Application of Quality by Design (QBD) to the Development and Valiadtion of Ensitrelvir Fumeric Acid in Tablet Dosage form by RP-HPLC

Abstract

This study aimed to develop mouth-disintegrating tablets of Flurbiprofen through a straightforward and scalable direct compression method, accompanied by a reliable UV-Visible spectrophotometric assay for drug analysis. The optimized UV method, performed in 0.1N HCl, identified a maximum absorbance at 257nm, enabling accurate quantification of Flurbiprofen within tablet formulations. Tablets were formulated using common super disintegrants sodium starch glycolate, crospovidone, and croscarmellose sodium and evaluated for critical quality characteristics such as hardness, friability, weight variation, and drug content, all of which met pharmacopeial standards. In vitro dissolution studies revealed rapid drug release across all batches, with the crospovidone based formulation demonstrating superior performance by releasing nearly 99% of the drug within 30 minutes. Comparative analysis confirmed that crospovidone facilitated faster dissolution compared to other super disintegrants under the test conditions. The study successfully achieved the goal of formulating efficient, patient-friendly Flurbiprofen mouth-disintegrating tablets with minimal excipients and a simple manufacturing approach, supported by a practical and robust analytical method for quality assurance.