HRP20130184T1 - Stabilni injekcijski oblik paracetamola spreman za uporabu - Google Patents

Stabilni injekcijski oblik paracetamola spreman za uporabu Download PDF

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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
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HR
Croatia
Prior art keywords
paracetamol
aqueous solution
stable aqueous
group
acid
Prior art date
Application number
HRP20130184AT
Other languages
English (en)
Inventor
Ioulia Tseti
Original Assignee
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Ioulia Tseti
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.)
Filing date
Publication date
Application filed by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., Ioulia Tseti filed Critical Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Publication of HRP20130184T1 publication Critical patent/HRP20130184T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof

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  • 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.
HRP20130184AT 2010-05-19 2013-03-04 Stabilni injekcijski oblik paracetamola spreman za uporabu HRP20130184T1 (hr)

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

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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 (7)

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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
US20230165928A1 (en) * 2020-04-30 2023-06-01 Blue Sky Innovation, Llc 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

Family Cites Families (10)

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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
US9399012B2 (en) * 2007-11-13 2016-07-26 Mallinckrodt Ip Reduced dose intravenous acetaminophen
WO2009098716A2 (en) * 2008-01-17 2009-08-13 Aptuit Laurus Private Limited Stable pharmaceutical aqueous compositions
US20090246276A1 (en) * 2008-01-28 2009-10-01 Graham Jackson Pharmaceutical Compositions
EP2253323B1 (en) * 2008-02-29 2019-04-10 Meiji Co., Ltd. Anti-allergic agent

Also Published As

Publication number Publication date
CY1113999T1 (el) 2016-07-27
EP2389923A1 (en) 2011-11-30
WO2011144335A8 (en) 2012-12-06
DK2389923T3 (da) 2013-03-18
CN102985069A (zh) 2013-03-20
CA2799666C (en) 2016-02-16
ZA201208605B (en) 2013-09-25
ES2403121T3 (es) 2013-05-14
US20130210922A1 (en) 2013-08-15
WO2011144335A1 (en) 2011-11-24
CA2799666A1 (en) 2011-11-24
MA34314B1 (fr) 2013-06-01
AP2012006597A0 (en) 2012-12-31
PL2389923T3 (pl) 2013-06-28
MY160458A (en) 2017-03-15
EP2389923B1 (en) 2013-01-30
UA104381C2 (uk) 2014-01-27
PT2389923E (pt) 2013-03-28
SI2389923T1 (sl) 2013-06-28
CN102985069B (zh) 2014-11-26
SMT201300038B (it) 2013-07-09
HK1182315A1 (en) 2013-11-29
AP3151A (en) 2015-03-31
RU2519764C1 (ru) 2014-06-20
TN2012000516A1 (en) 2014-04-01
US8877817B2 (en) 2014-11-04
BR112012029212A2 (pt) 2020-09-29

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