Demonstration of bioequivalence is a critical requirement for gaining marketing authorization of new drugs and generics. These requirements are specified in the Code of Federal Regulations, Title 21, Part 320 (21 CFR Part 320) as they apply to dosage forms intended for oral administration. Substantial ...

The manufacturing of compressed solids is a complex process, requiring several steps to render powders compressible, yet easily dispersed, and with the active ingredient dissolved when placed at the site of administration. As a result, the formulations that deliver the drugs to the site of action, ...

Many types of coatings are available. Sugar coating used to be a choice coating method years ago. This was mostly replaced with film coatings, as new polymers with better film-forming properties and equipment for applying these coatings became available. ...