HIGH-CONCENTRATION PREPARATION OF SOLUBLE THROMBOMODULIN

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Patent Number: EP1475098
Publication date: 2004-11-10
Inventor(s): NISHIO FUMIHIDE [JP]
Applicant(s): ASAHI KASEI PHARMA CORP [JP]
Requested Patent: EP1475098
Application Number: EP20030701758 20030117
Priority Number(s): WO2003JP00339 20030117; JP20020009951 20020118
IPC Classification: A61K38/36; A61K9/08; A61K47/10; A61K47/18; A61K47/26; A61P1/16; A61P3/10; A61P7/00; A61P7/02; A61P9/00; A61P9/08; A61P9/10; A61P15/00
EC Classification: A61K9/19, A61K38/36
Equivalents: WO03061687
Cited Documents:
Abstract
In preparing a high-concentrated soluble thrombomodulin-containing solution having a concentration of 10 mg/mL or above, foam-inhibiting effect can be attained by any means selected from among (a) allowing the presence of a nonionic surfactant, benzyl alcohol or chlorobutanol, (b) an inner wall of the container to be used in dissolving the soluble thrombomodulin-containing freeze-dried preparation is coated with silicone, and (c) a pressure in the container to be used in dissolving the soluble thrombomodulin-containing freeze-dried preparation is kept at a reduced pressure. Further, a soluble thrombomodulin freeze-dried preparation excellent in stability is also provided which can be dissolved in 0.1 mL to 2 mL of aqueous solution for dissolution to prepare a high-concentrated soluble thrombomodulin-containing solution having a concentration of 10 mg/mL or above and exhibiting an osmotic pressure ratio of 0.5 to 2.0 at the time of resolution.
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