Development of reservoir type transdermal drug delivery system of alfuzosinhydrochloride for the treatment of benign prostate hyperplasia

摘要

Benign prostate hyperplasia (BPH) is a condition occurring with geriatric group of patients. But the absolute bioavailability of alfuzosin is about 49% under fed conditions; the corresponding value under fasting conditions is approximately 25%. Hence there is a need for an alternative route of administration, the transdermal drug delivery system of alfuzosin hydrochloride consists of gel as a drug reservoir and a rate controlling membrane. Alfuzosin hydrochloride reservoir transdermal patches were prepared by fabricating drug reservoir in a rate controlling membrane. Drug reservoir gel was prepared using various polymers in different ratios along with permeation enhancers. Rate controlling membrane was prepared by solvent casting method using Eudragit RL100, HPMC K4M and Xanthan gum of different ratios and is evaluated separately. Ex-vivo studies were conducted on rat abdominal skin and the cumulative amount permeated in 24 hrs was 806.98±1.12μg/cm2 for F5 formulation over the control (30.85±0.74 μg/cm2). The flux was 29.5 μg/cm2/hr, lag time was 0.7 hrs, Permeability coefficient was 2.8 cm/hr and permeation was enhanced by 2.33 fold for F5 formulation. Out of the prepared formulations the F5 transdermal patch seem to be more efficient due to the steady state transdermal flux of 29.5μg/cm2/hr, lag time of 0.7 hrs, enhancement ratio of 2.33 with permeability coefficient of 2.8 cm/hr has been obtained. The optimized formula exhibited controlled drug release profile with zero order kinetics.