CA2394200C - Novel forms of pravastatin sodium - Google Patents

Novel forms of pravastatin sodium Download PDF

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Publication number
CA2394200C
CA2394200C CA002394200A CA2394200A CA2394200C CA 2394200 C CA2394200 C CA 2394200C CA 002394200 A CA002394200 A CA 002394200A CA 2394200 A CA2394200 A CA 2394200A CA 2394200 C CA2394200 C CA 2394200C
Authority
CA
Canada
Prior art keywords
pravastatin sodium
solution
pravastatin
forms
temperature
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
CA002394200A
Other languages
English (en)
French (fr)
Other versions
CA2394200A1 (en
Inventor
Vilmos Keri
Csaba Szabo
Edit Nagyne Arvai
Judith Aronhime
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Works PLC
Original Assignee
Teva Pharmaceutical Works PLC
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26866349&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2394200(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Works PLC filed Critical Teva Pharmaceutical Works PLC
Priority to CA002551203A priority Critical patent/CA2551203A1/en
Publication of CA2394200A1 publication Critical patent/CA2394200A1/en
Application granted granted Critical
Publication of CA2394200C publication Critical patent/CA2394200C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C69/00—Esters of carboxylic acids; Esters of carbonic or haloformic acids
    • C07C69/74—Esters of carboxylic acids having an esterified carboxyl group bound to a carbon atom of a ring other than a six-membered aromatic ring
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C69/00—Esters of carboxylic acids; Esters of carbonic or haloformic acids
    • C07C69/02—Esters of acyclic saturated monocarboxylic acids having the carboxyl group bound to an acyclic carbon atom or to hydrogen
    • C07C69/22—Esters of acyclic saturated monocarboxylic acids having the carboxyl group bound to an acyclic carbon atom or to hydrogen having three or more carbon atoms in the acid moiety
    • C07C69/33—Esters of acyclic saturated monocarboxylic acids having the carboxyl group bound to an acyclic carbon atom or to hydrogen having three or more carbon atoms in the acid moiety esterified with hydroxy compounds having more than three hydroxy groups
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C67/00—Preparation of carboxylic acid esters
    • C07C67/48—Separation; Purification; Stabilisation; Use of additives
    • C07C67/52—Separation; Purification; Stabilisation; Use of additives by change in the physical state, e.g. crystallisation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2602/00—Systems containing two condensed rings
    • C07C2602/02—Systems containing two condensed rings the rings having only two atoms in common
    • C07C2602/14—All rings being cycloaliphatic
    • C07C2602/26—All rings being cycloaliphatic the ring system containing ten carbon atoms
    • C07C2602/28—Hydrogenated naphthalenes

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA002394200A 1999-12-14 2000-12-14 Novel forms of pravastatin sodium Expired - Fee Related CA2394200C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA002551203A CA2551203A1 (en) 1999-12-14 2000-12-14 Novel forms of pravastatin sodium

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US17068599P 1999-12-14 1999-12-14
US60/170,685 1999-12-14
US19064900P 2000-03-20 2000-03-20
US60/190,649 2000-03-20
PCT/US2000/033867 WO2001043723A1 (en) 1999-12-14 2000-12-14 Novel forms of pravastatin sodium

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA002551203A Division CA2551203A1 (en) 1999-12-14 2000-12-14 Novel forms of pravastatin sodium

Publications (2)

Publication Number Publication Date
CA2394200A1 CA2394200A1 (en) 2001-06-21
CA2394200C true CA2394200C (en) 2006-10-03

Family

ID=26866349

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002394200A Expired - Fee Related CA2394200C (en) 1999-12-14 2000-12-14 Novel forms of pravastatin sodium

Country Status (15)

Country Link
US (3) US7001919B2 (enExample)
EP (1) EP1242051A4 (enExample)
JP (2) JP2003516959A (enExample)
KR (1) KR20020062340A (enExample)
CN (1) CN1434702A (enExample)
AU (1) AU779306B2 (enExample)
CA (1) CA2394200C (enExample)
CZ (1) CZ20021998A3 (enExample)
HK (1) HK1049441A1 (enExample)
HU (1) HUP0204005A3 (enExample)
IL (1) IL150187A0 (enExample)
PL (1) PL364929A1 (enExample)
SK (1) SK8312002A3 (enExample)
WO (1) WO2001043723A1 (enExample)
YU (1) YU45202A (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HK1049441A1 (zh) * 1999-12-14 2003-05-16 Biogal Gyogyszergyar Rt 普伐他丁钠的崭新形式
ATE374028T1 (de) * 2001-03-27 2007-10-15 Dainippon Sumitomo Pharma Co Kristallines isoxazol-derivat und medizinisches präparat daraus
EP1737449A1 (en) * 2004-03-01 2007-01-03 LEK Pharmaceuticals D.D. Pharmaceutical composition
KR20070038553A (ko) 2004-08-06 2007-04-10 트렌스폼 파마수티컬스 인코퍼레이티드 신규한 스타틴 약제학적 조성물 및 관련된 치료방법
CN101115706A (zh) * 2005-02-09 2008-01-30 特瓦药厂私人有限公司 制备普伐他汀钠的方法
JP4813841B2 (ja) * 2005-07-25 2011-11-09 キユーピー株式会社 プラバスタチンナトリウムの製造方法
CN101648867B (zh) * 2009-09-04 2012-07-11 天津大学 一种普伐他汀钠晶型及其制备方法和应用
EP2343054A1 (en) 2010-01-04 2011-07-13 LEK Pharmaceuticals d.d. Pellets and microparticles of pravastatin sodium and a process of making them
WO2012085191A1 (en) 2010-12-23 2012-06-28 Dsm Sinochem Pharmaceuticals Netherlands B.V. Crystalline form of pravastatine and process for the preparation thereof
TWI665190B (zh) 2013-11-15 2019-07-11 阿克比治療有限公司 ｛［５－（３－氯苯基）－３－羥基吡啶－２－羰基］胺基｝乙酸之固體型式，其組合物及用途
CN105949062B (zh) * 2016-06-24 2017-06-13 广东蓝宝制药有限公司 一种规模化制备普伐他汀钠d型晶体的工艺
CN111018714B (zh) * 2019-12-27 2020-09-04 广东蓝宝制药有限公司 一种获得高纯a晶型普伐他汀钠的制备方法

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4319039A (en) 1979-06-15 1982-03-09 Merck & Co., Inc. Preparation of ammonium salt of hypocholesteremic fermentation product
MX7065E (es) 1980-06-06 1987-04-10 Sankyo Co Un procedimiento microbiologico para preparar derivados de ml-236b
ATE69602T1 (de) 1985-09-13 1991-12-15 Sankyo Co Hydroxy-ml-236b-derivate, deren herstellung und anwendung.
US4857547A (en) * 1988-01-07 1989-08-15 Merck & Co., Inc. Novel HMG-CoA reductase inhibitors
US4857522A (en) 1988-03-21 1989-08-15 E. R. Squibb & Sons, Inc. Derivatives of pravastatin for inhibiting cholesterol biosynthesis
US5180589A (en) 1988-03-31 1993-01-19 E. R. Squibb & Sons, Inc. Pravastatin pharmaceuatical compositions having good stability
US5099035A (en) * 1989-02-27 1992-03-24 E. R. Squibb & Sons, Inc. Mevinic acid derivatives useful as antihypercholesterolemic agents and method for preparing same
US5140012A (en) * 1990-05-31 1992-08-18 E. R. Squibb & Sons, Inc. Method for preventing onset of restenosis after angioplasty employing pravastatin
US5202029A (en) * 1991-03-13 1993-04-13 Caron Kabushiki Kaisha Process for purification of hmg-coa reductase inhibitors
US5157025A (en) * 1991-04-01 1992-10-20 E. R. Squibb & Sons, Inc. Method for lowering serum cholesterol employing a phosphorus containing ace inhibitor alone or in combination with a cholesterol lowering drug
US5225202A (en) * 1991-09-30 1993-07-06 E. R. Squibb & Sons, Inc. Enteric coated pharmaceutical compositions
NZ250609A (en) 1992-12-28 1995-07-26 Sankyo Co Hexahydronaphthalene esters and ring closed lactones; preparation and medicaments
SI9300303A (en) 1993-06-08 1994-12-31 Krka Tovarna Zdravil Process for isolation of hypolipemic effective substance
IL112639A0 (en) 1994-03-11 1995-05-26 Bristol Myers Squibb Co A pharmaceutical composition containing pravastin
US5942423A (en) 1995-06-07 1999-08-24 Massachusetts Institute Of Technology Conversion of compactin to pravastatin by actinomadura
US5616595A (en) 1995-06-07 1997-04-01 Abbott Laboratories Process for recovering water insoluble compounds from a fermentation broth
US5883109A (en) 1996-07-24 1999-03-16 Bristol-Myers Squibb Company Method for lowering serum lipid levels employing an MTP inhibitor in combination with another cholesterol lowering drug
AU6726398A (en) 1997-02-20 1998-09-09 Gist-Brocades B.V. Nitrogen feed in statin fermentation
KR100210482B1 (ko) 1997-04-10 1999-07-15 김종인 스트렙토마이세스엑스포리아투스(streptomycesexfoliatus)yj-118과이를이용한프라바스타틴나트륨의제조방법
AU9264598A (en) 1997-08-22 1999-03-16 Gist-Brocades B.V. Statin production by fermentation
SI9800046A (sl) 1998-02-18 1999-08-31 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Postopek za pridobivanje inhibitorjev HMG-CoA reduktaze visoke čistosti
SI20072A (sl) 1998-09-18 2000-04-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Postopek za pridobivanje inhibitorjev HMG-CoA reduktaze
SI20305A (sl) 1999-08-06 2001-02-28 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Kristali natrijeve soli pravastatina
AU2161000A (en) * 1998-12-07 2000-06-26 Bristol-Myers Squibb Company Enteric coated pravastatin bead formulation
US6682913B1 (en) 1999-02-03 2004-01-27 Institute For Drug Research Ltd. Microbial process for preparing pravastatin
SK10932001A3 (sk) 1999-02-03 2002-06-04 Institute For Drug Research Ltd. Mikrobiálny spôsob výroby pravastatínu
HUP9902352A1 (hu) 1999-07-12 2000-09-28 Gyógyszerkutató Intézet Kft. Eljárás pravasztatin mikrobiológiai előállítására
WO2001039768A1 (en) 1999-11-30 2001-06-07 Biogal Gyogyszergyar Rt Process for recovering statin compounds from a fermentation broth
HK1049441A1 (zh) * 1999-12-14 2003-05-16 Biogal Gyogyszergyar Rt 普伐他丁钠的崭新形式
HRP20030347A2 (en) 2000-10-05 2005-04-30 Teva Gy�gyszergy�r R�szv�nyt�rsas�g Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same
DE10209305A1 (de) 2001-04-30 2002-10-31 Basf Ag Thermische Spaltung von Allophanaten

Also Published As

Publication number Publication date
EP1242051A1 (en) 2002-09-25
US20050288370A1 (en) 2005-12-29
JP2003516959A (ja) 2003-05-20
JP2005120105A (ja) 2005-05-12
HUP0204005A3 (en) 2003-05-28
WO2001043723A1 (en) 2001-06-21
KR20020062340A (ko) 2002-07-25
CZ20021998A3 (cs) 2003-02-12
US7001919B2 (en) 2006-02-21
US20010041809A1 (en) 2001-11-15
PL364929A1 (en) 2004-12-27
IL150187A0 (en) 2002-12-01
US20070197633A1 (en) 2007-08-23
SK8312002A3 (en) 2003-05-02
EP1242051A4 (en) 2004-05-12
AU2098701A (en) 2001-06-25
YU45202A (sh) 2005-11-28
HK1049441A1 (zh) 2003-05-16
HUP0204005A2 (hu) 2003-03-28
CA2394200A1 (en) 2001-06-21
CN1434702A (zh) 2003-08-06
AU779306B2 (en) 2005-01-13
US7262218B2 (en) 2007-08-28

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Effective date: 20091214