DK2306982T3 - Farmaceutiske præparater af rosuvastatin calcium - Google Patents
Farmaceutiske præparater af rosuvastatin calcium Download PDFInfo
- Publication number
- DK2306982T3 DK2306982T3 DK08776549T DK08776549T DK2306982T3 DK 2306982 T3 DK2306982 T3 DK 2306982T3 DK 08776549 T DK08776549 T DK 08776549T DK 08776549 T DK08776549 T DK 08776549T DK 2306982 T3 DK2306982 T3 DK 2306982T3
- Authority
- DK
- Denmark
- Prior art keywords
- minutes
- rosuvastatin calcium
- alkali metal
- composition
- carbonate
- Prior art date
Links
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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (8)
1. Farmaceutisk præparat omfattende i) rosuvastatin calcium; ii) et alkalimetalcarbonat eller -hydrogencarbonat, eller blandinger deraf; og iii) eventuelt et eller flere farmaceutisk acceptable hjælpestoffer kendetegnet ved, at rosuvastatin calcium og et alkalimetalcarbonat eller -hydrogencarbonat, eller en blanding deraf er til stede i et molært forhold i intervallet 1:0,43 - 1,75; hvor præparatet tilvejebringer en opløsningsprofil for rosuvastatin calcium i 0,1 N HC1 således, at rosuvastatin calcium frigives i intervallet 15 - 25 % på 5 minutter, 40 - 50 % på 10 minutter, 60 - 70 % på 15 minutter, 70 - 80 % på 20 minutter, 80 - 90 % på 30 minutter, 85 - 95 % på 45 minutter og 90 - 100% på 60 minutter; efter forbindelse med et opløsningsmedium ved 37 °C ± 0.5 °C ifølge USP-metode 1 (kurv) og ved kurvhastighed på 100 omdrejninger/minut.
2. Præparat et ifølge krav 1, hvor alkalimetallet i alkalimetalcarbonatet eller -hydrogencarbonatet er valgt blandt Na og K.
3. Præparat et ifølge krav 2, hvor alkalimetalcarbonatet kan være valgt blandt vandfrit Na2CC>3 eller vandfrit K2CO3 eller blandinger deraf.
4. Præparat et ifølge krav 1, hvor det farmaceutisk acceptable hjælpestof kan være valgt fra gruppen bestående af fyldstof, desintegrerende middel og et smøremiddel.
5. Præparat ifølge krav 1, hvor det farmaceutiske præparat foreligger i en oral dosisform.
6. Præparat ifølge krav 1, hvor den orale dosisform er en tablet.
7. Præparat ifølge krav 1, hvor det farmaceutiske præparat udviser en opløsningsprofil, hvor ikke mere end 85 % af den samlede mængde rosuvastatin calcium frigives på 30 minutter.
8. Præparat et ifølge krav 1, hvor alkalimetalcarbonatet eller -hydrogencarbonatet er til stede i en mængde i intervallet 0.5 vægt-% til 2 vægt-% af det farmaceutiske præparat.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2008/052595 WO2009156796A1 (en) | 2008-06-27 | 2008-06-27 | Pharmaceutical compositions of rosuvastatin calcium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2306982T3 true DK2306982T3 (da) | 2015-04-20 |
Family
ID=40386506
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08776549T DK2306982T3 (da) | 2008-06-27 | 2008-06-27 | Farmaceutiske præparater af rosuvastatin calcium |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US20110098315A1 (da) |
| EP (1) | EP2306982B1 (da) |
| JP (1) | JP2011525901A (da) |
| KR (1) | KR101283147B1 (da) |
| AU (1) | AU2008358622A1 (da) |
| BR (1) | BRPI0822782A2 (da) |
| CA (1) | CA2728539A1 (da) |
| DK (1) | DK2306982T3 (da) |
| EA (1) | EA201170101A1 (da) |
| ES (1) | ES2535106T3 (da) |
| GE (1) | GEP20135735B (da) |
| IL (1) | IL210102A0 (da) |
| MA (1) | MA32498B1 (da) |
| MX (1) | MX2010013834A (da) |
| PT (1) | PT2306982E (da) |
| TN (1) | TN2010000585A1 (da) |
| TR (1) | TR201101807T2 (da) |
| WO (1) | WO2009156796A1 (da) |
| ZA (1) | ZA201009057B (da) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8609138B2 (en) * | 2010-06-30 | 2013-12-17 | Mochida Pharmaceutical Co., Ltd. | ω3 fatty acid compound preparation |
| RO129060B1 (ro) * | 2013-04-25 | 2014-11-28 | Antibiotice S.A. | Compoziţie farmaceutică stabilă cu rosuvastatină calcică amorfă |
| KR102240429B1 (ko) * | 2013-05-06 | 2021-04-15 | 한미약품 주식회사 | 로수바스타틴 또는 이의 약학적으로 허용되는 염이 함유된 필름 코팅층을 포함하는 복합 제형 |
| KR20150079373A (ko) | 2013-12-30 | 2015-07-08 | 한미약품 주식회사 | 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 |
| KR20170083071A (ko) | 2014-11-11 | 2017-07-17 | 시오노기 앤드 컴파니, 리미티드 | 광에 대해서 불안정한 약물을 함유하는 다층 정제 |
| JP6108635B2 (ja) * | 2015-05-14 | 2017-04-05 | ダイト株式会社 | ロスバスタチン含有口腔内速崩壊錠 |
| ES2931301T3 (es) | 2019-07-31 | 2022-12-28 | Intas Pharmaceuticals Ltd | Composición farmacéutica que comprende inhibidores de la HMG-CoA reductasa y fenofibrato |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HU217629B (hu) * | 1991-12-12 | 2000-03-28 | Novartis Ag. | Eljárás fluvasztatint tartalmazó stabilizált gyógyszerkészítmények előállítására |
| GB0001621D0 (en) * | 2000-01-26 | 2000-03-15 | Astrazeneca Ab | Pharmaceutical compositions |
| EP1501546B1 (de) * | 2002-05-03 | 2012-10-10 | Hexal AG | Stabile pharmazeutische formulierung für eine kombination aus einem statin mit einem ace-hemmer |
| US20040132771A1 (en) * | 2002-12-20 | 2004-07-08 | Pfizer Inc | Compositions of choleseteryl ester transfer protein inhibitors and HMG-CoA reductase inhibitors |
| ATE428411T1 (de) * | 2003-11-07 | 2009-05-15 | Jj Pharma Inc | Hdl-verstärkende kombinationstherapie-komplexe |
| WO2006134604A1 (en) * | 2005-06-15 | 2006-12-21 | Hetero Drugs Limited | Combination composition of cholesterol absorption inhibitor and 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor |
| EP1905424A3 (en) * | 2006-02-02 | 2008-04-30 | Ranbaxy Laboratories Limited | Process for the preparation of a pharmaceutical composition comprising stabilized statin particles |
| MX2008016573A (es) * | 2006-07-06 | 2009-01-28 | Teva Pharma | Composiciones con farmacocinetica controlada. |
| WO2008062476A2 (en) * | 2006-10-31 | 2008-05-29 | Glenmark Pharmaceutical Limited | Pharmaceutical composition comprising rosuvastatin or pharmaceutically accepatble salts thereof |
-
2008
- 2008-06-27 KR KR1020107029131A patent/KR101283147B1/ko not_active IP Right Cessation
- 2008-06-27 WO PCT/IB2008/052595 patent/WO2009156796A1/en active Application Filing
- 2008-06-27 EA EA201170101A patent/EA201170101A1/ru unknown
- 2008-06-27 JP JP2011515641A patent/JP2011525901A/ja active Pending
- 2008-06-27 BR BRPI0822782A patent/BRPI0822782A2/pt not_active IP Right Cessation
- 2008-06-27 EP EP08776549.1A patent/EP2306982B1/en not_active Not-in-force
- 2008-06-27 TR TR2011/01807T patent/TR201101807T2/xx unknown
- 2008-06-27 AU AU2008358622A patent/AU2008358622A1/en not_active Abandoned
- 2008-06-27 DK DK08776549T patent/DK2306982T3/da active
- 2008-06-27 MX MX2010013834A patent/MX2010013834A/es not_active Application Discontinuation
- 2008-06-27 CA CA2728539A patent/CA2728539A1/en not_active Abandoned
- 2008-06-27 PT PT87765491T patent/PT2306982E/pt unknown
- 2008-06-27 US US12/997,248 patent/US20110098315A1/en not_active Abandoned
- 2008-06-27 ES ES08776549.1T patent/ES2535106T3/es active Active
- 2008-06-27 GE GEAP200812071A patent/GEP20135735B/en unknown
-
2010
- 2010-12-17 ZA ZA2010/09057A patent/ZA201009057B/en unknown
- 2010-12-17 TN TNP2010000585A patent/TN2010000585A1/fr unknown
- 2010-12-19 IL IL210102A patent/IL210102A0/en unknown
-
2011
- 2011-01-21 MA MA33550A patent/MA32498B1/fr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2728539A1 (en) | 2009-12-30 |
| KR101283147B1 (ko) | 2013-07-05 |
| ZA201009057B (en) | 2012-01-25 |
| ES2535106T3 (es) | 2015-05-05 |
| EP2306982B1 (en) | 2015-01-07 |
| EP2306982A1 (en) | 2011-04-13 |
| IL210102A0 (en) | 2011-02-28 |
| EA201170101A1 (ru) | 2011-08-30 |
| MX2010013834A (es) | 2011-02-21 |
| AU2008358622A1 (en) | 2009-12-30 |
| US20110098315A1 (en) | 2011-04-28 |
| MA32498B1 (fr) | 2011-07-03 |
| BRPI0822782A2 (pt) | 2015-09-29 |
| PT2306982E (pt) | 2015-05-18 |
| KR20110027711A (ko) | 2011-03-16 |
| TR201101807T2 (tr) | 2012-02-21 |
| WO2009156796A1 (en) | 2009-12-30 |
| JP2011525901A (ja) | 2011-09-29 |
| GEP20135735B (en) | 2013-01-25 |
| TN2010000585A1 (en) | 2012-05-24 |
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