Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – 9,10-seco- cyclopentanohydrophenanthrene ring system doai
Patent
1998-07-13
1999-10-19
Criares, Theodore J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
9,10-seco- cyclopentanohydrophenanthrene ring system doai
514 26, 514171, 514178, 514681, A61K 31705, A61K 3156, A61K 3159, A61K 3112
Patent
active
059689170
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the prevention and treatment of osteoporosis and to compositions for use in such prevention or treatment.
Compositions for the prevention and treatment of osteoporosis according to the present invention comprise a therapeutically effective amount of diosgenin, a therapeutically effective amount of vitamin K and a therapeutically effective amount of vitamin D. Optionally the composition also contains a therapeutically effective amount of vitamin B6 and/or vitamin A.
Method of preventing or treating osteoporosis according to the present invention comprises the administration to a subject in need thereof a therapeutically effective amount of diosgenin, a therapeutically effective amount of vitamin K and a therapeutically effective amount of vitamin D. Optionally the method of the present invention also comprises the administration of a therapeutically effective amount of vitamin B6 and/or vitamin A. The diosgenin, vitamin K, vitamin D and optional vitamins B6 and A may be administered simultaneously or sequentially. For simultaneous administration the components may be combined into a single dosage form or may be formulated into several dosage forms which are intended to be taken at the same time.
Diosgenin [(25R)-spirost-5-en-3.beta.-ol] used in the compositions and method of the present invention may be used in a chemically pure form which may be isolated from natural sources (eg from yams), may be prepared by chemical modification of saponins obtained from natural sources or may be prepared synthetically. Alternatively, an extract obtained from a natural source which is rich in diosgenin or a precursor thereto may be used. A suitable source would be an extract of yam. The amount of diosgenin to be administered per day is in the range 100 to 2000 mg preferably 150 to 1200 mg most preferably 300 to 1200 mg. This amount may be administered in a single dose or in more than one dose which may be taken at different times throughout the day.
The Term "Vitamin K" as used herein is intended to cover vitamin K in any of its forms (ie vitamin K1, vitamin K2, vitamin K3, vitamin K4, vitamin K5, vitamin K6 and vitamin K7) or any precursor or analogue to any of these vitamins (such as the naphthaquinones) which would give rise to vitamin K -like activity after administration. Preferred vitamin K components are provided by vitamin K1 and/or vitamin K2. The amount of vitamin K to be administered per day is in the range 5 to 5000 .mu.g, preferably 10 to 200 .mu.g. This amount may be administered in a single dose or in more than one dose which may be taken at different times throughout the day.
The term "Vitamin D" as used herein is intended to cover vitamin D in any of its forms (ie vitamin D1 vitamin D2, vitamin D3 or vitamin D4) or any precursor or analogue to any of these vitamins which would give rise to vitamin D-like activity after administration. The preferred form of vitamin D is vitamin D3. The amount of vitamin D to be administered per day is in the range 5 to 5000 .mu.g preferably 10 to 100 .mu.g. This amount may be administered in a single dose or in more than one dose which may be taken at different times throughout the day.
The term "Vitamin B6" as used herein is intended to cover pyridoxine hydrochloride or any other of the vitamins of the B6 complex (ie codecarboxyiase, pyridoxal hydrochloride or pyridoxamine dihydrochloride) or any precursors or analogues thereof which would give rise to vitamin B6-like activity. The amount of vitamin B6 to be administered per day is in the range 1 to 1000 mg, preferably 5 to 100 mg. This amount may be administered in a single dose or in more than one dose which may be taken at different times throughout the day.
The amount of vitamin A to be administered per day is in the range 1 to 4 mg. This amount may be administered in a single dose or in more than one dose which may be taken at different times during the day.
The pharmaceutical compositions of the present invention may be administered as oral dosage forms and may be solid dosage forms
Criares Theodore J.
The Boots Company PLC
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