Process to minimize polymorphism

Details Process to minimize polymorphism Process to minimize polymorphism

A - Human Necessities

61

K

A61K 47/42 (2006.01) A61K 9/10 (2006.01) A61K 9/14 (2006.01) A61K 31/5517 (2006.01) A61P 25/00 (2006.01)

Patent

CA 2716901

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 individ-ually.

L'invention concerne une formulation commerciale de formes pharmaceutiques à dispersion rapide (FDDF) qui requiert des temps de retenue sensibles, pendant lesquels de grandes quantités d'une matière pharmaceutiquement active sont façonnées en doses individuelles. Pendant les temps de retenue, des agents pharmaceutiques ayant tendance à présenter un polymorphisme dans un environnement aqueux peuvent cristalliser en diverses formes parfois imprévisibles. Ces formes cristallines peuvent nuire à l'efficacité de l'agent pharmaceutique. Afin de contrôler ce processus, on a essayé par exemple de diriger la cristallisation vers une forme stable. L'invention permet de supprimer la cristallisation grâce à la combinaison d'une gélatine de poisson de poids moléculaire standard et d'une faible température de traitement, la suppression de la cristallisation présentant un degré ne pouvant pas être obtenu à l'aide d'une gélatine de poisson de poids moléculaire standard ou d'une faible température de traitement utilisées individuellement.

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