A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/22 (2006.01) A61K 9/08 (2006.01) A61K 47/10 (2006.01) A61K 47/12 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01)
Patent
CA 2266666
The present invention relates to novel formulations of corticotropin releasing factor (CRF) having improved stability during storage over extended periods of time as liquids, which retain significant pharmaceutical activity during such storage and/or which are physiologically compatible. The formulations of the present invention comprise (a) a pharmaceutically effective concentration of CRF, (b) a buffer to maintain the pH of the formulation between about 2.0 to about 5.0 or about 6.0 to about 9.0 when in liquid form and (c) an alcohol such as mannitol, sorbitol, methanol, glycerol, or the like. Other aspects of the present invention involve addition of various other components to the formulations described herein for the purpose of decreasing the rate of degradation of the CRF peptide or increasing its solubility in solution. Finally, the present invention is further directed to methods for preparing such novel pharmaceutical formulations of CRF and methods of using those formulations to reduce inflammation and edema in mammals.
La présente invention concerne de nouvelles formulations pharmaceutiques du facteur de libération de la corticotropine (FLC) qui possèdent une meilleure stabilité lors du stockage sous forme de liquides pendant une longue période, qui conservent de manière sensible leur activité pharmaceutique pendant ladite période et/ou qui sont compatibles du point de vue physiologique. Les formulations de la présente invention comprennent: (a) une concentration de FLC efficace du point de vue pharmaceutique; (b) un tampon permettant de maintenir le pH de la formulation sous forme liquide entre environ 2,0 et 5,0 ou entre environ 6,0 et 9,0; et (c) un alcool tel que le mannitol, le sorbitol, le méthanol, le glycérol ou un alcool similaire. D'autres aspects de la présente invention concernent l'adjonction à ces formulations de divers autres composants, qui a pour but de baisser la vitesse de dégradation du peptide FLC ou d'augmenter sa solubilité dans une solution. L'invention se rapporte également à des méthodes de préparation de nouvelles formulations pharmaceutiques à base de FLC et d'utilisation desdites formulations visant à réduire l'inflammation et l'oedème chez les mammifères.
Hirtzer Pamela G.
Ho Bert
Khosrovi Behzad
Neurobiological Technologies Inc.
Neutron Row Ltd.
Smart & Biggar
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