Abiraterone acetate sublingual tablet and preparation method thereof

A technology of abiraterone acetate and sublingual tablet, applied in the field of medicine, can solve problems such as unfavorable workshop safety production, worker labor protection, limited dissolution improvement, etc. 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

[0026]

[0027] Preparation Process:

[0028] Dissolve abiraterone acetate, hydroxypropyl cellulose, and povidone in methanol, add lactose, stir evenly, fill in blisters, and then freeze-dry in a freeze dryer. The cover is press-sealed and packaged.

Embodiment 2

[0030]

[0031] Preparation Process:

[0032] Prescription quantity Weigh abiraterone acetate, hydroxypropyl cellulose, povidone and dissolve in dichloromethane, add mannitol, stir evenly, fill in blisters, then place in a lyophilizer to lyophilize, freeze After drying, the blister is sealed and packaged.

Embodiment 3

[0034]

[0035]

[0036] Preparation Process:

[0037] Dissolve abiraterone acetate, hydroxypropyl cellulose, and povidone in chloroform, add lactose, stir evenly, fill in blisters, and then freeze-dry in a freeze dryer. The cover is press-sealed and packaged.

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Abstract

The present invention relates to an abiraterone acetate sublingual tablet, wherein the preparation method comprises: dissolving abiraterone acetate, hydroxypropylcellulose and povidone in an organic solvent, adding a filler, uniformly dispersing, filling, carrying out freeze-drying, and packaging to form 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 10 min so as to ensure the efficacy of the medicine, 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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/58A61P35/00
CPCA61K9/006A61K9/2027A61K9/2054A61K31/58
Inventor 张贵民郝贵周何艳琴
Owner SHANDONG NEWTIME PHARMA
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