Pharmaceutical Dosage Forms I

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Unit 1 · Fundamentals of Dosage-Form Development 7 hrs

Pre-formulation studies — the concept, need and parameters assessed; drug–excipient compatibility studies; packaging selection for the various dosage forms; drug-product and container-closure interaction; and an introduction to the stability guidelines for new drug substances and products.

Unit 2 · Compressed Solids — Tablets 12 hrs

Tablet types and the granulation routes (wet, dry and direct compression); excipients and their roles; tooling types and specifications; compression machinery and process parameters; and the in-process and finished-product evaluation of tablets.

Unit 3 · Tablet Coating and Defects 12 hrs

Sugar coating, film coating and enteric coating — materials, processes and equipment; specialised coating techniques; tablet-coating defects, their causes and remedies; and the evaluation of coated tablets.

Unit 4 · Capsules 7 hrs

Hard gelatin capsules — formulation design, capsule shell composition and sizes, and filling methods (manual, semi-automatic and automatic); soft gelatin capsules — formulation, manufacture and applications; and the quality control and evaluation of capsule dosage forms.

Unit 5 · Modified-Release Dosage Forms 7 hrs

The rationale for sustained and controlled release; the polymers used in modified-release systems; matrix, reservoir and osmotic approaches; and the formulation and evaluation of sustained- and controlled-release products.