Optimasi Polivinil Alkohol dan Polietilen Glikol 400 dalam Sediaan Fast Dissolving Sublingual Film Salbutamol Sulfat

Abstract

Inaccurate use of salbutamol sulfate inhalers and low bioavailability are problems that can affect the effectiveness of therapy. Oral drug use also has low effectiveness because it undergoes first pass metabolism in liver. Fast dissolving sublingual film (FDSF) is a thin film preparation that can dissolve quickly when contact with sublingual saliva, so this preparation is able to provide a fast onset of action and avoid first-pass metabolism in liver. The purpose of this study to optimize PVA and PEG 400 in FDSF salbutamol sulfate preparations to obtain the optimal FDSF salbutamol sulfate formula. The FDSF salbutamol sulfate preparation was made from PVA as a film-forming polymer and PEG 400 as a plasticizer using the solvent casting method. Optimization of PVA and PEG 400 using factorial design with responses tested including disintegration time, swelling index and in vitro drug release. The results showed that PVA and PEG 400 affected in increasing disintegration time and swelling index, but decreasing drug release in vitro. The interaction PVA and PEG 400 affected in increasing of disintegration time and decreasing the swelling index. The optimum formula obtained is FDSF salbutamol sulfate containing 0.3 g PVA and 0.085 g PEG 400 for the manufacture of 29 films in a Petri dish 8.5 cm in diameter. The optimum formula resulted in 30,673 seconds of disintegration time, 1,510 of swelling index, 96,9 % of in vitro drug release within 30 minutes and there is no interaction between salbutamol sulfate and other excipients.