HRP20130184T1 - Stabilni injekcijski oblik paracetamola spreman za uporabu - Google Patents
Stabilni injekcijski oblik paracetamola spreman za uporabu Download PDFInfo
- Publication number
- HRP20130184T1 HRP20130184T1 HRP20130184AT HRP20130184T HRP20130184T1 HR P20130184 T1 HRP20130184 T1 HR P20130184T1 HR P20130184A T HRP20130184A T HR P20130184AT HR P20130184 T HRP20130184 T HR P20130184T HR P20130184 T1 HRP20130184 T1 HR P20130184T1
- Authority
- HR
- Croatia
- Prior art keywords
- paracetamol
- aqueous solution
- stable aqueous
- group
- acid
- Prior art date
Links
Classifications
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (15)
1. Stabilna vodena otopina paracetamola za uporabu u IV infuziji koja sadrži barem jedan spoj koji pomaže stabilnosti i otapanju paracetamola u otopini izabran iz grupe koja obuhvaća ciklodekstrine, barem jedan stabilizirajući spoj koji nosi barem jednu tiolnu funkcionalnu skupinu i barem jedan stabilizirajući spoj izabran iz grupe koja obuhvaća soli tiamina.
2. Stabilna vodena otopina prema zahtjevu 1, gdje su barem jedan spoj koji pomaže stabilnosti i otapanju paracetamola u otopini izabran iz grupe koja obuhvaća ciklodekstrine, barem jedan stabilizirajući spoj koji nosi barem jednu tiolnu funkcionalnu skupinu i barem jedan stabilizirajući spoj izabran iz grupe koja obuhvaća soli tiamina prisutni u ukupnoj koncentraciji između 0.001% i 20% m/v.
3. Stabilna vodena otopina prema zahtjevu 1 ili 2, gdje je barem jedan spoj koji pomaže stabilnosti i otapanju paracetamola u otopini izabran iz grupe koja obuhvaća hidroksialkil-beta-ciklodekstrine.
4. Stabilna vodena otopina paracetamola prema bilo kojem od zahtjeva 1 do 3, gdje barem jedan spoj koji pomaže stabilnosti i otapanju paracetamola u otopini jest 2-hidroksipropil-beta-ciklodekstrin.
5. Stabilna vodena otopina prema bilo kojem od zahtjeva 1 do 4, gdje je koncentracija barem jednog spoja koji pomaže stabilnosti i otapanju paracetamola u otopini između 0.2% m/v i 19% m/v, poželjno između 0.2% m/v i 6.0% m/v, posebno poželjno između 0.5% m/v i 3.0% m/v.
6. Stabilna vodena otopina paracetamola prema bilo kojem od zahtjeva 1 do 5, gdje se barem jedan stabilizirajući spoj koji nosi barem jednu tiolnu funkcionalnu skupinu izabire iz grupe koja obuhvaća tioglicerole, cistein, acetilcistein, tioglikolnu kiselinu i/ili njezine soli, ditiotreitol, reducirani glutation, tio-mliječnu kiselinu i/ili njezine soli, tioureu i merkaptoetansulfonsku kiselinu.
7. Stabilna vodena otopina paracetamola prema bilo kojem od zahtjeva 1 do 6, gdje barem jedan stabilizirajući spoj koji nosi barem jednu tiolnu funkcionalnu skupinu jest tioglicerol, poželjno monotioglicerol.
8. Stabilna vodena otopina paracetamola prema bilo kojem od zahtjeva 1 do 7, gdje je barem jedan stabilizirajući spoj koji nosi barem jednu tiolnu funkcionalnu skupinu prisutan u koncentraciji između 0.001% m/v i 0.2% m/v.
9. Stabilna vodena otopina paracetamola prema bilo kojem od zahtjeva 1 do 6, gdje barem jedan stabilizirajući spoj izabran iz grupe koja obuhvaća soli tiamina jest tiamin HCl.
10. Stabilna vodena otopina paracetamola prema bilo kojem od zahtjeva 1 do 9, gdje je barem jedan stabilizirajući spoj izabran iz grupe koja obuhvaća soli tiamina prisutan u koncentraciji između 0.00.1% m/v i 0.2% m/v.
11. Stabilna vodena otopina paracetamola prema bilo kojem od prethodnih zahtjeva, dalje sadrži sredstvo za kelatiranje.
12. Stabilna vodena otopina paracetamola prema zahtjevu 11, gdje se sredstvo za kelatiranje izabire iz grupe koja obuhvaća EDTA, nitrilotrioctenu kiselinu, etilendiamin-N,N’-dioctenu-N,N’-dipropionsku kiselinu, etilendiamin-tetra(metilen fosfatnu kiselinu), 2,2’(etilendiamino)-dimaslačnu kiselinu, etilen glikol bis(2-aminoetileter)-N,N,N’,N’-tetra octenu kiselinu, i/ili njihove soli, a poželjno je to EDTA.
13. Stabilna vodena otopina paracetamola prema zahtjevu 11 ili 12, gdje je sredstvo za kelatiranje prisutno u koncentraciji između 0.001% m/v i 0.2% m/v.
14. Stabilna vodena otopina paracetamola prema bilo kojem od prethodnih zahtjeva, gdje je pH između 4.0 i 7, i otopina je puferirana smjesom pufera izabranih između barem jednog u obliku kiseline i ioniziranom obliku od limunske, jabučne, octene, sorbinske, fosfatne, fumarne, mliječne, glukonske i vinske kiseline ili njihovih smjesa i poželjno je to dinatrijev fosfat dihidrat.
15. Stabilna vodena otopina paracetamola prema bilo kojem od prethodnih zahtjeva, gdje je koncentracija paracetamola između 0.20% i 10% m/v, poželjno između 0.5% i 1.5% m/v.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10005258A EP2389923B1 (en) | 2010-05-19 | 2010-05-19 | Stable ready to use injectable paracetamol formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20130184T1 true HRP20130184T1 (hr) | 2013-05-31 |
Family
ID=42338244
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20130184AT HRP20130184T1 (hr) | 2010-05-19 | 2013-03-04 | Stabilni injekcijski oblik paracetamola spreman za uporabu |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US8877817B2 (hr) |
| EP (1) | EP2389923B1 (hr) |
| CN (1) | CN102985069B (hr) |
| AP (1) | AP3151A (hr) |
| BR (1) | BR112012029212A2 (hr) |
| CA (1) | CA2799666C (hr) |
| CY (1) | CY1113999T1 (hr) |
| DK (1) | DK2389923T3 (hr) |
| ES (1) | ES2403121T3 (hr) |
| HK (1) | HK1182315A1 (hr) |
| HR (1) | HRP20130184T1 (hr) |
| MA (1) | MA34314B1 (hr) |
| MY (1) | MY160458A (hr) |
| PL (1) | PL2389923T3 (hr) |
| PT (1) | PT2389923E (hr) |
| RU (1) | RU2519764C1 (hr) |
| SI (1) | SI2389923T1 (hr) |
| SM (1) | SMT201300038B (hr) |
| TN (1) | TN2012000516A1 (hr) |
| UA (1) | UA104381C2 (hr) |
| WO (1) | WO2011144335A1 (hr) |
| ZA (1) | ZA201208605B (hr) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ZA201300398B (en) * | 2012-11-27 | 2013-09-25 | Genfarma Laboratories S L | Injectable liquid formulation of the combination of tramadol and paracetamol |
| WO2016008546A1 (en) * | 2014-07-18 | 2016-01-21 | Everbright Pharmaceuticals S.A.R.L. | Aqueous formulation comprising paracetamol and ibuprofen |
| CN105797166A (zh) * | 2016-03-30 | 2016-07-27 | 吉林长白山药业集团股份有限公司 | 用羟丙基环糊精包合对乙酰氨基酚制成液体制剂的方法 |
| WO2018192664A1 (en) | 2017-04-20 | 2018-10-25 | Hyloris Developments Sa | METHOD FOR PREPARING A COMPOSITION WITH A LOW DISSOLVED OXYGEN CONTENT, COMPRISING ACETAMINOPHEN, AND OPTIONALLY ONE OR MORE NSAIDs, AND A COMPOSITION OBTAINED THEREOF |
| WO2019180072A1 (en) | 2018-03-22 | 2019-09-26 | Bayer Pharma Aktiengesellschaft | Parenteral pharmaceutical composition comprising neladenoson bialanate |
| WO2021222835A1 (en) * | 2020-04-30 | 2021-11-04 | Purser Danny C | Compositions and methods comprising stable reduced glutathione |
| GR1010637B (el) * | 2023-01-13 | 2024-02-15 | Ιουλια Κλεωνος Τσετη | Σταθερο υδατικο διαλυμα παρακεταμολης για χρηση σε ενδοφλεβια εγχυση |
| WO2024246565A2 (en) | 2023-06-02 | 2024-12-05 | Ioulia Tseti | Pharmaceutical composition comprising ibuprofen |
| GR1010809B (el) * | 2023-09-13 | 2024-10-25 | Ιουλια Τσετη | Υδατικο διαλυμα ιβουπροφαινης παρακεταμολης για χρηση σε ενδοφλεβια χορηγηση |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CH648371A5 (de) | 1982-01-29 | 1985-03-15 | Fischer Ag Georg | Anschlusseinrichtung fuer armaturen. |
| US4727064A (en) | 1984-04-25 | 1988-02-23 | The United States Of America As Represented By The Department Of Health And Human Services | Pharmaceutical preparations containing cyclodextrin derivatives |
| FR2751875B1 (fr) | 1996-08-05 | 1998-12-24 | Scr Newpharm | Nouvelles formulations liquides stables a base de paracetamol et leur mode de preparation |
| JP2001233787A (ja) * | 2000-02-04 | 2001-08-28 | Patents Exploitation Co Bv | 小・中サイズのペプチド含有薬学的組成物 |
| US20040045546A1 (en) * | 2002-09-05 | 2004-03-11 | Peirce Management, Llc | Pharmaceutical delivery system for oral inhalation through nebulization consisting of inert substrate impregnated with substance (S) to be solubilized or suspended prior to use |
| FR2851164B1 (fr) * | 2003-02-14 | 2005-04-22 | Xuan Tho Nguyen | Formulation liquide injectable de paracetamol |
| JP5909750B2 (ja) * | 2007-11-13 | 2016-04-27 | マリンクロット アイピー | 低用量静脈内アセトアミノフェン |
| US20110015273A1 (en) * | 2008-01-17 | 2011-01-20 | Rajnarayana Kandhagatla | Stable pharmaceutical aqueous compositions |
| US20090246276A1 (en) * | 2008-01-28 | 2009-10-01 | Graham Jackson | Pharmaceutical Compositions |
| NZ587310A (en) * | 2008-02-29 | 2012-04-27 | Meiji Co Ltd | Anti-allergic agent comprising a fermentation product of a propionic acid bacterium |
-
2010
- 2010-05-19 PT PT100052588T patent/PT2389923E/pt unknown
- 2010-05-19 DK DK10005258.8T patent/DK2389923T3/da active
- 2010-05-19 PL PL10005258T patent/PL2389923T3/pl unknown
- 2010-05-19 EP EP10005258A patent/EP2389923B1/en active Active
- 2010-05-19 ES ES10005258T patent/ES2403121T3/es active Active
- 2010-05-19 SI SI201030168T patent/SI2389923T1/sl unknown
-
2011
- 2011-05-18 MA MA35461A patent/MA34314B1/fr unknown
- 2011-05-18 UA UAA201214331A patent/UA104381C2/uk unknown
- 2011-05-18 CA CA2799666A patent/CA2799666C/en not_active Expired - Fee Related
- 2011-05-18 CN CN201180024241.4A patent/CN102985069B/zh not_active Expired - Fee Related
- 2011-05-18 WO PCT/EP2011/002482 patent/WO2011144335A1/en active Application Filing
- 2011-05-18 US US13/695,785 patent/US8877817B2/en active Active
- 2011-05-18 AP AP2012006597A patent/AP3151A/xx active
- 2011-05-18 RU RU2012151433/15A patent/RU2519764C1/ru active
- 2011-05-18 BR BR112012029212-9A patent/BR112012029212A2/pt not_active Application Discontinuation
- 2011-05-18 MY MYPI2012004801A patent/MY160458A/en unknown
-
2012
- 2012-10-29 TN TNP2012000516A patent/TN2012000516A1/en unknown
- 2012-11-15 ZA ZA2012/08605A patent/ZA201208605B/en unknown
-
2013
- 2013-03-04 HR HRP20130184AT patent/HRP20130184T1/hr unknown
- 2013-03-22 CY CY20131100241T patent/CY1113999T1/el unknown
- 2013-04-03 SM SM201300038T patent/SMT201300038B/xx unknown
- 2013-08-16 HK HK13109609.9A patent/HK1182315A1/xx not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| US8877817B2 (en) | 2014-11-04 |
| AP2012006597A0 (en) | 2012-12-31 |
| DK2389923T3 (da) | 2013-03-18 |
| EP2389923B1 (en) | 2013-01-30 |
| EP2389923A1 (en) | 2011-11-30 |
| RU2519764C1 (ru) | 2014-06-20 |
| CA2799666A1 (en) | 2011-11-24 |
| CN102985069A (zh) | 2013-03-20 |
| SMT201300038B (it) | 2013-07-09 |
| US20130210922A1 (en) | 2013-08-15 |
| CN102985069B (zh) | 2014-11-26 |
| HK1182315A1 (en) | 2013-11-29 |
| MY160458A (en) | 2017-03-15 |
| ES2403121T3 (es) | 2013-05-14 |
| BR112012029212A2 (pt) | 2020-09-29 |
| CY1113999T1 (el) | 2016-07-27 |
| PT2389923E (pt) | 2013-03-28 |
| CA2799666C (en) | 2016-02-16 |
| TN2012000516A1 (en) | 2014-04-01 |
| SI2389923T1 (sl) | 2013-06-28 |
| ZA201208605B (en) | 2013-09-25 |
| UA104381C2 (uk) | 2014-01-27 |
| PL2389923T3 (pl) | 2013-06-28 |
| MA34314B1 (fr) | 2013-06-01 |
| WO2011144335A1 (en) | 2011-11-24 |
| WO2011144335A8 (en) | 2012-12-06 |
| AP3151A (en) | 2015-03-31 |
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