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Pharmaceutical composition of fulvestrant

A technology of fulvestrant and composition, applied in the field of pharmaceutical preparations, to achieve the effects of reducing injection volume, increasing solubility, and improving drug compliance

Active Publication Date: 2015-04-15
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Therefore, looking for a preparation that is less irritating, safe and effective, easy to use, and suitable for intramuscular injection has become the goal pursued by people, and the current commercially available products cannot meet this requirement.

Method used

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  • Pharmaceutical composition of fulvestrant
  • Pharmaceutical composition of fulvestrant
  • Pharmaceutical composition of fulvestrant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of 100mg / ml Fulvestrant Injection

[0035]

[0036]

[0037] Preparation: Get the prescribed amount of fulvestrant, ethanol (95%), benzyl alcohol, and medium-chain triglycerides, stir and mix at room temperature until fulvestrant is completely dissolved, add castor oil to the final volume (10ml), stir and mix uniform. Filter the mixed solution through a 0.2 micron filter 1-2 times to achieve the purpose of sterilization. Under sterile conditions, dispense the sample into injection vials or pre-filled injection devices, and obtain it after visual inspection.

Embodiment 2～6

[0038] Embodiment 2~6 Preparation of Fulvestrant Injection

[0039] The dosages of fulvestrant and medium-chain triglycerides in the prescription are as shown in the table below, and the dosages of other ingredients are the same as in Example 1, and the injection is prepared according to Example 1.

[0040] Table 1

[0041] Example

Embodiment 7

[0042] Example 7 Preparation of 100mg / ml Fulvestrant Injection

[0043] It is the same as Example 1, but during the preparation process, "filter 1-2 times through a 0.2 micron filter" is changed to "sterilize at a high temperature of 121° C. for 12 minutes".

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PUM

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Abstract

The invention relates to a pharmaceutical composition of fulvestrant. The pharmaceutical composition comprises: (1) fulvestrant; (2) at least one pharmaceutically acceptable alcohol; (3) medium-chain triglyceride; and (4) a castor oil matrix.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a fulvestrant preparation suitable for injection administration, as well as a preparation method and application of the preparation. Background technique [0002] According to the global tumor statistics report published in 2011, there were about 12.7 million cancer cases and 7.6 million cancer deaths in 2008, of which 56% were cases and 64% were deaths in developing countries. Breast cancer is the cancer with the highest morbidity and mortality among women, accounting for about 23% of the total cancer cases and 14% of the cancer deaths. In developing countries, breast cancer ranks first among female cancer deaths, surpassing cervical cancer, and breast cancer seriously endangers human health. [0003] There are estrogen receptors (ER) in many breast cancer cells. After estrogen binds to these receptors, it will promote cell proliferation and stimulate tumor growth throu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/565A61K47/14A61P35/00
Inventor 张勇徐宏江陈智林姜力勋
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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