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Self-microemulsion system for loading abiraterone acetate, composition and application

A technology of abiraterone acetate and a composition, which is applied in the directions of drug combination, emulsion delivery, medical preparations of inactive ingredients, etc., can solve the problems such as the need to improve the bioavailability, and achieves the improvement of the bioavailability of the drug and the improvement of the permeability. Membrane properties, the effect of reducing the impact

Active Publication Date: 2022-04-12
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pharmaceutical composition needs strong mechanical stirring to dissolve completely during the dissolution process, and the bioavailability after oral administration still needs to be improved

Method used

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  • Self-microemulsion system for loading abiraterone acetate, composition and application
  • Self-microemulsion system for loading abiraterone acetate, composition and application
  • Self-microemulsion system for loading abiraterone acetate, composition and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] A composition containing abiraterone acetate, which comprises the following components:

[0082] Abiraterone acetate: 1.118 parts by weight (accounting for about 4.30 wt% of the total mass of the composition).

[0083] Glycerol monolinoleate: 6.722 parts by weight (accounting for about 25.85 wt% of the total mass of the composition).

[0084] Medium-chain triglycerides: 1.991 parts by weight (accounting for about 7.66 wt% of the total mass of the composition).

[0085] Polyoxyethylene 40 hydrogenated castor oil: 4.973 parts by weight (accounting for about 19.13 wt% of the total mass of the composition).

[0086] Diethylene glycol monoethyl ether: 11.196 parts by weight (accounting for about 43.06 wt% of the total mass of the composition).

[0087] The preparation process is as follows: Take monolinoleic acid glyceride, medium chain triglyceride, polyoxyethylene 40 hydrogenated castor oil and mix evenly, then add abiraterone acetate, avoid light, fully dissolve and the...

Embodiment 2

[0089] A composition containing abiraterone acetate, which comprises the following components:

[0090] Abiraterone acetate: 1.170 parts by weight (accounting for about 4.50 wt% of the total mass of the composition).

[0091] Glycerol monolinoleate: 6.704 parts by weight (accounting for about 25.78 wt% of the total mass of the composition).

[0092] Medium-chain triglycerides: 1.986 parts by weight (accounting for about 7.64wt% of the total mass of the composition).

[0093] Polyoxyethylene 40 hydrogenated castor oil: 4.966 parts by weight (accounting for about 19.10 wt% of the total mass of the composition).

[0094] Diethylene glycol monoethyl ether: 11.174 parts by weight (accounting for about 42.98 wt% of the total mass of the composition).

[0095] The preparation process is as follows: Take monolinoleic acid glyceride, medium chain triglyceride, polyoxyethylene 40 hydrogenated castor oil and mix evenly, then add abiraterone acetate, avoid light, fully dissolve and then...

Embodiment 3

[0097] A composition containing abiraterone acetate, which comprises the following components:

[0098] Abiraterone acetate: 1.248 parts by weight (accounting for about 4.80 wt% of the total mass of the composition).

[0099] Glyceryl monolinoleate: 6.683 parts by weight (accounting for about 25.70 wt% of the total mass of the composition).

[0100] Medium-chain triglycerides: 1.979 parts by weight (accounting for about 7.61 wt% of the total mass of the composition).

[0101] Polyoxyethylene 40 hydrogenated castor oil: 4.950 parts by weight (accounting for about 19.04 wt% of the total mass of the composition).

[0102] Diethylene glycol monoethyl ether: 11.140 parts by weight (accounting for about 42.85 wt% of the total mass of the composition).

[0103] The preparation process is as follows: Take monolinoleic acid glyceride, medium chain triglyceride, polyoxyethylene 40 hydrogenated castor oil and mix evenly, then add abiraterone acetate, avoid light, fully dissolve and then ...

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PUM

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Abstract

The invention discloses a self-microemulsion system for loading abiraterone acetate, a composition and application. The self-microemulsion system for loading abiraterone acetate has excellent solubility and stability on abiraterone acetate, and the composition formed by dissolving abiraterone acetate in the system can significantly reduce the influence of food on abiraterone acetate absorption and reduce the difference before and after meals. Therefore, the medicine can be taken under the conditions of empty stomach and satiety, and the limitation of medicine taking time is reduced.

Description

technical field [0001] The invention relates to the technical field of abiraterone acetate preparations, in particular to a self-microemulsion system, composition and application for loading abiraterone acetate Background technique [0002] Abiraterone acetate is a white to off-white, non-hygroscopic crystalline powder; the chemical name is (3β)-17-(3-pyridyl)androst-5,16-dien-3-yl acetate, Its molecular formula is C 26 h 33 NO 2 . Abiraterone acetate is converted in vivo to the androgen biosynthesis inhibitor abiraterone, which inhibits 17α-hydroxylase / C17,20-lyase (CYP17). It can be used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-containing chemotherapy. However, abiraterone acetate is a lipophilic compound, its octanol-water partition coefficient is 5.12 (LogP), the pKa of aromatic nitrogen is 5.19, it is almost insoluble in water (less than 0.01mg / ml)...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/58A61K47/10A61K47/44A61P35/00A61P35/04
Inventor 易木林
Owner HUNAN HUIZE BIO PHARMA CO LTD
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