HRP20180143T1 - 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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- HRP20180143T1 HRP20180143T1 HRP20180143TT HRP20180143T HRP20180143T1 HR P20180143 T1 HRP20180143 T1 HR P20180143T1 HR P20180143T T HRP20180143T T HR P20180143TT HR P20180143 T HRP20180143 T HR P20180143T HR P20180143 T1 HRP20180143 T1 HR P20180143T1
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- Croatia
- Prior art keywords
- dosage form
- pharmaceutical dosage
- active agent
- pharmacologically active
- general formula
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- 239000002552 dosage form Substances 0.000 title claims 14
- 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 10
- 208000002193 Pain Diseases 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- 229920000642 polymer Polymers 0.000 claims 3
- 235000014113 dietary fatty acids Nutrition 0.000 claims 2
- 239000000194 fatty acid Substances 0.000 claims 2
- 229930195729 fatty acid Natural products 0.000 claims 2
- 210000004051 gastric juice Anatomy 0.000 claims 2
- 238000000338 in vitro Methods 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
- -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
- 150000002148 esters Chemical class 0.000 claims 1
- 150000004665 fatty acids Chemical class 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 238000000034 method Methods 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
- 229920002689 polyvinyl acetate Polymers 0.000 claims 1
- 239000011118 polyvinyl acetate Substances 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 230000009278 visceral effect Effects 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
- 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
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Indole Compounds (AREA)
Claims (10)
1. Farmaceutski oblik doziranja za primjenu dva puta dnevno, jednom dnevno ili rjeđe, koji sadrži farmakološki aktivno sredstvo prema općoj formuli (I)
[image]
naznačen time da R je -H ili -CH3,
ili njihova fiziološki prihvatljiva sol;
koji u skladu s Europskom farmakopejom. u in vitro uvjetima u 900 mL umjetnog želučanog soka pri pH 1.2 i 37 ± 0.5°C u skladu s postupkom s miješalicom s utegom kod 100 okr/min nakon 30 minuta otpušta barem 50 % tež. farmakološki aktivnog sredstva, u odnosu na ukupnu količinu farmakološki aktivnog sredstva koje je izvorno sadržano u farmaceutskom obliku doziranja; i
koji sadrži kruti polimerni materijal matrice u kojem je farmakološki aktivno sredstvo prema općoj formuli (I) dispergirano i imobilizirano u amorfnom ili polu-amorfnom stanju, te pri čemu je polimer odabran iz skupine koju čine polivinilpirolidon, kopolimeri vinilpirolidon-polivinilacetat, te njihove bilo koje kombinacije; i
pri čemu je relativni omjer mase polimera u odnosu na farmakološki aktivno sredstvo prema općoj formuli (I) barem 6:1.
2. Farmaceutski oblik doziranja prema zahtjevu 1, naznačen time da nadalje sadrži surfaktant.
3. Farmaceutski oblik doziranja prema zahtjevu 2, naznačen time da
- surfaktant ima HLB vrijednost od barem 10; i/ili
- sadržaj surfaktanta je barem 0.001 % tež., u odnosu na ukupnu masu farmaceutskog oblika doziranja.
4. Farmaceutski oblik doziranja prema zahtjevu 2 ili 3, naznačen time da je surfaktant odabran iz skupine koju čine esteri polioksietilen masnih kiselina, parcijalni esteri masnih kiselina polioksietilensorbitana i esteri sumporne kiseline.
5. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivno sredstvo prema općoj formuli (I) ima stereokemiju prema općoj formuli (I')
[image]
pri čemu je R definiran kao u zahtjevu 1.
6. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivno sredstvo 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.
7. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, koji u in vitro uvjetima u 900 ml umjetnog želučanog soka pri pH 1,2 nakon 30 minuta otpušta barem 80 % tež. farmakološki aktivnog sredstva prema općoj formuli (I), u odnosu na ukupnu količinu farmakološki aktivnog sredstva prema općoj formuli (I) koje je izvorno sadržano u obliku doziranja.
8. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži farmakološki aktivno sredstvo prema općoj formuli (I) u dozi od 10 µg do 50 µg ili od 300 µg do 500 µg.
9. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva naznačen time da je za uporabu za liječenje boli.
10. Farmaceutski oblik doziranja prema zahtjevu 9, naznačen time da je bol odabrana od akutne, visceralne, neuropatske ili kronične boli.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US37064310P | 2010-08-04 | 2010-08-04 | |
| EP10008116 | 2010-08-04 | ||
| EP11746175.6A EP2600839B1 (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 |
| PCT/EP2011/003909 WO2012016699A2 (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 |
|---|---|
| HRP20180143T1 true HRP20180143T1 (hr) | 2018-02-23 |
Family
ID=43481034
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180143TT HRP20180143T1 (hr) | 2010-08-04 | 2018-01-25 | 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 (28)
| Country | Link |
|---|---|
| EP (1) | EP2600839B1 (hr) |
| JP (1) | JP5792300B2 (hr) |
| KR (1) | KR101828768B1 (hr) |
| CN (1) | CN103179953A (hr) |
| AR (1) | AR082560A1 (hr) |
| AU (1) | AU2011287956B2 (hr) |
| BR (1) | BR112013002714A2 (hr) |
| CA (1) | CA2804878C (hr) |
| CL (1) | CL2012003582A1 (hr) |
| CO (1) | CO6640315A2 (hr) |
| CY (1) | CY1119887T1 (hr) |
| DK (1) | DK2600839T3 (hr) |
| EC (1) | ECSP13012419A (hr) |
| ES (1) | ES2665344T3 (hr) |
| HR (1) | HRP20180143T1 (hr) |
| HU (1) | HUE035543T2 (hr) |
| IL (1) | IL223880A (hr) |
| LT (1) | LT2600839T (hr) |
| MX (1) | MX345068B (hr) |
| NZ (1) | NZ604735A (hr) |
| PE (1) | PE20131107A1 (hr) |
| PL (1) | PL2600839T3 (hr) |
| PT (1) | PT2600839T (hr) |
| RS (1) | RS57027B1 (hr) |
| RU (1) | RU2582390C2 (hr) |
| SI (1) | SI2600839T1 (hr) |
| WO (1) | WO2012016699A2 (hr) |
| ZA (1) | ZA201300038B (hr) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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） |
| BR112018017167A2 (pt) | 2016-02-29 | 2019-01-02 | Gruenenthal Gmbh | titulação de cebranopadol |
| WO2024129782A1 (en) | 2022-12-12 | 2024-06-20 | Park Therapeutics, Inc. | Regimens and compositions useful for alleviating pain |
| WO2024173714A1 (en) | 2023-02-15 | 2024-08-22 | Park Therapeutics, Inc. | Regimens and compositions useful for alleviating pain |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR038681A1 (es) * | 2002-02-14 | 2005-01-26 | Solvay Pharm Bv | Formulacion oral de solucion solida de una sustancia activa pobremente soluble en agua |
| DE10252667A1 (de) * | 2002-11-11 | 2004-05-27 | Grünenthal GmbH | Spirocyclische Cyclohexan-Derivate |
| US20070048228A1 (en) * | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| 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 |
| DE102007009235A1 (de) * | 2007-02-22 | 2008-09-18 | Grünenthal GmbH | Spirocyclische Cyclohexan-Derivate |
-
2011
- 2011-08-04 KR KR1020137005272A patent/KR101828768B1/ko active IP Right Grant
- 2011-08-04 RS RS20180336A patent/RS57027B1/sr unknown
- 2011-08-04 CN CN2011800382299A patent/CN103179953A/zh active Pending
- 2011-08-04 BR BR112013002714A patent/BR112013002714A2/pt not_active IP Right Cessation
- 2011-08-04 PE PE2013000192A patent/PE20131107A1/es active IP Right Grant
- 2011-08-04 ES ES11746175.6T patent/ES2665344T3/es active Active
- 2011-08-04 LT LTEP11746175.6T patent/LT2600839T/lt unknown
- 2011-08-04 EP EP11746175.6A patent/EP2600839B1/en active Active
- 2011-08-04 AU AU2011287956A patent/AU2011287956B2/en not_active Ceased
- 2011-08-04 AR ARP110102820A patent/AR082560A1/es not_active Application Discontinuation
- 2011-08-04 JP JP2013522137A patent/JP5792300B2/ja not_active Expired - Fee Related
- 2011-08-04 SI SI201131434T patent/SI2600839T1/en unknown
- 2011-08-04 HU HUE11746175A patent/HUE035543T2/en unknown
- 2011-08-04 MX MX2013001114A patent/MX345068B/es active IP Right Grant
- 2011-08-04 WO PCT/EP2011/003909 patent/WO2012016699A2/en active Application Filing
- 2011-08-04 NZ NZ604735A patent/NZ604735A/en not_active IP Right Cessation
- 2011-08-04 RU RU2013109134/15A patent/RU2582390C2/ru not_active IP Right Cessation
- 2011-08-04 PT PT117461756T patent/PT2600839T/pt unknown
- 2011-08-04 PL PL11746175T patent/PL2600839T3/pl unknown
- 2011-08-04 DK DK11746175.6T patent/DK2600839T3/da active
- 2011-08-04 CA CA2804878A patent/CA2804878C/en not_active Expired - Fee Related
-
2012
- 2012-12-19 CL CL2012003582A patent/CL2012003582A1/es unknown
- 2012-12-19 CO CO12230427A patent/CO6640315A2/es not_active Application Discontinuation
- 2012-12-25 IL IL223880A patent/IL223880A/en active IP Right Grant
-
2013
- 2013-01-02 ZA ZA2013/00038A patent/ZA201300038B/en unknown
- 2013-02-04 EC ECSP13012419 patent/ECSP13012419A/es unknown
-
2018
- 2018-01-25 HR HRP20180143TT patent/HRP20180143T1/hr unknown
- 2018-02-05 CY CY20181100142T patent/CY1119887T1/el unknown
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