment models, Non-compartment models, physiological models, One compartment open model. (i) Intravenous Injection (Bolus), (ii) Intravenous infusion, and (iii) Extra-vascular administration, Pharmacokinetics parameters- K_E, t_1/2, V_d, AUC, Ka, Clt, and CL_R – Definitions methods of elimination, Understanding of their significance and applications.

Unit 4

• Multi-compartment models: Two-compartment open model, IV bolus kinetics of the multiple doses, Steady-state drug levels, Calculation of the loading maintenance doses and their significance.

Unit 5

• Nonlinear Pharmacokinetics: Introduction, Factors causing non-linearity, Michaelis-Menton method of estimating parameters, Explanation with an example of the drugs.

Pharmaceutical Biotechnology Syllabus

Theory (PT- 619)

Unit 1

1. Short description of biotechnology with a reference to the pharmaceutical sciences.
2. Biotechnology of enzymes- methods of enzyme immobilization and applications.
3. Biosensors- Biosensors working and applications in Pharmaceutical Industries.
4. Protein Engineering brief introduction.
5. Use of microbes in the pharmaceutical industry, production of various enzymes, general considerations- Amylase, Peroxidase, Catalase, Lipase, Penicillinase, and Protease.
6. A basic introduction to genetic engineering.

Unit 2

1. Study of the cloning vectors, Restrictions Endonuclease (RE), and DNA ligase.
2. Recombinant DNA technology, Applications of genetic engineering in medicines.
3. Application of recombinant DNA technology (rDNA) and genetic engineering in the production of Hormones-Insulin, Vaccines-Hepatitis, and Interferons.
4. A brief introduction to the Polymerase Chain Reaction (PCR).

Unit 3

Classification of the immunity- Cellular immunity and Humoral immunity.

1. The basic structure of Immunoglobulins.
2. General Structure and Function of MHC.
3. The general method of preparation of bacterial vaccines, viral vaccines, antitoxins, toxoids, serum-immune blood derivatives, and other products related to immunity.
4. Hypersensitivity reactions, Immune suppression, and immune stimulation.
5. Hybridoma technology- Applications, Production, and Purification.
6. Blood products and their plasma substituents.

Unit 4

1. Immunoblotting techniques- ELISA, Southern blotting, and Western blotting.
2. Genetic organization of the Prokaryotes and Eukaryotes.
3. Micro-bacterial genetics includes Conjunction, Transduction, Transformation, Plasmids, and Transposons.
4. Introduction to Microbial biotransformation and its application.
5. Mutation- Types of mutation and mutants.

Unit 5

1. Fermentation method and general requirements, Study of the equipment, Sterilization methods, media, aeration process, and stirring.
2. Large-scale production of Penicillins, Citric acid, Glutamic acid, Vitamin B12, and Griseofulvin.
3. Production of the fermenter design and its various controls.
4. Blood products- Collection, Storage, Production of whole human blood, Plasma substituents, and Dried human plasma.