This module aims to provide the student with details of drug formulation and packaging of pharmaceutical products
Physicochemical Properties:
Preformulation studies; Factors affecting Solubility and Dissolution Drug Stability; Particle size analysis; Excipient Compatability
Formulation:
Tablets, capsules, suppositories, creams, ointments, liquid dosage forms, controlled release systems, parenteral dosage forms. Milling, blending, drying, granulating and tableting processes.Immediate release, Extended release, Modified release, multiparticles, matrix formulations, non-enteric coatings, enteric coatings, films. Emulsions and emulsion stability, spray drying, spray congealing. New emerging technologies; Processing - QbD Q8, Q9, Q10, Scale-up, SUPAC, Continuous mixing; PAT - NIR, FBRM, Raman etc
Packaging
Counterfeit; Purpose of packaging, legislation, hazards which pharmaceutical products facePackaging materials: primary and secondary packaging, properties, advantages and disadvantages. Problems in packaging: special requirements and facilitiesLabelling: label preparation and control; labelling procedures; inclusion of inserts/leaflets, types currently used. Requirements under EC directives; Braille
Practical Course (Examples)
1. Formulation practical 1: milling and blending, particle size analysis2. Formulation practical II: granulating, drying, tableting/capsulation3. Pilot scale pre formulation design and formulation4. Tablet Testing - Particle sizing , disintegration, friability, hardness, dissolution testing
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |