HUP0203078A3 - Novel hydrate forms of alendronate sodium, processes for manufacture thereof, and pharmaceutical compositions thereof - Google Patents

Novel hydrate forms of alendronate sodium, processes for manufacture thereof, and pharmaceutical compositions thereof

Info

Publication number
HUP0203078A3
HUP0203078A3 HU0203078A HUP0203078A HUP0203078A3 HU P0203078 A3 HUP0203078 A3 HU P0203078A3 HU 0203078 A HU0203078 A HU 0203078A HU P0203078 A HUP0203078 A HU P0203078A HU P0203078 A3 HUP0203078 A3 HU P0203078A3
Authority
HU
Hungary
Prior art keywords
manufacture
processes
pharmaceutical compositions
hydrate forms
alendronate sodium
Prior art date
Application number
HU0203078A
Other languages
English (en)
Original Assignee
Teva Pharma
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 filed Critical Teva Pharma
Publication of HUP0203078A2 publication Critical patent/HUP0203078A2/hu
Publication of HUP0203078A3 publication Critical patent/HUP0203078A3/hu

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07FACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02Phosphorus compounds
    • C07F9/28Phosphorus compounds with one or more P—C bonds
    • C07F9/38Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07FACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02Phosphorus compounds
    • C07F9/28Phosphorus compounds with one or more P—C bonds
    • C07F9/38Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)]
    • C07F9/3804Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)] not used, see subgroups
    • C07F9/3839Polyphosphonic acids
    • C07F9/3873Polyphosphonic acids containing nitrogen substituent, e.g. N.....H or N-hydrocarbon group which can be substituted by halogen or nitro(so), N.....O, N.....S, N.....C(=X)- (X =O, S), N.....N, N...C(=X)...N (X =O, S)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
HU0203078A 1998-08-27 1999-08-27 Novel hydrate forms of alendronate sodium, processes for manufacture thereof, and pharmaceutical compositions thereof HUP0203078A3 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US9831398P 1998-08-27 1998-08-27
US12974399P 1999-04-16 1999-04-16
US14446199P 1999-07-19 1999-07-19
PCT/US1999/019838 WO2000012517A1 (en) 1998-08-27 1999-08-27 Novel hydrate forms of alendronate sodium, processes for manufacture thereof, and pharmaceutical compositions thereof

Publications (2)

Publication Number Publication Date
HUP0203078A2 HUP0203078A2 (hu) 2003-01-28
HUP0203078A3 true HUP0203078A3 (en) 2005-01-28

Family

ID=27378576

Family Applications (1)

Application Number Title Priority Date Filing Date
HU0203078A HUP0203078A3 (en) 1998-08-27 1999-08-27 Novel hydrate forms of alendronate sodium, processes for manufacture thereof, and pharmaceutical compositions thereof

Country Status (30)

Country Link
US (2) US6281381B1 (hu)
EP (1) EP1107974B1 (hu)
JP (2) JP2002523514A (hu)
KR (2) KR20010079701A (hu)
AT (1) ATE334993T1 (hu)
AU (1) AU5698899A (hu)
BG (1) BG65329B1 (hu)
BR (1) BR9913472A (hu)
CA (1) CA2341459A1 (hu)
CZ (1) CZ2001629A3 (hu)
DE (1) DE69932620T2 (hu)
DK (1) DK1107974T3 (hu)
EA (1) EA002739B1 (hu)
EE (1) EE04552B1 (hu)
ES (1) ES2270613T3 (hu)
HR (1) HRP20010129A2 (hu)
HU (1) HUP0203078A3 (hu)
IL (1) IL141423A (hu)
IS (1) IS5864A (hu)
LT (1) LT4888B (hu)
LV (1) LV12720B (hu)
NO (1) NO20010957L (hu)
NZ (1) NZ510682A (hu)
PL (1) PL346347A1 (hu)
PT (1) PT1107974E (hu)
RO (1) RO122854B1 (hu)
SI (1) SI20581B (hu)
SK (1) SK2482001A3 (hu)
WO (1) WO2000012517A1 (hu)
YU (1) YU14701A (hu)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2451881A1 (fr) * 2001-07-16 2003-01-30 Universite Paris 13 Nouveaux derives de bisphosphonates, leurs preparations et utilisations
GB2383042A (en) 2001-10-18 2003-06-18 Cipla Ltd Amorphous alendronate sodium
US20040052843A1 (en) * 2001-12-24 2004-03-18 Lerner E. Itzhak Controlled release dosage forms
EP2172192A1 (en) * 2001-12-24 2010-04-07 Teva Pharmaceutical Industries Ltd. Dosage form with a core tablet of active ingredient sheathed in a compressed annular body of powder of granular material, and process and tooling for producing it
ITMI20020146A1 (it) * 2002-01-29 2003-07-29 Lyogen Ltd Alendronato monosodico amorfo e processo per la sua preparazione
JP2005531532A (ja) * 2002-04-05 2005-10-20 メルク エンド カムパニー インコーポレーテッド アレンドロナートおよびビタミンd製剤を用いる骨吸収阻害法
US20080249068A1 (en) * 2002-09-05 2008-10-09 Deluca Hector F Method of Extending the Dose Range of Vitamin D Compounds
US20050113343A1 (en) * 2003-10-14 2005-05-26 Pliva - Research And Development Ltd. Solid-state form of alendronate sodium and preparation thereof
US20050181043A1 (en) * 2004-02-12 2005-08-18 Indranil Nandi Alendronate salt tablet compositions
US20050261250A1 (en) * 2004-05-19 2005-11-24 Merck & Co., Inc., Compositions and methods for inhibiting bone resorption
WO2005115331A2 (en) 2004-05-24 2005-12-08 The Procter & Gamble Company Enteric solid oral dosage form of bisphosphonate containing a chelating agent
CZ296937B6 (cs) * 2004-09-02 2006-07-12 Zentiva, A. S Trisodná sul kyseliny 4-amino-1-hydroxybutyliden-1,1-bisfosfonové
ATE440888T1 (de) * 2004-10-29 2009-09-15 Sandoz Ag Verfahren zur herstellung von glatiramer
US20060134190A1 (en) * 2004-12-16 2006-06-22 Banner Pharmacaps Inc. Formulations of bisphosphonate drugs with improved bioavailability
CZ297262B6 (cs) * 2004-12-28 2006-10-11 Zentiva, A. S. Trisodná sul kyseliny 4-amino-1-hydroxybutyliden-1,1-bisfosfonové
US8003820B2 (en) * 2005-10-20 2011-08-23 Dr. Reddy's Laboratories Limited Process for preparing bisphosphonic acids
AR058168A1 (es) * 2005-11-07 2008-01-23 Merck & Co Inc Sintesis del alendronato de sodio trihidratado
JP5523833B2 (ja) * 2006-10-27 2014-06-18 シグナル ファーマシューティカルズ,エルエルシー 4−[9−(テトラヒドロ−フラン−3−イル)−8−(2,4,6−トリフルオロ−フェニルアミノ)−9h−プリン−2−イルアミノ]−シクロヘキサン−1−オールを含む固体形態、それらの組成物、及びそれらの使用
ES2392890T3 (es) * 2006-11-22 2012-12-14 Eisai R&D Management Co., Ltd. Sal sódica de un compuesto disacarídico, procedimiento para la producción de la misma y uso de la misma
US20090076144A1 (en) * 2007-09-17 2009-03-19 Protia, Llc Deuterium-enriched bazedoxifene
US20090118238A1 (en) * 2007-09-17 2009-05-07 Protia, Llc Deuterium-enriched alendronate
US20090170815A1 (en) * 2007-12-28 2009-07-02 Roxane Laboratories Incorporated. Alendronate oral liquid formulations
JP2013510097A (ja) * 2009-11-03 2013-03-21 リウ、リー タンシノンiiaスルホン酸ナトリウム水和物、並びにその調製方法及び使用
RU2021125455A (ru) 2013-11-15 2021-10-05 Экебиа Терапьютикс, Инк. Твердые формы { [5-(3-хлорфенил)-3-гидроксипиридин-2-карбонил]амино} уксусной кислоты, их композиции и применения

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3016289A1 (de) 1980-04-28 1981-10-29 Henkel KGaA, 4000 Düsseldorf Verfahren zur herstellung von omega -amino-1-hydroxyalkyliden-1,1-bis-phosphonsaeuren
IT1201087B (it) * 1982-04-15 1989-01-27 Gentili Ist Spa Bifosfonati farmacologicamente attivi,procedimento per la loro preparazione e relative composizioni farmaceutiche
US4639338A (en) * 1984-08-06 1987-01-27 Ciba-Geigy Corporation Preparation of crystalline disodium 3-amino-1-hydroxypropane-1,1-diphosphonate pentahydrate
DE3434667A1 (de) 1984-09-21 1986-04-03 Henkel KGaA, 4000 Düsseldorf 4-dimethylamino-1-hydroxybutan-1,1-diphosphonsaeure, deren wasserloesliche salze, verfahren zu ihrer herstellung sowie ihre verwendung
IT1196315B (it) * 1984-10-29 1988-11-16 Gentili Ist Spa Procedimento per la preparazione di acidi difosfonici
US4711800A (en) * 1985-06-06 1987-12-08 Divincenzo Maureen Needlecraft with metallic substrate
US4922007A (en) * 1989-06-09 1990-05-01 Merck & Co., Inc. Process for preparing 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid or salts thereof
US5019651A (en) * 1990-06-20 1991-05-28 Merck & Co., Inc. Process for preparing 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid (ABP) or salts thereof
US5039819A (en) 1990-09-18 1991-08-13 Merck & Co., Inc. Diphosphonate intermediate for preparing an antihypercalcemic agent
US5159108A (en) 1990-09-18 1992-10-27 Merck & Co., Inc. Process for preparing an antihypercalcemic agent
JPH11506757A (ja) * 1995-06-06 1999-06-15 メルク エンド カンパニー インコーポレーテッド 二ナトリウムアレンドロネート製剤
CA2221417C (en) * 1995-06-06 2002-04-30 Merck & Co., Inc. Anhydrous alendronate monosodium salt formulations

Also Published As

Publication number Publication date
EP1107974A1 (en) 2001-06-20
BR9913472A (pt) 2002-03-05
EE200100126A (et) 2002-06-17
US6281381B1 (en) 2001-08-28
PT1107974E (pt) 2006-10-31
EP1107974B1 (en) 2006-08-02
EA200100184A1 (ru) 2001-10-22
DE69932620D1 (de) 2006-09-14
SI20581B (sl) 2008-06-30
PL346347A1 (en) 2002-02-11
BG105292A (en) 2001-12-29
YU14701A (sh) 2003-01-31
JP2002523514A (ja) 2002-07-30
US20030065214A1 (en) 2003-04-03
ATE334993T1 (de) 2006-08-15
KR20070034132A (ko) 2007-03-27
CZ2001629A3 (cs) 2001-08-15
LV12720B (en) 2002-02-20
LT4888B (lt) 2002-02-25
LT2001016A (en) 2001-10-25
NO20010957D0 (no) 2001-02-26
US6696601B2 (en) 2004-02-24
LV12720A (lv) 2001-09-20
IS5864A (is) 2001-02-26
RO122854B1 (ro) 2010-03-30
SI20581A (sl) 2001-12-31
EE04552B1 (et) 2005-10-17
WO2000012517A1 (en) 2000-03-09
BG65329B1 (bg) 2008-02-29
NO20010957L (no) 2001-04-26
HUP0203078A2 (hu) 2003-01-28
AU5698899A (en) 2000-03-21
EA002739B1 (ru) 2002-08-29
KR20010079701A (ko) 2001-08-22
EP1107974A4 (en) 2001-09-26
CA2341459A1 (en) 2000-03-09
DE69932620T2 (de) 2006-12-14
NZ510682A (en) 2003-09-26
DK1107974T3 (da) 2006-10-30
WO2000012517A9 (en) 2000-07-13
ES2270613T3 (es) 2007-04-01
JP2009143955A (ja) 2009-07-02
SK2482001A3 (en) 2002-01-07
HRP20010129A2 (en) 2005-04-30
IL141423A0 (en) 2002-03-10
IL141423A (en) 2005-09-25

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Legal Events

Date Code Title Description
FD9A Lapse of provisional protection due to non-payment of fees