不同聚合物平喘药缓释片的设计、研制与评价

Ashok Kumar, N. Goyal
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引用次数: 0

摘要

本研究的目的是定义和评估硫酸沙丁胺醇和茶碱框架片,延长出院剂型,用于治疗慢性阻塞性肺疾病(COPD)。对药物(硫酸沙丁胺醇和茶碱)与聚合物(HPMC K100M和黄原胶)共混粉末的松散容重、疏通容重、压缩指数和休止角进行了评价,取得了满意的效果。采用直接压缩法,以半合成聚合物羟丙基甲基纤维素(HPMC K100M)和天然聚合物黄原胶(h原胶)按不同配比制备缓释片,每片总重量为250 mg。然后对制备的片剂进行了各种物理测试,如直径、厚度、重量均匀性、硬度、脆性和药物含量。所有这些测试的结果都符合标准中提到的准则。体外溶出研究采用II型溶出仪进行24小时。其中F7在12 h时释药率为97.16±0.59%。这一发现表明,在特定浓度以上的HPMC K100M和黄原胶能够提供延长的药物释放剂型。
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Design, Development and Evaluation of Extended Release Tablets of Anti-asthmatic Agents using various Polymers
The aim of this investigation was to define and assess Salbutamol sulphate and Theophylline framework tablets, prolonged discharge dosage form, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Powder blends of the drugs (Salbutamol sulphate and Theophylline) and polymers (HPMC K100M and Xanthan Gum) were evaluated for loose bulk density, tapped bulk density, compressibility index and angle of repose which shows satisfactory results. The direct compression method was used for the preparation of Extended-release tablets using hydroxyl propyl methyl cellulose (HPMC K100M), a semi-synthetic polymer, and xanthan gum(a natural polymer) in changing ratios keeping the total weight 250 mg for each tablet. The fabricated tablets were then evaluated for various physical tests like diameter, thickness, uniformity of weight, hardness, friability and drug content. The results of all these tests were found to be satisfactory as per guidelines mentioned in the standards. The in-vitro dissolution study was carried out for 24 hours using type II dissolution apparatus. Among all the formulation, F7 shows 97.16 ±0.59 % of drug release at the end of 12 hours. This finding reveals that above a particular concentration of HPMC K100M and xanthan gum are capable of providing extended drug release from the dosage form.
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