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Stable pegylated interferon formulation

A technology of PEGylation and interferon, which is applied in the field of stable preparations and can solve problems such as deterioration

Inactive Publication Date: 2007-09-19
SCHERING AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some interferon-polymer conjugates deteriorate rapidly, even in frozen solutions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0045] Prepared pegylated interferon solutions containing different amounts of trehalose and sucrose cryoprotectant, freeze-dried in glass cylinders under different conditions, and tested the cake defects, moisture content and stability of pegylated interferon of the obtained freeze-dried powder sex. Table 2 below describes the composition of four of these solutions that were lyophilized using the lyophilization conditions listed in Table 1 above.

[0046] the solution a

Element

A

B

C

O

PEG 12000 - Interferon alpha-2b

100-300

μg / ml

100-300

μg / ml

100-300

μg / ml

100-300

μg / ml

Anhydrous Disodium Hydrogen Phosphate

1.5mg / ml

1.5mg / ml

1.5mg / ml

1.5mg / ml

Sodium dihydrogen phosphate monohydrate

1.5mg / ml

1.5mg / ml

1.5mg / ml

1.5mg / ml

Tween 80

0.1mg / ml

0.1mg / ml

0.1mg / ml

0.1mg / ml

sucrose

50mg / ml

20mg / m...

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Abstract

The present invention relates to lyophilized formulations of pegylated interferon which are prepared using trehalose as a cryoprotectant. The formulations have a low moisture content, which helps stabilize the pegylated interferon during storage of the formulations at room temperature. In addition, methods for preparing these formulations are provided.

Description

[0001] related application [0002] This application claims the benefit of US Provisional Application Serial No. 60 / 600,846, filed August 12,2004. field of invention [0003] The present invention relates to stable formulations of pegylated interferon conjugates which are useful in the treatment of various conditions for which interferon therapy would be beneficial. In particular, there is provided a formulation comprising the active pharmaceutical ingredients pegylated interferon and trehalose, which formulation is stable at room temperature after lyophilization. Background of the invention [0004] Interferons are a family of highly homologous proteins that inhibit viral replication, inhibit cell proliferation, and modulate immune responses. Human interferons are classified into three classes based on their cellular origin and antigenicity: alpha-interferons (leukocytes), beta-interferons (fibroblasts), and gamma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/21A61K47/26A61P35/00A61K47/48A61P31/12
CPCA61K9/0019A61K47/48215A61K38/212A61K38/21A61K9/19A61K47/26A61K31/7012A61K47/60A61P31/12A61P35/00A61P43/00A61K47/50
Inventor M·沙米姆A·达巴拉
Owner SCHERING AG
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