Development of Solid Oral Flexible Tablet OFT Formulation Platform for Pediatric and Geriatric Drug Delivery

Abstract

Development of patient-centric formulations had improved duringlast two decades. The global regulatory agencies such as FDA, EMEA andWHO had published various guidances for promoting the development ofage-appropriate formulations and to conduct clinical evaluations in pediatricand geriatric patients. This research work was carried out to design anddevelop Solid Oral Flexible Tablet (OFT) formulations for convenient drug newlineadministration, improve palatability, and acceptability among pediatric andgeriatric patients.The objective of designing OFT is to obtain benefits of chewable,ODT, and dispersible tablets in a single formulation platform to provideflexible dosing option for pediatric and geriatric patients. The research workfocuses on selection of excipients, taste masking and formulationdevelopment. Drug candidates were selected based on BCS class, dose,indication, dosing frequency and physiochemical properties. Cetirizine newlinehydrochloride, Carbamazepine, Aripiprazole, Olanzapine, and Cefixime wereselected as model drugs. Excipients were selected based on safety,physicochemical properties and their effect on pharmacokinetics of drugs.Formulations were developed using suitable process technologies. newline newline