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Nilotinib sustained-release implant for treating solid tumor

A slow-release implant, nilotinib 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: 2008-05-28
SHANDONG LANJIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the efficacy of the drug alone in the treatment of other solid tumors is unclear
Although the combination with other anticancer drugs such as paclitaxel may have a certain effect on lung cancer and other 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

[0080] will be 10 5 Tumor cells were inoculated subcutaneously in the right armpit of mice. When the tumor grew to about 1.0 cm (8 days after inoculation), the animals were randomly divided into normal saline group (control group), nilotinib intraperitoneal injection group (i.p. group) and nilotinib sustained-release implant group (three dose groups of low, medium and high), wherein the dose of intracavitary injection group contains the same amount of active ingredient as the low-dose sustained-release implant group. The size of the tumor was measured with a vernier caliper every 3 days after implant prevention, and the animals were sacrificed 20 days later, and the tumor was completely stripped and weighed after weighing the body weight. The tumor inhibition rate was calculated according to the following formula.

[0081] Tumor inhibition rate=(1-average tumor weight of administration group / average tumor weight of normal saline group)×100%

Embodiment 2

[0083] Put 95 mg of polylactic acid 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 5 mg of nilotinib, 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 5% nilotinib. The release time of the slow-release implant in physiological saline in vitro is 25-30 days, and the release time in mouse subcutaneous is 26-31 days.

Embodiment 3

[0085] Sustained-release implants were made according to the method described in Example 2, but the anticancer active ingredients contained were one of the following:

[0086] (A) 1% nilotinib and 99% polylactic acid;

[0087] (B) 5% nilotinib and 95% polylactic acid;

[0088] (C) 10% nilotinib and 90% polylactic acid;

[0089] (D) 15% nilotinib and 85% polylactic acid;

[0090] (E) 20% nilotinib and 80% polylactic acid.

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PUM

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Abstract

A sustained release implant includes 0.1%-50% (w / w) nilotinib, 50-99% sustained release excipients and 0-15% sustained release moderator. Sustained release excipients are one or the combination of poly (L-lactide-co-ethyl phosphate), poly (L-lactide-co- phosphoric acid propyl), glycolic acid and copolymer of glycolic acid and hydroxyacetic acid, and polifeprosan; sustained release moderator is one or combination of mannitol, sorbic alcohol and chondroitin; sustained release implant applied in local tumor can slowly release nilotinib onto local tumor, thus maintaining effective drug concentration of local tumor as well as significantly reducing overall toxic reaction, thus the invention not only reduces overall toxic reaction of nilotinib, but also selectively improves drug concentration in local tumor, enhancing the therapeutic effects of non-operative therapy such as chemotherapy drugs and radiotherapy. The implant can be used for treating solid tumors including lung cancer, esophageal carcinoma, gastric cancer, liver cancer, breast cancer, ovarian cancer, prostatic carcinoma, pancreatic cancer, bladder carcinoma, cerebroma, and colorectal cancer.

Description

(1) Technical field [0001] The invention relates to a nilotinib 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 China. 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] At present, there are many drugs for the treatment of tumors. However, many drugs have...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/505A61K47/34A61P35/00
Inventor 孔庆忠孙启亮
Owner SHANDONG LANJIN PHARMA
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