Design of experiment (doe) of a new formulation of praziquantel by using microcrystalline depolymerized cellulose

Abstract

The scope of the work iscarried outfor the development a new design of experiments of a new formulation of Praziquantel by using Microcrystalline depolymerized Cellulose. The Development trials of Praziquantel tablets USP 600 mg have been carried out with the remove of overages of API and preservatives (Parabeens) from the established formula of Praziquantel tablets USP 600 mg to finalize the manufacturing process and specifications. Trial batch was evaluated for feasibility of manufacturing process and designed target product profile. The compatibility studies were based on the composition of drug and excipients, the collected samples were stored at 25°C ± 2°C/ 60 % ± 5% RH, 40°C ± 2°C/ 75 % ± 5% for one month and 60ºC/80% RH for 15 days and were analyzed for description, assay and related substances.