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Gefitinib sustained-release implantation agent for curing entity tumour

A slow-release implant, gimatecan technology, applied in the field of medicine, can solve the problems of unclear effect, systemic toxicity 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

In vitro studies have shown that gematecan can inhibit the growth of vascular endothelium, however, the effect of using it alone to treat other 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

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Put 80 mg of sustained-release excipients (polylactic acid (PLA) with a molecular weight of 15,000-30,000) into a container, add a certain amount of organic solvent to dissolve and mix (subject to full dissolution), add 20 mg of gematecan, and re- Shake well and dry under vacuum to remove the organic solvent. The dried solid composition is shaped immediately, subpackaged and sterilized by radiation to obtain a slow-release implant containing 20% ​​gematecan. The drug release time of the slow-release implant in physiological saline in vitro is 22-28 days, and the drug release time in mouse subcutaneous is 20-30 days.

Embodiment 2

[0080] 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:

[0081] (A) 1% gematecan and 99% polylactic acid;

[0082] (B) 5% gematecan and 95% polylactic acid;

[0083] (C) 10% gematecan and 90% polylactic acid;

[0084] (D) 15% gematecan and 85% polylactic acid;

[0085] (E) 20% gematecan and 80% polylactic acid.

Embodiment 3

[0087] Put 85 mg of sustained-release excipients (PLGA with a molecular weight of 15,000-25,000, 50:50) into a container, add a certain amount of organic solvent to dissolve and mix (subject to full dissolution), add 15 mg of gematecan, and shake again After homogenization, the organic solvent was removed by vacuum drying. The dried solid composition is shaped immediately, subpackaged and sterilized by radiation to obtain a slow-release implant containing 15% gematecan. The release time of the sustained-release implant in physiological saline in vitro is 25-35 days, and the drug release time in mice subcutaneous is 23-32 days.

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PUM

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Abstract

The invention relates to a gimatecan sustained-release implant for the treatment of solid tumors, which is characterized in that the sustained-release implant contains anti-cancer effective amount of gimatecan, sustained-release excipient and certain amount of sustained-release regulator. The solid tumors include lung cancer, esophageal cancer, stomach cancer, liver cancer, breast cancer, ovarian cancer, prostate cancer, bladder cancer and colorectal cancer. The sustained-release excipient mainly comprises one or the combination of the copolymer of glycolic acid and hydroxyacetic acid, polifeprosan, poly (L-lactide-co-ethyl phosphate) and poly (L-lactide-co-propyl phosphate). The invention can slowly release the gimatecan in the local part of the tumor during the degradation and absorption process, so the invention can maintain the 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 gimatecan, 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.

Description

(1) Technical field [0001] The invention relates to a gematecan sustained-release implant for treating solid tumors, belonging to the technical field of medicines. (2) Background technology [0002] Malignant solid tumors account for more than 70% of all malignant tumors. However, unlike non-solid tumors such as hematological and lymphoid tumors, it is difficult for conventional chemotherapy to obtain long-term effective drug concentrations in solid tumors. Although spread occurs during tumor growth, expansive growth is still the dominant growth pattern in most malignant solid tumors. As a result, tissue pressures within tumors are significantly higher than in normal tissues. Not only that, the vascular disorder and intermittent blood flow caused by tumor growth often lead to the distribution of systemic chemotherapy drugs in other normal tissues and organs, and rarely enter solid tumors. Low concentrations of drugs not only cannot effectively kill cancer cells, but also p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/4745A61K47/34A61P35/00
Inventor 孔庆忠苏红清
Owner SHANDONG LANJIN PHARMA
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