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Dutasteride liquid hard capsule and preparation method thereof

A technology of liquid hard capsules and dutasteride, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve the problem of lack of dutasteride liquid hard capsules and poor stability of dutasteride , limit the dissolution of dutasteride and other problems, and achieve the effect of improving solubility, low production cost and improving stability

Active Publication Date: 2012-01-18
FERGUSON WUHAN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In terms of physical properties, dutasteride is a white and off-white crystalline powder with poor water solubility. As we all know, poor water solubility limits the dissolution of dutasteride, which in turn limits its gastrointestinal tract absorb
Moreover, dutasteride is not stable and is easily oxidized
At present, there are no products and related reports of dutasteride liquid hard capsules

Method used

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  • Dutasteride liquid hard capsule and preparation method thereof
  • Dutasteride liquid hard capsule and preparation method thereof
  • Dutasteride liquid hard capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: a kind of dutasteride liquid hard capsule, comprises hard capsule shell and content, wherein, the weight composition of described content is:

[0038] Dutasteride 0.5g

[0039] Caprylic / Capric Glycerides 320g

[0040] BHT0.05g

[0041] The preparation method is: take dutasteride, caprylic acid / capric glyceride and BHT according to the weight composition of the content, add dutasteride and BHT into caprylic acid / capric glyceride, mechanically stir to dissolve, and mix well , in order to speed up the dissolution, it can be stirred at 30 ℃ ~ 50 ℃, the obtained mixture is the content, the mixture is filled in the hard capsule shell, sealed with gelatin to obtain dutasteride liquid hard capsules, and a total of 1000 capsules.

Embodiment 2

[0042] Embodiment 2: the weight composition of content is:

[0043] Dutasteride 0.5g

[0044] Glyceryl Behenate 250g

[0045] BHT0.05g

[0046] The preparation method is the same as in Example 1.

Embodiment 3

[0047] Embodiment 3: the weight composition of content is:

[0048]

[0049] The preparation method is the same as in Example 1.

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Abstract

The invention discloses a dutasteride liquid hard capsule which comprises a hard capsule shell and contents, and the contents comprise dutasteride, a diluent and an anti-oxidant. The invention also discloses a preparation method of the dutasteride liquid hard capsule, which comprises the following steps: weighing dutasteride, the diluent and the anti-oxidant according to the weight composition of the contents, dissolving by stirring, well mixing to obtain a mixture which is the contents, filling the mixture into a hard capsule shell, sealing to obtain the dutasteride liquid hard capsule. The dutasteride liquid hard capsule of the invention has the characteristics of high disintegration and dissolution rate, and good stability, and the preparation method has the characteristics of simple operation, low production cost, and controllable quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dutasteride liquid hard capsule and a preparation method thereof. Background technique [0002] Dutasteride is a 5α-reductase inhibitor. There are two subtypes of 5α-reductase, namely type I and type II. Type I isozyme acts on the reproductive system, and type II isozyme mainly acts on the skin and Hepatic testosterone conversion. Dutasteride is 60 times more effective at inhibiting type I 5α reductase than finasteride, and it also has a strong effect on type II. Dutasteride can inhibit the conversion of testosterone into dihydrotestosterone (DHT), thereby inhibiting the production of male DHT. production, thereby inhibiting the growth of the prostate in BPH patients. Clinically, it is mainly used for the treatment of enlarged prostate, male pattern alopecia, seborrheic alopecia, and hereditary alopecia. [0003] Chemical name of dutasteride: (5α,17β)-(2,5-bis(trif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/58A61K47/14A61P17/14A61P13/08
Inventor 欧阳康乐许文峰黄飞
Owner FERGUSON WUHAN BIOTECH
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