Pharmaceutical Evaluation of Dosage Forms
Liquids: Labeling and packaging, description, content, appearance (colour, clarity, etc), pH, weight per ml, refractive index, etc.
Semi-solids: Labeling and packaging, description, content, appearance, weight per ml.
Tablets and Capsules: Labeling and packaging, description, appearance. Standard for tablets and capsules: Shape, weight, content of medicaments, diameter, hardness and friability; disintegration and dissolution tests for tablets and capsules. In- vitro dissolution tests for solid dosage forms: Natural convection Non-sink methods such as solvometer, hanging pellet, and static disc methods, forced convection non-sink methods such as Wruble, beaker, oscillating tube rotating disc, Sounder & Ellenbogen methods, and forced convection- sink methods (e.g., adsorption, partition, dialysis and column methods). Continuous flow through system.
Drug stability: Incompatibility in liquid dosage forms; chemical degradation of pharmaceutical products (hydrolysis, oxidation, isomerization, polymerization, decarboxylation and adsorption of carbon dioxide); physical factors influencing chemical degradation (temperature, moisture, light and radiation): factors influencing and methods of reducing chemical degradation; physical degradation of pharmaceutical products e.g., loss of volatile constituents, loss of water, adsorption of water, crystal growth, polymorphic changes and colour changes. Microbiological degradations.
Accelerated stability testing.
Packaging Materials general principles