Abstract

FORMULATION AND EVALUATION OF SELF EMULSIFYING DRUG DELIVERY SYSTEM LOADED BUCCAL FILM OF BCS CLASS II DRUG

Rajashree Gude*, Muskan Naik, Akshata Shirodker, Sagar Singh

Abstract

The pharmaceutical industry faces significant challenges in drug development, with approximately 40% of new drugs exhibiting low solubility, leading to challenges in achieving adequate bioavailability. One such drug affected by this issue is Darifenacin Hydrobromide (DH), an Anti-muscarinic agent crucial for treating conditions like Overactive Bladder and frequent urination. Despite its therapeutic potential, DH's oral administration suffers from poor bioavailability due to its inherently lipophilic nature and susceptibility to extensive firstpass metabolism. Utilizing a regular 23 Full Factorial Design, we investigated the influence of formulation variables, including the concentrations of HPMC E4M, PVA, and Glycerol, on critical parameters such as disintegration time and % drug content. This systematic approach allows us to develop an optimized oral film, designated as LSTF-9, which exhibits superior characteristics in terms of thickness, folding endurance, and in-vitro drug release performance. The culmination of our research efforts yields promising results, demonstrating the successful formulation of DH-LSEDDS and its integration into buccal films. By circumventing hepatic first- pass metabolism, our approach not only enhances DH solubility but also improves its dissolution profile, patient compliance, and safety. This innovative drug delivery strategy holds considerable potential for addressing the challenges associated with low solubility drugs, paving the way for the development of more effective pharmaceutical formulations.

Keywords: Self emulsifying drug delivery system, Darifenacin hydrobromide, Full factorial design, Buccal film.