[go: up one dir, main page]

IE55230B1 - Use of a cholecalciferol derivative - Google Patents

Use of a cholecalciferol derivative

Info

Publication number
IE55230B1
IE55230B1 IE1131/83A IE113183A IE55230B1 IE 55230 B1 IE55230 B1 IE 55230B1 IE 1131/83 A IE1131/83 A IE 1131/83A IE 113183 A IE113183 A IE 113183A IE 55230 B1 IE55230 B1 IE 55230B1
Authority
IE
Ireland
Prior art keywords
difluoro
dihydroxycholecalciferol
treatment
compound
fluorinated compound
Prior art date
Application number
IE1131/83A
Other versions
IE831131L (en
Original Assignee
Hoffmann La Roche
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US06/379,385 external-priority patent/US4599330A/en
Priority claimed from US06/379,384 external-priority patent/US4397847A/en
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of IE831131L publication Critical patent/IE831131L/en
Publication of IE55230B1 publication Critical patent/IE55230B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

1. The use 24,24-difluoro-1 alpha, 25-dihydroxycholecalciferol in the manufacture of a medicament for the treatment of osteoporosis. [EP0094644A1]

Description

3 3 55230 The invention is based on the finding of novel physiological properties of 24,24-difluoro-la,25-dihydroxy-cholecaIci-ferol, hereinafter denominated the fluorinated compound. Specifically it has been found that the fluorinated compound 5 is active against osteoporosis and in preventing milk fever, and can thus be utilized in the treatment of osteoporosis by administering to a patient suffering from osteoporosis an effective amount of the fluorinated compound, or can be utilized in the prevention of milk fever by administering to a pre-10 parturient female ruminant an effective amount of the fluorinated compound.
From US-A-4 201 881 and FR-A-2 453 151 it is known that 24, 24-difluoro-ΐα,25^dihydrorycholecalciferol (designated hereinafter as 24,24-(F)2-la,25-(OH)2~d3) can be used as a medicament on the 15 basis of its vitamin D activity (stimulation of intestinal calcium transport, mobilization of bone calcium).
Accordingly, the invention provides the use of the fluorinated compound in the manufacture of a medicament for the treatment of osteoporosis or the preventive treatment of milk fever.
The invention also provides preparations containing about 30 to 500 micrograms of difluoro-lo,25-dihydroxycholecalciferol in combination with a pharmaceutically acceptable inert carrier material for the preventive treatment of milk fever.
The foregoing activities of the fluorinated compound can 25 be demonstrated in the following tests: a) Anti-rachitogenlc activity in chicks White Leghorn chicks are placed in a vitamin O-deficient diet containing 1% calcium and 0.7% phosphorus, and arfe housed under ultraviolet-free lighting. The test compound is dissolved 30 in propylene glycol and administered orally for 21 consecutive days to the chicks which are one to two days of age at the start of treatment. Controls are treated 35S230 with vehicle alone. The chicks are autopsied on the day after the last treatment day and the tibia ash weights are determined. Nine to ten chicks are used for each treatment group and for the control group. The mean tibia ash weights expressed in mg are given in Table I. The results show that the fluorinated compound possess potent anti-rachito-genic activity.
Table I Dose (nq/chick^dav) Mean tibia ash weight (mg) 120.7+5.9 111.7+5.8 151.5+4.7 227.1+8.2 244.8+7.4 0 1 3 10 30 b) Intestinal calcium absorption in chicks White Leghorn chicks are placed on a vitamin D-defi- cient diet and are housed under ultraviolet-free lighting for 21 days. A single oral dose of test compound dissolved in propylene glycol is administered. At various times 45 after dosing, 2 uCi of Ca (chloride) are given orally and serum radioactivity is measured 45 minutes after administration of the isotope. Vehicle-treated controls are included at each time period. Ten or eleven chicks are used in each treatment and control group. The results given in Table II for la,25-dihydroxycholecalciferol (compound A) and for the fluorinated compound (B), show that the latter has potent intestinal calcium absorption activity of long duration (96 hours after a single oral 100 nanogram dose) and consequently possesses utility in the prevention of milk fever in preparturient female ruminants. 4 Table II Treatment Time (hours) Number of 45 Serum Ca chicks (cpm/0.2 ml) Vehicle 0.2 ml 24 11 992 + 81 Compound A 100 ng 11 1800 + 181 Compound B 100 ng 11 2064 + 170 Vehicle 0.2 ml 48 11 769 + 90 Compound A 100 ng 11 1006 + 133 m Compound B 100 ng 11 1539 + 99 Vehicle 0.2 ml 72 10 647 + 69 Compound A 200 ng 11 710 + 62 Compound B 100 ng 11 1164 + 90 Vehicle 0.2 ml 96 10 586 + 70 Compound B 100 ng 10' 998 + 61 15 c) Prevention of EHDP-induced mineralization block in rats 55230 Charles River male rats are treated for 10 consecutive days with the disodium salt of ethane-l-hydroxy-1,1-diphos-phonate (EHDP). This compound is given subcutaneously on each treatment day at a dose of 2 mg/0.2 ml/rat in distilled 20 water. The fluorinated compound is administered orally dissolved in propylene glycol on each treatment day. The rats are autopsied on the day after the last treatment day * and the tibias are processed by silver impregnation of the bone salts. The epiphyseal plate widths are measured with 25 a microscope. Activity is based upon dose-dependent narrowing of the widened epiphyseal plate induced by EHDP. Ten rats are used in each treatment group. Positive (EHDP alone) and negative (vehicles alone) control groups of ten rats each are included in each experiment. The results given in 30 Table III show that the fluorinated compound calcified the tibial epiphyseal plate in EHDP-blocked rats. 55230 Table III Dose Mean tibial epiphyseal plate width (no/rat/dav) _(micron)_' 1182 + 51 839 + 18 674 + 18 540 + 16 412 + 9 440 + 2 0 3 10 30 Vehicle controls (no EHDP) The fluorinated compound can be administered in dosages that are in the range of about 50-200, preferably 100 nanograms per day for the treatment of osteoporosis.
It can be administered orally, subcutaneously, intramuscularly, intravenously or intraperitoneally, for instance as tablets, capsules or elixirs for oral administration, or in sterile solutions or suspensions for parenteral administration. About 50-200 nanograms of the fluorinated compound is compounded with a pharmaceutically acceptable vehicle, carrier, excipient, binder, preservative, stabilizer and/or flavor in a unit dosage form. Illustrative of the adjuvants which may be incorporated into capsules are a binder, such as corn starch or gelatin; an excipient, such as dicalcium phosphate; a disintegrating, such as corn or potato starch or algenic acid; a lubricant, such as magnesium stearate; a sweetening agent, such as sucrose; a flavoring agent, such as peppermint, other materials may be present as coatings or to otherwise modify the physical form of the dosage unit. For instance, tablets may be coated with shellac, sugar or both. A syrup or elixir may contain the active compound, sucrose as a sweetening agent, methyl and propyl parabens as preservatives, a dye and a flavoring, such as orange flavor. Sterile compositions for injection can be formulated according to conventional pharmaceutical practice by dissolving or suspending the 6 6 5S230 fluorinated compound in a vehicle, such as water for injection, a naturally-occurring vegetable oil, such as sesame oil, or a synthetic fatty vehicle, such as ‘ethyl oleate. Buffers, preservatives and antioxidants can also be incor-5 porated.
The fluorinated compound can be administered in dosages in the range of about 30-500 micrograms per day for the prevention of milk fever in pregnant ruminant animals, especially in pregnant female bovines, preferably 10 about one to four days prior to parturition. The fluorinated compound can be formulated for oral administration by incorporation of 30-500 micrograms into fatty acid pellets. Sterile compositions for injection and/or topical administration can be formulated according to conventional 15 practice by dissolving or suspending the fluorinated compound in a vehicle, such as a 5-10¾ ethanol-water mixture; a naturally-occurring vegetable oil, such as sesame oil; or a synthetic fatty vehicle, such as ethyl oleate. For example, a suitable formulation for intravenous injection 20 would be 2-3 ml of a 5-10% ethanol-water solution containing 30-500, preferably 30-400 micrograms of the fluorinated compound. Exemplary of a suitable formulation for topical administration would be a vegetable oil solution or suspension containing 30-500, preferably 250-500 micrograms of 25 the fluorinated compound. The fluorinated compound may also be formulated for intramuscular injection by suspension of 50-500 micrograms of the fluorinated compound in a vehicle such as a 5-10% ethanol-water mixture or a 5-10% propylene glycol-water mixture. Buffers, preservatives and/or anti-30 oxidants can be incorporated into the foregoing formulations as required. 7 755230 Example A capsule containing pro capsule: 1. 24,24-difluoro-la,25-dihydroxycholecalciferol 50 ng 100 ng 200 ng 2. polyethylene glycol 400 200 mg 200 mg 200 mg 3. butylated hydroxyanisole 0.1 mg 0.1 mg 0.1 mg 4. ascorbyl palmitate 1.0 mg 1.0 mg 1.0 mg may be ' obtained by dissolving items 1, 3 and 4 in item 2 under an atmophere of nitrogen and encapsulating.

Claims (7)

1. Use of 24,24-difluoro-la,25-dihydroxycholecalciferol in the manufacture of a medicament for the treatment of osteoporosis.
2. use of 24,24-difluoro-la,25-dihydroxycholecaliferol in the manufacture of a medicament for the preventive treatment of milk fever.
3. A preparation containing about 30 to 500 micrograms of 24, 24-difluoro-la,25-dihydroxycholecalciferol in combination with a pharmaceutically acceptable inert carrier material for the preventive treatment of milk fever,
4. A method for the prevention of milk fever in ruminant animals, particularly in female bovine, which comprises administering to such an animal about 30 to 500 micrograms of 24,24-difluoro-lct,25-dihydroxycholecalciferol per day prior to parturition.
5. A method according to Claim 4, wherein said 24,24-difluoro-la,25-dihydroxycholecalciferol is administered about one to four days prior to parturition.
6. Use according to Claim 1 or 2 of 24,24-difluro-la,25-dihydro-xycholecalciferol, substantially has hereinbefore described.
7. A preparation according to Claim 3, substantially as hereinbefore described with particular reference to the accompanying Example. F. R. KELLY & CO., AGENTS FOR THE APPLICANTS.
IE1131/83A 1982-05-17 1983-05-16 Use of a cholecalciferol derivative IE55230B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/379,385 US4599330A (en) 1982-05-17 1982-05-17 Method of treating milk fever
US06/379,384 US4397847A (en) 1982-05-17 1982-05-17 Method of treatment

Publications (2)

Publication Number Publication Date
IE831131L IE831131L (en) 1983-11-17
IE55230B1 true IE55230B1 (en) 1990-07-04

Family

ID=27008599

Family Applications (1)

Application Number Title Priority Date Filing Date
IE1131/83A IE55230B1 (en) 1982-05-17 1983-05-16 Use of a cholecalciferol derivative

Country Status (8)

Country Link
EP (1) EP0094644B1 (en)
AU (1) AU563733B2 (en)
CA (1) CA1221031A (en)
DE (2) DE3317562A1 (en)
IE (1) IE55230B1 (en)
IL (1) IL68695A (en)
IT (1) IT1171672B (en)
NZ (1) NZ204223A (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4428946A (en) * 1982-07-26 1984-01-31 Wisconsin Alumni Research Foundation Method of preventing milk fever in dairy cattle
CA1272953A (en) 1984-10-08 1990-08-21 Yuji Makino Pharmaceutical composition for external use containing active-type vitamin d.sub.3
JP2856444B2 (en) * 1989-07-28 1999-02-10 呉羽化学工業株式会社 Vitamin D lower 3 metabolite preparation
GB202016614D0 (en) 2020-10-20 2020-12-02 King S College London Compounds

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3646203A (en) * 1969-04-30 1972-02-29 Wisconsin Alumni Res Found Method of treating milk fever in dairy cattle with 25-hydroxycholecalciferol
US3879548A (en) * 1974-01-21 1975-04-22 Wisconsin Alumni Res Found Method of treating milk fever in dairy cattle with 1-alpha-hydroxycholecalciferol
US4110446A (en) * 1977-07-14 1978-08-29 Wisconsin Alumni Research Foundation Method of treating milk fever in dairy cattle with 1,25-dihydroxycholecalciferol
US4284577A (en) * 1979-02-16 1981-08-18 Sachiko Yamada Novel vitamin D3 derivative and process for preparing the same
US4201881A (en) * 1979-03-28 1980-05-06 Wisconsin Alumni Research Foundation 24,24-Difluoro-1α,25-dihydroxycholecalciferol

Also Published As

Publication number Publication date
IL68695A (en) 1986-01-31
EP0094644B1 (en) 1986-07-30
IL68695A0 (en) 1983-09-30
AU1456283A (en) 1983-11-24
IT8321128A0 (en) 1983-05-17
DE3364904D1 (en) 1986-09-04
DE3317562A1 (en) 1983-11-17
NZ204223A (en) 1986-11-12
CA1221031A (en) 1987-04-28
EP0094644A1 (en) 1983-11-23
IE831131L (en) 1983-11-17
AU563733B2 (en) 1987-07-23
IT1171672B (en) 1987-06-10

Similar Documents

Publication Publication Date Title
EP1045695B1 (en) Use of 9-deoxy-2', 9-alpha-methano-3- oxa-4,5,6- trinor-3, 7-(1',3'-interphenylene) -13,14-dihydro- prostaglandin f 1? to treat peripheral vascular disease
AU719773B2 (en) Use of vitamin D2 or vitamin D4-derivatives for the manufacture of a medicament for the treatment of secondary hyperparathyroidism
US5348979A (en) Method of promoting nitrogen retention in humans
Edelstein et al. Gastrointestinal absorption of lead in chicks: involvement of the cholecalciferol endocrine system
US4438138A (en) Reduction of cholesterol with meta-chloro α-t-butylaminopropiophenone
GB2098066A (en) Vitamin d3 derivatives for preventing parturient paresis in dairy cattle
WO1995013062A1 (en) Butyric ester cyto-differentiating agents
IE55230B1 (en) Use of a cholecalciferol derivative
US3852453A (en) Method of enhancing vincamine compositions
KR100304312B1 (en) Zinc Supplemented Prostate Extract
Fullmer et al. Effect of cadmium administration on intestinal calcium absorption and vitamin D-dependent calcium-binding protein
CA1206882A (en) Use of cholecalciferol derivatives
US3317381A (en) Method for treating peptic ulcer
JPS63107929A (en) Drug containing novel vitamin d3 derivative as active ingredient
EP0385446A2 (en) Osteogenesis promotion with use of vitamin D derivatives
HK1005015B (en) Osteogenesis promotion with use of vitamin d derivatives
JPS58208231A (en) Medicine containing cholecalsiferol derivative
JPH0563452B2 (en)
GB2050164A (en) Ionising radiation protective compositions
US3360434A (en) Method for reducing blood pressure with phenylalanine derivatives
Boris et al. In vivo studies in chicks and rats of bone calcium mobilization by 1α, 25-dihydroxycholecalciferol (calcitriol) and its congeners
JPH07233062A (en) Composition for treating skin pruritus of patient requiring artificial dialysis and composition for treating hyperparathyroidism
US3786157A (en) Method of treating hyperglycemia
JPH0377173B2 (en)
Ershoff et al. Comparative effects of a purified diet and a natural food stock ration on the occurrence of periodontal lesions in thyrotoxic rats