Abstract

DESIGN AND EVALUATION OF ORO DISPERSIBLE FILMS OF LERCANIDIPINE HYDROCHLORIDE

Ravi Kumar. K*, Mercy Sulochana. M

Abstract

Hypertension became a major cause of concern in almost all age groups as it is one of the largest deaths causing disease for the mankind. The disadvantages of most of the antihypertensive drugs such as more frequent administration, extensive first pass metabolism, therapeutic inefficacy and variable bioavailability, make them ideal candidates for Oro Dispersible Film formulation. Lercanidipine Hydrochloride, a potent antihypertensive and antianginal drug is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration. However, absolute bioavailability is reduced to approximately 10% because of extensive first pass metabolism to inactive metabolites. In the present study, an attempt was made to formulate Lercanidipine hydrochloride oro dispersible films using natural polymers which are economic, safe and non-toxic. Lercanidipine hydrochloride oro dispersible films were formulated by solvent-casting method using polymers like Guar Gum, Sodium Alginate, Xanthan, Aloe Vera and Crospovidone as superdisintegrant. Formulation SAF2 with Sodium Algiante and crospovidone is considered as the optimized formulation as it showed faster disintegration rate (23sec), maximum in vitro drug release i.e., 99.26% within 8mins. No significant changes were observed during stability studies for the optimized formulation. It was concluded that Lercanidipine hydrochloride oro dispersible films can be formulated as a potentially useful tool for an effective treatment of hypertension and management of angina pectoris with improved bioavailability, rapid onset of action and with increased patient compliance

Keywords: Lercanidipine Hydrochloride, oro dispersible films, solvent-casting method