Fabrication and Evaluation of Fast Disintegrating Oral Hybrid Films of Propranolol Hydrochloride by Using Pectin and Synthetic Polymers

Newton Amj, R. Sm, K. Sukhjinder
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引用次数: 9

Abstract

The main aim of this investigation is to develop fast disintegrating oral films of Propranolol hydrochloride by using Pectin and synthetic polymers. The Propranolol HCl oro-dispersible films were formulated by using HPMC E15LV, HPMC regular, pectin, Carbopol, and PVA, as film forming polymers. The selected polymers were natural and synthetic water soluble polymers. Generally solvent casting method was used in the manufacture of the mouth dissolving films. The formula which incorporates pectin HPMC E15 LV 4:2 and pectin: Carbopol 3:2 ratios and also other varying ratio were used in the formulation of Oro-dispersible films. The quantity and type of plasticizer affected the formulation of films; Propranolol HCl has bitter taste so taste masking agents were used. Citric acid was used as a salivary stimulating agent. The prepared films were subjected to the analysis of various evaluation tests such as weight variation, tensile strength, thickness, surface pH, and drug content. The significant parameters such as disintegration and dissolution profiles also studied in detail since the product was prepared for fast dissolving in the oral cavity.
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用果胶和合成聚合物制备盐酸心得安口服复合快速崩解膜及评价
本研究的主要目的是利用果胶和合成聚合物制备快速崩解的盐酸心得安口服薄膜。以HPMC E15LV、HPMC regular、果胶、Carbopol和PVA为成膜聚合物,制备了盐酸心得安(Propranolol HCl)或分散膜。所选聚合物为天然和合成水溶性聚合物。口腔溶膜的制造一般采用溶剂铸造法。采用果胶HPMC E15 LV 4:2和果胶:卡波波尔3:2的配比及其他不同配比的配方制备oro分散膜。增塑剂的数量和种类影响薄膜的配方;盐酸心得安有苦味,故使用掩味剂。柠檬酸被用作唾液刺激剂。对制备的膜进行了各种评价试验分析,如重量变化、拉伸强度、厚度、表面pH和药物含量。由于该制剂为口腔快速溶出制剂,因此对其崩解、溶出等重要参数进行了详细的研究。
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