BACHELOR IN PHARMACY

Unit 1

Antibiotics

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

Antibiotics

Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products ofthe 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

Anti-tubercular Agents

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, 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:

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*.

Introduction to Drug Design

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.


CombinatorialChemistry:Conceptandapplications chemistry: solid phase and solution phase synthesis

Unit 2

Unit 3

Unit 4

Unit 5

Unit 1

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 the Gastrointestinal Tract

a. Antiulcer agents.

b. Drugs for constipation and diarrhoea.

c. Appetite stimulants and suppressants.

d. Digestants and carminatives.

Emeticsandanti-emetics

1. Chemotherapy

a. General principles of chemotherapy.

b. Sulfonamides and cotrimoxazole.

Antibiotics-Penicillins,cephalosporins,chloramphenicol,macrolides, quinolones and fluoroquinolins, tetracyclineand aminoglycosides

3. Chemotherapy

a. Antitubercular agents

b. Antileprotic agentsa. Antifungal agents

b. Antiviral drugs e.Anthelmintics

f. Antimalarial drugs

g. Antiamoebic agents

3. Chemotherapy

l. Urinary tract infections and sexually transmitted diseases.

m. Chemotherapy of malignancy.

4. Immunopharmacology

a. Immunostimulants

b. Immunosuppressant

Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

3. 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 compound and lead, mercury and arsenic poisoning.

4. Chronopharmacology

a. Definition of rhythm and cycles.

Biologicalclockandtheirsignificanceleadingtochronotherapy

Unit 2

Unit 3

Unit 4

Unit 5

Unit 1

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

PreparationandstandardizationofAyurvedicformulationsvizAristasandAsawas, Ghutika,Churna, Lehya and Bhasma

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: 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.

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, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy

b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.

RegulatoryIssues-RegulationsinIndia(ASUDTAB,ASUDCC),Regulationof manufacture of ASU drugs - Schedule Zof Drugs & Cosmetics Act for ASU drugs

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

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.

Unit 2

Unit 3

Unit 4

Unit 5

Unit 1

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

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.

Multicompartment models: Two compartment open model. IV bolus

Kinetics of multiple dosing, steady state drug levels, calculation of loading and mainetnance doses and their significance in clinical settins.

Pharmacokinetics:

Definition and introduction to Pharmacokinetics, 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

Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity.

a. Michaelis-menton method of estimating parameters, Explanation with example of drugs.

Unit 2

Unit 3

Unit 4

Unit 5

Unit 1

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.

a) Study of cloning vectors, restriction endonucleases and DNA ligase.

b) Recombinant DNA technology. Application of genetic engineering in medicine.

c) Application of r DNA technology and genetic engineering in the production of:

i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.

BriefintroductiontoPCR

a) Immuno blotting techniques- ELISA, Western blotting, Southern blotting.

b) Genetic organization of Eukaryotes and Prokaryotes

c) Microbial genetics including transformation, transduction, conjugation, plasmids and transposons.

d) Introduction to Microbial biotransformation and applications.

Mutation:Typesofmutation/mutants

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

BloodproductsandPlasma Substituties

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 Substituties.

Unit 2

Unit 3

Unit 4

Unit 5

Unit 1

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

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: Equaipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.

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.

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

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 2

Unit 3

Unit 4

Unit 5