苹果酸阿莫曲坦口腔溶解片的研制及评价

Gupta Ashish, Mahajan Mahesh, Sharma Pravin, Sharma Ravi, Koka Sweta, Darwhekar Gajanan
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引用次数: 2

摘要

口腔溶片在几秒钟内迅速溶解在唾液中,无需喝水或咀嚼。口腔溶片通常在15秒至3分钟内在口腔内溶解。苹果酸阿莫曲坦是一种抗偏头痛药物,味道苦,具有肝脏代谢作用。本研究以乙醇酸淀粉钠和交联棉糖钠为超崩解剂,采用直接加压法制备苹果酸阿莫曲坦口腔溶片,以提高患者的依从性,避免偏头痛药物常见的胃动力障碍,并使药物快速起效。考察其硬度、脆性、含量均匀性、润湿时间、吸水率和体外分散时间。短期稳定性研究表明,该制剂的药物含量和崩解时间无明显变化。关键词:苹果酸阿莫曲坦,强力崩解剂,乙醇酸淀粉钠,交联棉糖钠,味觉掩蔽
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation and Evaluation of Mouth Dissolving Tablet of Almotriptan Malate
Mouth dissolving tablet disintegrates and dissolves rapidly in the saliva, within a few seconds without the need of drinking water or chewing. A mouth dissolving tablet usually dissolves in the oral cavity within 15 seconds to 3 minutes. Almotriptan malate is an anti migraine drug with bitter taste and shows hepatic metabolism. In the present work, Mouth dissolving tablets of almotriptan malate were prepared by direct compression method using sodium starch glycolate and croscarmellose sodium as superdisintegrant with a view to enhance patient compliance and to avoid gastric dysmotility which is common with migraine drugs and for fast action of drug. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water-absorption ratio and in-vitro dispersion time. Short-term stability studies on the promising formulation indicated that there are no significant changes in drug content and disintegration time. Keywords: Almotriptan malate, Superdisintegrant, Sodium starch glycolate, Crosscarmellose sodium, Taste masking.
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