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Pharmaceutical preparation containing temozolomide, pharmaceutically acceptable salts or other derivatives thereof

The technology of a pharmaceutical preparation and temozolomide is applied in the field of freeze-dried preparations containing temozolomide, which can solve the problems of increasing the risk of medication and increasing the dissolution of the main drug, and achieves the effects of enhancing medication safety, enhancing solubilization effect and good redissolving effect.

Inactive Publication Date: 2015-01-14
北京恒瑞康达医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

increased drug risk
[0009] 3. Chinese patent CN 101869551 B discloses a freeze-dried powder injection of temozolomide for injection, which is characterized in that the solubilizer in the prescription is selected from L-alanine, L-alanine hydrochloride, L- amino acid, L-leucine hydrochloride, L-methionine or L-methionine hydrochloride; similarly, polysorbate 80 is also added to the prescription to increase the dissolution of the main drug, and the same There is also a certain risk of drug use

Method used

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  • Pharmaceutical preparation containing temozolomide, pharmaceutically acceptable salts or other derivatives thereof
  • Pharmaceutical preparation containing temozolomide, pharmaceutically acceptable salts or other derivatives thereof

Examples

Experimental program
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Effect test

Embodiment example 1

[0038] prescription:

[0039] Raw materials Dosage Temozolomide 250mg Mannitol 1.5g Arginine hydrochloride 400mg Sodium citrate 587.5mg hydrochloric acid Appropriate amount Water for Injection Add water to make up to 100ml

[0040] Preparation:

[0041] Weigh the above-mentioned mannitol, arginine hydrochloride, and sodium citrate, add 80ml of water for injection, and stir until dissolved. Then add an appropriate amount of hydrochloric acid to adjust the pH value to 2.0-5.0, add temozolomide and stir until dissolved. Add water for injection to make up to 100ml. Add an appropriate amount of activated carbon, stir for 15-20 minutes, and decarbonize. Then it was sterilized and filtered through a 0.22 μm microporous membrane filter. Aliquoted, freeze-dried, filled with nitrogen.

[0042] Freeze-drying process:

[0043] Pre-freezing period: Put the plate loaded with the medicine bottle into the freeze dryer, the pre-free...

Embodiment example 2

[0047] prescription:

[0048] Raw materials Dosage Temozolomide 250mg lactose 2.0g Arginine hydrochloride 400mg Sodium citrate 600mg hydrochloric acid Appropriate amount Water for Injection Add water to make up to 100ml

[0049] Preparation:

[0050] Weigh the above-mentioned mannitol, arginine hydrochloride, and sodium citrate, add 80ml of water for injection, and stir until dissolved. Then add an appropriate amount of hydrochloric acid to adjust the pH value to 2.0-5.0, add temozolomide and stir until dissolved. Add water for injection to make up to 100ml. Add an appropriate amount of activated carbon, stir for 15-20 minutes, and decarbonize. Then it was sterilized and filtered through a 0.22 μm microporous membrane filter. Aliquoted, freeze-dried, filled with nitrogen.

[0051] The freeze-drying process is the same as the implementation case one

Embodiment example 3

[0053] prescription:

[0054] Raw materials Dosage Temozolomide 250mg Dextran 1.5g Lysine hydrochloride 400mg Potassium dihydrogen phosphate 500mg hydrochloric acid Appropriate amount Water for Injection Add water to make up to 100ml

[0055] Preparation:

[0056] Weigh the above-mentioned mannitol, lysine hydrochloride, and potassium dihydrogen phosphate, add 80ml of water for injection, and stir until dissolved. Then add an appropriate amount of hydrochloric acid to adjust the pH value to 2.0-5.0, add temozolomide and stir until dissolved. Add water for injection to make up to 100ml. Add an appropriate amount of activated carbon, stir for 15-20 minutes, and decarbonize. Then it was sterilized and filtered through a 0.22 μm microporous membrane filter. Aliquoted, freeze-dried, filled with nitrogen.

[0057] The freeze-drying process is the same as the implementation case one

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Abstract

The invention discloses a pharmaceutical preparation containing temozolomide or pharmaceutically acceptable salts or other derivatives thereof, at least one water-based diluent and at least one cosolvent which is sufficient to substantially dissolve the temozolomide or pharmaceutically acceptable salts or other derivatives thereof and a preparing process thereof, and in particular, discloses the freeze-dried preparation containing the temozolomide.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and preparation process of temozolomide or a pharmaceutically acceptable salt or other derivative thereof, in particular to a freeze-dried preparation containing temozolomide, which belongs to the field of medicinal chemistry. Background technique [0002] Temozolomide is a class of antineoplastic drugs developed by M..F.G Stevens, E.S Newlands, etc., and transferred to Schering-Plough in 1992. It is mainly used clinically for the treatment of glioma and malignant melanoma. In October 1997, it was approved under the unanimous recommendation of the EU CPMP, and it was launched in Europe in 1998. On August 11, 1999, it was approved by the FDA to go on the market in the United States. On February 27, 2009, Temozolomide for Injection was approved by the FDA for marketing in the United States. [0003] Temozolomide (Temozolomide) chemical name is 3,4-dihydro-3-methyl-4-oxoimidazole [5,1-d] and 1,2,3,5...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4188A61K47/18A61K47/22A61K47/20A61P35/00
Inventor 隋鹏宋佳
Owner 北京恒瑞康达医药科技发展有限公司
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