Utilizing Quality by Design to Develop and Evaluate Extended-Release Upadacitinib Tablets Incorporating a Biosynthesized Polymer

Sunil Chowdary, K.; Napoleon, A. A.

doi:10.1007/s12247-023-09754-1

Cited by 1 publication

(1 citation statement)

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“…Further optimization done by using design expert software and software has suggested optimum concentration of polymer base on results of feasibility trials and criteria set in Design of Experiment software to ensures a robust process for achieving optimal extended-release brivaracetam tablet formulations. 15 Procedure for brivaracetam extended release tablet dissolution testing Film-coated brivaracetam extended release 100 mg tablet drug release examinations were conceded out using USP dissolution testing equipment type II (Paddle type; Electrolabs, Bangalore, India). A 12-hour dissolving test was conducted using 900 mL of USP-approved phosphate buffer PH 6.4 at 37°C and 50 rpm.…”

Section: Evaluation Of Pre-compression Parametersmentioning

confidence: 99%

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

Pund,

Mundada

2024

IJPQA

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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.

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Section: Evaluation Of Pre-compression Parametersmentioning

confidence: 99%