布立西坦口服溶液的处方工艺筛选及对有关物质的研究OA

Exploring the stability of brivaracetam oral solution,by examining the influence of formulation process on related substances in the solution.A method for related substances was established and validated.Scaling up the production of samples based on the optimized formulation composition and packaging form,and examining the stability of the product under high temperature and light conditions.The developed method for detecting related substances is feasible,achieving great separation of the active pharmacentical ingredient(API)and impurities.Controlling pH value of the product to 5.0-6.0 can effectively slow down the increase of related substances under high temperature;adding the API after the addition of anhydrous citric acid and sodium citrate can significantly reduce the level of related substances.This article developed a method for detecting related substances in brivaracetam oral solution and addressed the medication shortage for pediatric and elderly patients with epilepsy who have difficulty swallowing by optimizing the formulation process.