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Abiraterone acetate sublingual tablet and preparation method thereof

A technology of abiraterone acetate and sublingual tablets, which is applied in the field of medicine, can solve the problems of unfavorable workshop safety production, labor protection of workers, and limited improvement of dissolution, so as to improve the bioavailability of drugs, ensure the efficacy of drugs, and avoid stimulation. Effect

Active Publication Date: 2017-07-04
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the dissolution rate is improved, the process needs to prepare a solid dispersion, uses solvent chloroform, does not utilize workshop safety production and worker labor protection, and the dissolution improvement is limited, and 10min dissolution 64 %

Method used

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  • Abiraterone acetate sublingual tablet and preparation method thereof
  • Abiraterone acetate sublingual tablet and preparation method thereof
  • Abiraterone acetate sublingual tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030]

[0031] Preparation Process:

[0032] Prescription quantity takes by weighing abiraterone acetate, citric acid heating and melting, gets (1);

[0033] The prescription quantity is weighed and mixed with lactose, microcrystalline cellulose, povidone, and sodium carboxymethyl starch, (1) is added, granulated, and 20 mesh sieves are used to dry the granules, then magnesium stearate is added, mixed evenly, and pressed made in pieces.

Embodiment 2

[0035]

[0036] Preparation Process:

[0037] Prescription quantity takes by weighing abiraterone acetate, citric acid heating and melting, gets (1);

[0038] The prescription quantity takes microcrystalline cellulose, povidone, and cross-linked povidone and mixes them evenly, adds (1), granulates, 18 mesh sieves and drys the granules, then adds magnesium stearate, mixes evenly, and compresses the tablet. become.

Embodiment 3

[0040]

[0041] Preparation Process:

[0042] Prescription quantity takes by weighing abiraterone acetate, citric acid heating and melting, gets (1);

[0043] The prescription quantity is weighed and mixed with lactose, mannitol, povidone, and sodium carboxymethyl starch, (1) is added, granulated, 20-mesh sieved to dry the granules, and then magnesium stearate is added, mixed evenly, and compressed into tablets. become.

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Abstract

The present invention elates to an abiraterone acetate sublingual tablet and a preparation method thereof, and provides a tablet, which uses water as a dissolution medium, is not added with a surfactant, and has characteristics of rapid dissolution and good absorption. The preparation method comprises: carrying out heating melting on abiraterone acetate and a solid acid, granulating the mixed powder of a filler, a disintegrant and a binder, drying, adding a lubricant to the dried granules, and tableting to obtain the abiraterone acetate sublingual tablet. Compared to the abiraterone acetate sublingual tablet in the prior art, the abiraterone acetate sublingual tablet of the present invention has the following advantages that the abiraterone acetate sublingual tablet can be subjected to complete dissolution within 15 min so as to ensure the efficacy of the medicine, the additive is not required to be added, the complex micro-powder treatment does not required, and the bioavailability of the medicine is substantially improved.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to an abiraterone acetate sublingual tablet and a preparation method thereof. Background technique [0002] Abiraterone acetate is an oral cytochrome oxidase P450 (CYP450) c17 inhibitor, which reduces androgen levels by inhibiting the key enzyme in androgen synthesis - CYP450c17, and has no effect on androgens in the testis and other parts of the body. It has inhibitory effect and is used in the treatment of advanced prostate cancer. Its structural formula is: [0003] [0004] Abiraterone acetate is a lipophilic compound, easily soluble in organic solvents such as tetrahydrofuran, dichloromethane, especially alcohols; almost insoluble in water at pH2-12 at 20°C; slightly soluble in 0.1N hydrochloric acid, BCS classification belongs to Four types, so improving its dissolution rate and bioavailability is the key of the present invention when carrying out pharmaceutical prepara...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/58A61K47/36A61K47/38A61K47/32A61P35/00
CPCA61K9/0056A61K9/2027A61K9/2054A61K9/2059A61K31/58
Inventor 张贵民郝贵周张庆森
Owner SHANDONG NEWTIME PHARMA
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