Novel parenteral carbamazepine formulation

A - Human Necessities – 61 – K

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A61K 31/55 (2006.01)

Patent

CA 2624463

The present invention is directed to a carbamazepine-cyclodextrin inclusion complex useful for the parenteral administration of carbamazepine. The carbamazepine-cyclodextrin inclusion complex is prepared by the admixture of a modified cyclodextrin and carbamazepine in a physiologically acceptable fluid. Modified cyclodextrins include 2-hydroxypropyl-beta-cyclodextrin and sulfoalkyl cyclodextrins. More particularly, the sulfoalkyl cyclodextrins are those described and disclosed in U.S. Patent Nos. 5,134,127 and 5,376,645. A physiologically acceptable fluid includes sterile isotonic water, Ringer's lactate, D5W (5 % dextrose in water), physiological saline, and similar fluids suitable for parenteral administration.

La présente invention concerne un composé d'inclusion carbamazépine-cyclodextrine destiné à être utilisé pour l'administration par voie parentérale de carbamazépine. Ce composé d'inclusion carbamazépine-cyclodextrine est préparé par mélange d'une cyclodextrine modifiée et d'une carbamazépine dans un fluide de qualité physiologique. Les cyclodextrines modifiées comprennent la 2-hydroxypropyl-bêta-cyclodextrine et des cyclodextrines sulfoalkylées. Plus précisément, les cyclodextrines sulfoalkylées sont celles décrites et présentées dans les brevets U.S. Patent Nos. 5,134,127 et 5,376,645. Le fluide de qualité physiologique peut être une solution isotonique stérile à base d'eau, une solution de lactate de Ringer, une solution aqueuse de dextrose à 5 %, une solution saline physiologique et des fluides analogues convenant à une administration par voie parentérale.

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