Temperature-stable formulations, and methods of development...

Details Temperature-stable formulations, and methods of development... Temperature-stable formulations, and methods of development...

A - Human Necessities

61

K

A61K 31/58 (2006.01) A61K 47/10 (2006.01) A61K 47/18 (2006.01) A61K 47/34 (2006.01) A61P 29/00 (2006.01)

Patent

CA 2550811

One embodiment of the present invention relates to a method of preparing a concentrated pharmaceutical formulation, comprising the steps of: combining in a container a therapeutic agent, a solvent and at least one pharmaceutically acceptable excipient to give a solution; adding to said solution a seed crystal of said compound to give a heterogeneous mixture; and observing the stability of said heterogeneous mixture.

On décrit, dans un mode de réalisation, une méthode de préparation d'une formulation pharmaceutique concentrée, qui consiste à: combiner dans un récipient un agent thérapeutique, un solvant et au moins un excipient pharmaceutiquement acceptable pour obtenir une solution; ajouter à ladite solution un cristal germe dudit composé pour obtenir une mélange hétérogène; et constater la stabilité dudit mélange hétérogène.

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