DK2640370T3 - Sammensætninger til transdermal afgivelse af aktive midler - Google Patents

Sammensætninger til transdermal afgivelse af aktive midler Download PDF

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DK2640370T3
DK2640370T3 DK11805614.2T DK11805614T DK2640370T3 DK 2640370 T3 DK2640370 T3 DK 2640370T3 DK 11805614 T DK11805614 T DK 11805614T DK 2640370 T3 DK2640370 T3 DK 2640370T3
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pharmaceutically acceptable
acid
octanol
approx
active agent
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DK11805614.2T
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Oron Yacoby-Zeevi
Mara Nemas
Eduardo Zawoznik
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Neuroderm Ltd
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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    • 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
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/275—Nitriles; Isonitriles
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    • 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
    • A61K31/40—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
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
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    • A61K31/33—Heterocyclic compounds
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    • 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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
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    • A61K31/33—Heterocyclic compounds
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    • 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
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
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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
    • A61K31/435—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
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    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/49—Cinchonan derivatives, e.g. quinine
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • 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
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
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Claims (15)

  1. SAMMENSÆTNINGER TIL TRANSDERMAL AFGIVELSE AF AKTIVE MIDLER Patentkrav
    1. Farmaceutisk acceptabel transdermal sammensætning, der omfatter en fedtalkohol, en terpen og et aktivt middel, hvor fedtalkoholen er valgt blandt octanol, nonanol, decanol, undecanol eller dodecanol; terpenen er valgt blandt limonen, dipenten, a-pinen, γ-terpinen, β-myrcen, p-cymen, a-phellandren eller beta-caroten; og det aktive middel er valgt blandt opipramol, levodopa, carbidopa, physostigmin, chlorpheniramin, lidocanin, metoprolol, nicotin, diltiazem, quinidin, imipramin, quetiapin, venlafaxin, timolol, albuterol, phenytoin, entacapon eller et farmaceutisk acceptabelt salt deraf.
  2. 2. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 1, hvor (i) sammensætningen har ca. 1 til ca. 10 vægtprocent aktivt middel; og/eller (ii) sammensætningen har ca. 1 til ca. 5 vægtprocent fedtalkohol; og/eller (iii) sammensætningen har ca. 0,25 til ca. 5 vægtprocent terpen; og/eller (iv) fedtalkoholen er octanol, fortrinsvis 1-octanol; og/eller terpenen erd-limonen.
  3. 3. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 1 eller 2, der endvidere omfatter en fedtsyreester såsom lauroglycol, fortrinsvis hvor fedtsyreesteren er lauroglycol, og vægtforholdet mellem fedtalkohol og lauroglycol er ca. 3:1 til ca. 1,5:1.
  4. 4. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 3, hvor sammensætningen har ca. 0,1 til ca. 5,0 vægtprocent fedtsyreester.
  5. 5. Farmaceutisk acceptabel transdermal sammensætning ifølge et hvilket som helst af kravene 1 til 4, der endvidere omfatter (i) en celluloseester, fortrinsvis hydroxypropylmethylcellulose; og/eller (ii) en organisk syre, fortrinsvis valgt blandt ascorbinsyre, vinsyre, æblesyre, ravsyre, fumarsyre, citronsyre, mælkesyre, glutaminsyre eller asparaginsyre, mere fortrinsvis glutaminsyre, asparaginsyre eller vinsyre; og/eller (iii) en basisk aminosyre valgt blandt arginin, lysin eller histidin; og/eller (iv) propylenglycol.
  6. 6. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 1, hvor fedtalkoholen er octanol, terpenen er limonen, det aktive middel har en amingruppe, og sammensætningen endvidere omfatter en organisk syre.
  7. 7. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 6, hvor det aktive middel er opipramol eller et farmaceutisk acceptabelt salt deraf.
  8. 8. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 1, hvor fedtalkoholen er octanol, terpenen er limonen, det aktive middel har en amingruppe, og sammensætningen endvidere omfatter en basisk aminosyre.
  9. 9. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 8, hvor det aktive middel er carbidopa, levodopa eller et farmaceutisk acceptabelt salt deraf.
  10. 10. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 1, hvor fedtalkoholen er octanol, terpenen er limonen, det aktive middel har en amidgruppe, og sammensætningen endvidere omfatter en basisk aminosyre.
  11. 11. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 10, hvor det aktive middel er entacapon eller et farmaceutisk acceptable salt deraf.
  12. 12. Farmaceutisk acceptabel transdermal sammensætning ifølge et hvilket som helst af kravene 6 til 11, hvor (i) sammensætningen har ca. 0,5 til ca. 7,5 vægtprocent octanol; og/eller (ii) sammensætningen har ca. 0,25 til ca. 5 vægtprocent limonen.
  13. 13. Farmaceutisk acceptabel transdermal sammensætning ifølge et hvilket som helst af kravene 6 til 12, der endvidere omfatter lauroglycol, fortrinsvis hvor vægtforholdet mellem octanol og lauroglycol erca. 3:1 til ca. 1,5:1.
  14. 14. Farmaceutisk acceptabel transdermal sammensætning ifølge et hvilket som helst af kravene 6 til 13, der endvidere omfatter arginin.
  15. 15. Farmaceutisk acceptabel transdermal sammensætning ifølge krav 1, hvor fedtalkoholen er octanol, terpenen er limonen, og sammensætningen endvidere omfatter vinsyre.
DK11805614.2T 2010-11-15 2011-11-15 Sammensætninger til transdermal afgivelse af aktive midler DK2640370T3 (da)

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US41360810P 2010-11-15 2010-11-15
PCT/IL2011/000880 WO2012066537A2 (en) 2010-11-15 2011-11-15 Compositions for transdermal delivery of active agents

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US (2) US9415108B2 (da)
EP (1) EP2640370B1 (da)
DK (1) DK2640370T3 (da)
ES (1) ES2673219T3 (da)
HR (1) HRP20180924T1 (da)
HU (1) HUE037897T2 (da)
LT (1) LT2640370T (da)
PL (1) PL2640370T3 (da)
PT (1) PT2640370T (da)
RS (1) RS57334B1 (da)
SI (1) SI2640370T1 (da)
TR (1) TR201808178T4 (da)
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