Abstract

Aim of this research is to design Pregabalin Powder for Oral solution in a Sachet pack. The manufacturing process involved in formulating the product is by a simple direct blending and filling process. Apart from Pregabalin API, the excipients used in the final product includes Sorbitol as bulking agent, Sucralose as sweetener, Strawberry as flavor, Sodium Citrate as buffering agent and Sodium Benzoate as preservative. The finalized composition and process was completely optimized with respect to Critical Material Attribute (CMA) and Critical Process Parameter (CPP). The Physico-chemical characteristics, organoleptics and stability of the formulated product was found comparable to LYRICA® Oral Solution. Based on the accelerated stability results, the shelf life of the designed product was set to be stable for 24 months at controlled room temperature storage condition. The manufactured Pregabalin Powder for Oral solution in Sachet was found to be cost-effective compared to LYRICA® Oral Solution and expected to be appealing for patients both nationally and internationally. The designed product could become a potential alternative to already available capsule and oral solution in the market.