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US 2021/0059947 A1Published application
Method for producing freeze-dried formulation
AssigneeFUJIFILM Toyama Chemical Co., Ltd.
InventorsMakoto ONO, Takafumi HI ROTA, lori MIZOGAKI
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Abstract
This method for producing a freeze-dried formulation including an amorphous form of 6-fluoro-3-hydroxy-2-pyrazinecarboxamide sodium salt is useful as a method for producing a freeze-dried formulation having uniform quality.
Claims12
A method of producing a lyophilized preparation comprising amorphous sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide, the method comprising:
- (1) adjusting the temperature of an aqueous solution comprising a sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide to 20° C. or more;
- (2) cooling the aqueous solution obtained in the adjusting (1) to −40° C. or less within 1 hour to produce a frozen product;
- and
- (3) lyophilizing the frozen product obtained in the cooling (2).
1 more element
A method of producing a lyophilized preparation comprising amorphous sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide, the method comprising the steps of:
- (1) adjusting the temperature of an aqueous solution comprising a sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide to 40° C. or more;
- (2) cooling the aqueous solution obtained in the adjusting (1) to −40° C. or less within 3 hours to produce a frozen product;
- and
- (3) lyophilizing the frozen product obtained in the cooling (2).
1 more element
Dependencies are inferred from the claim text.