FORMULATION AND EVALUATION OF DESVENLAFAXINE HYDROCHLORIDE DISPERSIBLE TABLETS FOR MAJOR DEPRESSIVE DISORDER

Dhruvi Panchal* and Bansi Zalavadia

ABSTRACT

The present study aimed to formulate and optimize dispersible tablets of Desvenlafaxine using the direct compression method, focusing on achieving rapid disintegration and enhanced dissolution. Desvenlafaxine served as the active pharmaceutical ingredient, while Crospovidone and Pharmaburst were employed as disintegrants and co-processed excipients. All other excipients used were of analytical grade. Preformulation studies, including infrared spectral analysis, were conducted to assess drug-excipient compatibility. A 3² full factorial design was utilized to evaluate the impact of varying concentrations of Crospovidone and Pharmaburst on critical tablet properties. Nine formulations (F1–F9) were developed and assessed for parameters such as weight variation, hardness, friability, disintegration time, and dissolution profile. All formulations complied with Pharmacopeial standards, with disintegration times under 2 minutes and F8 and F9 disintegrating in under 30 seconds. Drug release was rapid, with F8 achieving over 90% release in 10 minutes, even with minimal disintegrant. The factorial design was statistically significant for both disintegrants, and the optimized batch P9 exhibited excellent physicochemical characteristics and stability over time. The findings confirm that dispersible tablets of Desvenlafaxine can be effectively developed using direct compression, and the optimized formulation P9 presents a promising candidate for rapid onset antidepressant therapy.

Keywords: Desvenlafaxine, Crospovidone, Pharmaburst, Factorial design, Direct Compression.