Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING FILMS OF ENALAPRIL MALEATE.

Harshada Deoghare*, Prajakta Ahire, Ghanashyam Yadav and Avish Maru

Abstract

Enalapril Maleate is an angiotensin converting enzyme (ACE) inhibitor, used mainly in the treatment of hypertension and angina pectoris. It shows low bioavailability 40-60% due to high hepatic first pass metabolism. Hence the present study investigated the possibility of developing Enalapril Maleate fast dissolving sublingual films allowing fast, reproducible drug dissolution in the oral cavity, thus by passing first pass metabolism to provide rapid onset of action of the drug. The fast dissolving films were prepared by solvent casting method. Hydroxylpropyl methylcellulose (HPMC K 15) and polyvinyl alcohol were used in combination as film forming polymer, due to their hydrophilic nature and palatable taste. To decrease the disintegration time of formulations sodium starch glycolate was used as disintegrating agent. Glycerin is used as a cooling agent, sodium lauryl sulphate is used as a oral penetration enhancer and mannitol, aspartame is used as sweetening agent. All the films formulations (F1-F9) was evaluated for their thickness, weight variations, tensile strength, percentage elongation, folding endurance, surface pH, in-vitro disintegration, drug content, in-vitro drug release and ex-vivo permeation. Disintegration time showed by the formulations was found to be in range of 20-40 sec. Formulations F2 showed 90% drug release within 15 min. The film showed an excellent stability at least for 4 weeks when stored at 400C and 75% in humidity.

Keywords: Enalapril Maleate, Fast Dissolving Films, Mouth Dissolving Films.