Optimasi Pektin dan Polivinil Alkohol dalam Sediaan Fast Dissolving Sublingual Film Salbutamol Sulfat

Abstract

Salbutamol sulfate is a β2-adrenergic receptor agonist drug that relieves bronchospasm in asthma with a short duration of action. Fast dissolving sublingual film (FDSF) is a thin film preparation that dissolves quickly to be delivered to systemic circulation through the mucous membrane at the base of the mouth. Pectin is an anionic polysaccharide that is water-soluble and functions as a good filmforming matrix. Polyvinyl alcohol (PVA) is a synthetic polymer that functions as a plasticizer to produce films with good flexibility and rapid drug release. The combination of pectin and PVA aims to produce films with high active ingredient release rate and good fold endurance. The film preparation method used is the solvent casting method for water-soluble materials. This research used an optimization method, namely factorial design with two factors and two levels. The responses used were disintegration time and fold endurance. Results of organoleptic tests, thickness uniformity, surface pH, disintegration time, fold endurance, and content determination for F1, FA, FB, and FAB have met the requirements. The response results of disintegration time and fold endurance were analyzed using Design Expert version 13.0.5 full version software to determine the optimum formula. FB was selected as the optimum formula with 200 mg pectin and 175 mg PVA. The optimum formula was verified using One Sample T-test on SPSS version 22 and showed no statistically significant difference. The optimum formula characteristics resulted in disintegration time of 16.51±2.05 seconds, fold endurance of 689.67±4.51 folds, and in vitro release percentage value of salbutamol sulfate of 96.24±0.81% within 60 seconds.