Formulation Development and Evaluation of Brivaracetam Extended- Release Tablets by QbD Approach

Press Release

Abstract

This research article outlines a systematic and science-based approach to formulate extended-release tablets of brivaracetam (BRV) by means of quality by design (QbD) method. BRV, a potent antiepileptic drug, faces challenges due to its short half-life, necessitating twice-daily dosing and impacting patient adherence. The study focuses on addressing these challenges through the development of extended-release tablets, aiming for once-daily dosing to enhance patient compliance and adherence. QbD is a systematic approach to developing pharmaceuticals, focusing on proactive risk management and quality assurance.

It is supported and recommended by regulatory bodies. QbD, seeks to enhance processes and guarantee consistent product quality by engaging in activities such as establishing target profiles and identifying crucial qualities. Feasibility trials involve the identification of optimal polymers and concentrations following USP regulations. Materials, including Vivapur 200, HPMC K4 M, Blanose 7H4XF, HPMC K 200, magnesium stearate, SYLOID 244 FPFP, and brivaracetam, are carefully selected. The formulation process includes precise weighing, blending, tablet compression, and quality control tests. Dissolution testing under simulated physiological conditions assesses drug release, with UV spectrophotometry quantifying brivaracetam release. Evaluation of pre-compression parameters ensures a thorough understanding of powder blend characteristics.

The study further presents the results and discussion on physical parameters and dissolution studies of feasibility trial formulations. In conclusion, the research establishes a foundation for the formulation development of extended-release BRV tablets, emphasizing the importance of the QbD approach in achieving optimal drug release profiles. The identified formulation (BRERT-17) is highlighted as the most promising, paving the way for future advancements in epilepsy management with improved patient compliance.

Download the full article as PDF here Formulation Development and Evaluation of Brivaracetam Extended- Release Tablets by QbD Approach

Materials

A gift sample of brivaracetam recived from Kimia Bioscinece Ltd, India. Vivapur obtained from JRS Pharma, Blanose 7H4XF procured from M/s Ashland, HPMC K4M, HPMC K100 & HPMC K200 M obtained as gift specimen from Colorcon India. Syloid  244 FPFP was received from M/s Grace USA as gift sample & Magnesium Stearate obtained from M/s Suddep Pharma India and Opadry Complete Film coating system 21K58794 white Received as gift sample from Colorcon India.

Pund A, Mundada A. Formulation Development and Evaluation of Brivaracetam Extended-Release
Tablets by QbD Approach. International Journal of Pharmaceutical Quality Assurance. 2024;15(1):372-381.


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