FORMULATION AND EVALUATION OF SUBLINGUAL TABLET OF VORTIOXETINE HYDROBROMIDE

Karan Prajapati*, Ms. Bhavana Patel, Dr. Pankaj H. Prajapati

ABSTRACT

The study aimed to develop and evaluate sublingual tablets of Vortioxetine Hydrobromide to improve its solubility and patient compliance. A β-Cyclodextrin (β-CD) inclusion complex was prepared in three different molar ratios to enhance the drug’s aqueous solubility, with the 1:2 ratio showing the highest solubility improvement. This was confirmed by DSC, which indicated reduced crystallinity, while FTIR confirmed no significant drug–excipient interactions. Tablets were formulated using direct compression, incorporating the optimized inclusion complex. A 3² full factorial design was employed to optimize the formulation, using MCC as a binder (X1) and Croscarmellose Sodium as a superdisintegrant (X2), with tablet disintegration time (Y1) and cumulative drug release (%CDR) (Y2) as dependent variables. The tablets were evaluated for both pre- and post-compression parameters. Among all batches, Batch F9 exhibited the best results, with a disintegration time of 47 sec and 99.5% drug release, complying with pharmacopeial standards. Stability testing under ICH guidelines confirmed the formulation’s physical and chemical stability. Overall, the study successfully developed a stable and effective sublingual tablet formulation of Vortioxetine Hydrobromide.

Keywords: Vortioxetine Hydrobromide, ?-Cyclodextrin, 32factorial design, solubility enhancement, inclusion complex, FTIR, DSC.