WO2004058235A3 - Method of increasing bioavailability of alendronate or other bis-phosphonate by predose administration of vitamin d derivative - Google Patents

Method of increasing bioavailability of alendronate or other bis-phosphonate by predose administration of vitamin d derivative Download PDF

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Publication number
WO2004058235A3
WO2004058235A3 PCT/US2003/040174 US0340174W WO2004058235A3 WO 2004058235 A3 WO2004058235 A3 WO 2004058235A3 US 0340174 W US0340174 W US 0340174W WO 2004058235 A3 WO2004058235 A3 WO 2004058235A3
Authority
WO
WIPO (PCT)
Prior art keywords
phosphonate
vitamin
bis
alendronate
derivative
Prior art date
Application number
PCT/US2003/040174
Other languages
French (fr)
Other versions
WO2004058235A2 (en
Inventor
Moshe Flashner-Barak
Itzhak E Lerner
Vered Rosenberger
Original Assignee
Teva Pharma
Moshe Flashner-Barak
Itzhak E Lerner
Vered Rosenberger
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
Application filed by Teva Pharma, Moshe Flashner-Barak, Itzhak E Lerner, Vered Rosenberger filed Critical Teva Pharma
Priority to JP2005509984A priority Critical patent/JP2006514695A/en
Priority to AU2003300984A priority patent/AU2003300984A1/en
Priority to GB0511750A priority patent/GB2411116B/en
Priority to DE10393906T priority patent/DE10393906T5/en
Publication of WO2004058235A2 publication Critical patent/WO2004058235A2/en
Publication of WO2004058235A3 publication Critical patent/WO2004058235A3/en
Priority to IL169127A priority patent/IL169127A0/en
Priority to HK06101577.3A priority patent/HK1078802A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention provides a method of increasing the bioavailability of a bis-phosphonate comprising administering an effective predose of a vitamin D derivative, such as alphacalcidol or calcitriol, and after a time interval, administering a therapeutic dose of bis-phosphonate, such as alendronate. The present invention also relates to the use of vitamin D derivatives and bisphosphonates for the manufacture of medicaments for treating osteoporosis, metastatic bone disease, and Paget's disease.
PCT/US2003/040174 2002-12-16 2003-12-16 Method of increasing bioavailability of alendronate or other bis-phosphonate by predose administration of vitamin d derivative WO2004058235A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2005509984A JP2006514695A (en) 2002-12-16 2003-12-16 Method for enhancing the overall utilization efficiency of alendronate or other bisphosphonates by pre-dose administration of vitamin D derivatives
AU2003300984A AU2003300984A1 (en) 2002-12-16 2003-12-16 Method of increasing bioavailability of alendronate or other bis-phosphonate by predose administration of vitamin d derivative
GB0511750A GB2411116B (en) 2002-12-16 2003-12-16 Increasing the bioavailability of alendronate by predose administration of alphacalcidol
DE10393906T DE10393906T5 (en) 2002-12-16 2003-12-16 A method of increasing the bioavailability of alendronate or another bisphosphonate by administering a pre-dose of a vitamin D derivative
IL169127A IL169127A0 (en) 2002-12-16 2005-06-09 Method of increasing bioavailability of alendronate or other bis-phosphonate by predose administration of vitamin d derivative
HK06101577.3A HK1078802A1 (en) 2002-12-16 2006-02-06 Increasing the bioavailability of alendronate by predose administration alphacalcidol

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US43368502P 2002-12-16 2002-12-16
US60/433,685 2002-12-16
US46020603P 2003-04-02 2003-04-02
US60/460,206 2003-04-02

Publications (2)

Publication Number Publication Date
WO2004058235A2 WO2004058235A2 (en) 2004-07-15
WO2004058235A3 true WO2004058235A3 (en) 2005-02-24

Family

ID=32685268

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/040174 WO2004058235A2 (en) 2002-12-16 2003-12-16 Method of increasing bioavailability of alendronate or other bis-phosphonate by predose administration of vitamin d derivative

Country Status (7)

Country Link
JP (3) JP2006514695A (en)
AU (1) AU2003300984A1 (en)
DE (1) DE10393906T5 (en)
GB (1) GB2411116B (en)
HK (1) HK1078802A1 (en)
IL (1) IL169127A0 (en)
WO (1) WO2004058235A2 (en)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8426391B2 (en) 2006-02-03 2013-04-23 Proventiv Therapeutics, Llc Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
WO2007094779A1 (en) * 2006-02-14 2007-08-23 Teva Pharmaceutical Industries Ltd. Pharmaceutical formulations of aliphatic amine polymers and methods for their manufacture
SI2679228T1 (en) 2006-06-21 2018-06-29 Opko Ireland Global Holdings, Ltd. Therapy using vitamin D repletion agent and vitamin D hormone replacement agent
CA2671727C (en) * 2006-12-20 2016-02-16 Genpharm Ulc A composition containing a bisphosphonic acid in combination with vitamin d
WO2008074145A1 (en) * 2006-12-20 2008-06-26 Genpharm Ulc Pharmaceutical composition comprising a hot-melt granulated lubricant
ES2403107T3 (en) 2007-04-25 2013-05-14 Cytochroma Inc. Vitamin D insufficiency and deficiency treatment method
DK3342405T3 (en) 2007-04-25 2019-11-11 Opko Ireland Global Holdings Ltd CONTROLLED RELEASE OF 25-HYDROXYVITAMINE D
EP2148685A4 (en) 2007-04-25 2010-07-28 Cytochroma Inc Methods and compounds for vitamin d therapy
WO2008134523A1 (en) 2007-04-25 2008-11-06 Proventiv Therapeutics, Llc Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease
KR101852042B1 (en) 2008-04-02 2018-04-25 사이토크로마 인코포레이티드 Methods, compositions, uses, and kits useful for vitamin d deficiency and related disorders
EP3636280A1 (en) 2010-03-29 2020-04-15 Opko Ireland Global Holdings, Ltd. Methods and compositions for reducing parathyroid levels
KR101847947B1 (en) 2013-03-15 2018-05-28 옵코 아이피 홀딩스 Ⅱ 인코포레이티드 Stabilized modified release vitamin d formulation
SG10201911274TA (en) 2014-08-07 2020-02-27 Opko Ireland Global Holdings Ltd Adjunctive therapy with 25-hydroxyvitamin d
SG10201913863TA (en) 2016-03-28 2020-03-30 Opko Ireland Global Holdings Limited Methods of vitamin d treatment
CN109364034B (en) * 2018-11-26 2021-05-04 正大制药（青岛）有限公司 Calcitriol preparation and preparation method thereof
CN116211818B (en) * 2023-03-10 2024-04-09 菲洋生物科技(吉林)有限公司 Tablet containing alendronate sodium and preparation method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001028564A1 (en) * 1999-10-20 2001-04-26 Yuyu Industrial Co., Ltd. Pharmaceutical compositions and preparations for treatment of metabolic bone disease
WO2003007916A1 (en) * 2001-07-17 2003-01-30 Teva Pharmaceutical Industries Ltd. Dosage forms for immediate gastric release of a calcium transport stimulator coupled with delayed gastric release of a bis-phosphonate

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001028564A1 (en) * 1999-10-20 2001-04-26 Yuyu Industrial Co., Ltd. Pharmaceutical compositions and preparations for treatment of metabolic bone disease
WO2003007916A1 (en) * 2001-07-17 2003-01-30 Teva Pharmaceutical Industries Ltd. Dosage forms for immediate gastric release of a calcium transport stimulator coupled with delayed gastric release of a bis-phosphonate

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
ERBEN R G ET AL: "Prevention of bone loss in ovariectomized rats by combined treatment with risedronate and 1[alpha],25-dihydroxyvitamin D3", JOURNAL OF BONE AND MINERAL RESEARCH 2002 UNITED STATES, vol. 17, no. 8, 2002, pages 1498 - 1511, XP008033377, ISSN: 0884-0431 *
FREDIANI BRUNO ET AL: "Effects of combined treatment with calcitriol plus alendronate on bone mass and bone turnover in postmenopausal osteoporosis. Two years of continuous treatment", CLINICAL DRUG INVESTIGATION, vol. 15, no. 3, March 1998 (1998-03-01), pages 235 - 244, XP002955329, ISSN: 1173-2563 *
GERTZ B J ET AL: "STUDIES OF THE ORAL BIOAVAILABILITY OF ALENDRONATE", CLINICAL PHARMACOLOGY & THERAPEUTICS, MOSBY-YEAR BOOK, ST LOUIS, MO, US, vol. 58, no. 3, September 1995 (1995-09-01), pages 288 - 298, XP001006243, ISSN: 0009-9236 *
MALAVOLTA N ET AL: "Calcitriol and alendronate combination treatment in menopausal women with low bone mass", INTERNATIONAL JOURNAL OF TISSUE REACTIONS, vol. 21, no. 2, 1999, pages 51 - 59, XP008033382, ISSN: 0250-0868 *
MASUD T ET AL: "Effects of cyclical etidronate combined with calcitriol versus cyclical etidronate alone on spine and femoral neck bone mineral density in postmenopausal osteoporotic women", ANNALS OF THE RHEUMATIC DISEASES, vol. 57, no. 6, June 1998 (1998-06-01), pages 346 - 349, XP008033380, ISSN: 0003-4967 *
NUTI RANUCCIO ET AL: "Effect of treatment with calcitriol combined with low-dosage alendronate in involutional osteoporosis", CLINICAL DRUG INVESTIGATION, vol. 19, no. 1, January 2000 (2000-01-01), pages 55 - 61, XP008033379, ISSN: 1173-2563 *

Also Published As

Publication number Publication date
AU2003300984A8 (en) 2004-07-22
HK1078802A1 (en) 2006-03-24
JP2014205711A (en) 2014-10-30
GB0511750D0 (en) 2005-07-20
IL169127A0 (en) 2009-02-11
DE10393906T5 (en) 2006-01-12
GB2411116B (en) 2009-04-29
WO2004058235A2 (en) 2004-07-15
AU2003300984A1 (en) 2004-07-22
JP2006514695A (en) 2006-05-11
GB2411116A (en) 2005-08-24
JP2011241221A (en) 2011-12-01

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