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[摘要]
片剂因剂量准确、服用方便、质量稳定被广泛应用.粉末直接压片工艺是制备片剂较为简便的方法.然而,受粉体流动性、可压性、稀释潜力等性质的影响,目前只有不到20%的活性药物成分(API)可通过粉末直接压片工艺制备成片剂.应用颗粒工程学,通过共处理技术将两种或多种辅料在颗粒水平上相结合,可改善辅料的性能,进而满足直接压片法对粉体性质的要求.本文讨论了共处理技术制备直接压片高功能辅料的优势、共处理技术常规方法并例举了已经上市的直接压片高功能辅料及其应用前景,为共处理技术制备高功能辅料应用于粉末直接压片工艺提供思路.
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[Abstract]
Tablet is the most commonly used dosage form because of accurate dosing, convenience in administration, excellent stability, and other advantages. However, it has been estimated that less than 20% of the active pharmaceutical ingredients (API) could be processed into tablets via direct compression because of the effects of flowability, compressibility, and dilution potency of API. Demands of excipients in direct compression process could be satisfied by powder engineering with coprocessing single excipient in particles level. This review briefly introduced advantages of coprocessing excipients, method for coprocessing, and properties of various coprocessed excipients available in the market, so as to provide ideas for promoting direct compression process.
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