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Method of micronization

A powder and protein technology, applied in powder delivery, pharmaceutical formulations, peptide/protein components, etc., can solve problems such as inapplicability

Active Publication Date: 2009-09-16
OMRIX BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Such methods are generally not suitable for biomolecules that are sensitive to thermal and / or physical degradation

Method used

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Examples

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Embodiment Construction

[0034] Exemplary embodiments of the present invention will be described with respect to SFVM produced by Super Fine Ltd. of Yokneam, Israel. However, it should be understood that other types of grinding machines may be used in accordance with the invention to practice the invention.

[0035] I. Materials

[0036] Biological product

[0037] All batches of human fibrinogen 2 and thrombin biologics were lyophilized at PFI, Tel Hashomer, Israel. Human fibrinogen 2 (sometimes also referred to as BAC2) is concentrated, virus-inactivated human plasma cryoprecipitate (cryoprecipitate is typically prepared as described in EP 534,178) composed primarily of fibrinogen ( approximately 85%) and is plasminogen-depleted (removal of plasminogen is typically performed as described in EP 1,390,485) and no antifibrinolytic agents are added. Biologics arrive as freeze-dried blocks in double-wrapped aluminum foil bags and thick polyethylene bags in a plastic dish. The double-wrapped dishes ...

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PUM

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Abstract

A method for micronization of a dispersion of particles comprising a protein having a predetermined level of biological activity. The method comprises introducing the dispersion into a vortex chamber milling apparatus under milling conditions which result in a protein powder having a particle size distribution of 5 to 100 [mu]m and / or exhibiting a 30 to 400 fold size reduction of the protein particle dispersion from its original size, and retaining at least 80% of the predetermined level of biological activity of the protein. The milling conditions include one or more parameters selected from the following: input pressure between 1 and 7 Bars; injector pressure between 0.2 and 5 Bars; loading rate between 0.1 and 5 kg / hour; and gas flow between 30 and 100 m / hour.

Description

technical field [0001] The present invention relates to methods for reducing the particle size of protein powders. technical background [0002] In recent years, a need has arisen to manufacture micron and submicron particle size pharmaceutical powder dispersions with controlled, narrow particle size distributions. Applications of such powders include, for example, pharmaceutical aerosols delivered by dry powder inhalers (which increases the bioavailability of water-insoluble drugs) and hemostatic devices consisting of biodegradable composite matrices impregnated with lyophilized powders of coagulation factors. The process of grinding powders to micron and submicron particle sizes is called micronization. [0003] Among the known micronization methods are those involving high shear rates and high energy input, such as jet milling or pulverization systems, ball milling, high pressure homogenization and microfluidization. Such methods are generally not suitable for biomolecu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B02C19/06A61K9/14
CPCA61K38/363A61K9/14A61K9/19B02C19/061A61K38/4833B02C19/06
Inventor 伊瑟烈·努尔利里亚纳·巴尔
Owner OMRIX BIOPHARM
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