Fast Dissolving/Disintegrating Dosage Forms (FDDFs) have been commercially available since the late 1990s. FDDFs were initially available as orodispersible tablets, and later, as orodipsersible films for treating specific populations (pediatrics, geriatrics, and psychiatric patients). Granules, pellets and mini tablets are among latest additions to these dosage forms, which are still in the development pipeline. As drug delivery systems, FDDFs enable quicker onset of action, immediate drug delivery, and sometimes offer bioavailability benefits due to buccal/sublingual absorption. With time, FDDF have evolved to deliver drugs in a sustained and controlled manner. Their current market and application is increasing in demands with advances in age adapted dosage forms for different patients and changing regulatory requirements that warrant mandatory assessments of new drugs and drug products before commercial availability.
This book presents detailed information about FDDFs from their inception to recent developments. Readers will learn about the technical details of various FDDF manufacturing methods, formulation aspects, evaluation and methods to conduct clinical studies. The authors also give examples of marketed fast disintegrating/dissolving drug products in US, Europe, Japan, and India. This reference is ideal for pharmacology students at all levels seeking information about this specific form of drug delivery and formulation.