Busulfan sustained-release implantation agent for curing entity tumour

A technology of sustained-release implants and busulfan, applied in the field of medicine, can solve problems such as unclear effects, systemic toxic and side effects that limit clinical application, etc.

Inactive Publication Date: 2008-05-21
SHANDONG LANJIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the efficacy of the drug in the treatment of solid tumors is unclear
Although the combination with other anticancer drugs may have a certain effect on some tumors, the systemic side effects caused by conventional administration limit its clinical application
The key problem is that the current application situation can not give full play to its clinical effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Put the weighed (80mg) sustained-release excipient (polylactic acid (PLA) with a molecular weight of 15000-25000) into the container, add a certain amount of organic solvent to dissolve and mix (subject to full dissolution), then add 20 mg of white Disinfect, re-shake and dry in vacuo to remove organic solvents. The dried solid composition is shaped immediately, subpackaged and sterilized by radiation to obtain a slow-release implant containing 20% ​​busulfan. The release time of the sustained-release implant in physiological saline in vitro is 16-24 days, and the release time in mouse subcutaneous is 15-25 days.

Embodiment 2

[0070] 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:

[0071] (A) 1% busulfan and 99% polylactic acid;

[0072] (B) 5% busulfan and 95% polylactic acid;

[0073] (C) 10% busulfan and 90% polylactic acid;

[0074] (D) 15% busulfan and 85% polylactic acid;

[0075] (E) 20% Busulfan and 80% Polylactic Acid.

Embodiment 3

[0077] Put the weighed (85mg) sustained-release excipient (PLGA with a molecular weight of 15000-25000, 50:50) into the container, add a certain amount of organic solvent to dissolve and mix (subject to complete dissolution), then add 15mg of Buxiao Ann, re-shake and vacuum-dry to remove organic solvents. The dried solid composition is shaped immediately, subpackaged and sterilized by radiation to obtain a slow-release implant containing 15% busulfan. The release time of the slow-release implant in physiological saline in vitro is 20-26 days, and the release time in mouse subcutaneous is 22-28 days.

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PUM

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Abstract

The invention relates to a busulfan sustained-release implant for the treatment of solid tumors, which is characterized in that the sustained-release implant contains anti-cancer effective amount of busulfan, sustained-release excipient and certain amount of sustained-release regulator. The sustained-release excipient mainly comprises one or the combination of the copolymer of glycolic acid and hydroxyacetic acid, polifeprosan and poly (L-lactide-co-propyl phosphate). The invention can slowly release the busulfan in the local part of the tumor during the degradation and absorption process, so the invention can maintain effective drug concentration at the local part of the tumor at the same time of significantly reducing systemic toxic reaction. The sustained-release implant is arranged at the local part of the tumor, which can not only reduce the systemic toxic reaction of busulfan, but can also selectively improve the drug concentration at the local part of the tumor and strengthen the treatment effects of chemotherapy drugs, radiation therapy and other non-surgical therapies. The solid tumors include pancreatic cancer, lung cancer, liver cancer, breast cancer, brain tumor, ovarian cancer, prostate cancer, esophageal cancer, lymphoma, osteosarcoma, colorectal cancer and so on.

Description

(1) Technical field [0001] The invention relates to a busulfan slow-release implant for treating solid tumors, belonging to the technical field of medicines. (2) Background technology [0002] 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 treating cancer has become a hot research topic at present. [0003] Busulfan (BUSULFAN, 1,4-butanediol dimethanesulfonate) is a bifunctional alkylatin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/255A61K47/34A61P35/00
Inventor 孔庆忠孔庆新
Owner SHANDONG LANJIN PHARMA
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