SI2600851T1 - Farmacevtska oblika odmerka, ki zajema 6'-fluoro-(n-metil- ali n,n-dimetil-)-4-fenil-4',9'-dihidro-3'h-spiro(cikloheksan-1,1'-pirano (3,4,b)indol)-4-amin, za zdravljenje nevropatske bolečine - Google Patents

Farmacevtska oblika odmerka, ki zajema 6'-fluoro-(n-metil- ali n,n-dimetil-)-4-fenil-4',9'-dihidro-3'h-spiro(cikloheksan-1,1'-pirano (3,4,b)indol)-4-amin, za zdravljenje nevropatske bolečine Download PDF

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Publication number
SI2600851T1
SI2600851T1 SI201131497T SI201131497T SI2600851T1 SI 2600851 T1 SI2600851 T1 SI 2600851T1 SI 201131497 T SI201131497 T SI 201131497T SI 201131497 T SI201131497 T SI 201131497T SI 2600851 T1 SI2600851 T1 SI 2600851T1
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Slovenia
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dosage form
active agent
pharmacologically active
pharmaceutical dosage
dose
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SI201131497T
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Nadja Gruning
Marc Schiller
Ingo Friedrich
Chris Kirby
Ashish Hemani
John Bothmer
Andreas Scholz
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Gruenenthal Gmbh
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Application filed by Gruenenthal Gmbh filed Critical Gruenenthal Gmbh
Publication of SI2600851T1 publication Critical patent/SI2600851T1/sl

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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
    • A61K31/33—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
    • A61K31/403—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 carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • 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
    • A61K9/08—Solutions
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (7)

  1. FARMACEVTSKA OBLIKA ODMERKA, KI ZAJEMA 6’-FLUORO-(N-METIL- ALI N,N-DIMETIL-)-4-FENIL-4’,9’-DIHIDRO-3’H-SPIRO[CIKLOHEKSAN-l,l’-PIRANO[3,4,B]INDOL]-4-AMIN, ZA ZDRAVLJENJE NEVROPATSKE BOLEČINE Patentni zahtevki
    1. Farmacevtska oblika odmerka, ki vsebuje farmakološko aktivno sredstvo v skladu s sološno formulo
    ih pri čemer je R -H ali -CH3, ali njegovo fiziološko sprejemljivo sol, - ki v pogojih in vitro pri 37 ± 0,5 °C v 900 ml umetnega gastričnega soka z vrednostjo pH 1,2 v skladu z metodo lopatice s sidrom pri 100 vrt./min po 30 minutah sprosti najmanj 80-odstotni masni delež farmakološko aktivnega sredstva v skladu s splošno formulo (I) glede na skupno količino farmakološko aktivnega sredstva, ki je izvorno v obliki odmerka, v skladu s splošno formulo (O; - ki vsebuje farmakološko aktivno sredstvo v odmerku od 10 pg do 190 pg, izraženem kot odmerek ekvivalenta mase, ki temelji na prosti bazi; in - pri čemer je farmakokinetični parameter tmax, izražen kot povprečna vrednost, v obsegu od 0,5 do 16 h; za uporabo pri zdravljenju kronične nevropatske bolečine, pri čemer se farmacevtska oblika odmerka dovaja peroralno enkrat dnevno.
  2. 2. Farmacevtska oblika odmerka za uporabo v skladu s patentnim zahtevkom 1, ki vsebuje farmakološko aktivno sredstvo v odmerku od 25 pg do 80 pg, izraženem kot odmerek ekvivalenta mase, ki temelji na prosti bazi.
  3. 3. Farmacevtska oblika odmerka za uporabo v skladu s patentnim zahtevkom 1 ali 2, ki vsebuje farmakološko aktivno sredstvo v odmerku od 10 pg do 50 pg, izraženem kot odmerek ekvivalenta mase, ki temelji na prosti bazi.
  4. 4. Farmacevtska oblika odmerka za uporabo v skladu s katerim koli zgornjim patentnim zahtevkom, pri čemer ima farmakološko aktivno sredstvo v skladu s splošno formulo (I) stereokemijo v skladu s splošno formulo (I')
    pri čemer je R opredeljen, kot je določeno v patentnem zahtevku 1.
  5. 5. Farmacevtska oblika odmerka za uporabo v skladu s katerim koli zgornjim patentnim zahtevkom, pri čemer je farmakološko aktivno sredstvo v skladu s splošno formulo (I) (1 r,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,r-pirano[3,4,b]indol]-4-amin ali njegova fiziološko sprejemljiva sol.
  6. 6. Farmacevtska oblika odmerka za uporabo v skladu s katerim koli zgornjim patentnim zahtevkom, ki vsebuje farmakološko aktivno sredstvo v skladu s splošno formulo (I) v količini, ki je v zvezi z enkratnim dovajanjem oblike odmerka subterapevtska.
  7. 7. Farmacevtska oblika odmerka za uporabo v skladu s katerim koli zgornjim patentnim zahtevkom, ki vsebuje farmakološko aktivno sredstvo v skladu s splošno formulo (I) v količini, ki je v zvezi z zdravljenjem akutne bolečine subterapevtska.
SI201131497T 2010-08-04 2011-08-04 Farmacevtska oblika odmerka, ki zajema 6'-fluoro-(n-metil- ali n,n-dimetil-)-4-fenil-4',9'-dihidro-3'h-spiro(cikloheksan-1,1'-pirano (3,4,b)indol)-4-amin, za zdravljenje nevropatske bolečine SI2600851T1 (sl)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US37063410P 2010-08-04 2010-08-04
US37064810P 2010-08-04 2010-08-04
US37064310P 2010-08-04 2010-08-04
EP10008116 2010-08-04
EP10008115 2010-08-04
EP10008117 2010-08-04
EP11746174.9A EP2600851B1 (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[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine for the treatment of neuropathic pain
PCT/EP2011/003908 WO2012016698A2 (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[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine for the treatment of neuropathic pain

Publications (1)

Publication Number Publication Date
SI2600851T1 true SI2600851T1 (sl) 2018-07-31

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ID=45556332

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Application Number Title Priority Date Filing Date
SI201131608T SI2600850T1 (sl) 2010-08-04 2011-08-04 Farmacevtska oblika odmerka, ki zajema 6'-fluoro-(N-metil- ali N,N- dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano (3,4,B)indol)-4-amin, za zdravljenje nociceptivne bolečine
SI201131497T SI2600851T1 (sl) 2010-08-04 2011-08-04 Farmacevtska oblika odmerka, ki zajema 6'-fluoro-(n-metil- ali n,n-dimetil-)-4-fenil-4',9'-dihidro-3'h-spiro(cikloheksan-1,1'-pirano (3,4,b)indol)-4-amin, za zdravljenje nevropatske bolečine

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SI201131608T SI2600850T1 (sl) 2010-08-04 2011-08-04 Farmacevtska oblika odmerka, ki zajema 6'-fluoro-(N-metil- ali N,N- dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano (3,4,B)indol)-4-amin, za zdravljenje nociceptivne bolečine

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US (3) US20120034297A1 (sl)
EP (3) EP2600850B1 (sl)
JP (2) JP5792299B2 (sl)
KR (2) KR20130097173A (sl)
CN (2) CN103237545A (sl)
AU (2) AU2011287954B2 (sl)
BR (2) BR112013002734A2 (sl)
CA (2) CA2805523C (sl)
CL (2) CL2013000218A1 (sl)
CO (2) CO6670579A2 (sl)
DK (2) DK2600850T3 (sl)
EC (2) ECSP13012423A (sl)
ES (1) ES2675316T3 (sl)
HR (2) HRP20180904T1 (sl)
HU (1) HUE039328T2 (sl)
IL (2) IL224155A (sl)
LT (2) LT2600850T (sl)
MX (2) MX354686B (sl)
NZ (2) NZ605888A (sl)
PE (2) PE20131096A1 (sl)
PL (2) PL2600850T3 (sl)
PT (1) PT2600851T (sl)
RS (2) RS57344B1 (sl)
RU (2) RU2638818C2 (sl)
SI (2) SI2600850T1 (sl)
TR (1) TR201808244T4 (sl)
WO (2) WO2012016697A2 (sl)
ZA (1) ZA201300655B (sl)

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