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Freezing-dried clofarabine powder injection and its preparation method

A technology of freeze-dried powder injection and clofarabine, which is applied in the field of freeze-dried preparations of clofarabine and its preparation, can solve the problems of poor solubility of clofarabine, potential safety hazards of clinical medication, and deformation of aluminum-plastic composite covers, etc. Rapid melting, avoiding the deformation of the aluminum-plastic composite cover, and improving the stability

Inactive Publication Date: 2008-02-13
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the problems of possible deformation of the aluminum-plastic combination cap, possible degradation of clofarabine, possible precipitation during storage, and potential safety hazards in clinical medication caused by intravenous high-temperature sterilization of clofarabine injection in foreign countries, the best way is to Clofarabine made into lyophilized formulation
Think through research, the main difficulty that clofarabine is made into freeze-drying is how clofarabine is dissolved in the solution of the volume suitable for freeze-drying (solves the problem of poor solubility of clofarabine), how to prevent filling in vials The precipitation of clofarabine solution during the freeze-drying process leads to stratification (solve the problem that the solubility of clofarabine is obviously affected by temperature and easy to precipitate at low temperature), and the problem of redissolving after freeze-drying

Method used

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  • Freezing-dried clofarabine powder injection and its preparation method
  • Freezing-dried clofarabine powder injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Common method prepares clofarabine freeze-dried powder injection (-25 ℃)

[0029] prescription

[0030] Clofarabine 20g

[0031] Mannitol 500g

[0032] Add water for injection to 15000ml

[0033]

[0034] A total of 1000 bottles were made

[0035] Take the prescribed amount of clofarabine and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of intermediates, and add injection after passing the test. Dilute to the full volume with water, filter with a 0.22 μm microporous membrane under aseptic conditions until clear, fill the filtrate into a sterile vial, partially plug it with a butyl rubber stopper, put it into a plate, and send it to a freeze dryer , close the door, turn on the freeze dryer, use heat transfer oil to cool the plate layer, so that the product temperature drops, when the sample...

Embodiment 2

[0038] Ordinary method prepares clofarabine freeze-dried powder injection (-40 ℃)

[0039] prescription

[0040] Clofarabine 20g

[0041] Mannitol 800g

[0042] Add water for injection to 15000ml

[0043]

[0044] A total of 1000 bottles were made

[0045] Take the prescribed amount of clofarabine and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of intermediates, and add injection after passing the test. Dilute to the full volume with water, filter with a 0.22 μm microporous membrane under aseptic conditions until clear, fill the filtrate into a sterile vial, partially plug it with a butyl rubber stopper, put it into a plate, and send it to a freeze dryer , close the door, turn on the freeze dryer, use heat transfer oil to cool the plate layer, so that the product temperature drops, w...

Embodiment 3

[0048] prescription

[0049] Clofarabine 20g

[0050] Mannitol 200g

[0051] Add water for injection to 8000ml

[0052]

[0053] A total of 1000 bottles were made

[0054] Take the prescribed amount of clofarabine and put it in a sterile container, add water for injection, heat slightly to dissolve, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of the intermediate, and use it under sterile conditions after passing the test. Filter through a 0.22 μm microporous membrane until clear, fill the filtrate in a sterile 25ml vial, partially plug it with a butyl rubber stopper, put it in a plate, turn on the freeze dryer in advance, and use heat transfer oil to cool the plate until the plate When the temperature reaches -40~-45°C, quickly send the clofarabine solution filled in sterile vials into the freeze dryer, close the door, and keep the plate temperature at -40~-45°C to lower the product...

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Abstract

The present invention relates to a Clofarabine freeze drying powder and the preparation method, which comprises Clofarabine and at least one biological acceptable excipient. Wight ratio of the Clofarabine and the excipient is from one to 10 till one to 50. The excipient is selected from one kind of mannitol and lactose. The optional choice is the mannitol. The preparation method is as following. The Clofarabine is melted with the injection water and the excipient is added. Followed by well mixing , filtration, packaging, adding stopper and loading in the plate. The freeze dryer is opened in advance. The platelayer is cooled with the heat conduction oil until temperature of the platelayer increases till minus 40 DEG Cto minus 50 DEG C. The Clofarabine solution packaged in the sterile silin bottle can be sent to the freeze dryer quickly.The box door is shut and the plate temperature is kept at minus 40 DEG Cto minus 50 DEG C and the box temperature is decreased. When the sample temperature reaches minus 40 DEG C, The plate cooling is stopped and the condenser is opened. At the same time the product temperature is maintaineed by cooling for 3 hours. When the temperature of the condenser reaches minus 40 DEG, the vacuum system is opened. After temperature holding, four steps of heating, sublimation, drying, plugging, box pressing and opening sealing can be started.

Description

technical field [0001] The present invention relates to a clofarabine freeze-dried powder injection and a preparation method thereof, which relate to a clofarabine freeze-dried preparation and a preparation method thereof, and the clofarabine freeze-dried powder injection prepared by the technical scheme of the present invention is used for treating relapse and refractory childhood acute lymphoblastic leukemia. Background technique [0002] Leukemia is a malignant tumor of the blood system, with an incidence rate of about 2-4 / 100,000 population. Leukemia in children ranks first among all kinds of malignant tumors in children. The age of predilection is from birth to 14 years old, affecting the whole age of children, but more common in 2-5 years old. It is one of the leading causes of death in children under 15 years of age. According to the onset of urgency, clinical, blood and bone marrow manifestations, etc., it is generally divided into acute and chronic. Among them, a...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7076A61P35/02
Inventor 叶东王宏响戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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