A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/14 (2006.01) A61K 9/20 (2006.01)
Patent
CA 2737528
A granulate for use in a pharmaceutical composition and a pharmaceutical composition manufacture using the granulate, where the granule comprises an active pharmaceutical ingredient (API) having a poor water solubility (i.e., less than about 1 mg/mL) which is intimately associated with at least one pharmaceutically acceptable hydrophilic polymer. The granule optionally contains one or more pharmaceutically acceptable excipients, such as disintegrants, wetting agents, diluents, binders, lubricants, glidants, coloring agents and flavoring agents. The invention also relates to a process for preparing the pharmaceutical granulate and pharmaceutical compositions containing the granulate.
L'invention porte sur un granulé pour utilisation dans une composition pharmaceutique et une fabrication de compositions pharmaceutiques utilisant les granulés, les granulés comprenant un ingrédient pharmaceutique actif (API) ayant une solubilité dans l'eau médiocre (c'est-à-dire, inférieure à environ 1 mg/ml), qui est intimement associé à au moins un polymère hydrophile pharmaceutiquement acceptable. Le granulé contient facultativement un ou plusieurs excipients pharmaceutiquement acceptables, tels que des désintégrants, des agents mouillants, des diluants, des liants, des lubrifiants, des glissants, des agents colorants et des agents aromatisants. L'invention porte également sur un procédé de préparation du granulé pharmaceutique et sur les compositions pharmaceutiques contenant le granulé.
Li Boyong
Reynolds Thomas D.
Deeth Williams Wall Llp
Mylan Inc.
Mylan Laboratories Inc.
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