Erythropoietin Liposomal dispersion

A technology of erythropoietin and liposome, which is applied in liposome delivery, extracellular fluid disease, glycopeptide components, etc., can solve the problems of EPO loss and high cost, and achieve improved stability, stable chemical degradation and coagulation Effect

Inactive Publication Date: 2005-01-19
CILAG GMBH INT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, the reverse phase method used therein incurs a large loss of unencapsulated EPO, which is undesirable and costly

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] liposome-based dispersion

[0052] A liposome-based dispersion of the following composition was prepared according to the method described in EP 0253619:

[0053] composition :

[0054] g / 100g

[0055] Erythropoietin 1 million international units

[0056] Hydrogenated lecithin (soybean) 0.500

[0057] Cholesterol 0.100

[0058] Ethanol (Pharma Undenatured) 0.500

[0059] Sodium dihydrogen phosphate dihydrate 0.1164

[0060] Disodium hydrogen phosphate dihydrate 0.2225

[0061] Sodium chloride 0.584

[0062] Pure water 97.9771

[0063] method :

[0064] Liposomes were prepared by making an aqueous solution of the electrolytes (buffers) sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate and sodium chloride in water for injection at 80°C. Separately, lecithin and cholesterol are dissolved in alcohol such as ethanol solution at 55-70°C. The aqueous solution is placed in a high-speed homogenizer to generate circul...

Embodiment 2

[0069] liposome-based dispersion

[0070] composition :

[0071] g / 100g

[0072] Erythropoietin 1 million international units

[0073] Hydrogenated lecithin (soybean) 0.500

[0074] Cholesterol 0.100

[0075] DPPA-Na 0.040

[0076] Ethanol (Pharma Undenatured) 0.500

[0077] Sodium dihydrogen phosphate dihydrate 0.1164

[0078] Disodium hydrogen phosphate dihydrate 0.2225

[0079] Sodium chloride 0.584

[0080] Pure water 97.9371

[0081] method :

[0082] The liposome dispersion of Example 2 was prepared according to the method of Example 1, except that before ethanol injection, DPPA-Na, lecithin and cholesterol were added to the ethanol solution.

Embodiment 3

[0084] liposome-based dispersion

[0085] composition :

[0086] g / 100g

[0087] Erythropoietin 1 million international units

[0088] Hydrogenated lecithin (soybean) 0.500

[0089] Cholesterol 0.100

[0090] DPPG-Na 0.050

[0091] Ethanol (Pharma Undenatured) 0.500

[0092] Sodium dihydrogen phosphate dihydrate 0.1164

[0093] Disodium hydrogen phosphate dihydrate 0.2225

[0094] Sodium chloride 0.584

[0095] Pure water 97.9271

[0096] method :

[0097] The liposome dispersion of Example 3 was prepared according to the method of Example 2.

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Abstract

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.

Description

field of invention [0001] The present invention relates to liposomal formulations of erythropoietin. In particular, the present invention relates to parenteral liposomal dosage forms prepared by ethanol injection technique, which have excellent stability. Background of the invention [0002] Erythropoietin (EPO) is a glycoprotein that is a major factor involved in the regulation of erythrocyte synthesis. Erythropoietin is produced in the kidney and works by stimulating precursor cells in the bone marrow to divide and differentiate into mature red blood cells. The recombinantly produced 165 amino acid glycoprotein has been used as an effective therapeutic agent for the treatment of various anemias, including anemia associated with chronic renal failure, zidovudine treatment of HIV-infected patients, and chemotherapy-treated cancer patients. Glycoproteins are administered parenterally by intravenous (IV) or subcutaneous injection (SC). [0003] Curre...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K38/14A61K38/18A61K38/22A61K47/16A61K47/18A61K47/24A61P43/00
CPCA61K9/0019A61K9/127A61K38/1816A61K47/183A61P43/00A61P7/00A61P7/06
Inventor R·奈夫S·德尔梅尼科A·维特尔F·-U·弗勒特尔
Owner CILAG GMBH INT
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