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    • 1. 发明申请
    • PROCESS TO MINIMIZE POLYMORPHISM
    • 最小化多态性的过程
    • WO2009108775A3
    • 2009-12-03
    • PCT/US2009035276
    • 2009-02-26
    • SCHERER TECHNOLOGIES INC R PHOWES SIMON A MMCLAUGHLIN ROSIEJORDAN ANDREWTIAN WEI
    • HOWES SIMON A MMCLAUGHLIN ROSIEJORDAN ANDREWTIAN WEI
    • A61K9/20A61M36/14
    • A61K31/5517A61K9/06A61K9/10A61K31/551A61K47/42
    • The commercial formulation of fast dispersing dosage forms (FDDF) requires substantial holding times during which large quantities of pharmaceutically active substance are formed into individual dosage units. During this holding time, pharmaceutical agents with a propensity to polymorphism in an aqueous environment may crystallize into various, and sometimes unpredictable forms. These crystalline forms may affect the efficacy of the pharmaceutical agent. Previous attempts to control this process have included attempts to direct crystallization into a stable form. The instant invention acts to suppress crystallization, by utilizing a combination of standard molecular weight fish gelatin and a low processing temperature, to suppress crystallization to a degree that is not accomplished by either the use of standard molecular weight fish gelatin or low processing temperatures individually.
    • 快速分散剂型(FDDF)的商业制剂需要大量的保持时间,在此期间大量的药物活性物质形成为单独的剂量单位。 在此期间,在水性环境中具有多态性倾向的药剂可能会结晶成各种有时不可预测的形式。 这些结晶形式可能影响药剂的功效。 以前尝试控制该方法的尝试包括将结晶直接导入稳定形式的尝试。 本发明通过利用标准分子量鱼明胶和低加工温度的组合来抑制结晶,以将结晶抑制到不能通过使用标准分子量鱼明胶或单独的低加工温度来实现的程度。