SK50462005A3 - Spôsoby stabilizácie atorvastatínu - Google Patents

Spôsoby stabilizácie atorvastatínu Download PDF

Info

Publication number: SK50462005A3
Authority: SK; Slovakia
Prior art keywords: oxygen; atorvastatin; kpa; absorber; partial pressure
Prior art date: 2003-08-05

Application number

SK5046-2005A

Other languages

English (en)

Slovak (sk)

Inventor

Pavel Ebek

Alena Prokopov

Eduard Svoboda

Stanislav R�Dl

Jan Stach

Martin Svoboda

Andrej Kovik

Adri�N Danko

Roman Petro

Miroslav Stri�Inec

Original Assignee

Zentiva, A. S.

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.)

2003-08-05

Filing date

2004-08-05

Publication date

2005-09-08

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34117186&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SK50462005(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2003-08-05 Priority claimed from CZ20032135A external-priority patent/CZ295027B6/cs

2004-08-03 Priority claimed from CZ20040857A external-priority patent/CZ296181B6/cs

2004-08-05 Application filed by Zentiva, A. S. filed Critical Zentiva, A. S.

2005-09-08 Publication of SK50462005A3 publication Critical patent/SK50462005A3/sk

Links

XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 title claims abstract description 48
XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 title claims abstract description 47
229960005370 atorvastatin Drugs 0.000 title claims abstract description 47
238000000034 method Methods 0.000 title claims description 38
230000006641 stabilisation Effects 0.000 title abstract description 9
238000011105 stabilization Methods 0.000 title abstract description 9
239000001301 oxygen Substances 0.000 claims abstract description 84
229910052760 oxygen Inorganic materials 0.000 claims abstract description 84
QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 83
239000006096 absorbing agent Substances 0.000 claims abstract description 42
239000000203 mixture Substances 0.000 claims abstract description 29
IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims abstract description 24
238000004806 packaging method and process Methods 0.000 claims abstract description 20
239000007789 gas Substances 0.000 claims abstract description 17
239000011261 inert gas Substances 0.000 claims abstract description 14
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239000012298 atmosphere Substances 0.000 claims description 13
239000003814 drug Substances 0.000 claims description 10
XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 9
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CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 6
AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims description 6
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OUCSEDFVYPBLLF-KAYWLYCHSA-N 5-(4-fluorophenyl)-1-[2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl]-n,4-diphenyl-2-propan-2-ylpyrrole-3-carboxamide Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@H]2OC(=O)C[C@H](O)C2)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 OUCSEDFVYPBLLF-KAYWLYCHSA-N 0.000 description 11
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CABVTRNMFUVUDM-VRHQGPGLSA-N (3S)-3-hydroxy-3-methylglutaryl-CoA Chemical compound O[C@@H]1[C@H](OP(O)(O)=O)[C@@H](COP(O)(=O)OP(O)(=O)OCC(C)(C)[C@@H](O)C(=O)NCCC(=O)NCCSC(=O)C[C@@](O)(CC(O)=O)C)O[C@H]1N1C2=NC=NC(N)=C2N=C1 CABVTRNMFUVUDM-VRHQGPGLSA-N 0.000 description 2
GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 2
XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
229920002261 Corn starch Polymers 0.000 description 2
XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
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RDOXTESZEPMUJZ-UHFFFAOYSA-N anisole Chemical compound COC1=CC=CC=C1 RDOXTESZEPMUJZ-UHFFFAOYSA-N 0.000 description 2
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CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
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HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
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PCZOHLXUXFIOCF-UHFFFAOYSA-N Monacolin X Natural products C12C(OC(=O)C(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 PCZOHLXUXFIOCF-UHFFFAOYSA-N 0.000 description 1
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RYMZZMVNJRMUDD-UHFFFAOYSA-N SJ000286063 Natural products C12C(OC(=O)C(C)(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 RYMZZMVNJRMUDD-UHFFFAOYSA-N 0.000 description 1
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VRAIHTAYLFXSJJ-UHFFFAOYSA-N alumane Chemical compound [AlH3].[AlH3] VRAIHTAYLFXSJJ-UHFFFAOYSA-N 0.000 description 1
125000003368 amide group Chemical group 0.000 description 1
150000001450 anions Chemical class 0.000 description 1
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TUPZEYHYWIEDIH-WAIFQNFQSA-N beta-carotene Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CCCC1(C)C)C=CC=C(/C)C=CC2=CCCCC2(C)C TUPZEYHYWIEDIH-WAIFQNFQSA-N 0.000 description 1
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229910003002 lithium salt Inorganic materials 0.000 description 1
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PCZOHLXUXFIOCF-BXMDZJJMSA-N lovastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)[C@@H](C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 PCZOHLXUXFIOCF-BXMDZJJMSA-N 0.000 description 1
229960004844 lovastatin Drugs 0.000 description 1
QLJODMDSTUBWDW-UHFFFAOYSA-N lovastatin hydroxy acid Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CC(C)C=C21 QLJODMDSTUBWDW-UHFFFAOYSA-N 0.000 description 1
239000011777 magnesium Substances 0.000 description 1
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UZKWTJUDCOPSNM-UHFFFAOYSA-N methoxybenzene Substances CCCCOC=C UZKWTJUDCOPSNM-UHFFFAOYSA-N 0.000 description 1
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238000012544 monitoring process Methods 0.000 description 1
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239000000546 pharmaceutical excipient Substances 0.000 description 1
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URGAHOPLAPQHLN-UHFFFAOYSA-N sodium aluminosilicate Chemical compound [Na+].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O URGAHOPLAPQHLN-UHFFFAOYSA-N 0.000 description 1
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- 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
- 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

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Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
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Chemical Kinetics & Catalysis (AREA)
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Obesity (AREA)
Organic Chemistry (AREA)
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Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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SK5046-2005A 2003-08-05 2004-08-05 Spôsoby stabilizácie atorvastatínu SK50462005A3 (sk)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
CZ20032135A CZ295027B6 (cs)	2003-08-05	2003-08-05	Způsob stabilizace farmaceutické kompozice
CZ20040857A CZ296181B6 (cs)	2004-08-03	2004-08-03	Zpusob stabilizace farmaceutické úcinné tuhé látky atorvastatinu
PCT/CZ2004/000045 WO2005011638A2 (en)	2003-08-05	2004-08-05	Methods for the stabilization of atorvastatin

Publications (1)

Publication Number	Publication Date
SK50462005A3 true SK50462005A3 (sk)	2005-09-08

Family

ID=34117186

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
SK5046-2005A SK50462005A3 (sk)	2003-08-05	2004-08-05	Spôsoby stabilizácie atorvastatínu

Country Status (13)

Country	Link
US (1)	US20080171784A1 (de)
EP (1)	EP1653930B1 (de)
AT (1)	ATE381322T1 (de)
CA (1)	CA2535225A1 (de)
DE (1)	DE602004010817T2 (de)
EA (1)	EA007345B1 (de)
ES (1)	ES2298763T3 (de)
HR (1)	HRP20060089B1 (de)
PL (2)	PL1653930T3 (de)
PT (1)	PT1653930E (de)
RS (1)	RS20060081A (de)
SK (1)	SK50462005A3 (de)
WO (1)	WO2005011638A2 (de)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US7674923B2 (en) *	2004-09-28	2010-03-09	Teva Pharmaceutical Industries Ltd	Process for preparing forms of atorvastatin calcium substantially free of impurities
TWI318571B (en) *	2005-06-10	2009-12-21	Lilly Co Eli	Formulation of a thienopyridine platelet aggregation inhibitor
EP1741427A1 (de) *	2005-07-06	2007-01-10	KRKA, D.D., Novo Mesto	Pharmazeutische Zusammensetzung enthaltend Simvastatin und Ezetimibe
CA2547216A1 (en)	2005-09-21	2007-03-21	Renuka D. Reddy	Process for annealing amorphous atorvastatin
EP1810667A1 (de)	2006-01-20	2007-07-25	KRKA, tovarna zdravil, d.d., Novo mesto	Pharmazeutische Zusammensetzung enthaltend amorphes Atorvastatin
CZ300047B6 (cs) *	2007-03-02	2009-01-21	Zentiva, A. S.	Farmaceutická kompozice s obsahem úcinné látky atorvastatinu
EP2127628A1 (de)	2008-05-27	2009-12-02	Ranbaxy Laboratories Limited	Einheitsdosenverpackung
TR200806300A2 (tr) *	2008-08-22	2010-03-22	B�Lg�� Mahmut	Çözünürlük artırıcı farmasötlk formulasyon
EP2522348B1 (de)	2009-12-25	2016-05-25	Sawai Pharmaceutical Co., Ltd.	Atorvastatinhaltiges beschichtetes präparat
US9717707B2 (en)	2011-12-08	2017-08-01	Hexal Ag	Pharmaceutical statin composition
TWI636783B (zh) *	2012-04-18	2018-10-01	友霖生技醫藥股份有限公司	含匹伐他汀（ｐｉｔａｖａｓｔａｔｉｎ）穩定配方的醫藥組合物
ES2695158T3 (es)	2013-03-14	2019-01-02	Fresenius Kabi Deutschland Gmbh	Sistema de envasado para fármacos sensibles al oxígeno
WO2014140095A1 (en)	2013-03-14	2014-09-18	Becton Dickinson France S.A.S.	Injectable morphine formulations
EP3184103A1 (de)	2015-12-21	2017-06-28	Hexal AG	Pharmazeutische zusammensetzung mit atorvastatin oder einem salz davon
EP3272336A1 (de)	2016-07-19	2018-01-24	Stada Arzneimittel Ag	Atorvastatin-zusammensetzung

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US5180589A (en) *	1988-03-31	1993-01-19	E. R. Squibb & Sons, Inc.	Pravastatin pharmaceuatical compositions having good stability
JP3254219B2 (ja) *	1993-01-19	2002-02-04	ワーナー−ランバート・コンパニー	安定な経口用のｃｉ−９８１製剤およびその製法
ATE418979T2 (de) *	2000-06-09	2009-01-15	Lek Pharmaceuticals	Stabilisiertes arzneimittel und arzneizubereitung
EP1243524A3 (de) *	2001-03-16	2004-04-07	Pfizer Products Inc.	Pharmazeutisches Kit fÜr sauerstoffempfindliche Medikamente
EP1241110A1 (de) *	2001-03-16	2002-09-18	Pfizer Products Inc.	Ausgabeeinheit für sauerstoff-empfindlichen Medikamenten
CA2475722A1 (en) *	2002-02-14	2003-08-21	Romi Barat Singh	Formulations of atorvastatin stabilized with alkali metal additions
SI21302A (sl) *	2002-10-11	2004-04-30	LEK farmacevtska dru�ba d.d.	Stabiliziran farmacevtski izdelek z amorfno aktivno učinkovino

2004
- 2004-08-05 PL PL04738465T patent/PL1653930T3/pl unknown
- 2004-08-05 DE DE602004010817T patent/DE602004010817T2/de not_active Expired - Lifetime
- 2004-08-05 EA EA200500819A patent/EA007345B1/ru not_active IP Right Cessation
- 2004-08-05 ES ES04738465T patent/ES2298763T3/es not_active Expired - Lifetime
- 2004-08-05 PL PL379195A patent/PL379195A1/pl unknown
- 2004-08-05 AT AT04738465T patent/ATE381322T1/de not_active IP Right Cessation
- 2004-08-05 CA CA002535225A patent/CA2535225A1/en not_active Abandoned
- 2004-08-05 US US10/567,109 patent/US20080171784A1/en not_active Abandoned
- 2004-08-05 EP EP04738465A patent/EP1653930B1/de not_active Revoked
- 2004-08-05 SK SK5046-2005A patent/SK50462005A3/sk not_active Application Discontinuation
- 2004-08-05 HR HR20060089A patent/HRP20060089B1/xx not_active IP Right Cessation
- 2004-08-05 PT PT04738465T patent/PT1653930E/pt unknown
- 2004-08-05 RS YUP-2006/0081A patent/RS20060081A/sr unknown
- 2004-08-05 WO PCT/CZ2004/000045 patent/WO2005011638A2/en not_active Ceased

Also Published As

Publication number	Publication date
US20080171784A1 (en)	2008-07-17
HRP20060089B1 (en)	2008-05-31
DE602004010817T2 (de)	2008-12-11
EA007345B1 (ru)	2006-08-25
EP1653930A2 (de)	2006-05-10
WO2005011638A2 (en)	2005-02-10
PL379195A1 (pl)	2006-07-24
PL1653930T3 (pl)	2008-06-30
PT1653930E (pt)	2008-03-12
EP1653930B1 (de)	2007-12-19
HRP20060089A2 (en)	2006-05-31
CA2535225A1 (en)	2005-02-10
ES2298763T3 (es)	2008-05-16
RS20060081A (sr)	2008-06-05
EA200500819A1 (ru)	2006-02-24
WO2005011638A3 (en)	2005-10-20
ATE381322T1 (de)	2008-01-15
DE602004010817D1 (de)	2008-01-31

Legal Events

Date

Code

Title

Description

2012-07-03

TC4A

Change of owner's name

Owner name: ZENTIVA, K.S., PRAHA, DOLNI MECHOLUPY, CZ

Effective date: 20120524

2012-11-05

FC9A

Refused patent application

Publication	Publication Date	Title
EP1653930B1 (de)	2007-12-19	Verfahren zur stabilisierung von atorvastatin
CN100372529C (zh)	2008-03-05	包含无定形活性物质的稳定药物制剂
KR20090087041A (ko)	2009-08-14	프라수그렐을 포함하는 물품
Narang et al.	2015	Impact of excipient interactions on solid dosage form stability
EP1901736B1 (de)	2010-04-21	Pharmazeutische zusammensetzung mit simvastatin und ezetimibe
CA2376709A1 (en)	2002-09-16	Pharmaceutical kit for oxygen-sensitive drugs
RU2407515C2 (ru)	2010-12-27	Лекарственный препарат с покрытием из сахара
EP1296672B1 (de)	2008-12-31	Stabilisiertes arzneimittel und arzneizubereitung
EA014936B1 (ru)	2011-04-29	Фармацевтическая композиция, содержащая аморфный аторвастатин
Mahajan et al.	2005	The effect of inert atmospheric packaging on oxidative degradation in formulated granules
CZ2004857A3 (cs)	2006-01-11	Zpusob stabilizace farmaceutické úcinné tuhé látky atorvastatinu
CZ15276U1 (cs)	2005-03-29	Stabilizovaný farmaceutický přípravek s obsahem atorvastatinu
UA82549C2 (uk)	2008-04-25	Спосіб стабілізації аторвастатину та фармацевтична композиція
CZ13674U1 (cs)	2003-09-16	Stabilizované balení atorvastatinu
JP2004073377A (ja)	2004-03-11	固形医薬組成物中の有効成分の安定化方法