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Abiraterone acetate tablet and preparing method thereof

A technology for abiraterone acetate and tablets, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations containing active ingredients, etc., can solve problems such as poor crystal fluidity, unfavorable crystal form stable storage, and crystal form destruction threats. , to achieve the effect of simple preparation method, excellent stability and good controllability

Inactive Publication Date: 2014-10-01
NANJING CAVENDISH BIO ENG TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The fluidity of this form of crystals is not good, and it needs to be rolled and compacted before it can be used in solid dosage form pharmaceutical preparations, and rolling will pose a threat of damage to the crystal form, which is not conducive to the stability of the crystal form and the storage after preparation

Method used

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  • Abiraterone acetate tablet and preparing method thereof
  • Abiraterone acetate tablet and preparing method thereof
  • Abiraterone acetate tablet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Abiraterone Acetate Tablets

[0063] Component

%(w / w)

Abiraterone acetate

34.97

lactose monohydrate

27.82

microcrystalline cellulose

21.21

Croscarmellose Sodium

10.00

povidone

3.50

Sodium dodecyl sulfate

1.00

Magnesium stearate

1.50

[0064] 1. Preparation process:

[0065] 1.1 Preparation before ingredients

[0066] 1.1.1 Screening

[0067] Get the crushed abiraterone acetate and pass through a 60-mesh sieve for subsequent use.

[0068] 1.2 Ingredients

[0069] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0070] 1.3 Hybrid

[0071] Weigh the prescribed amount of abiraterone acetate, 0.5% sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose and 3% croscarmellose sodium, and mix well.

[0072] 1.4 Granulation

[0073] Add 50% ethanol solution containing 10% PVP to the above mixture to make soft material, pa...

Embodiment 2

[0080] Abiraterone Acetate Tablets

[0081] Component

%(w / w)

Abiraterone acetate

34.97

lactose monohydrate

25.00

microcrystalline cellulose

23.53

Croscarmellose Sodium

10.00

povidone

3.50

Sodium dodecyl sulfate

1.50

Magnesium stearate

1.50

[0082] 1. Preparation process:

[0083] 1.1 Preparation before ingredients

[0084] 1.1.1 Screening

[0085] Get the crushed abiraterone acetate and pass through a 60-mesh sieve for subsequent use.

[0086] 1.2 Ingredients

[0087] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0088] 1.3 Hybrid

[0089] Weigh the prescribed amount of abiraterone acetate, 1.0% sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose and 3% croscarmellose sodium, and mix well.

[0090] 1.4 Granulation

[0091] Add 50% ethanol solution containing 10% PVP to the above mixture to make soft material, ...

Embodiment 3

[0098] Abiraterone Acetate Tablets

[0099] Component

%(w / w)

Abiraterone acetate

34.97

lactose monohydrate

27.82

microcrystalline cellulose

20.21

Croscarmellose Sodium

10.00

povidone

3.50

Sodium dodecyl sulfate

2.00

Magnesium stearate

1.50

[0100] 1. Preparation process:

[0101] 1.1 Preparation before ingredients

[0102] 1.1.1 Screening

[0103] Get the crushed abiraterone acetate and pass through a 60-mesh sieve for subsequent use.

[0104] 1.2 Ingredients

[0105] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0106] 1.3 Hybrid

[0107] Weigh the prescribed amount of abiraterone acetate, 1.0% sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose and 3% croscarmellose sodium, and mix well.

[0108] 1.4 Granulation

[0109] Add 50% ethanol solution containing 10% PVP to the above mixture to make soft material, ...

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Abstract

A stable abiraterone acetate tablet and a preparing method thereof are disclosed. The abiraterone acetate tablet is free of aerosil and is prepared from following components: abiraterone acetate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium dodecylsulfate and magnesium stearate. The abiraterone acetate tablet has characteristics of stability, simple preparation process and controllability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and more specifically relates to a stable abiraterone acetate preparation and a preparation method thereof. Background technique [0002] Abiraterone acetate, Abiraterone acetate, chemical name: (3β)-17-(3-pyridine) androst-5,16-dien-3-yl acetate, chemical structure: [0003] [0004] Abiraterone acetate is an oral 17α-hydroxylase / C17,20-lyase inhibitor, which can reduce androgen levels by inhibiting the key enzyme in androgen synthesis—CYP450c17, and has effects on androgen in testis and other parts of the body. Hormones have an inhibitory effect. [0005] Shenzhen Wanle Pharmaceutical Co., Ltd. disclosed four polymorphs of abiraterone acetate and their preparation methods in Chinese patent application CN200910189173.1 (application number, hereinafter referred to as patent application No. 173.1). Four crystal forms of abiraterone acetate: A, B, C and D. Polymorph C prov...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/58A61K47/38A61P5/28
Inventor 许永翔高瑞雪
Owner NANJING CAVENDISH BIO ENG TECH
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