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Pharmaceutical compositions comprising one or more steroids one or more tetrahydrofolate components and vitamin b12

A technology of tetrahydrofolate and hormones, applied in the direction of carbohydrate active ingredients, drug combinations, medical preparations containing active ingredients, etc., can solve the problems of insufficient recovery of folic acid levels, inequalities, etc.

Inactive Publication Date: 2011-04-27
BAYER IP GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, folic acid supplementation for women using hormonal contraceptives has the disadvantages of (a) this approach being insufficient to restore normal serum folate levels and (b) more importantly, the effect of such supplementation is limited by individual differences in folic acid metabolism. vary from individual to individual

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] A slatted contraceptive kit containing 28 tablets, each weighing 0.25 grams, was prepared. Of the 28 tablets, 21 contained composition A and 7 contained composition B. Compositions A and B are as follows:

[0055] Composition A Composition B

[0056] Ethinyl Estradiol 30μg

[0057] Levonorgestrel 150μg

[0058] Folic acid 0.5mg 0.5mg

[0059] Vitamin B12 1mg 1mg

[0060] Vitamin B6 50mg 50mg

[0061] Excipient Balance Balance

Embodiment 2

[0063] A stripped kit of 28 tablets for a sequential method of contraception was prepared. The kit contains 14 tablets of composition A and 14 tablets of composition B. Compositions A and B are as follows:

[0064] Composition A Composition B

[0065] Ethinyl estradiol 30μg 30μg

[0066] Levonorgestrel 150μg

[0067] Folic acid 0.5mg 0.5mg

[0068] Vitamin B12 1mg 1mg

[0069] Vitamin B6 50mg 50mg

[0070] Excipient Balance Balance

Embodiment 3

[0072] 40 women were randomly divided into 2 groups, 20 women in each group. Within 4 months, one group used the contraceptive kit described in Example 1. For the same length of time, another group received the same kit, but the kit contained no pills containing folic acid or vitamin B12 or vitamin B6.

[0073] Serum concentrations of folic acid, vitamin B12, and vitamin B6 were measured before and after the trial using the aforementioned method published in 2002 by the Clinical Laboratory of the University of California, San Diego. The study found that serum concentrations of these substances did not change significantly in the group that received oral contraceptives without folic acid, vitamin B12, or vitamin B6 over the course of the experiment. However, most of the women in the other group had significantly higher levels of folic acid, vitamin B12 and / or vitamin B6.

[0074] Some women were found deficient in folic acid, vitamin B12 and / or vitamin B6 before the experimen...

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PUM

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Abstract

The present invention is concerned with a kit for use in a hormonal contraceptive method or hormone replacement therapy in mammalian females, said kit comprising at least 10 oral dosage units containing at least 1 mug of one or more steroids selected from the group consisting of estrogens and progestogens; at least 0.1 mg of one or more tetrahydrofolate components selected from the group consisting of (6S)-tetrahydrofolic acid, 5-methyl-(6S)-tetrahydrofolic acid, 5-formyl-(6S)-tetrahydrofolic acid, 10-formyl-(6R)-tetrahydrofolic acid, 5,10-methylene-(6R)-tetrahydrofolic acid, 5,10-methenyl-(6R)-tetrahydrofolic acid, 5-formimino-(6S)-tetrahydrofolic acid, pharmaceutically acceptable salts of these tetrahydrofolic acids and glutamyl derivatives of these tetrahydrofolic acids; and at least 0.1 mg vitamin B 12. Other aspects of the present invention relate to a hormonal contraceptive method and a method of hormone replacement therapy comprising the at least once daily oral administration of one or more steroid containing dosage units to a mammalian female, wherein the dosage units additionally contain at least 0.1 mg of one or more of the aforementioned tetrahydrofolate components andat least 0.1 mg vitamin B 12.

Description

technical field [0001] The present invention relates to a kit comprising a plurality of oral dosage units for use in hormonal contraceptive methods or hormone replacement therapy in female mammals. The kit consists of at least ten dosage units comprising one or more steroids selected from estrogens and progestins, one or more tetrahydrofolate components, and vitamin B12. [0002] Other aspects of the invention relate to a method of hormonal contraception and a hormone replacement therapy for a mammalian female comprising orally administering one or more dosage units to a mammalian female at least once daily to provide an effective amount of Steroids thereby inhibiting ovulation and / or preventing or suppressing the symptoms of hypogonadism, wherein the dosage unit further comprises one or more components of tetrahydrofolate and vitamin B12. Background technique [0003] Folate depletion is associated with continuous oral administration of hormone preparations, especially whe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/565A61K31/519A61K31/714A61P15/18A61P5/30A61K31/566A61K31/56A61K31/57A61K31/70A61P15/12
CPCA61K31/565A61K31/56A61P15/00A61P15/12A61P15/18A61P5/30A61K31/714A61K31/567A61K31/57
Inventor 赫尔曼·扬·蒂杰曼·科林格本宁克
Owner BAYER IP GMBH