HRP20140622T4 - Farmaceutski pripravak ibuprofena za injekciju - Google Patents
Farmaceutski pripravak ibuprofena za injekciju Download PDFInfo
- Publication number
- HRP20140622T4 HRP20140622T4 HRP20140622TT HRP20140622T HRP20140622T4 HR P20140622 T4 HRP20140622 T4 HR P20140622T4 HR P20140622T T HRP20140622T T HR P20140622TT HR P20140622 T HRP20140622 T HR P20140622T HR P20140622 T4 HRP20140622 T4 HR P20140622T4
- Authority
- HR
- Croatia
- Prior art keywords
- ibuprofen
- pharmaceutical preparation
- preparation
- injection
- value
- Prior art date
Links
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 title claims 10
- 229960001680 ibuprofen Drugs 0.000 title claims 10
- 238000002347 injection Methods 0.000 title claims 7
- 239000007924 injection Substances 0.000 title claims 7
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 13
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 3
- 229960000281 trometamol Drugs 0.000 claims 3
- 206010061218 Inflammation Diseases 0.000 claims 2
- 208000002193 Pain Diseases 0.000 claims 2
- 206010037660 Pyrexia Diseases 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 230000004054 inflammatory process Effects 0.000 claims 2
- -1 polyethylene Polymers 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 239000004698 Polyethylene Substances 0.000 claims 1
- 239000004743 Polypropylene Substances 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000011521 glass Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920000573 polyethylene Polymers 0.000 claims 1
- 229920001155 polypropylene Polymers 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Claims (15)
1. Farmaceutski pripravak ibuprofena za injekciju koji sadrži vodenu otopinu ibuprofena i trometamola, naznačen time da je koncentracija ibuprofena između 2 i 6 mg/ml, koncentracija trometamola je između 1.8 i 5.8 mg/ml, a pH vrijednost je između 8.0 i 9.0.
2. Farmaceutski pripravak ibuprofena za injekciju prema Zahtjevu 1, naznačen time da je koncentracija ibuprofena oko 4 mg/ml.
3. Farmaceutski pripravak prema Zahtjevima 1 ili 2, naznačen time da je koncentracija trometamola približno 3.8 mg/ml.
4. Farmaceutski pripravak prema bilo kojem od prethodnih Zahtjeva 1 do 3, koji se može sterilizirati toplinom u autoklavu na temperaturi između 110°C i 130°C u trajanju između 2 i 190 minuta.
5. Farmaceutski pripravak prema Zahtjevu 4, naznačen time da se taj pripravak može sterilizirati toplinom u autoklavu na temperaturi od 121°C u trajanju od 15 minuta.
6. Farmaceutski pripravak ibuprofena za injekciju prema bilo kojem od prethodnih Zahtjeva 1 do 5 naznačen time da je, kad se taj pripravak drži u staklenim bočicama, pH vrijednost između 8.0 i 9.0.
7. Farmaceutski pripravak ibuprofena za injekciju prema bilo kojem od prethodnih Zahtjeva 1 do 5, naznačen time da je, kad se taj pripravak drži u polietilenskim bočicama, pH vrijednost između 8.0 i 9.0.
8. Farmaceutski pripravak ibuprofena za injekciju prema bilo kojem od prethodnih Zahtjeva 1 do 5 naznačen time da je, kad se taj pripravak drži u polipropilenskim bočicama, pH vrijednost između 8.0 i 9.0.
9. Farmaceutski pripravak ibuprofena za injekciju prema bilo kojem od prethodnih Zahtjeva 1 do 5, naznačen time da je, kad se taj pripravak drži u bočicama od PVC-a, pH vrijednost između 8.0 i 9.0.
10. Farmaceutski pripravak prema bilo kojem od prethodnih Zahtjeva, naznačen time da je pH vrijednost oko 8.5.
11. Farmaceutski pripravak prema bilo kojem od prethodnih Zahtjeva, koji nadalje sadrži neku sol u dovoljnoj količini koja tom pripravku pridaje osmolalitet od oko 300 mOsm/kg.
12. Farmaceutski pripravak prema Zahtjevu 11, naznačen time da je ta sol NaCl u koncentraciji od približno 7.7 mg/ml.
13. Pripravak prema bilo kojem od Zahtjeva od 1 do 12 za primjenu u liječenju bolova, upala ili groznice.
14. Pripravak prema Zahtjevu 13, koji se isporučuje u bočicama od 100 ml ili 200 ml.
15. Korištenje farmaceutskog pripravka prema bilo kojem od Zahtjeva od 1 do 12 u proizvodnji lijeka za liječenje bolova, upala ili groznice.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/ES2010/070330 WO2011144766A1 (es) | 2010-05-18 | 2010-05-18 | Composición farmacéutica de ibuprofeno para inyección |
| EP11720479.2A EP2571488B2 (en) | 2010-05-18 | 2011-05-18 | Pharmaceutical composition of ibuprofen for injection |
| PCT/EP2011/058087 WO2011144677A1 (en) | 2010-05-18 | 2011-05-18 | Pharmaceutical composition of ibuprofen for injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20140622T1 HRP20140622T1 (en) | 2014-09-26 |
| HRP20140622T4 true HRP20140622T4 (hr) | 2017-10-06 |
Family
ID=43589415
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20140622TT HRP20140622T4 (hr) | 2010-05-18 | 2014-06-30 | Farmaceutski pripravak ibuprofena za injekciju |
Country Status (35)
| Country | Link |
|---|---|
| US (1) | US9114165B2 (hr) |
| EP (1) | EP2571488B2 (hr) |
| JP (1) | JP6018048B2 (hr) |
| KR (1) | KR101770808B1 (hr) |
| CN (1) | CN102892410B (hr) |
| AU (1) | AU2011254583B2 (hr) |
| BR (1) | BR112012029171B1 (hr) |
| CA (1) | CA2798575C (hr) |
| CL (1) | CL2012003119A1 (hr) |
| CO (1) | CO6650419A2 (hr) |
| CR (1) | CR20120559A (hr) |
| CY (1) | CY1115394T1 (hr) |
| DK (1) | DK2571488T4 (hr) |
| EC (1) | ECSP12012274A (hr) |
| ES (1) | ES2478491T5 (hr) |
| HK (1) | HK1177424A1 (hr) |
| HR (1) | HRP20140622T4 (hr) |
| IL (1) | IL222497A0 (hr) |
| MA (1) | MA34176B1 (hr) |
| ME (1) | ME01834B (hr) |
| MX (1) | MX2012013402A (hr) |
| MY (1) | MY160302A (hr) |
| NZ (1) | NZ602957A (hr) |
| PE (1) | PE20130374A1 (hr) |
| PL (1) | PL2571488T5 (hr) |
| PT (1) | PT2571488E (hr) |
| RS (1) | RS53408B2 (hr) |
| RU (1) | RU2012154628A (hr) |
| SG (1) | SG185061A1 (hr) |
| SI (1) | SI2571488T2 (hr) |
| SM (1) | SMT201400103B (hr) |
| TN (1) | TN2012000487A1 (hr) |
| UA (1) | UA103290C2 (hr) |
| WO (2) | WO2011144766A1 (hr) |
| ZA (1) | ZA201207948B (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9072710B2 (en) * | 2012-03-16 | 2015-07-07 | Cumberland Pharmaceuticals Inc. | Injectable ibuprofen formulation |
| CN104323988A (zh) * | 2014-11-27 | 2015-02-04 | 北京蓝丹医药科技有限公司 | 一种用于注射的右旋布洛芬药物组合物 |
| CN105055389B (zh) * | 2015-08-03 | 2018-08-10 | 北京蓝丹医药科技有限公司 | 一种用于早产儿先天性心脏病的布洛芬药物组合物 |
| CN105997901A (zh) * | 2016-07-27 | 2016-10-12 | 济南东方开元医药新技术有限公司 | 小儿注射用布洛芬氨丁三醇冻干粉针组合物及制备方法 |
| EP3893840A1 (en) * | 2018-12-14 | 2021-10-20 | Fresenius Kabi Austria GmbH | Pharmaceutical compositions for parenteral administration comprising ibuprofen and a phosphate buffer |
| CN112526013B (zh) * | 2020-11-20 | 2022-09-06 | 人福普克药业（武汉）有限公司 | 超高液相色谱法检测布洛芬药物中有关物质浓度方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19912436A1 (de) | 1999-03-19 | 2000-09-21 | Merckle Gmbh | Ibuprofen-Lösung |
| US20040132823A1 (en) | 2001-11-02 | 2004-07-08 | Leo Pavliv | Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid |
| ES2253326T3 (es) | 2001-11-02 | 2006-06-01 | Cumberland Pharmaceuticals Inc. | Composicion farmaceutica de acido 2-(4-isobutilfenilo)propionico. |
| ITMI20040235A1 (it) | 2004-02-13 | 2004-05-13 | Therapicon Srl | Preparazione farmaceutica per il cavo orale |
-
2010
- 2010-05-18 WO PCT/ES2010/070330 patent/WO2011144766A1/es active Application Filing
-
2011
- 2011-05-18 JP JP2013510623A patent/JP6018048B2/ja active Active
- 2011-05-18 PT PT11720479T patent/PT2571488E/pt unknown
- 2011-05-18 ES ES11720479.2T patent/ES2478491T5/es active Active
- 2011-05-18 WO PCT/EP2011/058087 patent/WO2011144677A1/en active Application Filing
- 2011-05-18 SI SI201130206T patent/SI2571488T2/sl unknown
- 2011-05-18 CA CA2798575A patent/CA2798575C/en active Active
- 2011-05-18 MY MYPI2012700890A patent/MY160302A/en unknown
- 2011-05-18 DK DK11720479.2T patent/DK2571488T4/en active
- 2011-05-18 PE PE2012002182A patent/PE20130374A1/es not_active Application Discontinuation
- 2011-05-18 RU RU2012154628/15A patent/RU2012154628A/ru unknown
- 2011-05-18 RS RS20140366A patent/RS53408B2/sr unknown
- 2011-05-18 BR BR112012029171-8A patent/BR112012029171B1/pt active IP Right Grant
- 2011-05-18 NZ NZ60295711A patent/NZ602957A/en unknown
- 2011-05-18 AU AU2011254583A patent/AU2011254583B2/en active Active
- 2011-05-18 PL PL11720479T patent/PL2571488T5/pl unknown
- 2011-05-18 EP EP11720479.2A patent/EP2571488B2/en active Active
- 2011-05-18 SG SG2012079570A patent/SG185061A1/en unknown
- 2011-05-18 ME MEP-2014-74A patent/ME01834B/me unknown
- 2011-05-18 UA UAA201214485A patent/UA103290C2/ru unknown
- 2011-05-18 KR KR1020127032850A patent/KR101770808B1/ko active IP Right Grant
- 2011-05-18 CN CN201180024380.7A patent/CN102892410B/zh not_active Ceased
- 2011-05-18 US US13/641,921 patent/US9114165B2/en active Active
- 2011-05-18 MA MA35330A patent/MA34176B1/fr unknown
- 2011-05-18 MX MX2012013402A patent/MX2012013402A/es active IP Right Grant
-
2012
- 2012-10-09 TN TNP2012000487A patent/TN2012000487A1/en unknown
- 2012-10-17 EC ECSP12012274 patent/ECSP12012274A/es unknown
- 2012-10-17 IL IL222497A patent/IL222497A0/en unknown
- 2012-10-22 ZA ZA2012/07948A patent/ZA201207948B/en unknown
- 2012-11-01 CR CR20120559A patent/CR20120559A/es unknown
- 2012-11-07 CL CL2012003119A patent/CL2012003119A1/es unknown
- 2012-12-17 CO CO12228358A patent/CO6650419A2/es unknown
-
2013
- 2013-04-10 HK HK13104392.1A patent/HK1177424A1/xx not_active IP Right Cessation
-
2014
- 2014-06-30 HR HRP20140622TT patent/HRP20140622T4/hr unknown
- 2014-07-29 SM SM201400103T patent/SMT201400103B/xx unknown
- 2014-07-30 CY CY20141100574T patent/CY1115394T1/el unknown
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