SI20581B - Nove hidratne oblike natrijevega alendronata, postopki za njihovo pridobivanje in ustrezne farmacevtske učinkovine - Google Patents
Nove hidratne oblike natrijevega alendronata, postopki za njihovo pridobivanje in ustrezne farmacevtske učinkovine Download PDFInfo
- Publication number
- SI20581B SI20581B SI9920070A SI9920070A SI20581B SI 20581 B SI20581 B SI 20581B SI 9920070 A SI9920070 A SI 9920070A SI 9920070 A SI9920070 A SI 9920070A SI 20581 B SI20581 B SI 20581B
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- SI
- Slovenia
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- compound according
- hydroxybutylidene
- amino
- bisphosphonic acid
- equivalents
- Prior art date
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic System
- C07F9/02—Phosphorus compounds
- C07F9/28—Phosphorus compounds with one or more P—C bonds
- C07F9/38—Phosphonic acids RP(=O)(OH)2; Thiophosphonic acids, i.e. RP(=X)(XH)2 (X = S, Se)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic System
- C07F9/02—Phosphorus compounds
- C07F9/28—Phosphorus compounds with one or more P—C bonds
- C07F9/38—Phosphonic acids RP(=O)(OH)2; Thiophosphonic acids, i.e. RP(=X)(XH)2 (X = S, Se)
- C07F9/3804—Phosphonic acids RP(=O)(OH)2; Thiophosphonic acids, i.e. RP(=X)(XH)2 (X = S, Se) not used, see subgroups
- C07F9/3839—Polyphosphonic acids
- C07F9/3873—Polyphosphonic 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)
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Physical Education & Sports Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Rheumatology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Public Health (AREA)
- Veterinary Medicine (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)
Abstract
Predstavljene so nove hidratne oblike natrijevegaalendronata z vsebnostjo vode med približno enimin približno dvanajstimi procenti in postopki zanjihovo pridobivanje. Predstavljene so tudi nove kristaline oblike natrijevega alendronata B, D, E,F, G, in H in postopki za njihovo pridobivanje. Te nove oblike natrijevega alendronata so primerne kot sestavine farmacevtskih učinkovin za zdravljenje pospešene kostne resorpcije pri boleznih kosti.
Claims (18)
1 Sl 20581 NOVE HIDRATNE OBLIKE NATRIJEVEGA ALENDRONATA, POSTOPKI ZA NJIHOVO PRIDOBIVANJE IN NJIHOVI FARMACEVTSKI SESTAVKI PATENTNI ZAHTEVKI 1. Spojina mononatrijeva sol 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline z vsebnostjo vode 5.1% do 7.0%.
2. Kristalen mononatrijev alendronat monohidrat po zahtevku 1.
3. Spojina po patentnem zahtevku 1, značilna po tem, da ima vrhove v rentgenskem difraktogramu praškastega vzorca pri vrednostih dva theta 12.7± 0.2, 16.2±0.2, 17.3±0.2, 17.6±0.2, 24.8+0.2 in 25.5±0.2 stopinj.
4. Metoda za pripravo spojine po kateremkoli patentnem zahtevku od 1 do 3, ki obsega korake: a) obdelavo enega ekvivalenta 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline z enim ekvivalentom natrijeve baze v alkanolu z 1 do 4 atomi ogljika, ki obsega 5 do 200 ekvivalentov vode; in b) izoliranje omenjene spojine po kateremkoli patentnem zahtevku od 1 do 3.
5. Metoda za pripravo spojine po kateremkoli patentnem zahtevku od 1 do 3, ki obsega korake: a) obdelavo mononatrijeve soli 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline v alkanolu z 1 do 4 atomi ogljika z 20-40 ekvivalenti vode; in b) izoliranje omenjene spojine po kateremkoli patentnem zahtevku od 1 do 3.
6. Metoda za pripravo spojine po kateremkoli patentnem zahtevku od 1 do 3, ki obsega korake: 2 a) obdelavo dinatrijeve soli 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline v alkanolu z 1 do 4 atomi ogljika z 20-40 ekvivalenti vode in enim ekvivalentom alendronske kisline; in b) izoliranje omenjene spojine po kateremkoli patentnem zahtevku od 1 do 3.
7. Metoda za pripravo spojine po kateremkoli patentnem zahtevku od 1 do 3, ki obsega korake: a) obdelavo trinatrijeve soli 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline v alkanolu z 1 do 4 atomi ogljika z 20-40 ekvivalenti vode in dvema ekvivalentoma alendronske kisline; in b) izoliranje omenjene spojine po kateremkoli patentnem zahtevku od 1 do 3.
8. Metoda za pripravo spojine po kateremkoli patentnem zahtevku od 1 do 3, ki obsega korake: a) obdelavo tetranatrijeve soli 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline v alkanolu z 1 do 4 atomi ogljika z 20-40 ekvivalenti vode in tremi ekvivalenti alendronske kisline; in b) izoliranje omenjene spojine po kateremkoli patentnem zahtevku od 1 do 3.
9. Metoda po patentnem zahtevku 5, 6, 7 ali 8, pri čemer je nižji alkanol pri stopnji a) etanol.
10. Metoda po patentnem zahtevku 5, pri čemer je natrijeva sol 4-amino-1-hidroksibutiliden-1,1- bisfosfonske kisline mononatrijeva sol trihidrat.
11. Metoda po patentnem zahtevku 4, pri čemer je spojina 4-amino-1-hidroksibutiliden-1,1- bisfosfonska kislina v monohidratni obliki.
12. Metoda po kateremkoli izmed patentnih zahtevkov 4 do 8, pri čemer je nižji alkanol izbran iz skupine, ki sestoji iz metanola, etanola in izopropanola.
13. Metoda po patentnem zahtevku 4, pri čemer je natrijeva baza izbrana iz skupine, ki sestoji iz natrijevega hidroksida, natrijevega metoksida in natrijevega etoksida. 3
14. Metoda po patentnem zahtevku 4, pri čemer je spojina 4-amino-1-hidroksibutiliden-1,1- bisfosfonska kislina v brezvodni obliki.
15. Kristalna oblika mononatrijevega alendronata monohidrata, značilna po tem, da ima vrhove v rentgenskem difraktogramu praškastega vzorca pri vrednostih dva theta 12.7±0.2, 16.2+0.2, 17.3+0.2, 17.6+0.2, 24.8±0.2 in 25.5+0.2.
16. Farmacevtski sestavek, ki obsega farmacevtsko učinkovito množino spojine, definirane v kateremkoli izmed zahtevkov 1 do 3 ali 15, ali je pripravljena po kateremkoli izmed zahtevkov 4 do 14.
17. Uporaba farmacevtskega sestavka po zahtevku 16 za pripravo zdravila za zdravljenje in/ali preventivo izgube kostne mase pri neki osebi.
18. Metoda za pripravo spojine po patentnem zahtevku 1, ki obsega korake: a) reakcijo enega ekvivalenta 4-amino-1-hidroksibutiliden-1,1-bisfosfonske kisline z enim ekvivalentom natrijeve baze v vodni raztopini organskega topila izbranega iz skupine, ki sestoji iz acetona, DMSO, DMF, acetonitrila, alkoholov, polialkoholov, polialkoholnih etrov, piridina, sulfolana, N-metil pirolidinona in dioksana, in b) izoliranje spojine omenjene v patentnem zahtevku 1.
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 |
|---|---|
| SI20581A SI20581A (sl) | 2001-12-31 |
| SI20581B true SI20581B (sl) | 2008-06-30 |
Family
ID=27378576
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9920070A SI20581B (sl) | 1998-08-27 | 1999-08-27 | Nove hidratne oblike natrijevega alendronata, postopki za njihovo pridobivanje in ustrezne farmacevtske učinkovine |
Country Status (30)
| Country | Link |
|---|---|
| US (2) | US6281381B1 (sl) |
| EP (1) | EP1107974B1 (sl) |
| JP (2) | JP2002523514A (sl) |
| KR (2) | KR20070034132A (sl) |
| AT (1) | ATE334993T1 (sl) |
| AU (1) | AU5698899A (sl) |
| BG (1) | BG65329B1 (sl) |
| BR (1) | BR9913472A (sl) |
| CA (1) | CA2341459A1 (sl) |
| CZ (1) | CZ2001629A3 (sl) |
| DE (1) | DE69932620T2 (sl) |
| DK (1) | DK1107974T3 (sl) |
| EA (1) | EA002739B1 (sl) |
| EE (1) | EE04552B1 (sl) |
| ES (1) | ES2270613T3 (sl) |
| HR (1) | HRP20010129A2 (sl) |
| HU (1) | HUP0203078A3 (sl) |
| IL (1) | IL141423A (sl) |
| IS (1) | IS5864A (sl) |
| LT (1) | LT4888B (sl) |
| LV (1) | LV12720B (sl) |
| NO (1) | NO20010957L (sl) |
| NZ (1) | NZ510682A (sl) |
| PL (1) | PL346347A1 (sl) |
| PT (1) | PT1107974E (sl) |
| RO (1) | RO122854B1 (sl) |
| SI (1) | SI20581B (sl) |
| SK (1) | SK2482001A3 (sl) |
| WO (1) | WO2000012517A1 (sl) |
| YU (1) | YU14701A (sl) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4220382B2 (ja) * | 2001-07-16 | 2009-02-04 | ユニヴェルシテ・パリ・１３ | 新しいビスホスホナート誘導体、その製造法及び使用 |
| GB2383042A (en) * | 2001-10-18 | 2003-06-18 | Cipla Ltd | Amorphous alendronate sodium |
| EP1465606A4 (en) * | 2001-12-24 | 2009-04-22 | Teva Pharma | DOSAGE FORM WITH PASTILLE CORE ACTIVE PRINCIPLE COATED IN COMPRESSED ANNULAR BODY OF POWDER OR GRANULAR SUBSTANCE, AND METHOD AND TOOLS FOR PRODUCTION OF SAID DOSAGE FORM |
| US20040052843A1 (en) * | 2001-12-24 | 2004-03-18 | Lerner E. Itzhak | Controlled release dosage forms |
| ITMI20020146A1 (it) * | 2002-01-29 | 2003-07-29 | Lyogen Ltd | Alendronato monosodico amorfo e processo per la sua preparazione |
| WO2003086415A1 (en) * | 2002-04-05 | 2003-10-23 | Merck & Co., Inc. | Method for inhibiting bone resorption with an alendronate and vitamin d formulation |
| 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 |
| CN1956706A (zh) | 2004-05-24 | 2007-05-02 | 宝洁公司 | 包含一种螯合剂的双膦酸酯肠溶固体口服剂型 |
| CZ296937B6 (cs) * | 2004-09-02 | 2006-07-12 | Zentiva, A. S | Trisodná sul kyseliny 4-amino-1-hydroxybutyliden-1,1-bisfosfonové |
| DE602005016292D1 (de) * | 2004-10-29 | 2009-10-08 | 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 |
| EP2615091B1 (en) * | 2006-10-27 | 2016-01-20 | Signal Pharmaceuticals, LLC | Solid forms comprising 4-[9-(3S)-(tetrahydro-furan-3-yl)-8-(2,4,6-trifluoro-phenylamino)-9H-purin-2-ylamino]-trans-cyclohexan-1-ol, compositions thereof, and uses therewith |
| 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 |
| US20090118238A1 (en) * | 2007-09-17 | 2009-05-07 | Protia, Llc | Deuterium-enriched alendronate |
| US20090076144A1 (en) * | 2007-09-17 | 2009-03-19 | Protia, Llc | Deuterium-enriched bazedoxifene |
| 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 |
| PE20160945A1 (es) | 2013-11-15 | 2016-09-26 | Akebia Therapeutics Inc | Formas solidas de acido {[5-(3-clorofenil)-3-hidroxipiridin-2-carbonil]amino}acetico, composiciones, y usos de las mismas |
Family Cites Families (12)
| 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 |
| US5159108A (en) | 1990-09-18 | 1992-10-27 | Merck & Co., Inc. | Process for preparing an antihypercalcemic agent |
| US5039819A (en) * | 1990-09-18 | 1991-08-13 | Merck & Co., Inc. | Diphosphonate intermediate for preparing an antihypercalcemic agent |
| CA2221844A1 (en) * | 1995-06-06 | 1996-12-12 | Merck & Co., Inc. | Disodium alendronate formulations |
| CA2221417C (en) * | 1995-06-06 | 2002-04-30 | Merck & Co., Inc. | Anhydrous alendronate monosodium salt formulations |
-
1999
- 1999-08-27 AU AU56988/99A patent/AU5698899A/en not_active Abandoned
- 1999-08-27 ES ES99944004T patent/ES2270613T3/es not_active Expired - Lifetime
- 1999-08-27 YU YU14701A patent/YU14701A/sh unknown
- 1999-08-27 EE EEP200100126A patent/EE04552B1/xx not_active IP Right Cessation
- 1999-08-27 IL IL14142399A patent/IL141423A/xx not_active IP Right Cessation
- 1999-08-27 PT PT99944004T patent/PT1107974E/pt unknown
- 1999-08-27 BR BR9913472-1A patent/BR9913472A/pt not_active Application Discontinuation
- 1999-08-27 DK DK99944004T patent/DK1107974T3/da active
- 1999-08-27 RO ROA200100219A patent/RO122854B1/ro unknown
- 1999-08-27 KR KR1020077004456A patent/KR20070034132A/ko not_active Application Discontinuation
- 1999-08-27 JP JP2000567539A patent/JP2002523514A/ja not_active Withdrawn
- 1999-08-27 SK SK248-2001A patent/SK2482001A3/sk unknown
- 1999-08-27 SI SI9920070A patent/SI20581B/sl not_active IP Right Cessation
- 1999-08-27 CA CA002341459A patent/CA2341459A1/en not_active Abandoned
- 1999-08-27 PL PL99346347A patent/PL346347A1/xx not_active Application Discontinuation
- 1999-08-27 EP EP99944004A patent/EP1107974B1/en not_active Expired - Lifetime
- 1999-08-27 CZ CZ2001629A patent/CZ2001629A3/cs unknown
- 1999-08-27 WO PCT/US1999/019838 patent/WO2000012517A1/en not_active Application Discontinuation
- 1999-08-27 DE DE69932620T patent/DE69932620T2/de not_active Expired - Fee Related
- 1999-08-27 HU HU0203078A patent/HUP0203078A3/hu unknown
- 1999-08-27 US US09/384,145 patent/US6281381B1/en not_active Expired - Fee Related
- 1999-08-27 EA EA200100184A patent/EA002739B1/ru not_active IP Right Cessation
- 1999-08-27 KR KR1020017002535A patent/KR20010079701A/ko active Search and Examination
- 1999-08-27 NZ NZ510682A patent/NZ510682A/en not_active IP Right Cessation
- 1999-08-27 AT AT99944004T patent/ATE334993T1/de not_active IP Right Cessation
-
2001
- 2001-02-22 HR HR20010129A patent/HRP20010129A2/hr not_active Application Discontinuation
- 2001-02-26 IS IS5864A patent/IS5864A/is unknown
- 2001-02-26 NO NO20010957A patent/NO20010957L/no not_active Application Discontinuation
- 2001-02-26 LT LT2001016A patent/LT4888B/lt not_active IP Right Cessation
- 2001-02-26 BG BG105292A patent/BG65329B1/bg unknown
- 2001-04-05 LV LVP-01-26A patent/LV12720B/en unknown
- 2001-07-03 US US09/898,756 patent/US6696601B2/en not_active Expired - Fee Related
-
2009
- 2009-02-18 JP JP2009035788A patent/JP2009143955A/ja active Pending
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