直接加压法制备制霉菌素腰果胶黏附含片的处方前研究

Ana Paula Leme De Magalhães, F. A. Carmo, C. Mansur
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引用次数: 1

摘要

腰果胶是从腰果树(Anacardium occidentale L.)中提取的一种支链杂多糖。纯化的腰果胶(PCG)不含植物污染物,具有高溶解性。几项研究表明,这种聚合物可以在制药工业中用于片剂的生产。最近,我们的研究小组报告说,PCG可以用作直接压片生产的片剂的稀释剂。制霉菌素(Nys)是治疗口腔念珠菌感染的首选药物,以悬浮液的形式存在。该治疗包括每天高达6剂500000 IU的nys悬浮液,导致患者的治疗粘附力低。本研究的目的是研究PCG与nys和其他赋形剂(调味剂和润滑剂)一起的行为,以供未来通过直接压片制备粘口腔片。为此,我们对药物和赋形剂的物理混合物进行了配方前测试(FTIR、TGA、XRD、溶解度、pH、粒度、溶胀度和粉末流动性)。结果非常好,表明PCG是一种具有此类应用潜力的聚合物。
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Pre-formulation Study for Preparation of Mucoadhesive Buccal Tablets Containing Nystatin and Cashew Gum by Direct Compression
Cashew gum is a branched chain heteropolysaccharide extracted from the cashew tree (Anacardium occidentale L.). Purified cashew gum (PCG) is free of plant contaminants and is highly soluble. Several studies have indicated this polymer can be relevant in the pharmaceutical industry for production of tablets. Recently, our research group reported that PCG can be used as a diluent for tablets produced by direct compression. Nystatin (Nys) is the drug of first choice for treatment of oral candidiasis, in the form of a suspension. The treatment consists of up to six daily doses of a suspension of nys at 500,000 IU, causing low therapeutic adhesion by patients. The objective of this study was to investigate the behavior of PCG together with nys and other excipients (flavoring agents and lubricating agent) for future manufacture of mucoadhesive buccal tablets by direct compression. For that purpose, we performed pre-formulation tests (FTIR, TGA, XRD, solubility, pH, granulometry, swelling degree and powder flow) with physical mixtures of the drug and excipients. The results were excellent, demonstrating that PCG is a polymer with potential for this type of application.
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