Journal of Bioequivalence & Bioavailability

Effect of formulation development and API characteristics on fast dissolving dosage forms bioequivalence studies

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Gulay Yelken Demirel

Scientific Tracks Abstracts: J Bioequiv Availab

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?

Biography :

Gulay Yelken Demirel completed his Bachelor’s degree in Chemistry from University of Gazi (Ankara, Turkey) followed by a Master’s degree at Medicinal and Pharmaceutical
Chemistry (faculty of pharmacy) from same university. She is also a Turkish Patent Attorney. She has nine years experience in R&D department of generic pharmaceutical
companies. She worked at the Pharmaceutical Technology Department and gained experience in pre-formulation and formulation studies, new combination and techniques
for formulation development studies, OTC and herbal drugs formulations, bioequivalence batches preparation and in-vitro studies, drug product dossier preparing with
main focus on generic drugs for different market applications. Presently, she owns the R&D Project Group Executive position at Sanovel Pharmaceuticals. She has several
published papers in the academic areas and over 35 patents & patent applications in the industrial areas on pharmaceutical dosage forms.