BIOPHARMACEUTICS AND PHARMACOKINETICS

Biopharmaceutics 

Introduction & their role in formulation development & clinical settings, fate of drugs after administration. 

Drug absorption: drug absorption mechanisms, factors affecting drug absorption (physiochemical, biological, metabolic, formulations and dosage form considerations). 

Drug distribution & protein binding of drugs 

Distribution of drug through organ /tissue - factors affecting distribution 

(Physicochemical properties of drugs, organ/tissue size, blood flow to the organ, physiological barriers  to the distribution of drugs, drug binding blood / tissue / macromolecules). 

Protein /tissue binding of drugs- factors affecting protein binding of drugs, significance and kinetics, tissue binding of drugs. 

Drug metabolism & excretion of drugs 

Biotransformation of drugs- drug metabolizing enzymes & organs, phase I & phase II reactions, factors affecting biotransformation, drug metabolism significance, extrahepatic metabolism, pharmacological activity of metabolite, deposition of metabolite. 

Excretion of drugs - renal excretion of drug, factors affecting renal excretion of drugs, nonrenal routes of excretion of drug & factors affecting them, enterohepatic circulation. 

Pharmacokinetics 

Introduction, basic concepts- rate processes in biological systems, pharmacokinetics parmneters- Cmax, tmax, AUC, biological half life, apparent volume of distribution, clearance (hepatic, renal, organ, metabolite). 

Pharmacokinetics drug interaction and their significance in combination therapy. 

Clinical pharmacokinetics: dosage adjustment in patient with and without renal and hepatic failure. 

Compartment models 

Basic concepts, one & two compartment models- pharmacokinetics of drug absorption, distribution and elimination under following conditions: 

 i) Intravenous bolus injection 

ii) Intravenous infusion 

iii) Oral single dose 

Application of pharmacokinetic principles & computation of parameters by graphical approach. 

PHARMACEUTICAL BUSINESS MANAGEMENT

General Management (Production and Control) 

Management concepts: Policies, goals and objectives, principles of management, functions of management, levels of management, management information systems (MIS); 

Production Planning and Quality Control - Production Forecasting, Process production, Batch Production, Process planning, Economic Batch quantity. Problems of Productivity; Integration of modem management practices and principles of Total Quality Management (TQM) with requirements specified in GMP, GSP, ISO 19000, GB/T 19000 and ES 29000. 

Industrial Management (Pharmaceutical Industry) 

Pharmaceutical manufacture, Development, Location-Factors influencing, Special provisions. 

Plant Layout: Types of plant layout, Factors influencing plant layout, Methods of factory layout, Special provisions, Storage space requirements, Layouts-Sterile or aseptic area, tablets production area. 

Building: Compartmentalized facilities-Rooms, floors, walls and ceilings. 

Pharmaceutical Process Flow and Work Study: General Flow Patterns, Work Station Design, Process Flow Diagrams - Production of Tablets, Work Study and Work Measurement. 

Utilities and Services: Power, Water, Air conditioning systems, Dust collection systems, Compressed air systems, Vacuum and special gases. 

Good Manufacturing Practices: Equipment and documentation (Records). 

Materials and Stores Management 

Materials Purchasing Procedure, Stores Organization - location and layout of stores, receiving, inspection of materials, Issue, Control of store and store stocks, Stock accounting and records. Selection of site for drug store, Layout design for drug store and compliance with control measures; Inventory control - Objectives, Economic order Quantity, ABC analysis. 

Personnel Management 

Selection, Appointment, Training, Transfer, Promotion and demotion policies, Remuneration, Job Evaluation and merit rating. 

Industrial Psychology - Concept, Individual and group behaviour, X and Y theory, Hawthrone experiments, morale, motivation and fatigue. 

Marketing Management 

Meaning and Scope, Types of Target Market, size, composition, demographic description and socio-psychological characteristics of the consumer, marketing mix. 

Market consideration in product development - product classification, product planning, product differentiation, Branded V s Generic, new Product Development. Distribution Channels - Selection of Channels, Wholesaler and retailers, role and distribution. 

Pricing policies - factors affecting price, selective and exclusive pricing, discount policies, Credit policies, Patent policies, 

Sales Promotion policies - Objectives, detailing to physician, professional personnels sampling, window and interior display, media planning and publicity.

PHARMACEUTICAL ANALYSIS – II (INSTRUMENTAL METHODS OF ANALYSIS)

UV /Visible Spectroscopy 

Regions of Electromagnetic spectrum, properties of EMR, atomic and molecular spectra, Beer - Lambert's law and deviations from Beer's law Principles and theoretical aspects of UVN/Visible Spectroscopy, electronic transition, effect of conjugation, concept of chromophore and auxochrome, bathochromic, hypsochromic, hyperchromic and hypochromic shifts Instrumentation - components of spectrophotometer, types of spectrophotometers, Solvents and sample handling, Applications - Qualitative and quantitative analysis - single component 

IR spectroscopy 

Principles and theoretical aspects - Molecular vibrations, Hook’s Law, Intensity and position of IR bands, Measurement of IR spectrum, finger print region and characteristic absorption of various functional groups. 

Instrumentation - Spectrophotometer components, Sample preparation and handling Application - Interpretation of IR spectra of simple organic compounds, quantitative applications. 

i)NMR - A brief introduction to the principle and instrumentation, chemical shift, spin-spin interaction, shielding and de shielding. 

ii)MS - A brief introduction to the principle and instrumentation, various methods of ion production and fragmentation rules. 

iii)Fluorescence spectroscopy - Fundamentals, radiative and non radiative process, mirror image relation ship, fluorescence and molecular structure, properties of fluorescence. Instrumentation - components of spectrofluorimeter and applications 

Electrochemical methods 

i) Amperometric titrations 

ii) Potentiometry - principles and theoretical aspects - electrodes, measurement of cell potential, end point evaluation methods, potentiometric titrations, Null point potentiometry and application. 

iii) Conductometry - principles and theoretical aspects, conductance, equivalent and molar conductance, effect of dilution on conductance, conductivity water, cell constant, conductivity cell, measurement of conductivity, conductimetric titrations and applications. Other analytical techniques - Principle, Instrumentation and application of following instrumental methods of analysis nephelometry, turbidometry, flame photometryand differential thermal analysis 

Chromatography: Principle, instrumentation and experimental details and applications of paper chromatography, TLC, column chromatography, gas chromatography, HPLC and HPTLC. 

Electrophoresis : Principle, instrumentation, experimental details and applications of paper and gel electrophoresis . 

MEDICINAL CHEMISTRY-II

Local Anesthetics - (Lidocaine and Bupivacaine). 

Narcotic analgesics - (Pethidine and Fentenyl), Narcotic antagonists - (Nalaxone), 

Peripheral analgesics, Antipyretics & Anti-inflammatory agents - (Aspirin, Paracetamol, Piroxicam, Ibuprofen and Diclofenac Sodium). 

Anti-neoplastic agents - (Chlorambucil, Busulfan, Fluorouracil, Methotrexate and Tamoxifen), 

Chemotherapeutic agents, Sulfonamides - (Sulphamethoxazole and Sulphadioxine) Antibiotics - General Classification of Antibiotics; Beta-Iactam antibiotics - (Penethicillin, Ampicillin, Cloxacillin); Cephalosporins - (Cephalexin); Tetracyclines - (Chlortetracycline, Oxytetracycline), Quinolones - (Norfloxacin and Ciprofloxacin); Aminoglycosides, Macrolides, Polypeptides; Miscellaneous - (Chloromphenicol and Novobiocin). 

Antituberular drugs - (INH, PAS, Ethambutol); Antileprotic drugs - (Dapsone); Antifungal drugs - (Ketoconazole and Fluconazole); Antiviral drugs - (Zidovodine ); Antimalarial drugs - (Chloroquine, Pyrimethamine, Primaquine); Anthelmentic drugs - (Diethyl carbamazine citrate, Albendazole, Niclosamide, Pyrantel formate and Piperazine citrate); Antiprotozoal drugs - (Metronidazole, Tinidazole). 

Drugs acting on CNS: CNS stimulants and psychotropic agents - (Imipramine and Amiryptiline ), 

General Anesthetics - (Halothane, Ketamine, Enflurane), 

Sedative & Hyponotics - (Phenobarbitone, Glutethimide, Zolpiclone), Anxiolytics - (Diazepam, Medazolam, Buspirone). 

Antipsychotic (Tranquilizing) agents: (Chlorpromazine, Thiothixene, Haloperidol and Pimozide) 

Anticonvulsants - (Phenytoin, Carbamazepine, Ethosuximide), 

Antiparkinsonism drugs - (Benztropine and Carbidopa). 

PHARMACEUTICAL BIO TECHNOLOGY

Genetic Engineering

Introduction, History, Development, Application and Scope Genetics, DNA/RNA replication, Restriction Endonucleases, DNA Ligases, Vectors, Hosts, Cloning strategies, Gene Expression in Recombinant DNA. Application of recombinant DNA in manufacture of biological products such as Insulin, Human growth hormones, Interferons and Interleukins. 

Biochemical Engineering – Fermentation Technology 

Introduction, development and maintenances of industrial micro-organisms, batch and continuous fermentations, process controls, oxygen supply and demand, single and multiple bubble aeration, sparger aeration, foam control equipment, scale-up of Fermentors.

Microbiological Assay of antibiotics and Vitamin B_{12 .}

Study of culture, media, production conditions, extraction and purification of the following: 

Antibiotics – Semi synthetic penicillin’s, streptomycin and erythromycin as per IP.  

Hormones - Insulin Production 

Enzymes – Amylase and Diastase; Immobilization and their applications in drug manufacture.  

Biomass – Lactobacillus sporogenes  

Immunization Products

Manufacture, Standardization, Storage, Labeling and Specific Applications of the following vaccines: Bacterial vaccines, toxoids, viral vaccines, Rickettsial vaccines, Rabies, MMR, BCG, DPT, Cholera, Hepatitis B and Polio 

Standardization and Storage of the following Passive immunization products – Anti toxins, Anti venom, Immune sera and other products related to immunity and Immuno Diagnostics;  

Blood and Glandular Products  

Collection, processing and storage of whole human blood, Concentrated human R.B.C. dried human plasma, Human plasma protein fraction, dried human serum, Human fibrinogen, Human thrombin, human normal immunoglobulin, Human fibrin foam, Plasma substitutes – Ideal requirements, PVP, Dextran 40, Control of blood products, Transfusion products. 

Preparation of extracts and isolation of pure substances and their dosage forms from Pituitary, Adrenal, Pancreas and Thyroid glands;. 

Biotransformations and Animal Cell Biotechnology  

Microbial transformation of steroids: Introduction, Types and methods of transformations mediated by microorganisms, design of biotransformation processes and selection of organisms. 

Animal cell culture: Techniques, Media used and Applications. 

Hybridoma culture: Production of monoclonal antibodies and their applications.