Baptiste BOIT,Alain FRANCOIS,Philippe LEFEVRE,Damien PASSE
申请号：
US16748222
公开号：
US20200155460A1
申请日:
2020.01.21
申请国别(地区):
US
年份:
2020
代理人:
摘要：
A process for preparing a coagglomerate of crystalline mannitol and of starch includes spray-drying or granulating a mixture of a “solution” of mannitol and of starch, the starch being suspended in the mannitol solution. The coagglomerate has a laser volume mean diameter D4,3 between 60 and 500 μm, and a mannitol/starch ratio is between 99.5/0.5 and 50/50. The coagglomerate, when mixed with 1.2% of magnesium stearate and formed into a cylindrical tablet with convex faces, a diameter of 13 mm, a thickness of 6 mm, and a weight of 0.734 g, has a crushing strength greater than 120 N. 100 g of said coagglomerate has a flow of between 3 and 15 seconds, measured according to European Pharmacopoeia 5.0, volume 1, 01/2005: 20916, section 2.9.1.6.
