Formulation Development and Evaluation of Orally Disintegrating Antiretroviral Pediatric Tablet

Abstract

The primary aim of the work was to design an immediate release orally disintegrating tablet for the management of HIV in the pediatric population. Orally disintegrating table provides very prominent result in dysphagic patients like pediatrics and geriatrics who had diffulticies in swallowing of tablet. This project is the part of the ongoing project at Emcure pharma, the project is may be for ANDA (suitability petitions, changes in dosage form, strength s as compare of RLD). Three different APIs are used for formulating the anti retro viral orally disintegrating tablet for pediatric use. The Preformulation study was carried out to check the purity and compatibility of the APIs with the excipients selected. The drug excipients study proved that drug and excipients are compatible with each other. The preliminary trials batches were formulated by trial and error bases to finalize the pre optimized formula. The final optimisation to check the impact on dependent variables (disintegration time and in vitro dissolution) was done with the help of the design expert software by applying 23 full-factorial design. All the batches are evaluated for the various parameters to obtain the final optimised batch. The final optimised formula was selected based on the results observed for DOE trials. The formulation was prepared and evaluated for the physical and mechanical parameters like; thickness, disintegration time, hardness, dispersion time, dissolution test, in-vitro drug release profile. The research proved that as per DOE trials in which increase in disintegrant and anti caking agent and decrease in lubricating agent will show less disintegration time and faster dissolution compare to other formulations.