Pharmaceutical Dosage Form II
Formulation and evaluation of semisolid, sterile (parenteral, ophthalmic) and controlled-release dosage forms.
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Course contents — unit by unit · PCI NEP 2020 BP504T
Unit 1 · Monophasic Liquids 6 hrs
The need for, and the advantages and limitations of, liquid dosage forms; monophasic versus biphasic systems and solubility-enhancement techniques; vehicles and solvents including pharmaceutical waters (types, manufacture and quality control of purified and distilled water) and solvent classes by toxicity; the formulation, manufacture and quality control of solutions, syrups and elixirs and of powders for reconstitution; and measuring, filling and packaging, container–closure integrity and automation in liquid manufacturing.
Unit 2 · Biphasic Liquids — Suspensions 6 hrs
The formulation and manufacture of suspensions — additives and the classification of suspending agents; in-process and finished-product quality control; instabilities and packaging; and advances including nanosuspensions, dry powders for reconstitution and raft-forming systems.
Unit 3 · Biphasic Liquids — Emulsions 6 hrs
The formulation and manufacture of emulsions — additives and the classification of emulsifying agents; in-process and finished-product quality control; instabilities and packaging; and advances including nano-emulsions, micro-emulsions and SMEDDS/SNEDDS.
Unit 4 · Pressurised Dosage Forms and Inhalers 6 hrs
Aerosols and metered-dose inhalers — concepts, propellant classification and selection, valves and containers, and the formulation, manufacture and quality control of the product, including leak testing, spray pattern, delivered dose and particle-size/aerodynamic performance; together with dry-powder inhalers and their formulation and evaluation.
Unit 5 · Semisolid Dosage Forms 6 hrs
The theory of semisolid dosage forms — definition and purpose, drug-permeation pathways through skin, factors affecting permeation and physical and chemical permeation enhancers; the formulation, manufacture and evaluation of ointments (including base selection), creams, gels and jellies, pastes, and suppositories and pessaries; and advances such as xerogels and emulgels.
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