POWDER FORMULATION COMPRISING THROMBIN AND FIBRINOGEN

The invention relates to sterile powder compositions suitable for medical use comprising thrombin and fibrinogen, and to methods for producing the same, wherein the thrombin powder is produced from a liquid feedstock, wherein the feedstock comprises a solution or a suspension of thrombin, preferably...

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Bibliographic Details
Main Authors MARTYN, GLEN, WHITFIELD, NICOLA KIM, HENDRICUS VAN PINXTEREN, LAURENS ADRIANUS
Format Patent
LanguageEnglish
French
German
Published 13.01.2016
Subjects
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Summary:The invention relates to sterile powder compositions suitable for medical use comprising thrombin and fibrinogen, and to methods for producing the same, wherein the thrombin powder is produced from a liquid feedstock, wherein the feedstock comprises a solution or a suspension of thrombin, preferably a solution, wherein the powder is produced by removal of liquid by a process selected from aseptic spray drying or aseptic fluid bed drying, and wherein the powder resulting from removal of liquid from the feedstock exhibits at least 80% of the thrombin potency or activity of the liquid feedstock, and wherein the fibrinogen powder is produced by removal of liquid from a feedstock, wherein the feedstock comprises a solution or a suspension of fibrinogen, preferably a solution, by aseptic spray drying or aseptic fluid bed drying, and wherein said composition is packaged as a sterile final pharmaceutical product for medical use.
Bibliography:Application Number: EP20140709244