Formulation And Evaluation Of Ketoprofen Delayed Release Pellets By Using Non-Pareil Seeds

Abstract

The present study focuses on the formulation and evaluation of delayed-release pellets of ketoprofen using non-pareil seeds as the core material. Ketoprofen, a widely used nonsteroidal anti-inflammatory drug (NSAID), is known for its efficacy in managing pain and inflammation but poses risks of gastrointestinal side effects. To mitigate these adverse effects and improve patient compliance, a delayed-release formulation was developed. The process began with the coating of non-pareil seeds with ketoprofen using a fluidized bed coater. Various polymeric coatings were applied to achieve the desired delayed-release profile, including ethyl cellulose and hydroxypropyl methylcellulose phthalate (HPMCP). The pellets were then subjected to comprehensive evaluation through a series of tests to assess their physical and chemical properties. Key parameters evaluated included: Particle Size and Distribution: Ensuring uniformity and consistency in pellet size. Surface Morphology: Using scanning electron microscopy (SEM) to confirm the integrity and smoothness of the coating. Drug Content: Determining the uniform distribution of ketoprofen within the pellets. In Vitro Release Studies: Conducting dissolution tests to evaluate the release profile of ketoprofen under simulated gastrointestinal conditions. Stability Studies: Assessing the stability of the pellets under various environmental conditions. The results demonstrated that the ketoprofen pellets exhibited a controlled and delayed release profile, reducing the drug release in the gastric environment while ensuring adequate release in the intestinal pH. This delayed-release behaviour is anticipated to reduce gastrointestinal side effects and enhance the therapeutic efficacy of ketoprofen. In conclusion, the formulation of ketoprofen delayed-release pellets using non-pareil seeds proved to be a promising approach for improving the drug’s safety and efficacy profile. Further in vivo studies and clinical trials are recommended to validate these findings and explore the potential for commercial application.