DEVELOPMENT AND EVALUATION OF NANOCRYSTALS BASED CAPSULE OF DABIGATRAN ETEXILATE MESYLATE

Harshil Bhuva* and Bhakti Shah

ABSTRACT

DEM is an anti -coagulant drug which is used for the treatment of deep vein thrombosis and pulmonary embolism. DEM belongs to BCS class II (low solubility and high permeability) and having absorption at small intestine. So, the study was performed to prepare the Nanocrystals based capsule Thus the aim of my project is formulation and evaluation of nanocrystals-based capsule of dabigatran etexilate mesylate. In this Project Work assemble antisolvent precipitation technique used to formulated nanocrystals of DEM with 1000 rpm Stirring speed of mechanical stirrer and using PVPK30 & EUDRAGIT RL 100 as a polymer. 32 factorial design were used to optimize variables. Particle size, %EE, %CDR at 180 mins Dependent variables and stirring speed and polymer ratio is independent variables. Applied factorial design Optimized the batch and evaluated by % EE, %CDR, particle size, zeta potential, and SEM. The study successfully formulated DEM nanocrystals using a solvent-antisolvent method, addressing the drug’s solubility limitations. Optimization via factorial design validated the impact of polymer ratio and homogenization speed on critical quality attributes. The optimized nanocrystals exhibited enhanced dissolution, bioavailability, and stability, positioning them as a viable alternative to conventional formulations. This approach not only improves DEM’s therapeutic efficacy but also offers a scalable strategy for other poorly soluble drugs.

Keywords: Dabigatran Etexilate Mesylate, Deep Vein Thrombosis, Nano crystals, 32 full factorial design, Optimization.