发明申请
US20090226522A1 PROCESS TO MINIMIZE POLYMORPHISM 审中-公开
最小化多态性的过程

PROCESS TO MINIMIZE POLYMORPHISM
摘要:
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.
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