HRP20151337T1 - Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili n,n-dimetil)-4-fenil-4',9'-dihidro-3'h-spiro[cikloheksan-1,1'-pirano[3,4,b]indol]-4-amin - Google Patents
Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili n,n-dimetil)-4-fenil-4',9'-dihidro-3'h-spiro[cikloheksan-1,1'-pirano[3,4,b]indol]-4-amin Download PDFInfo
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- HRP20151337T1 HRP20151337T1 HRP20151337TT HRP20151337T HRP20151337T1 HR P20151337 T1 HRP20151337 T1 HR P20151337T1 HR P20151337T T HRP20151337T T HR P20151337TT HR P20151337 T HRP20151337 T HR P20151337T HR P20151337 T1 HRP20151337 T1 HR P20151337T1
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- Croatia
- Prior art keywords
- dosage form
- pharmaceutical dosage
- general formula
- form according
- active substance
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- 239000002552 dosage form Substances 0.000 title claims 15
- SIKJAQJRHWYJAI-UHFFFAOYSA-N Indole Chemical compound C1=CC=C2NC=CC2=C1 SIKJAQJRHWYJAI-UHFFFAOYSA-N 0.000 title claims 5
- 239000013543 active substance Substances 0.000 claims 7
- 239000004094 surface-active agent Substances 0.000 claims 5
- 208000002193 Pain Diseases 0.000 claims 4
- 235000014113 dietary fatty acids Nutrition 0.000 claims 2
- 229930195729 fatty acid Natural products 0.000 claims 2
- 239000000194 fatty acid Substances 0.000 claims 2
- PZOUSPYUWWUPPK-UHFFFAOYSA-N indole Natural products CC1=CC=CC2=C1C=CN2 PZOUSPYUWWUPPK-UHFFFAOYSA-N 0.000 claims 2
- RKJUIXBNRJVNHR-UHFFFAOYSA-N indolenine Natural products C1=CC=C2CC=NC2=C1 RKJUIXBNRJVNHR-UHFFFAOYSA-N 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- -1 polyoxyethylene Polymers 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 208000000094 Chronic Pain Diseases 0.000 claims 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical class OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 208000005298 acute pain Diseases 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 150000004665 fatty acids Chemical class 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 210000004051 gastric juice Anatomy 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 208000004296 neuralgia Diseases 0.000 claims 1
- 230000002981 neuropathic effect Effects 0.000 claims 1
- 208000021722 neuropathic pain Diseases 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 230000009278 visceral effect Effects 0.000 claims 1
- 208000009935 visceral pain Diseases 0.000 claims 1
- 238000005550 wet granulation Methods 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (12)
1. Farmaceutski oblik doziranja za oralnu primjenu dva puta dnevno, jednom dnevno ili rjeđe, koji sadrži farmakološki aktivnu tvar prema općoj formuli (I)
[image]
naznačen time da R je -H ili -CH3,
ili njegova fiziološki prihvatljiva sol
i surfaktant, pri čemu surfaktant ima HLB vrijednost od barem 10.
2. Farmaceutski oblik doziranja prema zahtjevu 1, naznačen time da je tableta.
3. Farmaceutski oblik doziranja prema zahtjevima 1 ili 2, naznačen time da dodatno sadrži jedno ili više farmaceutskih pomoćnih sredstava odabranih iz skupine koja se sastoji od sredstva protiv prianjanja, veziva, sredstva za razgradnju, punila, sredstava za razrjeđivanje, sredstava za klizivost, lubrikanata i konzervansa.
4. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da je udio surfaktanta barem 0.001 tež.-%, bazirano na ukupnoj težini farmaceutski oblik doziranja.
5. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da se priprema pomoću vlažne granulacije iz vodene tekućine za granuliranje koja sadrži farmakološki aktivnu tvar prema općoj formuli (I) i surfaktant.
6. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da je surfaktant odabran iz skupine koja se sastoji od estera masnih kiselina polioksietilena, djelomičnih estera masnih kiselina polioksietilensorbitana i estera sumporne kiseline.
7. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivna tvar prema općoj formuli (I) ima stereokemiju prema općoj formuli (I')
[image]
pri čemu R je definiran kao u zahtjevu 1.
8. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivna tvar prema općoj formuli (I) je (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, (1r,4r)-6'-fluoro-N-metil-4-fenil-4',9'-dihidro-3'H-spiro[cikloheksan-1,1'-pirano-[3,4,b]indol]-4-amin, ili njihova fiziološki prihvatljiva sol.
9. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da oslobađa pod in vitro uvjetima u 900 mL umjetnog želučanog soka kod pH 1.2 nakon 30 minuta barem 80 tež.-% farmakološki aktivne tvari prema općoj formuli (I), bazirano na ukupnoj količini farmaceutski aktivne tvari prema općoj formuli (I) koja je izvorno sadržana u obliku doziranja.
10. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži farmakološki aktivnu tvar prema općoj formuli (I) u dozi od 10 µg do 50 µg ili od 300 µg do 500 µg.
11. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva naznačen time da je za uporabu za liječenje boli.
12. Farmaceutski oblik doziranja prema zahtjevu 11, naznačen time da je bol odabrana od akutne, visceralne, neuropatske ili kronične boli.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US37064810P | 2010-08-04 | 2010-08-04 | |
| EP10008117 | 2010-08-04 | ||
| PCT/EP2011/003900 WO2012016695A2 (en) | 2010-08-04 | 2011-08-04 | 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 |
| EP11745928.9A EP2600846B1 (en) | 2010-08-04 | 2011-08-04 | 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20151337T1 true HRP20151337T1 (hr) | 2016-01-01 |
Family
ID=43382487
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20151337TT HRP20151337T1 (hr) | 2010-08-04 | 2015-12-07 | Farmaceutski oblik doziranja koji sadrži 6'-fluoro-(n-metil- ili n,n-dimetil)-4-fenil-4',9'-dihidro-3'h-spiro[cikloheksan-1,1'-pirano[3,4,b]indol]-4-amin |
Country Status (27)
| Country | Link |
|---|---|
| EP (1) | EP2600846B1 (hr) |
| JP (1) | JP6010534B2 (hr) |
| KR (1) | KR101882663B1 (hr) |
| CN (1) | CN103079548A (hr) |
| AR (1) | AR082561A1 (hr) |
| AU (1) | AU2011287952B2 (hr) |
| BR (1) | BR112013002696A2 (hr) |
| CA (1) | CA2804077C (hr) |
| CL (1) | CL2012003583A1 (hr) |
| CO (1) | CO6640317A2 (hr) |
| DK (1) | DK2600846T3 (hr) |
| EC (1) | ECSP13012424A (hr) |
| ES (1) | ES2563735T3 (hr) |
| HK (1) | HK1183612A1 (hr) |
| HR (1) | HRP20151337T1 (hr) |
| HU (1) | HUE028436T2 (hr) |
| IL (1) | IL223888A (hr) |
| MX (1) | MX2013000015A (hr) |
| NZ (1) | NZ605841A (hr) |
| PE (1) | PE20131106A1 (hr) |
| PL (1) | PL2600846T3 (hr) |
| PT (1) | PT2600846E (hr) |
| RS (1) | RS54659B1 (hr) |
| RU (1) | RU2589831C2 (hr) |
| SI (1) | SI2600846T1 (hr) |
| TW (1) | TWI526445B (hr) |
| WO (1) | WO2012016695A2 (hr) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20131096A1 (es) | 2010-08-04 | 2013-10-10 | Gruenenthal Chemie | Forma de dosificacion farmaceutica que comprende 6'-fluoro-(n-metil-o n,n-dimetil)-4-fenil-4',9-dihidro-3'h-espiro[ciclohxan-1,1'-pirano[3,4,b]indol]-4-amina para el tratamiento de dolor neuropatico |
| DK2797924T3 (en) * | 2011-12-12 | 2016-08-01 | Gruenenthal Gmbh | Solid forms of (1 R, 4 R) -6 & apos; fluoro- (N, N-dimethyl) -4-phenyl-4 ', 9'-dihydro-3'H-spiro [cyclohexane-1,1'-pyran [3,4-b] indole] -4-amine and sulfuric acid |
| JP6276702B2 (ja) * | 2011-12-12 | 2018-02-07 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | （１ｒ，４ｒ）−６’−フルオロ−Ｎ，Ｎ−ジメチル−４−フェニル−４’，９’−ジヒドロ−３’Ｈ−スピロ−［シクロヘキサン−１，１’−ピラノ［３，４，ｂ］インドール］−４−アミン塩酸塩の固体形態 |
| US9855286B2 (en) * | 2012-05-18 | 2018-01-02 | Gruenenthal Gmbh | Pharmaceutical composition comprising (1r,4r)-6′-fluoro-N,N-di methyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano-[3,4,b]indol]-4-amine and a salicylic acid component |
| US9345689B2 (en) * | 2012-05-18 | 2016-05-24 | Gruenenthal Gmbh | 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 an anticonvulsant |
| US9320725B2 (en) * | 2012-05-18 | 2016-04-26 | Gruenenthal Gmbh | 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 a gabapentinoid |
| 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 |
| US9308196B2 (en) * | 2012-05-18 | 2016-04-12 | Gruenenthal Gmbh | Pharmaceutical composition comprising (1 r,4r) -6'-fluoro-N ,N-dimethyl-4-phenyl-4',9'-d ihydro-3'H-spiro[cyclohexane-1,1'-pyrano-[3,4,b]indol]-4-amine and an oxicam |
| US20130310435A1 (en) | 2012-05-18 | 2013-11-21 | Gruenenthal Gmbh | 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 |
| US8912226B2 (en) * | 2012-05-18 | 2014-12-16 | Gruenenthal Gmbh | 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 a NSAR |
| US20130310385A1 (en) | 2012-05-18 | 2013-11-21 | Gruenenthal Gmbh | 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 Antidepressants |
| WO2014205261A1 (en) * | 2013-06-19 | 2014-12-24 | The Brigham And Women's Hospital, Inc. | Nanocomposite hydrogels |
| TW201642853A (zh) * | 2015-01-23 | 2016-12-16 | 歌林達有限公司 | 用於治療肝功能之損傷及／或腎功能之損傷個體疼痛之西博帕多（Ｃｅｂｒａｎｏｐａｄｏｌ） |
| EP4353311A2 (en) | 2015-07-20 | 2024-04-17 | The Brigham and Women's Hospital, Inc. | Shear-thinning compositions as an intravascular embolic agent |
| BR112018017167A2 (pt) | 2016-02-29 | 2019-01-02 | Gruenenthal Gmbh | titulação de cebranopadol |
| CA3178470A1 (en) * | 2020-04-03 | 2021-10-07 | Vertex Pharmaceuticals Incorporated | Modulators of alpha-1 antitrypsin |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6294192B1 (en) * | 1999-02-26 | 2001-09-25 | Lipocine, Inc. | Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents |
| DE10252667A1 (de) * | 2002-11-11 | 2004-05-27 | Grünenthal GmbH | Spirocyclische Cyclohexan-Derivate |
| DE102005005446A1 (de) * | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| DE102006046745A1 (de) * | 2006-09-29 | 2008-04-03 | Grünenthal GmbH | Gemischte ORL1/µ-Agonisten zur Behandlung von Schmerz |
-
2011
- 2011-08-04 DK DK11745928.9T patent/DK2600846T3/en active
- 2011-08-04 JP JP2013522134A patent/JP6010534B2/ja not_active Expired - Fee Related
- 2011-08-04 NZ NZ605841A patent/NZ605841A/en not_active IP Right Cessation
- 2011-08-04 TW TW100127868A patent/TWI526445B/zh not_active IP Right Cessation
- 2011-08-04 RS RS20160105A patent/RS54659B1/en unknown
- 2011-08-04 HU HUE11745928A patent/HUE028436T2/hu unknown
- 2011-08-04 ES ES11745928.9T patent/ES2563735T3/es active Active
- 2011-08-04 PE PE2013000193A patent/PE20131106A1/es active IP Right Grant
- 2011-08-04 BR BR112013002696A patent/BR112013002696A2/pt not_active IP Right Cessation
- 2011-08-04 AR ARP110102821A patent/AR082561A1/es not_active Application Discontinuation
- 2011-08-04 AU AU2011287952A patent/AU2011287952B2/en not_active Ceased
- 2011-08-04 CA CA2804077A patent/CA2804077C/en not_active Expired - Fee Related
- 2011-08-04 EP EP11745928.9A patent/EP2600846B1/en active Active
- 2011-08-04 MX MX2013000015A patent/MX2013000015A/es active IP Right Grant
- 2011-08-04 WO PCT/EP2011/003900 patent/WO2012016695A2/en active Application Filing
- 2011-08-04 SI SI201130711T patent/SI2600846T1/sl unknown
- 2011-08-04 RU RU2013109138/15A patent/RU2589831C2/ru not_active IP Right Cessation
- 2011-08-04 PL PL11745928T patent/PL2600846T3/pl unknown
- 2011-08-04 KR KR1020137005293A patent/KR101882663B1/ko active IP Right Grant
- 2011-08-04 PT PT117459289T patent/PT2600846E/pt unknown
- 2011-08-04 CN CN2011800382208A patent/CN103079548A/zh active Pending
-
2012
- 2012-12-19 CO CO12230455A patent/CO6640317A2/es not_active Application Discontinuation
- 2012-12-19 CL CL2012003583A patent/CL2012003583A1/es unknown
- 2012-12-25 IL IL223888A patent/IL223888A/en active IP Right Grant
-
2013
- 2013-02-04 EC ECSP13012424 patent/ECSP13012424A/es unknown
- 2013-08-16 HK HK13109593.7A patent/HK1183612A1/xx not_active IP Right Cessation
-
2015
- 2015-12-07 HR HRP20151337TT patent/HRP20151337T1/hr unknown
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