Hendecanoic acid testosterone self emulsified soft capsule composition and its preparation method

A technology of self-emulsifying soft capsule and testosterone undecanoate, applied in the field of self-emulsifying soft capsule composition and preparation field of testosterone undecanoate, to achieve the effects of stable performance, improved absorption speed and degree, and low cost

Inactive Publication Date: 2005-10-26
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far there is no report about the preparation of testosterone undecanoate into a self-emulsifying drug delivery system

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0014] A kind of mass percentage (%) of testosterone undecanoate self-emulsifying soft capsule composition

[0015] Testosterone Undecanoate 10.7

[0016] Glyceryl caprylate 41.7

[0017] Polysorbate-80 31.4

[0018] Polysorbate-20 16.2

[0019] Preparation: Dissolve testosterone undecanoate in glyceryl caprate, add polysorbate-80 and polysorbate-20 to form a uniform solution, mix the solution with 20ml of 0.1mol / L hydrochloric acid at 37℃, and gently use a glass rod Stir to obtain a translucent emulsion with blue opalescence, with a particle size of about 3 μm.

example 2

[0021] Another mass percentage (%) of testosterone undecanoate self-emulsifying soft capsule composition

[0022] Testosterone Undecanoate 7.0

[0023] Glyceryl Caprylate 27.0

[0024] Polysorbate-80 28.0

[0025] Polysorbate-20 41.0

[0026] Preparation: Dissolve testosterone undecanoate in glyceryl caprate, add polysorbate-80 and polysorbate-20 to form a homogeneous solution, mix the solution with 20ml 37℃ 0.1mol / L hydrochloric acid, gently use a glass rod Stir to obtain a translucent emulsion with blue opalescence, with a particle size of about 3 μm.

example 3

[0028] The third mass percentage (%) of testosterone undecanoate self-emulsifying soft capsule composition

[0029] Testosterone Undecanoate 10.0

[0030] Glyceryl caprylate 41.2

[0031] Polysorbate-85 24.4

[0032] Polysorbate-20 24.4

[0033] Preparation: Dissolve testosterone undecanoate in vegetable oil, add polysorbate-85 and polysorbate-20 to form a uniform solution, mix the solution with 20ml of 0.1mol / L hydrochloric acid at 37°C, and gently stir with a glass rod to obtain Blue opalescent transparent emulsion, most of the particle size is below 2μm.

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PUM

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Abstract

A self-emulsifying composite softgel of testosterone undecanoate is proportionally prepared from testosterone undecanoate, oil phase and emulsifier through dissolving testosterone undecanoate in oil phase, adding oil phase, stirring, and loading in softcapsule. It can be automatically emulsified in stomach for high curative effect.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to an oral soft capsule preparation and a preparation method, in particular to a self-emulsifying soft capsule composition of testosterone undecanoate and a preparation method. Background technique [0002] Testosterone undecanoate (TU) is a derivative of testosterone. It has strong androgenic and assimilative effects. Androgen can significantly promote protein synthesis (assimilation) and reduce amino acid decomposition (dissimilation), so that muscle growth and weight gain can be achieved. In addition, it also has the effect of enhancing bone marrow hematopoietic function. At present, the main dosage forms are injections and soft capsules, which are clinically used for male sexual dysfunction and infertility, male sexual dysfunction with abnormal sex chromosomes (Kranfield syndrome), and aplastic anemia. Testosterone undecanoate is very soluble in chloroform or benzene, soluble in ethanol, s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/565
Inventor 胡巧红梁文权钦富华
Owner ZHEJIANG UNIV
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