Fast-dissolving oral films containing dextromethorphan/phenylephrine for sinusitis treatment: formulation, characterization and optimization.

IF 4.4 3区 医学 Q2 ENGINEERING, BIOMEDICAL
Progress in Biomaterials Pub Date : 2022-09-01 Epub Date: 2022-07-07 DOI:10.1007/s40204-022-00191-w
Mozhgan Moonesan, Fariba Ganji, Arezoo Soroushnia, Fatemeh Bagheri
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引用次数: 1

Abstract

This work uses optimization study to formulate a patient-friendly antitussive fast-dissolving oral film based on phenylephrine hydrochloride (Phen) and dextromethorphan hydrobromide (Dex). The designed films were based on hydroxypropylmethyl cellulose (HPMC) with two grades (E5 and E50) as a film-forming polymer by the solvent-casting method. Polyethylene glycol with two molar masses (400 and 1000) was used as a plasticizer, while aspartame was used as a sweetener and microcrystalline cellulose intended to act as a disintegrant. To find an optimum formulation, a response surface methodology and a central composite design were employed. The percentage of HPMC E50, and PEG, as a plasticizer, were considered to be the design factors. Film thickness, surface pH, disintegration time, dissolution percent, tensile strength, elongation percent and folding endurance were considered to be the responses. A film with 11.46% E50, 88.54% E5, 25% of two drugs (8.4% of Phen and 16.6% of Dex) and 18.54% plasticizer is designed and prepared as the optimum formulation for Phen/Dex fast-dissolving oral films, with 95% confidence levels.

含右美沙芬/苯肾上腺素治疗鼻窦炎的速溶口服薄膜:配方、表征和优化。
本研究以盐酸苯肾上腺素(Phen)和氢溴酸右美沙芬(Dex)为原料,通过优化研究制备了一种对患者友好的止咳速溶口服薄膜。以羟丙基甲基纤维素(HPMC)为基材,以E5和E50两个等级为成膜聚合物,采用溶剂浇铸法制备成膜膜。两摩尔质量(400和1000)的聚乙二醇被用作增塑剂,阿斯巴甜被用作甜味剂,微晶纤维素被用作崩解剂。为寻找最佳配方,采用响应面法和中心复合设计。设计因素考虑了HPMC E50和PEG作为增塑剂的比例。薄膜厚度、表面pH值、崩解时间、溶出率、抗拉强度、伸长率和折叠耐久性是影响反应的主要因素。设计制备了E50为11.46%、E5为88.54%、苯乙酯为8.4%、苯乙酯为16.6%、增塑剂为18.54%的Phen/Dex速溶口服膜最佳配方,置信水平为95%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Progress in Biomaterials
Progress in Biomaterials MATERIALS SCIENCE, BIOMATERIALS-
CiteScore
9.60
自引率
4.10%
发文量
35
期刊介绍: Progress in Biomaterials is a multidisciplinary, English-language publication of original contributions and reviews concerning studies of the preparation, performance and evaluation of biomaterials; the chemical, physical, biological and mechanical behavior of materials both in vitro and in vivo in areas such as tissue engineering and regenerative medicine, drug delivery and implants where biomaterials play a significant role. Including all areas of: design; preparation; performance and evaluation of nano- and biomaterials in tissue engineering; drug delivery systems; regenerative medicine; implantable medical devices; interaction of cells/stem cells on biomaterials and related applications.
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