Preparation method of fosaprepitant dimeglumine freeze-dried preparation for injection

A technology of fosaprepitant dimeglumine and freeze-dried preparations, which is applied in the field of preparation of fosaprepitant dimeglumine freeze-dried preparations for injection, and can solve the problems of slow redissolving, slow redissolving and poor clarity of products and other problems, to achieve the effect of loose products, stable quality and good clarity
CN102166199AInactive Publication Date: 2011-08-31WUHAN LEADPHARM TECH CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
WUHAN LEADPHARM TECH CO LTD
Publication Date
2011-08-31
Estimated Expiration
Not applicable · inactive patent
Patent Text Reader

Abstract

A fosaprepitant dimeglumine freeze-dried preparation prepared by adopting the invention has the characteristics of porosity, stable quality, high redissolution speed, good clarity and the like. The invention provides a preparation method of a fosaprepitant dimeglumine freeze-dried preparation for injection, which comprises the following steps: (A) pre-freezing: firstly, cooling a fosaprepitant dimeglumine injection to (-12)-(-14) DEG C, and freezing through temperature oscillation; and then, cooling to (-32)-(-35) DEG C, and oscillating and freezing for 42-62 minutes; (B) sublimating: vacuumizing in a box body until the air pressure is 12-17 Pa, heating a product to (-35)-(-37) DEG C, and preserving the temperature for 8-10 hours; and intermittently injecting nitrogen gas, oscillating for 1-1.5 hours by taking air pressure (17-22 Pa) in the box body as an amplitude, heating the product to (-25)-(-29) DEG C, and preserving the temperature for 15-18 hours; and (C) drying: gradually heating the medicament to 38-42 DEG C, and preserving the temperature for 1-2 hours.
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Description

technical field

[0001] The invention relates to a drug fosaprepitant dimeglumine for treating vomiting caused by chemotherapy, in particular to a preparation method of a freeze-dried formulation of fosaprepitant dimeglumine for injection. Background technique

[0002] Fosaprepitant dimeglumine is a substance P / neurokinin 1 (NK-1) receptor antagonist used in the treatment of chemotherapy-induced nausea and vomiting (CINV). It is suitable for intravenous injection in combination with other antiemetic drugs to prevent acute and delayed nausea and vomiting caused by initial and repeated administration of moderately emetic and high-dose emetic anticancer drug chemotherapy (including high-dose cisplatin). This product is the prodrug of aprepitant (aprepitant) oral preparation, which is rapidly converted into aprepitant in the body after injection.

[0003] Prepare the freeze-dried preparation of fosaprepitant dimeglumine for injection according to the conventional method. The pro...

Claims

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