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EP0089245A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

A stable interferon beta composition and a method of stabilizing interferon beta

Assignee: Inter-Yeda Ltd
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Filing: 1983-03-16
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Granted: —
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Expires: 2003-03-16
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Abstract

Abstract This invention relates to a method of stabilizing Interferon beta (Human Fibroblast Interferon (HFIF)), wherein a highly purified Interferon beta solution, admixed with known excipients therefor, is dialysed against an acetate buffer at pH 3.5 for about 48 hours. The resulting Interferon beta solution is admixed with from 0.5% to 10% wt/volume of polyvinyl pyrrolidone prior to or following filtration through a sterile filter, dispensed into glass vials, lyophilized, and the vials are sealed in vacuo and stored at 4 DEG C.

Inventors

  • 👤 Samuel Cymbalisto

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-06 03:10
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/19; A61K38/21; A61K38/215; A61K47/00; A61K47/30; A61K47/32

Claims Analysis

Total Claims: 8
Claim 1
Independent Claim 28 words
A stable Interferon β composition comprising a buffered solution of highly purified Interferon and conventional excipients, said solution being stabilized by 0.5 to 10% wt/volume of polyvinyl pyrrolidone.
Claim 2
Dependent Claim 28 words
A stable Interferon β composition comprising a buffered solution of highly purified Interferon and conventional excipients, said solution being stabilized by 0.5 to 10% wt/volume of polyvinyl pyrrolidone.
Claim 3
Dependent Claim 17 words
A composition as claimed in Claim ' 1, wherein the excipients are mannitol and human serum albumin.
Claim 4
Dependent Claim 21 words
A composition as claimed in Claim 1 or 2, wherein the buffer is an acetate buffer having a pH of 3.5.
Claim 5
Dependent Claim 21 words
A composition as claimed in any one of the preceding claims packaged in a glass vial, lyophilized and sealed in vacuo.
Claim 6
Independent Claim 66 words
A method of stabilizing Interferon β , wherein a highly purified Interferon β solution, admixed with known excipients therefor, is dialysed against an acetate buffer solution, the resulting Interferon solution is admixed with from 0.5 to 10% wt/volume of polyvinyl pyrrolidone prior to or following filtration through a sterile filter, dispensed into glass vials, lyophilized, and the vials are sealed in vacuo and stored at 4°C.
Claim 7
Independent Claim 66 words
A method of stabilizing Interferon β , wherein a highly purified Interferon β solution, admixed with known excipients therefor, is dialysed against an acetate buffer solution, the resulting Interferon solution is admixed with from 0.5 to 10% wt/volume of polyvinyl pyrrolidone prior to or following filtration through a sterile filter, dispensed into glass vials, lyophilized, and the vials are sealed in vacuo and stored at 4°C.
Claim 8
Dependent Claim 14 words
A stabilized Interferon β composition whenever obtained by the method claimed in Claim 5.

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