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    • 1. 发明申请
    • ANHDYROUS LACTOSE AGGLOMERATES AND THE PREPARATION THEREOF
    • 高分子乳糖聚合物及其制备方法
    • US20090081308A1
    • 2009-03-26
    • US11722968
    • 2005-12-21
    • Klaas Daniel KussendragerBouwe Walsma
    • Klaas Daniel KussendragerBouwe Walsma
    • A61K47/30B29C67/02A61P43/00A61K9/14
    • C13K5/00A61K9/2018C13B50/004
    • The invention relates to a process for the preparation of anhydrous lactose agglomerates, said process comprising (i) subjecting essentially anhydrous lactose primary particles comprising at least 60 wt % crystalline-lactose in a granulator to a wet granulation step at a temperature in the range of 30-100° C. using a binder solution, wherein the granulation mass is subjected to drying for at least part of the granulation step, and (ii) after-drying the granulation mass. The anhydrous lactose agglomerates thus produced comprise at least 50 wt %-lactose crystallites and have a total water content in the range of 0-1.0 wt %, which is required according to the standards laid down by the Pharmacopoeia for anhydrous lactose excipients. These agglomerates combine have excellent compactibility and flowability properties and are particularly useful as excipient in moisture-sensitive applications.
    • 本发明涉及一种制备无水乳糖附聚物的方法,所述方法包括(i)在造粒机中将基本上含有至少60重量%结晶乳糖的无水乳糖一次粒子在湿法制粒步骤中在 30-100℃,使用粘合剂溶液,其中造粒物质至少部分造粒步骤进行干燥,和(ii)将造粒物料干燥。 如此生产的无水乳糖附聚物包含至少50重量%的乳糖微晶,并且具有0-1.0重量%的总含水量,根据“药典”为无水乳糖赋形剂制定的标准是必需的。 这些团聚体组合具有优异的紧密性和流动性,并且在湿度敏感应用中特别可用作赋形剂。