Optimization of Super disintegrants in Clonazepam Orally Fast Disintegrating Tablets: Impact on Dissolution, Drug Release and Stability

The present study systematically investigated the role of sodium starch glycolate, kollidon CL, and ludiflash in nine (9) formulations (F-1 to F-9) of clonazepam orally fast disintegrating tablets (OFDT) developed via direct compression. Advanced preformulating assessments ensured optimal flow properties and compressibility, facilitating robust tablet manufacturing. In vitro dissolution studies revealed that formulations incorporating different superdisintegrants (F-3, F-6, and F-9) exhibited superior drug release profiles with faster drug release, attributed to the concentration and characteristics of the excipients, with F-5 demonstrating the highest dissolution efficiency (94%). Drug release kinetics followed first-order models with anomalous (non-Fickian) diffusion mechanisms, highlighting the interplay between formulation composition and drug release behavior. Similarity factor (f2) analysis confirmed moderate alignment with the marketed product, identifying key areas for further optimization. Stability testing, conducted under ICH guidelines, demonstrated the long-term integrity of all formulations. This study bridges a critical research gap by providing an in-depth analysis of superdisintegrants selection, dissolution behavior, and stability, offering a strategic approach for optimizing OFDT formulations for improved therapeutic efficacy and patient compliance. Author SummaryOptimization of superdisintegrants in clonazepam orally fast disintegrating tablets : Impact on dissolution, drug release, and stability is based on the pharmaceutical formulation and development of OFDT of clonazepam, a benzodiazepine used for treating epilepsy and panic disorders. The research aims to enhance the disintegration efficiency, dissolution rate, and bioavailability of the drug by incorporating three superdisintegrants: sodium starch glycolate, kollidon CL, and ludiflash through the direct compression method, a widely used pharmaceutical manufacturing process. The study involves preformulation analysis, physicochemical evaluation, in vitro dissolution studies, and stability testing under ICH guidelines, ultimately identifying F-5 as the most effective formulation with 94% dissolution efficiency. The findings contribute to the optimization of excipient selection in fast-dissolving formulations to improve the therapeutic performance and patient compliance of clonazepam.