Pharmaceutical compositions comprising one or more steroids one or more tetrahydrofolate components and vitamin b12
3 Assignments
0 Petitions
Accused Products
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 μg 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 and at least 0.1 mg vitamin B 12.
-
Citations
65 Claims
-
1-17. -17. (canceled)
-
18. 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:
-
a) at least 1 μ
g of one or more steroids selected from the group consisting of estrogens and progestogens;
b) 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
c) at least 0.1 mg vitamin B12. - View Dependent Claims (19, 20, 21, 22, 23)
-
- 24. A method of protecting the developing foetus in a pregnant mammalian female, said method comprising administering to the mammalian female prior to conception one or more oral dosage units containing steroids, one ore more tetrahydrofolate components and vitamin B12, wherein said dosage units contain 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 B12.
- 32. A method of preventing neurological symptoms associated with vitamin B12 deficiency in mammalian females using a hormonal contraceptive that has been reinforced with folate, said method comprising administering to the mammalian female one or more oral dosage units containing steroids, one ore more tetrahydrofolate components and vitamin B12, said steroids being provided in an effective amount to inhibit ovulation, wherein said dosage units contain 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 B12.
- 41. A method of preventing neurological symptoms associated with B12 deficiency in mammalian females undergoing hormonal replacement therapy, said method comprising administering to the mammalian female one or more oral dosage units containing steroids, one ore more tetrahydrofolate components and vitamin B12, said steroids being provided in an effective amount to prevent or suppress symptoms of hypogonadism, wherein said dosage units contain 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 B12.
- 50. A method of preventing folate deficiency in mammalian females using a hormonal contraceptive, said method comprising administering to the mammalian female one or more oral dosage units containing steroids, one ore more tetrahydrofolate components and vitamin B12, said steroids being provided in an effective amount to inhibit ovulation, wherein said dosage units contain 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 B12.
- 58. A method of preventing folate deficiency in mammalian females undergoing hormone replacement therapy, said method comprising administering to the mammalian female one or more oral dosage units containing steroids, one ore more tetrahydrofolate components and vitamin B12, said steroid being provided in an effective amount to prevent or suppress symptoms of hypogonadism, wherein said dosage units contain 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 B12.
Specification