Optimasi Pektin dan Carboxymethylcellulose Sodium dalam Sediaan Fast Dissolving Sublingual Film Salbutamol Sulfat

Abstract

Salbutamol sulfate is a short-acting β2-adrenergic receptor agonist as a bronchodilator in treating asthma. Salbutamol sulfate is available in oral, inhalation, and injection dosage forms which still have disadvantages, namely low bioavailability, risk of misuse, and less comfortable for patients to use, so it is necessary to develop the preparation into Fast Dissolving Sublingual Film (FDSF). FDSF is a pharmaceutical dosage form designed to dissolve quickly under the tongue (sublingual), making it possible to be directly absorbed into the bloodstream through the sublingual mucosa and can immediately provide effects for patients. The aim of the study was to determine the optimum formula for making FDSF using a combination of polymers, namely pectin and carboxymethylcellulose sodium (CMC Na). The research method used was factorial design with the main response being disintegration time and folding endurance. The results of data analysis using Design expert version 13.0.5.0 software obtained the optimum formula, namely the combination of pectin at 300 mg and CMC Na at 10 mg. This data analysis also shows that the combination of pectin and CMC Na can cause a decrease in disintegration time and folding endurance. The test results using one sample t-test on SPSS 22.0 software at 95% confidence level showed that the optimum formula had a disintegration time of 4.67 ± 1.02 seconds and folding endurance of 725.33 ± 4.73 folds which had a significance value > 0.05. Salbutamol sulfate in the optimum formula is also able to release as much as 95.19 ± 1.30% within 60 seconds which shows that it meets the requirements. Based on these results, it can be concluded that the optimum formula meets the requirements of a good salbutamol sulfate FDSF preparation