Optimasi Pektin dan Gliserin dalam Sediaan Fast Dissolving Sublingual Film Salbutamol Sulfat

Abstract

Salbutamol sulfate is a SABA (Short-Acting Beta-Agonist), a selective ꞵ2 adrenergic receptor agonist in the lungs that can inhibit the contraction of bronchial smooth muscle which can increase smooth muscle relaxation and bronchodilation (Marques and Vale, 2022). Fast dissolving sublingual film (FDSF) is a drug that is administered under the tongue and has several advantages such as flexibility, easy administration, rapid onset because it goes directly to the systemic circulation, so it avoids the first pass metabolism in the liver and degradation in the gastrointestinal tract (Sallam et al., 2017). In this study, optimization was carried out using factorial design to determine the optimum formula using low level and high level of pectin polymer and glycerin plasticizer. The evaluation results of F1, FA, FB and FAB have met the criteria of a good film including organoleptic testing, surface pH, thickness uniformity and drug content. The test results of disintegration time in the formula with the shortest time are F1<FB<FAFA>FB>F1 with total folds of 822; 674; 407; and 353 times, respectively. The results of the two responses were used to determine the optimum formula using Design Expert 13.0.5.0 software and obtained the optimum formula in the form of pectin of 300 mg and glycerin of 39.742 mg. The optimum formula was verified by comparing the response prediction with the verification results using One Sample T-test on SPSS 22.0 software and both responses showed that there was no significant difference (sig>0.05%). The optimum formula was characterized using in vitro dissolution test to determine the amount of salbutamol sulfate released from the preparation when in contact with the medium and showed that the % release was 97.409% ± 0.924%.