DOSAGE FORMULATION DESIGN (PHARMACEUTICS – III)

Pre Formulation Studies 

Study of Physical Properties of Drug: Particle size, Shape, pKa, Solubility, Partition Coefficient, Crystallinity, Polymorphism and Hygroscopicity, 

Powder Characteristics: Bulk density, Flow Properties, Solid State stability, Solution stability, and Stability Protocol, Dissolution and Organoleptic property and their effect on formulation. 

Study of Chemical Properties of Drug: Hydrolysis, Oxidation, Polymerization etc., and their influence on formulation and stability of the Products. 

Sustained Action Pharmaceuticals 

Concept, Benefits, Limitations, Advantages & Disadvantages, Definition of various types of prolonged action pharmaceuticals. 

Sustained Action Oral Products: Theory-Zero order release approximation, First order release approximation, Approaches based on drug modification and dosage form modification, in vitro & in vivo evaluation of the sustained release products. Formulation -Drug complexes, Encapsulated slow release granules, Tabletted slow release granulations and matrix tablets. 

Microencapsulation: Applications, Core and Coat materials, Techniques- Air suspension, Coacervation-Phase separation, Pan Coating, Spray Drying & Spray congealing, Solvent Evaporation,. Polymerisation. 

New Drug Delivery Systems

Importance, Formulation and Applications. 

Transdermal Drug Delivery Systems: Concept, Advantages and disadvantages, Approaches used in developing Transdermal drug delivery systems (4 types), in vitro evaluation of Transdermal drug delivery systems. 

Liposomes: Formulation, Preparation of liposomes-physical dispersion and solvent dispersion, Characterisation of Liposomes, Applications in Pharmacy. 

Occular Drug Delivery Systems: Concept, Advantages and disadvantages, Mucoadhesives, design of Occuserts (Pilo 40 and Pilo 20), Erodable inserts. 

Nanoparticles: A brief introduction to Nanoparticle technology and Nanoparticles as drug carriers in controlled & targeted drug delivery systems. 

Performance Evaluation Methods 

Bioavailability: Definitions, Objectives, Considerations, Assessments, Enhancement Methods, Dissolution Studies for solid dosage forms and methods of interpretation of dissolution data. 

In vitro and In vivo methods of evaluation 

Bioequivalence: Definition, Objectives, Testing Protocols and Procedures, Experimental Design of single dose bioequivalence study and Statistical Interpretation of data. 

Concepts of Process Validation: Definition, Importance, types of validation in Pharmaceutical Operations and Introduction to different process validation methods. Concepts of Good Manufacturing Practices in Production of Pharmaceutical Products 

Quality Control and Assurance 

Introduction, Quality Assurance, Sources of Quality variation, 

Control of Quality variation: Raw Materials Control - Raw Material Quality Assurance Monograph, Active or Therapeutic Materials Control, 

Quality Assurance at startup - Raw Materials Processing, Compounding, Packing materials. Quality Assurance during packing operation - Auditing, Concept of statistical Quality Control and Quality Control Charts. 

Control & Assurance of Manufacturing practices: Personal, Equipment & Buildings. Control of records - Master formula record, Batch production record. 

Control of production procedures - Manufacturing control, Packing Control and Labels control. Stabilization and stability testing protocols for various pharmaceutical products. 

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 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. 

HOSPITAL & CLINICAL PHARMACY

Introduction to Hospital and Hospital Pharmacy 

Hospital and its Organisation,  

Hospital Pharmacy: Objectives, Functions, Organisation, Planning, Personnel and Administration of Hospital Pharmacy Services; Hospital Drug Policy – General Considerations; 

Hospital Committees: Purpose, Organization and Functions of Pharmacy and Therapeutic Committee (PTC), Role of Hospital Pharmacist in Hospital Committees and Practice of Rational Drug Therapy and Drug Exchange Program; 

Hospital Formulary  

Organization, Formulary Content, Preparation and Distribution; Pharmacy Procedural Manual Preparation; Drug distribution, Dispensing to Inpatient and Ambulatory Patient care, Dispensing of ancillary and controlled substance; Procurement and Distribution of alcohol; Manufacturing of Bulk and sterile supplies; Storage and Handling of Radio isotopic Pharmaceuticals; Budget Planning, Purchasing and Inventory Control; Use of Surgical Instruments & Hospital Equipment. 

Clinical Pharmacy   

Introduction, Scope, History and Development of Clinical Pharmacy; Investigational use of Drugs and Drug Therapy Monitoring with examples, Adverse Drug Reaction Management; Drug and Poison Information, Medication history review and Patient Counseling; Patient Compliance, Patient Data Analysis and its Use in evaluation of Clinical Tests for Common Disease States and Organ Functional Tests (Liver, Pulmonary and Renal) for Drug Therapy; Definition and Differences of Generic and Prescription Drugs; 

Basic Principles of Drug Therapy  

Concepts of Essential Drugs and Rational Drug Use; 

Drug Distribution: Out Patient and In Patient Services; Unit dose drug distribution systems, floor ward stock systems, satellite pharmacy services, central sterile services and bed side pharmacy; 

Drug- Drug Interactions: Mechanism of Pharmacokinetic and Pharmacodynamic interactions with suitable examples; Food and Drug interactions. Incidence, Classification and Surveillance Methods of Adverse Reactions of Drugs; Therapeutic Aspects of Pharmaco Genetics; 

Drug induced Disease – Dermatological, Hepatic, GI, Renal, Gout, Parkinsonism, Cancer, Depression, Psychosis, Ototoxicity, Ocular toxicity and Teratogenicity. Adverse drug reactions.  

Pharmaco Therapy of Diseases 

Diseases: – Symptoms, Manifestation, Patho-Physiology and Etiology of - Gastrointestinal diseases: Peptic ulcer, Ulcerative colitis, Hepatitis & Cirrhosis (Liver). Cardio Vascular System diseases – Angina Pectoris, Acute Myocardial Infunction, Atherosclerosis, Essential Hypertension, Cardiac arrhythmia. Respirtory diseases – Asthma and T.B.; STD – HIV, Syphilis and Gonorrhea.; Anemia, Parkinsonism, Diabetes, Gout and Rheumatiod arthritis. 

Pharmaco Therapy and Critical Analysis of Rational Use of Drugs in the following Disorders: Cardio Vascular, Respiratory, Renal, Gastro-Intestinal, Nervous, Psychiatric, Rheumatic, Hematological, Endocrine and Infections.