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Optimization of Pectin and Hydroxypropyl Methly Cellulose in Fast Dissolving Sublingual Film Salbutamol Sulfate
Last modified: 2025-06-07
Abstract
Salbutamol sulfate is a β-2 adrenergic agonist that works by relaxing bronchial smooth muscles. This drug is suitable for the sublingual fast-disintegrating film (FDSF) delivery system, which offers advantages such as high flexibility and bypassing first-pass metabolism in the liver. A combination of hydrophilic polymers like pectin and HPMC enhances drug release compared to lipophilic polymers. This study applied a 2-level factorial design method, with pectin (0.20 g at low level and 0.30 g at high level) and HPMC (0.01 g at low level and 0.015 g at high level) to determine the optimal formulation. All formulas met the evaluation criteria, including organoleptic and pH testing. Analysis using Design Expert software 13.0.5.0 identified the optimal formulation at the low level of pectin (0.20 g) and HPMC (0.01 g). This formulation showed the shortest disintegration time (12 seconds) and the highest folding endurance (700 times). Verification using a t-test demonstrated no significant differences between experimental results and predictions (p>0.05). In vitro dissolution testing revealed that 98.94%±0.57 of salbutamol sulfate dissolved within 60 seconds.
Keywords
Salbutamol sulfate, FDSF, pectin, HPMC