DK2224917T3 - Sammensætning med nikotin og opipramol samt anvendelse deraf - Google Patents

Sammensætning med nikotin og opipramol samt anvendelse deraf Download PDF

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DK2224917T3
DK2224917T3 DK08855517.2T DK08855517T DK2224917T3 DK 2224917 T3 DK2224917 T3 DK 2224917T3 DK 08855517 T DK08855517 T DK 08855517T DK 2224917 T3 DK2224917 T3 DK 2224917T3
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nicotine
opipramol
disease
pharmaceutically acceptable
pharmaceutical composition
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Eliahu Heldman
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Neuroderm Ltd
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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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/465—Nicotine; Derivatives thereof
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • 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
    • A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4406—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 3, e.g. zimeldine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
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    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
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    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • A—HUMAN NECESSITIES
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    • A61P25/34—Tobacco-abuse
    • A—HUMAN NECESSITIES
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    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Claims (19)

  1. Sammensætning med nikotin og opipramol samt anvendelse deraf Patentkrav
    1. Farmaceutisk sammensætning, der omfatter en nikotinagonist og en nikotinacetylcholinreceptor (nAChR)-desensibiliseringsinhibitor og en farmaceutisk acceptabel bærer, hvor nikotinagonisten er nikotin eller et farmaceutisk acceptabelt salt eller et N-oxid deraf; og nAChR-desensibiliseringsinhibitoren er opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf.
  2. 2. Farmaceutisk sammensætning ifølge krav 1, hvor nikotinagonisten er nikotin, og nAChR-desensibiliseringsinhibitoren er opipramol.
  3. 3. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor nikotinagonisten og nAChR-desensibiliseringsinhibitoren forekommer i et vægtforhold mellem nikotinagonist og nAChR-desensibiliseringsinhibitor på ca. 1:2 til ca. 1:100, fortrinsvis ca. 1:5 til ca. 1:20, mere fortrinsvis ca. 1:14.
  4. 4. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 3, hvor sammensætningen er egnet til oral, parenteral, transkutan, mukosal eller transdermal administration eller inhalationsadministration og fortrinsvis er i form af et tyggegummi, en tyndfilm, en pose, et transdermalt plaster, en kapsel, en tablet eller en næsespray.
  5. 5. Farmaceutisk sammensætning ifølge krav 4, der er et transdermalt plaster, som omfatter nikotin og opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf og en farmaceutisk acceptabel bærer, der er egnet til transdermal eller topisk administration.
  6. 6. Farmaceutisk sammensætning ifølge krav 5, hvor det transdermale plaster er formuleret med henblik på at tilvejebringe i det væsentlige kontinuerlig afgivelse af nikotinet og opipramolen til en patient.
  7. 7. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 6, der er udformet til controlled release-afgivelse af nikotinagonisten og nAChR-desensibiliseringsinhibitoren med en forudbestemt afgivelseshastighed, hvor den forudbestemte afgivelseshastighed fortrinsvis i det væsentlige er kontinuerlig i løbet af mindst 1 dag.
  8. 8. Farmaceutisk controlled release-sammensætning ifølge krav 7, der omfatter nikotin og opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf.
  9. 9. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 8 til anvendelse ved behandling af en sygdom, lidelse eller tilstand i centralnervesystemet (CNS) eller det perifere nervesystem (PNS) eller til anvendelse ved inducering af ophør med rygning.
  10. 10. Farmaceutisk sammensætning til anvendelse ifølge krav 9, hvor CNS- eller PNS- sygdommen, -lidelsen eller -tilstanden er valgt blandt en kognitiv lidelse, Alzheimers sygdom, Parkinsons sygdom, angst, depression, skizofreni, attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), vaskulær demens, Lewy body-sygdom, posttraumatisk demens, Picks sygdom, multipel sklerose, Jakob-Creutzfeldts sygdom, nikotinafhængighed, alkoholafhængighed, cannabisafhængighed, neurologiske tilstande associeret med erhvervet immundefektsyndrom (AIDS) eller Huntingtons sygdom.
  11. 11. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 8 til anvendelse ved behandling eller undertrykkelse af tobaks- eller nikotinafhængighed eller -anvendelse og dermed inducering af ophør med rygning.
  12. 12. Kit, der omfatter en farmaceutisk sammensætning, der omfatter nikotin eller et farmaceutisk acceptabelt salt eller et N-oxid deraf, en farmaceutisk sammensætning, der omfatter opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf, og instruktioner vedrørende administration af sammensætningerne til behandling af en CNS- eller PNS-sygdom, -lidelse eller -tilstand eller til inducering af ophør med rygning, til anvendelse ved behandling af en CNS- eller PNS-sygdom, -lidelse eller-tilstand eller til anvendelse ved inducering af ophør med rygning.
  13. 13. Kit til anvendelse ifølge krav 12, hvor hver farmaceutisk sammensætning er i form af et transdermalt plaster.
  14. 14. Kit til anvendelse ifølge krav 13, hvilket kit omfatter et første plaster, der omfatter nikotin, og et andet plaster, der omfatter opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf.
  15. 15. Kit til anvendelse ifølge krav 14, hvilket omfatter et første plaster, der omfatter nikotin, og et andet plaster, der omfatter opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf, og en farmaceutisk acceptabel bærer, som er egnet til transdermal eller topisk administration.
  16. 16. Kit til anvendelse ifølge krav 15, hvor hvert plaster er formuleret med henblik på at tilvejebringe i det væsentlige kontinuerlig afgivelse af nikotinet og opipramolen.
  17. 17. Kit til anvendelse ifølge et hvilket som helst af kravene 12 til 16, hvor CNS-lidelsen er valgt blandt en kognitiv lidelse, Alzheimers sygdom, Parkinsons sygdom, angst, depression, skizofreni, attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), vaskulær demens, Lewy body-sygdom, posttraumatisk demens, Picks sygdom, multipel sklerose, Jakob-Creutzfeldts sygdom, nikotinafhængighed, alkoholafhængighed, cannabisafhængighed, neurologiske tilstande associeret med erhvervet immundefektsyndrom (AIDS) eller Huntingtons sygdom.
  18. 18. Medicinsk controlled release-indretning, der omfatter en sammensætning, der omfatter nikotin og opipramol eller et farmaceutisk acceptabelt salt eller en farmaceutisk acceptabel ester deraf; hvilken medicinske controlled release-indretning er i stand til af afgive sammensætningen til en patient med en forudbestemt afgivelseshastighed.
  19. 19. Medicinsk controlled release-indretning ifølge krav 18, hvor den forudbestemte afgivelseshastighed i det væsentlige er kontinuerlig i løbet af mindst 1 dag.
DK08855517.2T 2007-11-26 2008-11-26 Sammensætning med nikotin og opipramol samt anvendelse deraf DK2224917T3 (da)

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US99016107P 2007-11-26 2007-11-26
PCT/IL2008/001546 WO2009069126A1 (en) 2007-11-26 2008-11-26 Compositions comprising nicotinic agonists and methods of using same

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US (5) US8273731B2 (da)
EP (1) EP2224917B1 (da)
JP (1) JP5456687B2 (da)
KR (1) KR101613742B1 (da)
CN (1) CN101925352B (da)
AR (1) AR069752A1 (da)
AU (1) AU2008331102B2 (da)
BR (1) BRPI0819911A2 (da)
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CL (1) CL2008003507A1 (da)
CY (1) CY1119768T1 (da)
DK (1) DK2224917T3 (da)
ES (1) ES2642873T3 (da)
HR (1) HRP20171476T1 (da)
HU (1) HUE035105T2 (da)
LT (1) LT2224917T (da)
MX (1) MX2010005804A (da)
PL (1) PL2224917T3 (da)
PT (1) PT2224917T (da)
SI (1) SI2224917T1 (da)
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AR069752A1 (es) 2010-02-17
KR101613742B1 (ko) 2016-04-19
US20150306109A1 (en) 2015-10-29
PL2224917T3 (pl) 2018-02-28
US8921356B2 (en) 2014-12-30
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US20170128432A1 (en) 2017-05-11
WO2009069126A1 (en) 2009-06-04
US20130172321A1 (en) 2013-07-04
BRPI0819911A2 (pt) 2017-06-13
JP5456687B2 (ja) 2014-04-02
AU2008331102A1 (en) 2009-06-04
US20090149446A1 (en) 2009-06-11
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CA2744736A1 (en) 2009-06-04
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JP2011504490A (ja) 2011-02-10
HUE035105T2 (en) 2018-05-02
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CA2744736C (en) 2015-06-09
US20180303818A1 (en) 2018-10-25
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US8273731B2 (en) 2012-09-25

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