Dutasteride liquid soft capsules

A technique for dutasteride and soft capsules, which is applied in the field of dutasteride liquid soft capsules, can solve problems such as the meaninglessness of dutasteride solubility, and achieve the effects of stable and controllable quality, simple preparation process, and improved dissolution rate

Inactive Publication Date: 2014-06-04
CHONGQING PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, using glyceryl behenate or caprylic / capric glycerin alone as a solvent has no effect on improving the solubility of dutasteride

Method used

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  • Dutasteride liquid soft capsules
  • Dutasteride liquid soft capsules
  • Dutasteride liquid soft capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] prescription:

[0022] Dutasteride 0.153g

[0023] Medium Chain Triglycerides 19.885g

[0024] Glyceryl monocaprylate 80g

[0025] BHT0.005g

[0026] Preparation method: Weigh the prescribed amount of dutasteride and BHT, dissolve it in the mixture of monocaprylic glycerin and medium-chain triglyceride heated to 70°C, stir evenly, and fill it into soft capsules to obtain dutasteride Soft capsules, made 306 soft capsules altogether.

Embodiment 2

[0028] prescription:

[0029] Dutasteride 0.153g

[0030] Medium Chain Triglycerides 94.647g

[0031] Glyceryl Monocaprylate 5g

[0032] BHT 0.2g

[0033] Preparation method: Weigh the prescribed amount of dutasteride and BHT, dissolve it in the mixture of monocaprylic glycerin and medium-chain triglyceride heated to 35°C, stir evenly, and fill it into soft capsules to obtain dutasteride Soft capsules, made 306 soft capsules altogether.

Embodiment 3

[0035] prescription:

[0036] Dutasteride 0.05g

[0037] Medium Chain Triglycerides 49.94g

[0038] Glyceryl monocaprylate 50g

[0039] BHT0.01g

[0040] Preparation method: Weigh the prescribed amount of dutasteride and BHT, dissolve it in the mixture of monocaprylic glycerin and medium-chain triglyceride heated to 60°C, stir evenly, and fill it into soft capsules to obtain dutasteride Soft capsules, made 100 soft capsules altogether.

[0041]

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Abstract

The present invention relates to dutasteride liquid soft capsules and a preparation method thereof. The soft capsules comprise a capsule shell and contents, wherein the contents mainly comprise, by weight, 0.05-0.3% of dutasteride, 19.8-94.8% of medium chain triglyceride, and 5-80% of mono-caprylin glycerate. The soft capsules have characteristics of rapid dissolution, simple preparation process and the like.

Description

[0001] technical field [0002] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a liquid soft capsule of dutasteride. The soft capsule includes a capsule shell and contents, wherein the contents are mainly composed of 0.05%-0.3% of dutasteride, medium-chain triglyceride 19.8%-94% ester, 5%-80% monocaprylic glyceride, and 0.005%-0.2% antioxidant. technical background [0003] Chemical name of dutasteride: (5α,17β)-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-aza-androst-1-ene-17-carboxamide , its chemical structure is: [0004] [0005] Dutasteride is the second generation of 5α-reductase inhibitors, researched and developed by Glaxo, and was approved by the U.S. Food and Drug Administration (FDA) on October 10, 2002. The product name is Avolve. Clinically, it is mainly used for the treatment of prostatic hypertrophy, male alopecia, seborrheic alopecia, and hereditary alopecia. It is the first and only drug that simultaneously...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/58A61K47/08A61P13/08A61P17/14
Inventor 丁彦吉张涛王立
Owner CHONGQING PHARMA RES INST
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