Abstract
Objective: This research aims to determine the amount of hydroxypropyl methylcellulose (HPMC) and chitosan, which can produce the optimum buccal film formula and to determine the release kinetics of diltiazem hydrochloride in vitro.
 Methods: The film was prepared by the solvent casting method. The formula's optimization was carried out using factorial design, which was processed using Design Expert 11.0.0 software, while the release kinetics was analyzed using the DDSolver program.
 Results: The optimization results show that HPMC and chitosan (30 mg: 10 mg) is the amount of polymer that can produce the optimum formula. The buccal film formula has a swelling index of 2.92, a mucoadhesive strength of 64.40 gF, and a mucoadhesive residence time of 464 min. In vitro release study showed 97.64% release of Diltiazem hydrochloride after 480 min. The release kinetic’s of diltiazem hydrochloride follow the Korsmeyer Peppas model.
 Conclusion: Thus, it can be concluded that the prepared formulation of the buccal mucoadhesive film can be a delivery system for diltiazem hydrochloride.
Highlights
Hypertension is a persistent increase in systolic and diastolic blood pressure more than 140 mmHg and 90 mmHg
The buccal delivery system is suitable as an alternative for diltiazem hydrochloride drug delivery because it could avoid the first-pass metabolism
The folding endurance test of each formula shows that the films resist to more than 300 times fold. These results indicate that the film is not damaged due to movement and mechanical friction in the oral environment [19]
Summary
Hypertension is a persistent increase in systolic and diastolic blood pressure more than 140 mmHg and 90 mmHg. Diltiazem hydrochloride can reduce Hypertension [1]. Diltiazem hydrochloride has 40% bioavailability due to first-pass metabolism [2]. The buccal delivery system is suitable as an alternative for diltiazem hydrochloride drug delivery because it could avoid the first-pass metabolism. The bilayered buccal film consists of an insoluble backing layer and a mucoadhesive layer containing drugs. The backing layer uses to regulate the drug release in one direction so that it prevents the drug from dissolving in saliva, prevents loss of the drug from the top, and can mask the drug's bitter taste [6]. The mucoadhesive layer uses to prolong drug contact with mucus [7]
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