Oral solid composition of abiraterone and preparation method thereof

A technology of abiraterone and abiraterone acetate, applied in the direction of drug combination, medical preparations containing active ingredients, pharmaceutical formulas, etc.

Inactive Publication Date: 2013-12-18
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007]Although abiraterone acetate is effective in oral treatment of advanced prostate cancer, its physical characteristics of compressibility and poor solubility have brought serious problems to the development of formulations

Method used

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  • Oral solid composition of abiraterone and preparation method thereof
  • Oral solid composition of abiraterone and preparation method thereof
  • Oral solid composition of abiraterone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1~6

[0061] The prescription of embodiment 1~6 sees table 1:

[0062] The prescription of table 1 embodiment 1~6

[0063] Example Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Average particle size of abiraterone acetate particles 1.024μm 3.133μm 9.968μm 20.225μm 29.873μm 50.325μm Abiraterone acetate 250mg 250mg 250mg 250mg 250mg 250mg lactose 200mg 200mg 200mg 200mg 200mg 200mg microcrystalline cellulose 160mg 160mg 160mg 160mg 160mg 160mg Croscarmellose Sodium 40mg 40mg 40mg 40mg 40mg 40mg povidone 30mg 30mg 30mg 30mg 30mg 30mg Magnesium stearate 5mg 5mg 5mg 5mg 5mg 5mg

[0064] Preparation Process:

[0065] 1. Take the abiraterone acetate bulk drug (also known as the original drug or raw material, the same below) with the above-mentioned average particle size for later use;

[0066] 2. Pass the lactose, mi...

Embodiment 7~12

[0081] The prescription of embodiment 7~12 sees table 4:

[0082] The prescription form of table 4 embodiment 7~12

[0083] Example Example 7 Example 8 Example 9 Example 10 Example 11 Example 12 Average Particle Size of Abiraterone Acetate 5.492μm 5.492μm 5.492μm 12.462μm 12.462μm 12.462μm Abiraterone acetate 250mg 250mg 62.5mg 1000mg 125mg 500mg lactose 150mg —— —— 240mg 300mg 100mg microcrystalline cellulose 100mg —— 180mg —— 200mg 100mg Mannitol —— 200mg —— —— —— —— starch —— —— 150mg 100mg —— —— pregelatinized starch —— 120mg —— —— —— —— Croscarmellose Sodium 40mg —— —— 20mg 25mg —— Crospovidone —— 30mg —— —— —— 40mg Sodium carboxymethyl starch —— —— 45mg 20mg —— —— povidone 30mg —— 35mg —— —— 35mg hypromellose —— 15mg —— 15mg 10mg —— Sodium dodecyl sulfate 20mg —...

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Abstract

The invention relates to an oral solid composition of abiraterone and a preparation method thereof. The composition contains abiraterone acetate with a particle size of 1-30 micrometers and pharmaceutic adjuvants.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an oral solid pharmaceutical composition of abiraterone and a preparation method thereof. The composition comprises abiraterone acetate with a particle size of 1-30um and pharmaceutical auxiliary materials. technical background [0002] Abiraterone acetate, chemical name: (3β)-17-(3-pyridyl)-androst-5,16-dien-3-ol acetate, its chemical structure is shown in formula I . [0003] [0004] [0005] Abiraterone acetate can be converted into abiraterone in the body. Abiraterone is a cytochrome oxidase P450 (CYP450)c17 inhibitor, which reduces androgen levels by inhibiting the key enzyme in androgen synthesis-CYP450c17, so , Abiraterone not only inhibits the androgen produced by the testes but also other parts of the body such as the adrenal gland. [0006] Androgens can promote the growth of prostate cancer cells. At present, castration therapy, including ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/58A61P13/08A61P35/00
Inventor 王立张涛
Owner CHONGQING PHARMA RES INST
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