Method for preparing suspensions of low-solubility materials

Details Method for preparing suspensions of low-solubility materials Method for preparing suspensions of low-solubility materials

A - Human Necessities

61

K

A61K 9/00 (2006.01) A61K 9/10 (2006.01) A61K 47/32 (2006.01)

Patent

CA 2756000

A process for producing a pharmaceutical suspension that comprises an active pharmaceutical ingredient ("API") having low solubility, the process comprises: (a) preparing a first solution comprising a carboxy-containing vinyl polymer and a solvent; and (b) adding a compound of the API to said first solution under conditions of high- shear mixing for a time from about 5 minutes to about 5 hours, said compound being soluble in said solvent, thereby producing a suspension of particles of said API in a composition comprising said carboxy-containing vinyl polymer; wherein a concentration of said API in said suspension is higher than a solubility of said API in said solvent. The present invention also provides a suspension produced by such process.

L'invention porte sur un procédé de production d'une suspension pharmaceutique qui comprend un principe pharmaceutique actif (« API ») ayant une faible solubilité. Le procédé comprend les opérations consistant à : (a) préparer une première solution comprenant un polymère vinylique à teneur en carboxy et un solvant ; et (b) ajouter un composé de l'API à ladite première solution dans des conditions de mélange à cisaillement élevé pendant un laps de temps d'environ 5 minutes à environ 5 heures, ledit composé étant soluble dans ledit solvant, produisant ainsi une suspension de particules dudit API dans une composition comprenant ledit polymère vinylique à teneur en carboxy, une concentration dudit API dans ladite solution étant supérieure à une solubilité dudit API dans ledit solvant. La présente invention porte également sur une suspension produite par un tel procédé.

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