Fulvestrant pharmaceutical composition

A kind of technology of fulvestrant and composition, applied in the field of pharmaceutical preparations

Active Publication Date: 2015-02-11
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is clear that currently available products cannot meet this requirement

Method used

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  • Fulvestrant pharmaceutical composition
  • Fulvestrant pharmaceutical composition
  • Fulvestrant pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: Preparation of 50mg / ml fulvestrant injection

[0025]

[0026] Preparation: Weigh the prescribed amount of fulvestrant, ethanol (95%) and benzyl alcohol and mix, stir until fulvestrant is completely dissolved; add the prescribed amount of medium-chain triglycerides to the above solution, stir, and mix well ; Add the prescribed amount of castor oil to the final volume (500ml), stir and mix. Filter the mixed solution through a 0.2 μm filter for 1 to 2 times to sterilize. In sterile, N-filled 2 Under protection, dispense samples into vials or prefilled syringes.

Embodiment 2

[0027] Embodiment 2: Preparation of 50mg / ml fulvestrant injection

[0028]

[0029]

[0030] Preparation: Weigh the prescribed amount of fulvestrant, ethanol (95%) and benzyl alcohol and mix, stir until fulvestrant is completely dissolved; add the prescribed amount of triglyceride caprylate-caprate to the above solution, stir, mix Evenly; add the prescribed amount of castor oil to the final volume (500ml), stir and mix. Filter the mixed solution through a 0.2 μm filter for 1 to 2 times to sterilize. In sterile, N-filled 2 Under protection, dispense samples into vials or prefilled syringes.

Embodiment 3

[0031] Embodiment 3: Preparation of 50mg / ml fulvestrant injection

[0032]

[0033] Preparation: Weigh the prescription amount of fulvestrant, ethanol (95%) and benzyl alcohol and mix them, stir until the fulvestrant is completely dissolved; add the prescription amount of glycerol triacetate to the above solution, stir, and mix well; add Add the prescribed amount of castor oil to the final volume (500ml), stir and mix. Filter the mixed solution through a 0.2 μm filter for 1 to 2 times to sterilize. In sterile, N-filled 2 Under protection, dispense samples into vials or prefilled syringes.

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Abstract

The invention relates to a fulvestrant pharmaceutical composition. Specifically, the invention relates to the fulvestrant-containing pharmaceutical composition for intramuscular injection, wherein the pharmaceutical composition comprises 1) fulvestrant, 2) a castor oil matrix; 3) at least one pharmaceutically acceptable alcohol, and 4) one or any mixture selected from the group consisting of medium-chain triglyceride, triglycerol caprylate-caprate, glyceryl triacetate, ethyl acetate and isopropyl myristate. The pharmaceutical composition is excellent in pharmaceutical safety and stability performance, and better in bioavailability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing fulvestrant. Specifically, the present invention relates to a novel sustained-release pharmaceutical preparation suitable for injection, which uses fulvestrant as an active ingredient. Background technique [0002] Breast cancer is a disease in which breast ductal epithelial cells lose their normal characteristics and proliferate abnormally under the action of various internal and external carcinogenic factors, so that they exceed the limit of self-repair and become cancerous. Breast cancer is one of the most common malignant tumors in women, with the characteristics of high incidence, strong invasiveness, and slow progression of the disease. The China Population Association released the "China Breast Disease Survey Report" in Beijing on February 1, 2010, which shows that the mortality rate of breast cancer in urban areas in my c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/565A61K47/14A61P35/00A61P35/04
Inventor 董礼黄玉超孙长安王小雷
Owner JIANGSU HANSOH PHARMA CO LTD
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