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Mitozolomide controlled-release planting dose for treating entity tumor

A technology for sustained-release implants and mituzolamide, which is applied in the field of medicine and can solve the problems of fast release and instability of sustained-release preparations

Inactive Publication Date: 2008-06-18
SHANDONG LANJIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the sustained-release preparations made by the existing methods release faster and unstable, so that they cannot bring into play their clinical effects well.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Put the weighed (85 mg) sustained-release excipient (PLGA with a molecular weight of 20,000-25,000, 75:25) into the container, add a certain amount of organic solvent to dissolve and mix (subject to full dissolution), then add 10 mg of Mito Zolamide and 5 mg mannitol, re-shake, and then vacuum-dry to remove the organic solvent. The dried solid composition is shaped immediately, subpackaged and sterilized by radiation to obtain a slow-release implant containing 10% mitozolomide. The release time of the sustained-release implant in physiological saline in vitro is 24-30 days, and the release time in mice subcutaneous is 25-32 days without burst release.

Embodiment 2

[0065] Sustained-release implants were made according to the method described in Example 1, but the anti-cancer active ingredients contained were one of the following:

[0066] (1) 1%-10% mitozolomide and 90%-99% glycolic acid and glycolic acid copolymer and 0.5%-15% mannitol;

[0067] (2) 10%-20% of mitazolamide and 80%-90% of glycolic acid and glycolic acid copolymer and 0.5%-10% of sorbitol;

[0068] (3) 20%-30% of mitazolamide and 70%-80% of glycolic acid and glycolic acid copolymer and 0.5%-10% of sodium chloride;

[0069] (4) 30%-40% of mitazolamide, 60%-70% of glycolic acid and glycolic acid copolymer and 0.25%-5% of mannitol;

[0070] (5) 5% mitozolomide and 93% glycolic acid and glycolic acid copolymer and 2% sodium chloride;

[0071] (6) 10% mitozolomide and 85% glycolic acid and glycolic acid copolymer and 5% mannitol;

[0072] (7) 20% mitozolomide and 75% glycolic acid and glycolic acid copolymer and 5% mannitol;

[0073] (8) 30% mitozolomide and 65% copolymer ...

Embodiment 3

[0075] Put the weighed (80mg) slow-release excipient (PLGA with a molecular weight of 15000-25000, 50:50) and 5mg of sodium chloride into the container, add a certain amount of organic solvent to dissolve and mix (subject to full dissolution) , add 15 mg of mitozolomide, re-shake, and then vacuum dry to remove the organic solvent. The dried solid composition is shaped immediately, subpackaged and sterilized by radiation to obtain a slow-release implant containing 15% mitozolomide. The release time of the sustained-release implant in physiological saline in vitro is 20-28 days, and the release time in mice subcutaneous is 24-28 days, without burst release.

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PUM

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Abstract

Disclosed is a mitoxatrone diamox sustained release implant for treating solid tumor, which is characterized in that the sustained release implant contains anticancer effective amount of mitoxatrone diamox, sustained release excipient and a certain of sustained release regulator. The solid tumor comprises pancreatic cancer, lung cancer, liver cancer, breast cancer, brain tumor, ovarian cancer, prostate cancer, esophagus cancer, lymphoma, osteosarcoma and colorectal cancer. The sustained release excipient is mainly one or the combination of copolymer of glycolic acid and hydroxyacetic acid, polifeprosan, poly( L-lactide-co-ethyl phosphate) and poly( L-lactide-co-phosphoric propyl). In the processes of degradation and absorption, the sustained release implant can slowly release the mitoxatrone diamox on part of the tumor, so the sustained release implant obviously lowers systemic toxicity of the mitoxatrone diamox and can keep effective drug concentration on part of the tumor. If the sustained release implant is placed on part of the tumor, the sustained release implant not only can lower the systemic toxicity of the mitoxatrone diamox but also can selectively improve the drug concentration on part of the tumor and can enhance the efficacy of the non-operative treatment such as chemotherapeutic drugs and radiotherapy , etc.

Description

(1) Technical field [0001] The invention relates to a mitozolomide sustained-release implant for treating solid tumors, belonging to the technical field of medicines. (2) Background technology [0002] Although the research on cancer has made great progress, its mortality rate is still in the forefront of various common causes of death. The latest data show that in 2006, 3 million people died of cancer in my country. The incidence of cancer is increasing year by year and tends to be younger. Statistics show that in less than 20 years, the incidence of cancer in my country has increased by 69%, and the mortality rate has increased by 29.4%. According to the latest statistics from the World Health Organization, the global cancer incidence rate will increase by 50% by 2020, and the number of patients will increase to 15 million. It is estimated that 4 million people will die of cancer every year in my country in 2020. Therefore, exploring an effective method or drug for treat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4188A61K47/34A61K47/36A61K47/42A61P35/00
Inventor 孔庆忠侯洪春
Owner SHANDONG LANJIN PHARMA
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