Gulay Yelken Demirel
Sanovel Pharmaceuticals, Turkey
Title: Effect of formulation development and API characteristics on fast dissolving dosage forms bioequivalence studies
Biography
Biography: Gulay Yelken Demirel
Abstract
Fast Dissolving Dosage Forms represent excellent opportunities for life cycle management to the pharmaceutical companies. They have many advantages like ease of swallowing, administration without water, quick onset of action for improving both patient convenience and compliance as benefits for patient; extended life cycle, product differentiation, patent protection. But there are some challenges for formulation development studies for the generic companies. In the sense of generic companies, developing a Fast Dissolving Formulation version of an existing immediate-release product means that the two formulations must be bioequivalent and this can be challenging for in-vivo studies especially if the method of taste masking retards the dissolution rate of the active ingredient after disintegration. On the other hand, what will be the effects on the BE studies if the API has significant degree of buccal or sublingual absorption occurs in this case?