| |
PHARMACEUTICAL DRUG DESIGN AND DEVELOPMENT |
| |
|
|
| COURSE : IC-101 |
Duration : |
12 months |
| |
Qualification : |
Minimum BS, B.Pharm |
|
| |
|
| |
| Module - 1(Basic): |
| |
The basic module is designed to provide students an in-depth knowledge of applied pharmaceutical sciences, bio-pharmaceutics, and Chemical and Regulatory affairs. Novel concepts in leading edge industrial pharmaceutical research, applied statistics and experimental design are a major component of the module.
This course covers state-of-the-art pharmaceutical processing, identifying underlying chemical process engineering principles and providing quantitative approaches to drug product manufacturing process design and optimization. It also provides interdisciplinary training in focusing on issues relating to in quality testing, drug absorption and bioavailability |
| |
| Course includes: |
|
 |
Overview of Pharmaceutical industry. |
 |
Basic information about drug discovery and development. |
 |
Drug dosage formulation and role of key operational units in drug manufacturing processes. |
 |
Role of the Pharmaceutical industry in the global market and its implications. |
 |
Drug development cycle and the investment required. |
|
| |
| This course is focused on the development of a working knowledge of the Federal Code of Regulations and its impact on the pharmaceutical and allied industries. The history of the Federal Governments regulation of the pharmaceutical industry is studied. Also covered are the industries response and the methodologies it uses to comply with these regulations. |
| |
|
| |
| Module – 2 (Intermediate): |
| |
| The intermediate module focuses on practical training in pharmaceutical experimental design, formulation technology and manufacturing techniques. Hands-on experience is acquired through team-based projects, in compliance with GMP and GLP, in our state-of-the-art research laboratories and manufacturing plant. |
| |
| Course includes: |
|
 |
Process development and scale-up technology, |
 |
Method development and process development technique using HPLC, Dissolution, UV-VIS |
 |
Manufacturing instrument calibration |
 |
Cleaning validation technique. |
 |
Coating technology trainees acquire an understanding of the scientific principles of coating processes, |
 |
Chromatography HPLC/GC andTLC. |
 |
Tablet compression technique. |
|
| |
Understanding of the various equipments, filling mechanisms, and properties of materials suitable for encapsulation.
Analysis of certain drug products with one or more than one active ingredient. Use of internal standard in the analysis techniques. Lambert beer’s law. Use of light law in pharmaceutical industry. HPLC/GC trouble-shooting and column selection in analysis. FDA laws for regulated industry. Other regulatory bodies such as ICH, EPA, OSHA, DEP, DEA etc. |
| |
|
| |
|
| |
| Module – 3 (Advanced): |
| |
The advanced module provides an opportunity to engage in independent drug development and research projects. The focus is on drug delivery, dosage form design, process development and scale-up technology.
This course examines pharmaceutical separation processes in a variety of systems under a variety of conditions. |
|
 |
Physicochemical basis of separations, flux-force relations and phase equilibrium phenomena will be considered to provide a fundamental background to equilibrium separation processes |
 |
External field-based processes and membrane-based separations in closed systems. |
 |
A variety of separation processes will be studied in detail, including distillation, extraction, crystallization, absorption, ion exchange, Moving bed processes, electrophoresis, freeze drying, |
 |
Micro filtration /ultra filtration, reverse osmosis, evaporation and others. Integrated pharmaceutical product manufacturing flow sheets will also be studied. Micro-encapsulation and the ability to identify and correct coating defects. |
 |
Writing technique of manufacturing method, SOP and technical writing skills are acquired throughout the module. |
|
| |
| |
|
| |
|
| |
| Module – 4 (Internship): |
| |
Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience through working with staff and faculty on one of the many unique projects undertaken at the Institute. |
|
|
| |
Top |
| |
|