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Pharmaceutical preparations for contraception and for preventing the risk of congenital malformations

A congenital, pharmaceutical technology, applied in the field of kits, tablets, film tablets, can solve problems such as vitamin B deficiency without mentioning

Inactive Publication Date: 2009-07-22
BAYER SCHERING PHARMA OY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Folate deficiency can be compensated by giving folate / folic acid, but no mention of B vitamins 12 lack
Thus, with hidden vitamin B 1 2 Dangers of Lack

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Tablets are prepared with the following composition:

[0042] Chip:

[0043] Dienogest 2.000mg or 1.500mg

[0044] Ethinylestradiol 0.015mg

[0045] Metafolin 0.451mg

[0046] Lactose monohydrate 28.720mg

[0047] Corn starch 15.000mg

[0048] Maltodextrin 3.750mg

[0049] Magnesium stearate 0.500mg

[0050] Ethinylestradiol-β-cyclodextrin complex can also be used as ethinylestradiol. In the case of using ethinyl estradiol-β-cyclodextrin complex (1:2), use no more than or about 10 times the amount.

[0051] All substances are mixed and granulated in a suitable manner. After finishing the granulation process, metafolin absorption, remixing, tabletting and optional film coating process are carried out.

Embodiment 2

[0053] Blood is collected from healthy young women of childbirth age at 8-week intervals and erythrocyte folate levels are determined by validated microbiological, immunological, or instrumental (e.g., HPLC, LC-MS / MS) methods, or their Appropriate combination.

[0054] Approximately 8 weeks after the first blood draw (screening phase), 451 μg of 5-methyl-(6S)-tetrahydrofolate calcium salt was given daily for approximately 40 weeks, or alternatively, at each In the first 21 days of a specific cycle, 2 or 1.5 mg of dienogest, 15 μg of ethinyl estradiol, and 451 μg of 5-methyl-(6S)-tetrahydrofolate calcium salt (metafolin) were given simultaneously ( Tablet according to Example 1). In the immediately following phase, 451 μg of 5-methyl-(6S)-tetrahydrofolate calcium salt was administered in tablet form for 7 consecutive days. Dienogest 2.0 or 1.5 mg, ethinyl estradiol 15 μg and metafolin 451 μg were given again for 21 days (second cycle), and metafolin only 451 μg for another 7 ...

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PUM

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Abstract

The invention relates to a pharmaceutical composition for contraception c ontaining, in a daily dose, 2.0 mg or 1.5 mg of 17.alpha.-cyanomethyl-17-ss-h ydroxyestra-4,9-diene-3on (dienogest) and 0.015 mg of 17.alpha.-ethinylestra diol (ethinylestradiol) and (6S)-5-methyltetrahydrofolate, preferably as cal cium salt of the (6S)-5-methyltetrahydrofolic acid (metafolin) together with one or more pharmaceutically acceptable auxiliary agents / carriers. The inve ntive pharmaceutical composition is an oral contraceptive as well as an agen t for reducing the risk of congenital malformations. The invention also rela tes to a kit comprising 21 daily dose units of the pharmaceutical compositio n and 7 daily dose units containing only (6S)-5-methyltetrahydrofolate, pref erably also metafolin.

Description

technical field [0001] The present invention relates to a pharmaceutical composition used for contraception and reducing the risk of congenital malformations. In daily dose, the pharmaceutical composition comprises: [0002] - 2.0 mg of 17α-cyanomethyl-17-β-hydroxyestr-4,9-dien-3-one (dienogest), 0.015 mg of 17α-ethynylestradiol (ethinyl estradiol), and (6S)-5-methyltetrahydrofolate ((6S)-5-MTHF), or [0003] - 1.5 mg of dienogest, 0.015 mg of ethinyl estradiol, and (6S)-5-methyltetrahydrofolate ((6S)-5-MTHF), [0004] And one or more pharmaceutically acceptable adjuvants / carriers. [0005] The invention also relates to a kit comprising: 21 daily dosage units of the combination of active compounds described above, and 7 daily dosage units comprising (6S)-5-MTHF. [0006] The invention also relates to a tablet, preferably a film tablet, comprising the active compound combination described above. The tablet core contains a portion of dienogest, no (6S)-5-MTHF or a portion of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/57A61K31/519A61P15/00
CPCA61K9/2018A61K9/2054A61P15/00A61P15/18A61P5/30A61P5/34A61K31/525A61K31/57A61K31/585A61K9/20A61K31/567A61K31/565
Inventor C·克劳森
Owner BAYER SCHERING PHARMA OY
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