Abstract

FORMULATION, EVALUATION AND OPTIMIZATION OF SUBLINGUAL TABLET OF APREMILAST

Pankil Patel*, Jayanti Bajag, Snehal Patel, Chintan Aundhia, Kartik Pandya, Priyank Patel

ABSTRACT

A sublingual tablet of Apremilast along with solubility enhancement was successfully formulated by employing solvent evaporation method followed by direct compression method. Solid dispersions of Apremilast were prepared with Copovidone VA 64 to improve the solubility of drug. Preformulation studies of drugs were performed; the XRPD analysis revealed that there is no chemical interaction with excipients used was compatible with drug. Preliminary batches DP1 to DP9 prepared by taking various method of preparation and various disintegrant based on evaluation solvent evaporation technique and cross carmellose calcium best among all. Factorial batches P1 to P9 prepared by taking Drug: polymer ratio and cross carmellose in different proportion and applies 32 factorial designs. Evaluation parameters like Hardness, disintegration time, wetting time, assay and dissolution will be evaluated for all the formulations. P4 batch evaluated for various parameters and results found well within acceptable limits. P4 batch found stable up to 1 month in stability. Hence, the P4 batch was the optimized batch.

Keywords: Apremilast, Sublingual Tablet, Psoriasis.