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
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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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