Abstract

FORMULATION AND EVALUATION OF ALFUZOSIN HYDROCHLORIDE ORAL FILMS

S. Manasa Ravali and Dr. P. J. Prasuna Sundari*

ABSTRACT

Oral films are drug delivery systems wherein the film disintegrates, the drug dissolves rapidly and is absorbed through the buccal mucosa into the systemic circulation. Oral Films are advantageous to formulate drugs that cause gastric irritation or undergo first pass metabolism. This delivery system is suitable for paediatric, geriatric, bedridden patients and patients with fear of choking. Alfuzosin Hydrochloride (AH) is an α-adrenergic blocking agent used to treat hypertension and benign prostatic hyperplasia (BPH). AH undergoes extensive first pass metabolism and its oral bioavailability is 49%. The aim of this study is to formulate and evaluate oral films of Alfuzosin Hydrochloride. AH films were prepared by solvent casting technique using different concentrations of various polymers (HPMC E-15, HPMC E-5, Pullulan, Methocel E-3). The films were evaluated for mechanical properties, disintegration time, folding endurance, and in-vitro drug release. Evaluation data indicated the film formulated with HPMC E-15 to be the best. This film disintegrated in 30sec and there was 99.1% cumulative drug release in 6mins. It can be suggested from this study, that oral films are a suitable approach for delivery of Alfuzosin Hydrochloride. The optimized formulation F2 has followed Higuchi model.

Keywords: Oral Films, Alfuzosin Hydrochloride, Benign prostatic hyperplasia HPMC, Pullulan, Solvent casting method.