SI2849740T1 - Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in paracetamol ali propacetamol - Google Patents
Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in paracetamol ali propacetamol Download PDFInfo
- Publication number
- SI2849740T1 SI2849740T1 SI201330870T SI201330870T SI2849740T1 SI 2849740 T1 SI2849740 T1 SI 2849740T1 SI 201330870 T SI201330870 T SI 201330870T SI 201330870 T SI201330870 T SI 201330870T SI 2849740 T1 SI2849740 T1 SI 2849740T1
- Authority
- SI
- Slovenia
- Prior art keywords
- active ingredient
- pharmacologically active
- pain
- pharmaceutical composition
- pharmaceutical
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract 15
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract 5
- 229960005489 paracetamol Drugs 0.000 title claims abstract 5
- 229960003192 propacetamol Drugs 0.000 title claims abstract 4
- QTGAJCQTLIRCFL-UHFFFAOYSA-N propacetamol Chemical compound CCN(CC)CC(=O)OC1=CC=C(NC(C)=O)C=C1 QTGAJCQTLIRCFL-UHFFFAOYSA-N 0.000 title claims abstract 4
- 239000002831 pharmacologic agent Substances 0.000 claims abstract 14
- SIKJAQJRHWYJAI-UHFFFAOYSA-N Indole Chemical compound C1=CC=C2NC=CC2=C1 SIKJAQJRHWYJAI-UHFFFAOYSA-N 0.000 claims abstract 2
- 150000003839 salts Chemical class 0.000 claims abstract 2
- 208000002193 Pain Diseases 0.000 claims 7
- 239000002552 dosage form Substances 0.000 claims 3
- 150000001875 compounds Chemical class 0.000 claims 2
- 206010058019 Cancer Pain Diseases 0.000 claims 1
- 208000000094 Chronic Pain Diseases 0.000 claims 1
- 206010019233 Headaches Diseases 0.000 claims 1
- 206010065390 Inflammatory pain Diseases 0.000 claims 1
- 206010028391 Musculoskeletal Pain Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 231100000869 headache Toxicity 0.000 claims 1
- 150000003840 hydrochlorides Chemical class 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000007912 intraperitoneal administration Methods 0.000 claims 1
- 238000007913 intrathecal administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 150000002688 maleic acid derivatives Chemical class 0.000 claims 1
- 230000002981 neuropathic effect Effects 0.000 claims 1
- 230000003040 nociceptive effect Effects 0.000 claims 1
- 230000002093 peripheral effect Effects 0.000 claims 1
- 230000002980 postoperative effect Effects 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 230000001107 psychogenic effect Effects 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 208000009935 visceral pain Diseases 0.000 claims 1
Classifications
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- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
-
- 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
- A61K31/407—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 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
-
- 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]
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Pain & Pain Management (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Emergency Medicine (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Claims (13)
- EP 2849740 BI Farmacevtski sestavek, ki obsega (lr,4r)-6’-fluoro-N,N-dimetil-4-fenil-4’,9,-dihidro-3’H-spiro[cikloheksan-l,r-pirano[3,4,b]indol]-4-amin in paracetamol ali propacetamol Patentni zahtevki1. Farmacevtski sestavek, ki obsega: (a) prvo farmakološko aktivno sestavino, izbrano izmed spojine s splošno formulo (I) in fiziološko sprejemljivih soli le-te(I) in (b) drugo farmakološko aktivno sestavino, izbrano izmed paracetamola ali propacetamola.
- 2. Farmacevtski sestavek po zahtevku 1, kjer je prva farmakološko aktivna sestavina kemična spojina s formulo (I):(I) v obliki hidrokloridne, hemicitratne ali maleatne soli.
- 3. Farmacevtski sestavek po zahtevku 1 ali 2, kjer je druga farmakološko aktivna sestavina paracetamol.
- 4. Farmacevtski sestavek po katerem koli od prejšnjih zahtevkov, kjer je relativno masno razmerje prve farmakološko aktivne sestavine proti drugi farmakološko aktivni sestavini v območju od 1 : 30 do 1 : 1 000 000.
- 5. Farmacevtski sestavek po katerem koli od prejšnjih zahtevkov za uporabo pri preprečevanju ali zdravljenju bolečine.
- 6. Farmacevtski sestavek po zahtevku 5, kjer je bolečina: - periferna, centralna ali mišičnoskeletna bolečina; in/ali - akutna, subakutna ali kronična bolečina; in/ali - zmerna do huda bolečina; in/ali - nevropatska ali psihogena ali nociceptivna ali mešana bolečina; in/ali - bolečina v križu, visceralna bolečina ali glavobol; in/ali - pooperacijska (pokirurška) bolečina, bolečina zaradi raka ali vnetna bolečina.
- 7. Farmacevtska odmema oblika, ki obsega farmacevtski sestavek po katerem koli od prejšnjih zahtevkov.
- 8. Farmacevtska odmema oblika po zahtevku 7, ki vsebuje prvo farmakološko aktivno sestavino v odmerku 10-1200 pg.
- 9. Farmacevtska odmema oblika po zahtevku 7 ali 8, ki vsebuje drugo farmakološko aktivno sestavino v odmerku 100-8 000 mg.
- 10. Farmacevtska odmema oblika po katerem koli od zahtevkov 7-9, kjer je odmerek prve farmakološko aktivne sestavine v območju od 1 : 20 do 20 : 1 količine, ki je enako učinkovita kot odmerek druge farmakološko aktivne sestavine.
- 11. Farmacevtska odmema oblika po katerem koli od zahtevkov 7-10, ki je za peroralno, intravenozno, intraperitonealno, transdermalno, intratekalno, intramuskulamo, intranazalno, transmukozno, subkutano ali rektalno dajanje.
- 12. Komplet, ki obsega prvo farmacevtsko odmemo obliko, ki obsega prvo farmakološko aktivno sestavino, kot je definirana v zahtevku 1 ali 2, in drugo farmacevtsko odmemo obliko, ki obsega drago farmakološko aktivno sestavino, kot je definirana v zahtevku 1 ali 3.
- 13. Komplet po zahtevku 12, kjer sta prva in druga farmacevtska odmema oblika prilagojeni za sočasno ali zaporedno dajanje, bodisi na enak ali drugačen način dajanja.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12003897 | 2012-05-18 | ||
| PCT/EP2013/001468 WO2013170969A1 (en) | 2012-05-18 | 2013-05-16 | Pharmaceutical composition comprising (1r,4r)-6'-fluoro-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano'[3,4,b]indol]-4-amine and paracetamol or propacetamol |
| EP13723674.1A EP2849740B1 (en) | 2012-05-18 | 2013-05-16 | Pharmaceutical composition comprising (1r,4r)-6'-fluoro-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano'[3,4,b]indol]-4-amine and paracetamol or propacetamol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2849740T1 true SI2849740T1 (sl) | 2018-01-31 |
Family
ID=48468208
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201330870T SI2849740T1 (sl) | 2012-05-18 | 2013-05-16 | Farmacevtski sestavek, ki obsega (1r,4r)-6'-fluoro-N,N-dimetil-4-fenil- 4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano(3,4,b)indol)-4-amin in paracetamol ali propacetamol |
Country Status (22)
| Country | Link |
|---|---|
| US (3) | US20130310435A1 (sl) |
| EP (1) | EP2849740B1 (sl) |
| JP (1) | JP6116676B2 (sl) |
| CN (2) | CN104302282A (sl) |
| AU (1) | AU2013262075B2 (sl) |
| BR (1) | BR112014028561A2 (sl) |
| CA (1) | CA2873644A1 (sl) |
| CY (1) | CY1119610T1 (sl) |
| DK (1) | DK2849740T3 (sl) |
| EA (1) | EA026949B1 (sl) |
| ES (1) | ES2650441T3 (sl) |
| HR (1) | HRP20171438T1 (sl) |
| HU (1) | HUE034676T2 (sl) |
| IL (1) | IL235651B (sl) |
| LT (1) | LT2849740T (sl) |
| MX (1) | MX352596B (sl) |
| NO (1) | NO2849740T3 (sl) |
| PL (1) | PL2849740T3 (sl) |
| PT (1) | PT2849740T (sl) |
| RS (1) | RS56617B1 (sl) |
| SI (1) | SI2849740T1 (sl) |
| WO (1) | WO2013170969A1 (sl) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10022353B2 (en) | 2015-01-23 | 2018-07-17 | Grünenthal GmbH | Cebranopadol for treating pain in subjects with impaired hepatic and/or impaired renal function |
| JP7373904B2 (ja) | 2016-02-29 | 2023-11-06 | パーク・セラピューティクス・インコーポレイテッド | セブラノパドールの滴定 |
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| EP0068838B1 (en) | 1981-06-26 | 1986-09-17 | The Upjohn Company | Analgesic process and composition |
| US4389393A (en) | 1982-03-26 | 1983-06-21 | Forest Laboratories, Inc. | Sustained release therapeutic compositions based on high molecular weight hydroxypropylmethylcellulose |
| US4404208A (en) | 1982-06-30 | 1983-09-13 | E. I. Du Pont De Nemours And Company | Analgesic mixture of nalbuphine and tiflamizole |
| IE55189B1 (en) | 1982-07-08 | 1990-06-20 | Wyeth John & Brother Ltd | Pharmaceutical compositions |
| US4765989A (en) | 1983-05-11 | 1988-08-23 | Alza Corporation | Osmotic device for administering certain drugs |
| US4612008A (en) | 1983-05-11 | 1986-09-16 | Alza Corporation | Osmotic device with dual thermodynamic activity |
| US4783337A (en) | 1983-05-11 | 1988-11-08 | Alza Corporation | Osmotic system comprising plurality of members for dispensing drug |
| DE3665538D1 (en) | 1985-01-23 | 1989-10-19 | Asta Pharma Ag | Synergistic combination of flupirtin and non-steroidal anti-phlogistics |
| EP0473655B1 (en) | 1989-05-22 | 1997-01-15 | Biochemical Veterinary Research Pty. Ltd. | Divalent metal salts of indomethacin |
| CA2112378A1 (en) | 1991-07-04 | 1993-01-21 | Masakazu Kanazawa | Analgesic preparation |
| JPH05221857A (ja) * | 1992-02-14 | 1993-08-31 | Arakusu:Kk | 配合解熱鎮痛剤 |
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| DE10360792A1 (de) | 2003-12-23 | 2005-07-28 | Grünenthal GmbH | Spirocyclische Cyclohexan-Derivate |
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| AU2011287955B2 (en) * | 2010-08-04 | 2015-07-09 | Grünenthal GmbH | Pharmaceutical dosage form comprising 6'-fluoro-(N-methyl- or N,N-dimethyl-)-4-phenyl-4',9'-dihydro-3'H-spiro[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine for the treatment of neuropathic pain |
| EP2600846B1 (en) * | 2010-08-04 | 2015-11-25 | Grünenthal GmbH | Pharmaceutical dosage form comprising 6'-fluoro-(n-methyl- or n,n-dimethyl-)-4-phenyl-4',9'-dihydro-3'h-spiro[cylohexane-1,1'-pyrano[3,4,b]indol]-4-amine |
| US9320729B2 (en) | 2012-05-18 | 2016-04-26 | Gruenenthal Gmbh | Pharmaceutical composition comprising (1r,4r)-6′-flouro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano-[3,4,b]indol]-4-amine and a propionic acid derivative |
-
2013
- 2013-05-13 US US13/892,969 patent/US20130310435A1/en not_active Abandoned
- 2013-05-16 EP EP13723674.1A patent/EP2849740B1/en not_active Not-in-force
- 2013-05-16 HU HUE13723674A patent/HUE034676T2/hu unknown
- 2013-05-16 JP JP2015511955A patent/JP6116676B2/ja active Active
- 2013-05-16 MX MX2014012723A patent/MX352596B/es active IP Right Grant
- 2013-05-16 PL PL13723674T patent/PL2849740T3/pl unknown
- 2013-05-16 RS RS20171229A patent/RS56617B1/sr unknown
- 2013-05-16 HR HRP20171438TT patent/HRP20171438T1/hr unknown
- 2013-05-16 NO NO13723674A patent/NO2849740T3/no unknown
- 2013-05-16 CN CN201380025683.XA patent/CN104302282A/zh active Pending
- 2013-05-16 SI SI201330870T patent/SI2849740T1/sl unknown
- 2013-05-16 EA EA201401272A patent/EA026949B1/ru not_active IP Right Cessation
- 2013-05-16 ES ES13723674.1T patent/ES2650441T3/es active Active
- 2013-05-16 BR BR112014028561A patent/BR112014028561A2/pt not_active IP Right Cessation
- 2013-05-16 CN CN201810706944.9A patent/CN108524498A/zh active Pending
- 2013-05-16 CA CA2873644A patent/CA2873644A1/en not_active Abandoned
- 2013-05-16 DK DK13723674.1T patent/DK2849740T3/da active
- 2013-05-16 LT LTEP13723674.1T patent/LT2849740T/lt unknown
- 2013-05-16 AU AU2013262075A patent/AU2013262075B2/en not_active Ceased
- 2013-05-16 WO PCT/EP2013/001468 patent/WO2013170969A1/en not_active Ceased
- 2013-05-16 PT PT137236741T patent/PT2849740T/pt unknown
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2014
- 2014-11-12 IL IL235651A patent/IL235651B/en active IP Right Grant
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2017
- 2017-10-06 US US15/726,761 patent/US20180092867A1/en not_active Abandoned
- 2017-11-20 CY CY20171101212T patent/CY1119610T1/el unknown
-
2019
- 2019-07-03 US US16/502,651 patent/US11311504B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| ES2650441T3 (es) | 2018-01-18 |
| JP2015516449A (ja) | 2015-06-11 |
| JP6116676B2 (ja) | 2017-04-19 |
| HRP20171438T1 (hr) | 2017-11-03 |
| HUE034676T2 (hu) | 2018-02-28 |
| CN108524498A (zh) | 2018-09-14 |
| MX2014012723A (es) | 2015-01-15 |
| EP2849740B1 (en) | 2017-09-13 |
| CA2873644A1 (en) | 2013-11-21 |
| WO2013170969A1 (en) | 2013-11-21 |
| LT2849740T (lt) | 2017-12-27 |
| CN104302282A (zh) | 2015-01-21 |
| CY1119610T1 (el) | 2018-04-04 |
| US11311504B2 (en) | 2022-04-26 |
| AU2013262075B2 (en) | 2017-10-26 |
| MX352596B (es) | 2017-11-30 |
| IL235651A0 (en) | 2015-01-29 |
| IL235651B (en) | 2018-08-30 |
| US20130310435A1 (en) | 2013-11-21 |
| US20180092867A1 (en) | 2018-04-05 |
| EP2849740A1 (en) | 2015-03-25 |
| BR112014028561A2 (pt) | 2017-07-25 |
| HK1204940A1 (en) | 2015-12-11 |
| PT2849740T (pt) | 2017-12-13 |
| NO2849740T3 (sl) | 2018-02-10 |
| US20190350884A1 (en) | 2019-11-21 |
| EA026949B1 (ru) | 2017-06-30 |
| AU2013262075A1 (en) | 2015-01-22 |
| EA201401272A1 (ru) | 2015-05-29 |
| PL2849740T3 (pl) | 2018-03-30 |
| DK2849740T3 (da) | 2017-11-20 |
| RS56617B1 (sr) | 2018-02-28 |
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