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目的评价甘露醇-交联聚维酮复合辅料(Man-Cro)的功能性质量,并研究其在口崩片剂中的应用。方法比较甘露醇-交联聚维酮复合辅料与甘露醇、交联聚维酮及其物理混合物之间的物性表征和粉体学性质,并考察其应用于布洛芬口崩片的体外溶出及体内生物利用度。结果甘露醇-交联聚维酮复合辅料在制备形成新的类球形态,具有良好的流动性、可压性、充填性及崩解性,符合口崩片直接压片需要。利用该复合辅料制备的布洛芬口崩片,经测试体外溶出快速,并与市售布洛芬片在大鼠体内生物等效。结论甘露醇-交联聚维酮复合辅料可采用直接压片工艺制备口崩片。
Objective To evaluate the functional quality of mannitol-crospovidone (Man-Cro) and to study its application in the oral tablet. Methods The physical characterization and powder properties of mannitol-crospovidone composite excipients with mannitol, crospovidone and their physical mixtures were compared and their in vitro dissolution And in vivo bioavailability. Results Mannitol - cross - linked povidone composite excipients in the preparation of a new formation of spherical morphology, with good flowability, compressibility, filling and disintegration, in line with the requirements of the orally disintegrating tablet direct compression. Ibuprofen orally disintegrating tablets prepared by using the composite excipients were tested in vitro for rapid dissolution and were bioequivalent to the commercially available ibuprofen tablets in rats. Conclusion Mannitol - cross-linked povidone composite excipients can be prepared by direct compression tablet orally disintegrating tablets.