A kind of production technology of carfilzomib freeze-dried preparation for injection

A technology of carfilzomib and freeze-dried preparations, which is applied in the field of medicine, can solve the problems of increased risk of clinical medication, high levels of related substances, and long time for liquid preparation, and achieve flexible production and operation time, low endotoxin, and extended storage The effect of the time limit

Active Publication Date: 2021-06-29
KINDOS PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Carfilzomib liquid for injection is sensitive to oxygen, light, and temperature. In the process of preparing the liquid, too much light, high liquid temperature or too high dissolved oxygen will lead to high levels of related substances in the product. ; The raw material medicine also has the problems of slow dissolution rate and long time of liquid preparation process, and the antibacterial property of the liquid medicine itself is poor at the same time
[0003] In view of the poor stability of carfilzomib for injection and its sensitivity to oxygen, the method of adding antioxidants is often used at present, such as the invention patent CN107802606A
After adding antioxidants, the prescription is inconsistent with the original research product. There is no clinical data to prove whether the addition of antioxidants will affect the clinical efficacy, whether there will be side effects, and increase the risk of clinical medication

Method used

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  • A kind of production technology of carfilzomib freeze-dried preparation for injection
  • A kind of production technology of carfilzomib freeze-dried preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A production process of carfilzomib freeze-dried preparation for injection, comprising the steps of:

[0028] A. At room temperature, add water for injection into the liquid preparation tank, then add 150 parts by weight of sulfobutyl-β-cyclodextrin, and stir until dissolved;

[0029] B. Add 2.5 parts by weight of anhydrous citric acid, stir until dissolved, and fill the solution with nitrogen;

[0030] C. Add 3 parts by weight of carfilzomib bulk drug under stirring conditions, stir and sonicate until dissolved, and reduce the temperature of the drug solution to 2°C;

[0031] D, slowly adding NaOH solution to adjust the pH to 3.0, and set the volume to 1000 parts by weight with water for injection;

[0032] E. After the liquid preparation is completed, immediately pre-filter the liquid medicine into a buffer tank, and fill the headspace with nitrogen to maintain pressure;

[0033] F. Sterilization and filtration, aseptic filling, freeze-drying, nitrogen repressurizat...

Embodiment 2

[0036] A production process of carfilzomib freeze-dried preparation for injection, comprising the steps of:

[0037] A. At room temperature, add water for injection into the liquid preparation tank, then add 200 parts by weight of sulfobutyl-β-cyclodextrin, and stir until dissolved;

[0038] B. Add 4 parts by weight of anhydrous citric acid, stir until dissolved, fill the solution with nitrogen, and fill the solution with nitrogen until the dissolved oxygen content is less than 1ppm. ;

[0039] C. Add 4 parts by weight of the carfilzomib bulk drug under stirring conditions, stir and sonicate until dissolved, and reduce the temperature of the drug solution to 8°C;

[0040] D, slowly adding NaOH solution to adjust the pH to 4.0, and set the volume to 1000 parts by weight with water for injection;

[0041] E. After the liquid preparation is completed, immediately pre-filter the liquid medicine into a buffer tank, and fill the headspace with nitrogen to maintain pressure;

[00...

Embodiment 3

[0047] A production process of carfilzomib freeze-dried preparation for injection, comprising the steps of:

[0048] A. At room temperature, add water for injection into the liquid preparation tank, then add 180 parts by weight of sulfobutyl-β-cyclodextrin, and stir until dissolved;

[0049] B. Add 3 parts by weight of anhydrous citric acid, stir until dissolved, fill the solution with nitrogen, and fill the solution with nitrogen until the dissolved oxygen content is less than 1ppm. ;

[0050] C. Add 3.5 parts by weight of the carfilzomib bulk drug under stirring conditions, stir and sonicate until dissolved, and reduce the temperature of the drug solution to 3°C;

[0051] D, slowly adding NaOH solution to adjust the pH to 3.5, and set the volume to 1000 parts by weight with water for injection;

[0052] E. After the liquid preparation is completed, immediately pre-filter the liquid medicine into a buffer tank, and fill the headspace with nitrogen to maintain pressure;

[00...

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PUM

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Abstract

The invention discloses a production process of a carfilzomib freeze-dried preparation for injection, which comprises the following steps: adding water for injection into a liquid preparation tank at room temperature, and then adding 150 to 200 parts by weight of sulfobutyl-β-cyclo Dextrin, stir until dissolved; add 2.5~4 parts by weight of anhydrous citric acid, stir until dissolved, and fill the solution with nitrogen; add 3~4 parts by weight of raw material under stirring, stir and sonicate until dissolved, reduce The temperature of the medicinal solution is 2-8°C; slowly add NaOH solution to adjust the pH value, and dilute the volume to 1000 parts by weight with water for injection; pressure; sterile filtration, aseptic filling, freeze-drying, nitrogen repressurization, unloading and capping to obtain the finished product. Through the control of oxygen, liquid mixing temperature and process time limit in the process, the products produced have low endotoxin, low impurities and good stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a production process of a carfilzomib freeze-dried preparation for injection. Background technique [0002] Carfilzomib for injection is a proteasome inhibitor approved by the US FDA on July 20, 2012 for the treatment of certain multiple myeloma patients. Carfilzomib liquid for injection is sensitive to oxygen, light, and temperature. In the process of preparing the liquid, too much light, high liquid temperature or too high dissolved oxygen will lead to high levels of related substances in the product. The crude drug also has the problems of slow dissolving speed and long solution preparation time, and the bacteriostatic property of the drug solution itself is relatively poor. [0003] In view of the poor stability of carfilzomib for injection and its sensitivity to oxygen, the method of adding antioxidants is often used at present, such as the invention patent CN107802606A. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/08A61K47/40A61P35/00
CPCA61K9/19A61K38/08A61K47/40A61P35/00
Inventor 屈倩倩庄昌萌史宣宇田欣欣
Owner KINDOS PHARM CO LTD
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