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Dutasteride soft capsule with stable quality

A technology of dutasteride and soft capsules, applied in the field of new formulations of dutasteride soft capsules, to achieve stable dissolution and good stability

Active Publication Date: 2014-10-01
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The capsule skin should have no effect on the dissolution of the active ingredient

Method used

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  • Dutasteride soft capsule with stable quality
  • Dutasteride soft capsule with stable quality
  • Dutasteride soft capsule with stable quality

Examples

Experimental program
Comparison scheme
Effect test

Embodiment l

[0043] The preparation of embodiment 1 dutasteride preparation soft capsule

[0044]

[0045] A total of 1000 capsules were made

[0046] Preparation:

[0047] 1) Preparation of contents: Weigh 0.5g of dutasteride, add 75.0g of glyceryl monocaprylate, 150.0g of propylene glycol monocaprylate, and 24.5g of polyethylene glycol caprylic / capric glyceride, and heat to dissolve And mix evenly to get the content.

[0048] 2) Glue preparation: Weigh 40.5g of gelatin, 21.8g of glycerin, 0.43g of titanium dioxide and 0.05g of yellow iron oxide, add an appropriate amount of purified water, heat to dissolve and mix evenly to obtain a glue.

[0049] 3) Pressed pill forming: the prepared contents and glue are pressed into soft capsules by a soft capsule machine to obtain dutasteride soft capsules.

Embodiment 2～9

[0050] The preparation of embodiment 2~9 dutasteride preparation soft capsules

[0051] See Table 1 for the prescription of the capsule content, and the preparation method is the same as that of Example 1. In the table, the unit of the dosage of each component is gram.

[0052] The amount and ratio of each component in the content of dutasteride soft capsules in the examples 1 to 9 in table 1

[0053]

[0054]

[0055] Test Example 1 Contrast Test of Dissolution of Tasteride Soft Capsules

[0056] Test object: the dutasteride soft capsules that make in embodiment 1-9, commercially available (Lot No. 061778A)

[0057] Test method: adopt the basket method in the dissolution test method in appendix XC of "Chinese Pharmacopoeia" 2010 edition, take 6 pills from each test object (named NO.1~NO.6 respectively) for determination;

[0058] The dissolution medium is 0.1N hydrochloric acid (containing 2.0% sodium lauryl sulfate), and the rotation speed is 50 rpm;

[0059] Sampl...

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Abstract

The invention provides a dutasteride soft capsule. The dutasteride soft capsule contains dutasteride and an oleaginous base and is characterized in that the oleaginous base contains polyethylene glycol fatty acid glyceride and / or propylene glycol fatty acid ester, or employs medium-chain fatty acid glyceride. According to the invention, polyethylene glycol fatty acid glyceride and / or propylene glycol fatty acid ester is used as the oleaginous base for dutasteride for the first time; compared with preparations in the prior art, the soft capsule prepared in the invention has a good dissolution rate and high stability.

Description

technical field [0001] The invention relates to a dutasteride soft capsule, in particular to a new formula of the dutasteride soft capsule with good dissolution rate of active ingredients and better formulation stability. Background technique [0002] Dutasteride (Dutasteride) is a drug used to treat benign prostatic hyperplasia. Because of its poor water solubility, improving its dissolution and bioavailability is an important problem to be solved in the preparation. [0003] Dutasteride soft capsules developed by Glaxo , its FDA instructions show that in addition to the active ingredient dutasteride in the capsule content, the oily base is a mixture of various ingredients, including caprylic acid / capric monoglyceride diester mixture (may include caprylic monoglyceride, capric acid monoglyceride, monoglyceride, caprylic acid diglyceride, capric acid diglyceride, caprylic acid diglyceride, etc.); also contains antioxidant 2,6-di-tert-butyl-4-methylphenol (BHT); capsule ski...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/58A61K47/34A61K47/14A61P13/08
Inventor 陈李平管璐晗陈博
Owner CHONGQING HUAPONT PHARMA
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