片劑因劑量準(zhǔn)確、服用方便、質(zhì)量穩(wěn)定被廣泛應(yīng)用.粉末直接壓片工藝是制備片劑較為簡便的方法.然而,受粉體流動(dòng)性、可壓性、稀釋潛力等性質(zhì)的影響,目前只有不到20％的活性藥物成分(API)可通過粉末直接壓片工藝制備成片劑.應(yīng)用顆粒工程學(xué),通過共處理技術(shù)將兩種或多種輔料在顆粒水平上相結(jié)合,可改善輔料的性能,進(jìn)而滿足直接壓片法對粉體性質(zhì)的要求.本文討論了共處理技術(shù)制備直接壓片高功能輔料的優(yōu)勢、共處理技術(shù)常規(guī)方法并例舉了已經(jīng)上市的直接壓片高功能輔料及其應(yīng)用前景,為共處理技術(shù)制備高功能輔料應(yīng)用于粉末直接壓片工藝提供思路.

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.