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Stable pharmaceutical composition of peginterferon alpha-2b

A composition and drug technology, applied in the field of preparing the composition, can solve the problems of antigenic short pharmacological half-life and the like

Inactive Publication Date: 2015-07-08
LUPIN LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, like many other parenterally administered proteins, its use has some limitations due to antigenicity (leading to the formation of neutralizing antibodies) and short pharmacological half-life (thus leading to repeated doses administered to achieve desired blood levels) ( US6180096)

Method used

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  • Stable pharmaceutical composition of peginterferon alpha-2b

Examples

Experimental program
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Effect test

example 1

[0039] The formulation method for the Peg-IFN medicine includes 3 steps, namely preparation of the formulation body, filling into vials and freeze-drying. The formulated body is prepared by diluting the drug product with a formulation buffer to bring the formulated body to the desired concentration. Formulation buffer was prepared by adding disodium phosphate dihydrate and citric acid in required amounts (as mentioned in Table 1) to WFI followed by mixing. To this solution was added the required amount of cryoprotectant HPBCD, sodium chloride and polysorbate 80 in a stepwise manner, and after adjusting the pH the desired volume was adjusted with WFI. The formulation buffer was then sterile filtered through a 0.22μ sterile grade PES filter. Based on dosing calculations, the required amount of Peg-IFN (in the same formulation) was sterile diluted with filtered formulation buffer to bring the Peg-IFN composition to the desired concentration. The formulated bulk was filtered thr...

example 2

[0043] The method used to prepare the PEG-IFNα-2b composition is described in Example 1, wherein the cryoprotectant used was HPBCD. Excipients and amounts of PEG-IFNα-2b are provided in Table 2.

[0044] Table 2: Unit formulations of PEG-IFNα-2b compositions in stability studies

[0045] Element

example 3

[0047] The method used to prepare the PEG-IFNα-2b composition was the same as that described in Example 1, wherein the cryoprotectant used was sucralose. The amounts of excipients and PEG-IFNα-2b are provided in Table 3.

[0048] Table 3: Unit formulations of PEG-IFNα-2b compositions in stability studies

[0049] Element

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Abstract

The present invention relates to the stable pharmaceutical compositions comprising PEG- interferon alpha-2b. More particularly, it relates to the stable pharmaceutical compositions comprising PEG-interferon alpha-2b and cryoprotectant selected from the group consisting of 2-Hydroxy propyl beta-cyclodextrin, sucralose, or polyvinylpyrrolidone 4000. It also relates to the methods of manufacturing the composition, method of administration and kits containing the same.

Description

technical field [0001] The present invention provides stable pharmaceutical compositions comprising PEG-interferon alpha-2b. The invention also provides a method for preparing the composition, a method for administering the composition and a kit comprising the composition. Background technique [0002] Interferons are cytokines secreted by eukaryotic cells in response to infection by pathogens such as bacteria, viruses or parasites. These proteins therefore have therapeutic potential against various infections, mainly viral infections and proliferation abnormalities such as cancer (Pfeffer et al., 1998 Cancer Research 58, 2489-2499). [0003] Human interferons are classified into 3 classes based on their cellular origin and antigenicity: alpha-interferons (leukocytes), beta-interferons (fibroblasts) and gamma-interferons (B cells) (US 7632491). Recombinant alpha interferon was first approved by the US FDA for the treatment of hairy cell leukemia more than two decades ago. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K47/40A61K47/48A61K9/19A61P31/12A61P35/00
CPCA61K47/26A61K9/0019A61K47/183A61K38/212A61K9/19A61K47/48215A61K47/40A61K47/32A61K47/12A61K47/60A61K47/20A61P1/16A61P31/12A61P31/14A61P31/20A61P35/00A61P35/04
Inventor P·N·韦德伽玛A·D·阿普特-德斯潘德R·S·莫迪
Owner LUPIN LTD
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