Co-solvent compositions and methods for improved delivery of...

A - Human Necessities – 61 – K

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A61K 9/08 (2006.01) A61K 9/00 (2006.01) A61K 9/19 (2006.01)

Patent

CA 2702243

The present invention provides for methods of using terf-butyl alcohol (TBA) co-solvent systems in the formula- tion and production of a pharmaceutical agent with low solubility. The present invention also provides for pharmaceutical compositions male using the novel co-solvent system. In one embodiment, the invention provides for a method of making dantrolcnc sodium (DS) tormulation for intravenous use (DS-[V). This instautaneous reconstitution of the DS-(V product constitutes a significant improvement in the pharmacotherapy of patients undergoing malignant hyperthermia during surgery

La présente invention a pour objets des procédés utilisant des systèmes de co-solvants d'alcool tert-butylique (TBA) dans la formulation et la production d'un agent pharmaceutique présentant une faible solubilité. La présente invention fournit également des compositions pharmaceutiques produites à l'aide du nouveau système de co-solvants. Dans un mode de réalisation, l'invention fournit un procédé permettant de fabriquer une formulation de dantrolène sodique (DS) destinée à une utilisation intraveineuse (DS-IV). Cette reconstitution instantanée du produit DS-IV constitue une amélioration significative de la pharmacothérapie des patients subissant une hyperthermie maligne au cours d'une opération chirurgicale.

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