PROPRANOLOL HYDROCHLORIDE ORALLY DISINTEGRATING FILM (ODF) FORMULATION USING SOLVENT CASTING AND ROLLING METHOD
Febriyenti*, Regina Andayani, Nurul Hasanah Assofiah, Azizah Mursal*
ABSTRACT
Propranolol hydrochloride (HCl) is a non-selective beta-blocker that is commonly used to treat hypertension, myocardial infarction, and arrhythmia. Conventional tablet preparations often make it difficult for pediatric, geriatric, or gastrointestinal patients with gastrointestinal disorders. To overcome these problems, propranolol hydrochloride was formulated into an Orally Disintegrating Film (ODF). This thin film-shaped preparation disintegrates in the oral cavity within less than a minute, eliminating the need for water. The purpose of this study is to formulate propranolol hydrochloride into ODF using the solvent casting method and rolling method. In the solvent casting method, HPMC E3 is used as the polymer, and three types of plasticizers (glycerin, propylene glycol (PG), and polyethylene glycol (PEG) 400 were employed at two concentrations. The best formula using PEG 400 (F5) produces a transparent, homogeneous, dry film in 72 hours and with a disintegration time of 46.03 ± 0.57 seconds. Content uniformity was 95.38 ± 1.95 (AV = 7.79). The rolling method was developed to speed up the drying process and increase production. The best formula R3 using 6 ml of distilled water produces a transparent, homogeneous, quick-drying film (12 hours), has a disintegration time of 36.00 ± 1.00 seconds, and content uniformity was 99.44% (AV = 13.29).
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