WO2011088806A3 - A method of industrial production of an amorphous form of atorvastatin with a high specific surface area and its use in a dosage form - Google Patents
A method of industrial production of an amorphous form of atorvastatin with a high specific surface area and its use in a dosage form Download PDFInfo
- Publication number
- WO2011088806A3 WO2011088806A3 PCT/CZ2011/000003 CZ2011000003W WO2011088806A3 WO 2011088806 A3 WO2011088806 A3 WO 2011088806A3 CZ 2011000003 W CZ2011000003 W CZ 2011000003W WO 2011088806 A3 WO2011088806 A3 WO 2011088806A3
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- atorvastatin
- surface area
- specific surface
- high specific
- industrial production
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
- C07D207/30—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
- C07D207/34—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
-
- 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
Abstract
The invention deals with an amorphous form of the hemicalcium salt of (3R,5R) 7-[3-phenyl- 4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropylpyrrol-1-y1]-3,5-dihydroxyheptanoic acid (atorvastatin of formula I) with a high specific surface area, based on controlled precipitation, and its use in a medical dosage form. (I)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11707780A EP2526089A2 (en) | 2010-01-19 | 2011-01-12 | A method of industrial production of an amorphous form of atorvastatin with a high specific surface area and its use in a dosage form |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CZ20100039A CZ201039A3 (en) | 2010-01-19 | 2010-01-19 | Method of industrial production of amorphous form of (3R,5R) 7-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid hemicalcium salt (atorvastatin) with low specific surface and use thereof in medicamento |
CZPV2010-39 | 2010-01-19 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2011088806A2 WO2011088806A2 (en) | 2011-07-28 |
WO2011088806A3 true WO2011088806A3 (en) | 2011-09-22 |
Family
ID=43902821
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CZ2011/000003 WO2011088806A2 (en) | 2010-01-19 | 2011-01-12 | A method of industrial production of an amorphous form of atorvastatin with a high specific surface area and its use in a dosage form |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP2526089A2 (en) |
CZ (1) | CZ201039A3 (en) |
WO (1) | WO2011088806A2 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SG11201505680RA (en) | 2013-02-21 | 2015-09-29 | Pfizer | Solid forms of a selective cdk4/6 inhibitor |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CZ2003987A3 (en) * | 2003-04-08 | 2004-11-10 | Zentiva A. S. | Process for preparing amorphous form of hemi calcium salt of (3R,5R) 7-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid (atorvastatin) suitable for industrial production and apparatus for making the same |
US20090124817A1 (en) * | 2007-11-09 | 2009-05-14 | The Industry & Academic Cooperation In Chungnam National University | Process for Preparing Amorphous Atorvastatin Calcium Nanoparticles |
Family Cites Families (15)
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---|---|---|---|---|
US4681893A (en) | 1986-05-30 | 1987-07-21 | Warner-Lambert Company | Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis |
FI94339C (en) | 1989-07-21 | 1995-08-25 | Warner Lambert Co | Process for the preparation of pharmaceutically acceptable [R- (R *, R *)] - 2- (4-fluorophenyl) -, - dihydroxy-5- (1-methylethyl) -3-phenyl-4 - [(phenylamino) carbonyl] -1H- for the preparation of pyrrole-1-heptanoic acid and its pharmaceutically acceptable salts |
HRP960312B1 (en) | 1995-07-17 | 2001-10-31 | Warner Lambert Co | NOVEL PROCESS FOR THE PRODUCTION OF AMORPHOUS /R-(R*, R*)/-2-(4-FLUOROPHENYL)-"beta", "delta"-DIHYDROXY-5-PHENYL-4-/(PHENYLAMINO)CARBONYL/-1H-PYRROLE -1-HEPTANOIC ACID CALCIUM SALT (2 : 1) |
JP3296564B2 (en) | 1995-07-17 | 2002-07-02 | ワーナー−ランバート・コンパニー | Crystalline [R- (R ▲ *, R ▲ *)]-2- (4-fluorophenyl) -β, δ-dihydroxy-5- (1-methylethyl) -3-phenyl-4 -[(Phenylamino) carbonyl] -1H-pyrrole-1-heptanoic acid hemicalcium salt (atorvastatin) |
HRP960313B1 (en) | 1995-07-17 | 2002-08-31 | Warner Lambert Co | Form iii crystalline (r- (r*, r*)-2- (4-fluorophenyl) -beta-delta-hydroxy-5-(1-methylethyl) -3-phenyl-4- ((phenylamino) carbonyl -1h-pyrrole-1-heptanoic acid calcium salt (2:1) |
IN191236B (en) | 1999-05-25 | 2003-10-11 | Ranbaxy Lab Ltd | |
HU226640B1 (en) | 1999-10-18 | 2009-05-28 | Egis Gyogyszergyar Nyilvanosan | Process for producing amorphous atorvastatin calcium salt |
WO2001036384A1 (en) | 1999-11-17 | 2001-05-25 | Teva Pharmaceutical Industries Ltd. | Polymorphic form of atorvastatin calcium |
SI20425A (en) | 1999-12-10 | 2001-06-30 | LEK tovarna farmacevtskih in kemi�nih izdelkov d.d. | Preparation of amorphous atorvastatin |
WO2002008368A1 (en) | 2000-07-21 | 2002-01-31 | Cargill, Incorporated | Method for removing contaminants from vegetable oil and lecithin |
JP2002038174A (en) | 2000-07-24 | 2002-02-06 | Nippon Mitsubishi Oil Corp | Refrigerating machine oil composition |
WO2002057228A1 (en) | 2001-01-17 | 2002-07-25 | Biocon India Limited | Atorvastatin calcium |
EP1423364B1 (en) | 2001-06-29 | 2015-11-04 | Warner-Lambert Company LLC | Crystalline forms of [r-(r*,r*)]-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin) |
EP1572638A4 (en) | 2001-08-31 | 2010-05-05 | Morepen Lab Ltd | An improved process for the preparation of amorphous atorvastatin calcium salt (2:1) |
CZ296967B6 (en) | 2002-02-01 | 2006-08-16 | Zentiva, A.S. | Process for preparing amorphous form of hemicalcium salt of (3R,5R)7-[3-phenyl-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropylpyrrol-l-yl]-3,5-dihydroxyheptanoic acid (atorvastatin) |
-
2010
- 2010-01-19 CZ CZ20100039A patent/CZ201039A3/en unknown
-
2011
- 2011-01-12 WO PCT/CZ2011/000003 patent/WO2011088806A2/en active Application Filing
- 2011-01-12 EP EP11707780A patent/EP2526089A2/en not_active Withdrawn
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CZ2003987A3 (en) * | 2003-04-08 | 2004-11-10 | Zentiva A. S. | Process for preparing amorphous form of hemi calcium salt of (3R,5R) 7-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid (atorvastatin) suitable for industrial production and apparatus for making the same |
US20090124817A1 (en) * | 2007-11-09 | 2009-05-14 | The Industry & Academic Cooperation In Chungnam National University | Process for Preparing Amorphous Atorvastatin Calcium Nanoparticles |
Non-Patent Citations (6)
Title |
---|
"FDA Approval package for Lipitor", 7 April 2000 (2000-04-07), XP002635528, Retrieved from the Internet <URL:www.fda.org> * |
"Ph. Eur. 4", 2004, COUNCIL OF EUROPE EQDM, XP002635527 * |
"Ph. Eur. 7.1 monograph on Atorvastatin", 2010, COUNCIL OF EUROPE EQDM, XP002636005 * |
ARUNKUMAR N ET AL: "Preparation and solid state characterization of atorvastatin nanosuspensions for enhanced solubility and dissolution", INTERNATIONAL JOURNAL OF PHARMTECH RESEARCH, SHPINX KNOWLEDGE HOUSE, IN, vol. 1, no. 4, 1 October 2009 (2009-10-01), pages 1725 - 1730, XP008136161, ISSN: 0974-4304, Retrieved from the Internet <URL:http://sphinxsai.com/PTVOL4/index_pharm_1_vol4.htm> * |
KIM M S ET AL: "Preparation, characterization and in vivo evaluation of amorphous atorvastatin calcium nanoparticles using supercritical antisolvent (SAS) process", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM, NL, vol. 69, no. 2, 1 June 2008 (2008-06-01), pages 454 - 465, XP022664260, ISSN: 0939-6411, [retrieved on 20080118], DOI: DOI:10.1016/J.EJPB.2008.01.007 * |
ZHANG H X ET AL: "Micronization of atorvastatin calcium by antisolvent precipitation process", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 374, no. 1-2, 5 June 2009 (2009-06-05), pages 106 - 113, XP026109001, ISSN: 0378-5173, [retrieved on 20090304], DOI: DOI:10.1016/J.IJPHARM.2009.02.015 * |
Also Published As
Publication number | Publication date |
---|---|
CZ201039A3 (en) | 2011-07-27 |
WO2011088806A2 (en) | 2011-07-28 |
EP2526089A2 (en) | 2012-11-28 |
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