Abiraterone acetate pharmaceutical composition, preparation, preparation method and application thereof

A technology of abiraterone acetate and its composition, which is applied in the direction of drug combination, drug delivery, and pharmaceutical formulation, which can solve the problems of slow drug dissolution rate and absorption, high risk of adverse reactions, and poor patient compliance, and achieve treatment costs. Effect of reducing, enriching drugs and pathways, increasing bioavailability

Active Publication Date: 2021-12-24
武汉九珑人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the defects of low bioavailability, slow drug dissolution rate and absorption, poor patient compliance and high risk of adverse reactions in the abiraterone acetate pharmaceutical composition in the prior art, the present invention provides an abiraterone acetate medicine The composition, preparation, preparation method and application thereof improve drug dissolution rate and bioavailability, enhance drug absorption; reduce preparation specifications and therapeutic doses, improve patient compliance and safety, and reduce adverse reactions The production and preparation process is simplified, and the cost is reduced; the beneficial effect of the present invention is verified through in vivo tests; the drugs and approaches for treating prostate cancer tumors are greatly enriched

Method used

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  • Abiraterone acetate pharmaceutical composition, preparation, preparation method and application thereof
  • Abiraterone acetate pharmaceutical composition, preparation, preparation method and application thereof
  • Abiraterone acetate pharmaceutical composition, preparation, preparation method and application thereof

Examples

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Effect test

Embodiment 1

[0081] Embodiment 1: Abiraterone acetate tablet preparation

[0082] (1) 69 parts of lactose and 10 parts of sodium starch glycolate are premixed to obtain a premix;

[0083] (2) Mix 10 parts of povidone and 100 parts of water to obtain an aqueous binder solution, and use a fluidized bed to prepare the premix and the aqueous binder solution into matrix particles;

[0084] (3) 10 parts of abiraterone acetate are dissolved in 300 parts of chloroform, sprayed onto the matrix particles, dried,

[0085] (4) granulate, add 1 part of magnesium stearate, mix, tabletting, obtain abiraterone acetate tablet.

Embodiment 2

[0086] Embodiment 2: Abiraterone acetate tablet preparation

[0087] (1) 50 parts of lactose and 9 parts of sodium starch glycolate are premixed to obtain a premix;

[0088] (2) Mix 20 parts of povidone and 200 parts of water to obtain an aqueous binder solution, and use a fluidized bed to prepare the premix and the aqueous binder solution into matrix particles;

[0089] (3) 20 parts of abiraterone acetate are dissolved in 600 parts of chloroform, sprayed onto the matrix particles, dried,

[0090] (4) granulate, add 1 part of magnesium stearate, mix, tabletting, obtain abiraterone acetate tablet.

Embodiment 3

[0091]Embodiment 3: preparation of abiraterone acetate tablet

[0092] (1) 50 parts of lactose, 10 parts of microcrystalline cellulose and 9.5 parts of sodium carboxymethyl starch are premixed to obtain a premix;

[0093] (2) Mix 20 parts of starch and 200 parts of water to obtain an aqueous binder solution, and use a fluidized bed to prepare the premix and the aqueous binder solution into matrix granules;

[0094] (3) 10 parts of abiraterone acetate are dissolved in 350 parts of chloroform and 350 parts of ethanol, sprayed onto the matrix particles, dried,

[0095] (4) granulate, add 0.05 part of magnesium stearate, mix, tabletting, obtain abiraterone acetate tablet.

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Abstract

The invention discloses an abiraterone acetate pharmaceutical composition, a preparation, a preparation method and application thereof. The abiraterone acetate pharmaceutical composition comprises matrix particles and abiraterone acetate, wherein the abiraterone acetate is coated on the surfaces of the matrix particles; and the matrix particles comprise a diluent, a disintegrating agent and an adhesive. The preparation method of the abiraterone acetate pharmaceutical composition comprises the following steps of (1) mixing the diluent, the disintegrating agent, the adhesive and a solvent, and granulating to obtain matrix particles; and (2) dissolving abiraterone acetate in an organic solvent to obtain an abiraterone acetate solution, coating the matrix particles with the abiraterone acetate solution, and drying. According to the abiraterone acetate pharmaceutical composition, the dissolution rate of active ingredients is obviously improved; the medicine absorption is enhanced; the bioavailability is improved; and the taking compliance and safety of a patient are effectively improved.

Description

technical field [0001] The invention relates to an abiraterone acetate pharmaceutical composition, preparation, preparation method and application thereof. Background technique [0002] Abiraterone acetate is a prodrug of abiraterone that is converted to abiraterone in the body. Abiraterone is an oral CYP17 inhibitor, which can effectively reduce the prostate-specific antigen (PSA) in prostate cancer patients by inhibiting the activities of C17, C20-lyase and 17α-hydroxylase in the key enzyme CYP17 in androgen synthesis Level. Abiraterone has an inhibitory effect on the androgen in the testis, prostate and adrenal gland tissue. Abiraterone directly antagonizes the androgen receptor and is also one of the main mechanisms of action for the treatment of castration-resistant prostate cancer (CRPC). Abiraterone acetate tablets have become the first-line drug for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the global pharmaceutical market. Abirat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K9/16A61K9/20A61K9/48A61P35/00
CPCA61K31/58A61K9/1676A61K9/2077A61K9/2059A61K9/1652A61K9/0053A61P35/00
Inventor 刘诚周凯汪洋李晨邓娟王晓宇李淑云黄恋清符洁
Owner 武汉九珑人福药业有限责任公司
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