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Prescription technique for improving stability of desogestrel

A desogestrel and stability technology, applied in the field of prescription technology for desogestrel stability, can solve the problem of drug stability and increase the difficulty of large-scale production

Inactive Publication Date: 2013-09-04
NOVAST LABORATORIES (CHINA) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because desogestrel (Desogestrel) is easily oxidatively degraded, drug stability issues have increased the difficulty of product development, especially mass production, so the shelf life of this oral contraceptive so far is 12-18 months

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example

[0014] Example: 1 million tablets of desogestrel and ethinyl estradiol are prescribed, the lubricant is magnesium stearate and the dosages are as follows:

[0015] Element Batch size (kg) weight percentage desogestrel 0.150 0.150% Ethinyl Estradiol 0.030 0.030% Vitamin E 0.500 0.500% Chloroform (volatile during the process) 10.000 0.000% medical supplements 98.820 98.820% Magnesium stearate 0.500 0.500% batch weight 100.000 100.000%

specific Embodiment approach

[0016] The specific implementation mode of the present invention comprises the following steps:

[0017] A. Dissolve 0.15 kg of desogestrel, 30 g of ethinyl estradiol and 500 g of vitamin E in 10 kg of chloroform, stir until completely dissolved, so that desogestrel, ethinyl estradiol and vitamin E are in molecular distribution state solution, each active drug molecule is surrounded and protected by multiple antioxidant molecules;

[0018] B. Add 98.820 kg of pharmaceutical excipients into the fluidized bed granulator, use purified and heated high-pressure air to make the medicinal excipients "boiling" in the fluidized bed, and at the same time, process step A containing antioxidant The active drug solution of the agent is sprayed on the "boiling" pharmaceutical excipients at a specified speed (50-300 g / min). After the drug is sprayed, continue to use purified and heated high-pressure air to dry the excipient particles containing the active drug ;

[0019] C, the dried granu...

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PUM

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Abstract

The invention discloses a prescription technique for improving the stability of desogestrel. According to the prescription technique, active medicines of the prescription are dissolved in a solvent mixture of which the weight is 5-200 times the weight of the active medicine; the active medicines are desogestrel and ethinylestradiol; the solvent mixture is chloroform or other solvent mixtures; and the active medicines are completely dissolved in the solvent mixture, and then an antioxygen of which the amount is 2-10 times the amount of the active medicines is added; the antioxygen including vitamin C or vitamin E is dissolved, so that the active medicines and the antioxygen are a solution at molecular distribution state, and each active medicine molecule is surrounded and protected by a plurality of antioxygen molecules. The prescription technique disclosed by the invention improves the stability of main medicines of the oral contraceptive and has the advantage that the shelf time of the oral contraceptive consisting of desogestrel and ethinylestradiol is as long as 24 months, etc.

Description

technical field [0001] The invention relates to a prescription process for the stability of desogestrel, in particular to a prescription process for improving the stability of desogestrel. Background technique [0002] Oral contraceptives composed of Desogestrel and Ethinyl Estradiol are one of the best-selling third-generation oral contraceptives in the pharmaceutical market in developed countries. Compared with other first-generation and second-generation oral contraceptives composed of progesterone and estrogen, it has higher efficacy and lower side effects. Since desogestrel (Desogestrel) is easily oxidatively degraded, the problem of drug stability increases the difficulty of product development, especially mass production, so the shelf life of this oral contraceptive so far is 12-18 months. Contents of the invention [0003] The object of the present invention is to overcome the above deficiencies, and to provide a kind of oral contraceptive composed of desogestrel ...

Claims

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Application Information

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IPC IPC(8): A61K31/567A61K47/22A61K9/28A61P15/18
Inventor 张国华陈义生
Owner NOVAST LABORATORIES (CHINA) LTD
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