Erythropoietin liposomal dispersion

Details Erythropoietin liposomal dispersion Erythropoietin liposomal dispersion

A - Human Necessities

61

K

A61K 9/127 (2006.01) A61K 38/18 (2006.01) A61K 38/22 (2006.01) A61K 47/18 (2006.01)

Patent

CA 2320072

The present invention relates to a liposome based formulation of erythropoietin comprising: (a) an effective amount of an erythropoietin; (b) a lipidic phase comprising: (i) lecithin or hydrogenated lecithin; (ii) optionally, a charged electropositive or electronegative lipid compound; and (iii) cholesterol or a derivative thereof selected from cholesterol esters, polyethylene glycol derivatives of cholesterol (PEG-cholesterols) and organic acid derivatives of cholesterols; and (c) a phosphate buffer. The liposome-based parenteral dosage form of the invention is prepared by means of an ethanol injection technique. The composition avoids the need for use of human serum albumin and exhibits superior stability.

L'invention porte sur une préparation d'érythropoïétine comportant: (a) une dose efficace d'érythropoïétine; (b) une phase lipidique comprenant: (i) de la lécithine ou de la lécithine hydrogénée, (ii) facultativement un composé lipidique à charge électropositive ou électronégative, et (iii) du cholestérol ou l'un de ses dérivés choisis parmi des esters de cholestérol, des dérivés PEG du cholestérol ou des acides organiques dérivés du cholestérol; et (c) un tampon de phosphate. La forme posologique à administration parentérale à base de liposomes se prépare à l'aide d'une technique d'injection d'éthanol. La préparation qui évite d'avoir recours à l'albumine sérique humaine présente une très bonne stabilité.

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