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A suspension comprising fibrinogen, thrombin and alcohol and a method of coating a carrier with the same

A technology of fibrinogen and suspension, which is applied in the field of suspension and can solve problems such as virus contamination

Inactive Publication Date: 2004-04-07
TAKEDA NYCOMED
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In WO96 / 40033, the disadvantage of bovine thrombin used in TachoComb® is emphasized that the use of bovine or other species of thrombin may cause harmful viral contamination and possible transmission of bovine diseases such as bovine spongiform encephalitis

Method used

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  • A suspension comprising fibrinogen, thrombin and alcohol and a method of coating a carrier with the same
  • A suspension comprising fibrinogen, thrombin and alcohol and a method of coating a carrier with the same
  • A suspension comprising fibrinogen, thrombin and alcohol and a method of coating a carrier with the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I

[0150] In this embodiment, the suspension contains human fibrinogen formula B and human thrombin formula B.

[0151] By applying the following quantities and parameters, a final suspension volume of 3500 ml was obtained using the Group II method:

[0152] Fibrinogen Blend:

[0153] - 2800ml ethanol (94% at 2-8°C)

[0154] -492.5g Human Fibrinogen Formula B

[0155] -493.5mg riboflavin

[0156] The fibrinogen mixture was stored at 2-8°C for 20 hours while stirring. Thrombin Mixture:

[0157] -100ml ethanol (100% at -30°C)

[0158] - 12.27g Human Thrombin Formula B

[0159] The thrombin mixture was stored at -30°C for 18 hours. suspension:

[0160] - 157ml thrombin mix was added to the fibrinogen mix.

[0161] - Ethanol 94% at 2-8°C was added to make the final suspension volume 3500ml.

[0162] Suspension characteristics:

[0163] 1. Ethanol concentration: 94.3%

[0164] 2. Outflow time measured from the steel device shown on the left side of Figure 9: 36.5 seconds ...

Embodiment II

[0181] In this embodiment, the suspension contains human fibrinogen formula C and human thrombin formula C.

[0182] By applying the following quantities and parameters, a final suspension volume of 3500 ml was obtained using the Group II method:

[0183] Fibrinogen Blend:

[0184] - 2252ml ethanol (94% at 2-8°C)

[0185] -370.7g Human Fibrinogen Formula C

[0186] -493.5mg riboflavin

[0187] The fibrinogen mixture was stored at 2-8°C for 20 hours while stirring. Thrombin Mixture:

[0188] -188ml ethanol (100% at -30°C)

[0189] -12 vials of Human Thrombin Formula C / 12ml of water for injection,

[0190] The thrombin mixture was stored at -30°C for 18 hours. suspension:

[0191] - 164.5ml of thrombin mix was added to the fibrinogen mix.

[0192] - Ethanol 94% at 2-8°C was added to make the final suspension volume 3500ml.

[0193] Suspension characteristics:

[0194] 1. Ethanol concentration: 94.1%

[0195] 2. Outflow time measured from the steel device shown on the...

Embodiment III

[0213] In this embodiment, the suspension contains human fibrinogen formula B, human thrombin formula B, and aprotinin.

[0214] A final suspension volume of 1000 ml is obtained by applying the following quantities and parameters, using the Group II method:

[0215] Fibrinogen Blend:

[0216] - 820ml ethanol (100% at 2-8°C), 39.4ml water for injection,

[0217] and 10.6ml aprotinin

[0218] -90.67g micronized human fibrinogen formula C

[0219] -141mg riboflavin

[0220] The fibrinogen mixture was stored at 2-8°C for 20 hours while stirring. Thrombin Mixture:

[0221] -50ml ethanol (100% at -30°C)

[0222] -3.75g human thrombin formula B

[0223] The thrombin mixture was stored at -30°C for 16 hours. suspension:

[0224] Add the full volume of thrombin mix to the fibrinogen mix.

[0225] 100% ethanol at 2-8[deg.] C. was added to make the final suspension volume 1000 ml.

[0226] Suspension characteristics:

[0227] 1. Ethanol concentration: 95%

[0228] 2. Outflow...

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Abstract

A suspension of fibrinogen, thrombin, alcohol and optionally aprotinin is obtained by mixing fibrinogen in alcohol with thrombin in alcohol. The suspension contains fibrinogen and thrombin particles with a Folk Ward mean diameter of 25-100 mum. The thrombin may be human, bovine or recombinant. The fibrinogen may be human or recombinant. A method for coating a carrier, such as a collagen sponge, with the suspension, and a method for drying the coating is disclosed. The coated collagen carrier may be used as a ready-to-use absorbable composition for tissue gluing, tissue sealing and hemostasis wherein the carrier is coated with solidly fixed components of fibrin glue, i.e. fibrinogen and thrombin.

Description

field of invention [0001] The invention relates to a suspension comprising fibrinogen, thrombin, alcohol and optionally aprotinin. The invention also relates to a method for preparing such suspensions, and a method for coating supports with such suspensions. The carrier can be a collagen carrier, such as a collagen sponge. The invention also relates to a method for drying the coating of a carrier, in particular a collagen carrier coated with the suspension according to the invention, so as to obtain a coated collagen carrier with an active substance immobilized in a solid state on said carrier. [0002] The coated collagen carrier can be used as a ready-to-use absorbable composition for tissue adhesion, tissue sealing and hemostasis consisting essentially of a fibrin glue coated with a solid immobilizing component: fibrinogen and thrombin carrier composition. Such immobilizing compositions may be applied directly to, for example, the wound surface. Upon contact with blood,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K38/46A61K38/48A61K47/34A61K47/36A61K47/38A61K47/42A61LA61L15/16A61L15/22A61L15/32A61L15/42A61L15/44A61L15/64A61L24/00A61L24/08A61L24/10A61L27/00A61L31/04A61P7/04A61P41/00C08H1/06C08JC08J9/30C08LC08L89/06
CPCA61L24/106A61F13/36A61L15/325A61L15/32C08L89/06A61L2400/04A61L15/425A61F2013/00472A61L31/046C08H1/06A61L24/08A61L31/041A61L15/225A61L31/044A61P41/00A61P7/04C08L89/00A61L15/60
Inventor 阿尔佛雷德·肖费勒
Owner TAKEDA NYCOMED
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