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b-pharmacy (PCI) III year / II sem

latest 2022-23 Edition

B.Pharmacy PCI (Semester-VI) SET Of 6 SUBJECTS ( A Textbook Of Pharmaceutical Biotechnology, A Textbook Of Pharmaceutical Quality Assurance, A Textbook Of Herbal Drug Technology, A Textbook Of Medicinal Chemistry-III, A Textbook Of Pharmacology-III, A Textbook Of Biopharmaceutics And Pharmacokinetics) Revised Edition

B.Pharmacy PCI (Semester-VI) SET Of 6 SUBJECTS ( A Textbook Of Pharmaceutical Biotechnology, A Textbook Of Pharmaceutical Quality Assurance, A Textbook Of Herbal Drug Technology, A Textbook Of Medicinal Chemistry-III, A Textbook Of Pharmacology-III, A Textbook Of Biopharmaceutics And Pharmacokinetics) Revised Edition

SET OF 6 SUBJECTS

1. A Textbook of Pharmaceutical Biotechnology
2. A Textbook of Pharmaceutical Quality Assurance
3. A Textbook of Herbal Drug Technology
4. A Textbook of Medicinal Chemistry-III
5. A Textbook of Pharmacology-III
6. A Textbook of Biopharmaceutics and Pharmacokinetics.

Latest 2022 Edition

A Textbook Of Pharmaceutical Biotechnology, B.Pharmacy VI-Semester, As Per The Syllabus Prescribed By PCI And B.Pharmacy III-Year II-Sem (R17) Open Elective-II, JNTU-Hyderabad, Latest 2022 Edition

A Textbook Of Pharmaceutical Biotechnology, B.Pharmacy VI-Semester, As Per The Syllabus Prescribed By PCI And B.Pharmacy III-Year II-Sem (R17) Open Elective-II, JNTU-Hyderabad, Latest 2022 Edition

SYLLABUS

UNIT-I

(a) Brief introduction to biotechnology with reference to pharmaceutical sciences.
(b) Enzyme biotechnology-Methods of enzyme immobilization and applications.
(c) Biosensors - Working and applications of biosensors in pharmaceutical industries.
(d) Brief introduction to protein engineering.
(e) Use of microbes in industry. Production of enzymes-general consideration-amylase, catalase, peroxidase, lipase, protease, penicillinase.
(f) Basic principles of genetic engineering.

UNIT-II

(a) Study of cloning vectors, restriction endonucleases and DNA ligase.
(b) Recombinant DNA technology. Application of genetic engineering in medicine.
(c) Application of rDNA technology and genetic engineering in the production of:
(i) Interferon
(ii) Vaccines-Hepatitis-B
(iii) Hormones-Insulin.
(d) Brief introduction to PCR.

UNIT-III

Types of Immunity-humoral immunity, cellular immunity (a) Structure of immunoglobulins.
(b) Structure and function of MHC.
(c) Hypersensitivity reactions, immune stimulation and immune suppressions.
(d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins, serum-immune blood derivatives and other products relative to immunity.
(e) Storage conditions and stability of official vaccines.
(f) Hybridoma technology-Production, purification and applications.
(g) Blood products and plasma substitutes.

UNIT-IV

(a) Immuno blotting techniques-ELISA, western blotting, southern blotting.
(b) Genetic organization of eukaryotes and prokaryotes.
(c) Microbal genetics including transformation, transduction, conjunction, plasmids and transposons.
(d) Introduction to microbial biotransformation and applications.
(e) Mutation: Types of mutation/mutants.

UNIT-V

(a) Fermentation methods and general requirements, study of media, equipments, sterilization methods, aeration process, stirring.
(b) Large scale production fermenter design and its various controls.
(c) Study of the production of - penicillins, citric acid, Vitamin B12, glutamic acid, griseofulvin.
(d) Blood products: Collection, processing and storage of whole human blood, dried human plasma, plasma substitutes.

Latest 2022 Edition

Pharmaceutical Quality Assurance, B.Pharmacy (Semester-VI) As Per The Syllabus Prescribed By (PCI) & III-Year II-Sem (JNTU-HYD, R17, Open Elective-II)

Pharmaceutical Quality Assurance, B.Pharmacy (Semester-VI) As Per The Syllabus Prescribed By (PCI) & III-Year II-Sem (JNTU-HYD, R17, Open Elective-II)

SYLLABUS

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 and ISO 14000: Overview, benefits, elements, steps for registration.
NABL Accreditation: Principles and procedure.

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 non-clinical laboratory study, records and reports, disqualification of testing facilities.

UNIT-IV

Complaints: Complaints and evaluation of complaints, handling of returned goods, 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, material management.

Latest 2022 Edition

A Textbook Of Herbal Drug Technology, B.Pharmacy (Semester-VI) As Per the Syllabus Prescribed by (PCI) Pharmacy Council of India

A Textbook Of Herbal Drug Technology, B.Pharmacy (Semester-VI) As Per the Syllabus Prescribed by (PCI) Pharmacy Council of India

SYLLABUS

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:
(a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy.
(b) Preparation and standardization of Ayurvedic formulations viz Aristas, 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 gastrointestinal diseases.
Study of following herbs as health food: Alfa alfa, chicory, ginger, fenugreek, garlic, honey, amla, ginseng, ashwagandha, spirulina.
Herb-Drug and Herb-Food Interactions:
General introduction to interactions and classification. Study of following drugs and their possible side effects and interactions: Hypericum, kava-kava, Gingko biloba, ginseng, garlic, pepper and 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 - colourants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavours and 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
(a) Definition of the terms: Patent, IPRs, farmer’s right, breeder’s right, bioprospecting and biopiracy.
(b) Patenting aspects of traditional knowledge and natural products. Case study of curcuma and neem.
Regulatory Issues:
Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU drugs - Schedule Z of Drugs and 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 space, storage area, machinery and equipments, standard operating procedures, health and hygiene, documentation and records.

Latest 2022 Edition

A Textbook Of Medicinal Chemistry-III, B.Pharmacy (Semester-VI) As Per The Syllabus Prescribed By (PCI) Pharmacy Council Of India) 2022 Edition

A Textbook Of Medicinal Chemistry-III, B.Pharmacy (Semester-VI) As Per The Syllabus Prescribed By (PCI) Pharmacy Council Of India) 2022 Edition

SYLLABUS

UNIT-I

Antibiotics:
Historical background, nomenclature, stereochemistry, structure activity relationship, chemical degradation, classification and important products of the following classes.
Beta-Lactam antibiotics: Penicillin, cephalosporins, beta-lactamase inhibitors, monobactams.
Aminoglycosides: Streptomycin, neomycin, kanamycin.
Tetracyclines: 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. Miscellaneous: Chloramphenicol*, clindamycin.
Prodrugs:
Basic concepts and application of prodrugs design.
Antimalarials:
Etiology of malaria. Quinoline: 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

Antitubercular Agents:
Synthetic antitubercular agents: Isoniazid*, ethionamide, ethambutol, pyrazinamide, para aminosalicylic acid. Antitubercular 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*, methenamine.
Antiviral Agents:
Amantadine hydrochloride, rimantadine hydrochloride, idoxuridine, trifluridine, 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, butaconazole, 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, praziquantel, 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*.

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, Tafts steric parameter and Hansch analysis. Pharmacophore modeling and docking techniques.
Combinatorial Chemistry:
Concept and applications of combinatorial chemistry, solid-phase and solution-phase synthesis.

Latest 2022 Edition

A Textbook Of Pharmacology-III, B.Pharmacy VI-Semester, As Per The Latest Syllabus Of Pharmacy Council Of India, 2022 Edition

A Textbook Of Pharmacology-III, B.Pharmacy VI-Semester, As Per The Latest Syllabus Of Pharmacy Council Of India, 2022 Edition

SYLLABUS

Unit-I

1. Pharmacology of Drugs Acting on Respiratory System
(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 Gastrointestinal Tract
(a) Antiulcer agents
(b) Drugs for constipation and diarrhoea
(c) Appetite stimulants and suppressants
(d) Digestants and carminatives
(e) Emetics and antiemetics.

Unit-II

3. Chemotherapy
(a) General principles of chemotherapy
(b) Sulfonamides and cotrimoxazole
(c) Antibiotics - Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and fluoroquinolones, tetracyclines and aminoglycosides.

Unit-III

3. Chemotherapy
(a) Antitubercular agents
(b) Antileprotic agents
(c) Antifungal agents
(d) Antiviral drugs
(e) Anthelmintics
(f) Antimalarial drugs
(g) Antiamoebic agents.

Unit-IV

3. Chemotherapy: Urinary tract infections and sexually transmitted diseases. Chemotherapy of malignancy. 4. Immunopharmacology: (a) Immunostimulants
(b) Immunosuppressant.
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars.

Unit-V

5. Principles of Toxicology:
(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 compounds and lead, mercury and arsenic poisoning.
6. Chronopharmacology:
(a)Definition of rhythm and cycles.
(b)Biological clock and their significance leading to chronotherapy.

Latest 2022 Edition

A Textbook Of Biopharmaceutics And Pharmacokinetics, B.Pharmacy VI-Semester, As Per The Latest Syllabus Of Pharmacy Council Of India, 2022 Edition

A Textbook Of Biopharmaceutics And Pharmacokinetics, B.Pharmacy VI-Semester, As Per The Latest Syllabus Of Pharmacy Council Of India, 2022 Edition

SYLLABUS

Unit-I

Introduction: Biopharmaceutics
Absorption: Mechanisms of drug absorption through GIT, factors influencing drug absorption through GIT, absorption of drug from non per oral extravascular 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 of metabolic pathways. Renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, non-renal routes of drug excretion.
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. (a) Intravenous injection (bolus)
(b) Intravenous infusion
(c) Extra-vascular administrations.
Pharmacokinetics Parameters - KE, t½, Vd, AUC, Ka, ClT and ClR-definitions, methods of elimination, understanding of their significance and applications.

Unit-IV

Multicompartment Models Two compartment open model-i.v bolus, kinetics of multiple dosing, steady state drug levels, calculation of loading and maintenance doses and their significance in clinical settings.

Unit-V

Non-linear Pharmacokinetics: (a) Introduction
(b) Factors causing non-linearity
(c) Michaelis-Menten method of estimating parameters, explanation with example of drugs.