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Stable liquid interferon formulations

A technology of interferon and stabilizer, which is applied in the field of β-interferon liquid preparations, can solve the problems of increasing needle-stick injuries and dripping ingredients, and achieve the effects of reducing drug delivery methods, improving dosage accuracy, and simplifying packaging

Inactive Publication Date: 2000-02-23
BIOGEN MA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Freeze-dried formulations have the disadvantage of requiring multiple packaging due to the need to provide sterile water for injection separately
Moreover, lyophilized formulations require several manipulations before use, which increases the possibility of needle stick injuries and dripping ingredients during injection preparation

Method used

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  • Stable liquid interferon formulations
  • Stable liquid interferon formulations
  • Stable liquid interferon formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 3

[0072] 5. Adsorption of interferon to the surface

[0073] We have also determined that interferon will adsorb to certain surfaces, and its storage in glass containers requires that at least one surface of the container in contact with the interferon be coated or covered with a material that prevents or substantially eliminates adsorption. The surface may be chemically or physically inert to adsorption. Exemplary materials for this purpose are known to those of ordinary skill in the art and may include, for example, sprayed or baked silicone, polypropylene or polytetrafluoroethylene (PTFE). We used the preferred 60 μg / ml liquid formulations (BG9589-1, 2, 3 and 4: summarized in Table 1 below), filled in 1 ml long Type I glass syringes and 0.75 ml Type I glass vials, which Spray-on silicone (Beckon Dickinson) was applied. Samples were then analyzed by reverse phase HPLC (rpHPLC) to determine protein concentration. The data showed that sample solutions filled in glass vials ha...

Embodiment 8

[0117] The following examples are provided to illustrate embodiments of the invention, but should not be construed as limiting the scope of the invention.

Embodiment 1

[0118] Embodiment 1: test method

[0119] The physicochemical properties of beta-interferon in our liquid formulations were determined using several well-characterized methods, which can also be used to measure the properties of other interferons.

[0120] The presence / absence of insoluble aggregates was detected by measuring the absorbance at 320 nm and the transmittance at 580 nm. Soluble protein was determined by measuring the absorbance at 278-280 nm (extinction coefficient of 1.5), or by reversed-phase high-performance liquid chromatography (HPLC) using the known peak concentration of beta-interferon in the formulation buffer as a standard. concentration. The liquid formulation samples were centrifuged before the test. The percentage of soluble aggregates was determined by size exclusion chromatography on a TSK-Gel(R) G2000SWXL column (Toso Haas, Montgomeryville, PA) to separate aggregates from [beta]-interferon monomers. The peak area detected at 280 nm was used to ca...

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Abstract

Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3 % and 5 % by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contact with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.

Description

field of invention [0001] The present invention relates to a method for stabilizing human beta-interferon and a stable liquid preparation of beta-interferon. Background of the invention [0002] Interferons are proteins with various biological activities, some of which have antiviral, immunomodulatory and antiproliferative effects. They are relatively small, species-specific, single-chain polypeptides that are produced by mammalian cells in response to various inducements, such as viruses, peptides, mitogens, and others. Interferon protects animal tissues and cells from virus attack and is an important host defense mechanism. In most cases, interferons provide better protection to the tissues and cell types from which they are produced than to other types of tissues and cells, suggesting that interferons derived from humans should be more effective than those from human sources in the treatment of human diseases. Interferons from other species were more effective. [0003...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/21A61K47/18A61P43/00
CPCA61K9/0019A61K47/183A61K38/215A61P25/28A61P31/12A61P31/18A61P35/00A61P35/04A61P37/02A61P43/00A61K47/18
Inventor M·D·迪比西M·斯泰普斯李文莉E·沙林
Owner BIOGEN MA INC
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