DK2952191T3 - Sublingual apomorfin - Google Patents

Sublingual apomorfin Download PDF

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Publication number
DK2952191T3
DK2952191T3 DK15175258.1T DK15175258T DK2952191T3 DK 2952191 T3 DK2952191 T3 DK 2952191T3 DK 15175258 T DK15175258 T DK 15175258T DK 2952191 T3 DK2952191 T3 DK 2952191T3
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Denmark
Prior art keywords
apomorphine
pharmaceutical composition
unit dosage
dosage form
film
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DK15175258.1T
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English (en)
Inventor
Anthony John Giovinazzo
Nathan John Bryson
Somer Marc L De
David Bruce Hedden
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Sunovion Pharmaceuticals Inc
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Publication of DK2952191T3 publication Critical patent/DK2952191T3/da

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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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • 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
    • A61P25/16—Anti-Parkinson drugs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Zoology (AREA)
  • Reproductive Health (AREA)
  • Psychology (AREA)
  • Endocrinology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (11)

1. Farmaceutisk præparat i enhedsdosisform, som er formuleret til sublingual administration, hvor enhedsdosisformen har en første portion, der omfatter apomorfinpartikler, som omfatter et syreadditionssalt af apomorfin, og en anden portion, der omfatter et pH-neutraliserende middel, hvor enhedsdosisformen omfatter glycerolmonostearat.
2. Farmaceutisk præparat ifølge krav 1, hvor enhedsdosisformen desuden omfatter en antioxidant.
3. Farmaceutisk præparat ifølge krav 2, hvor antioxidanten er valgt fra gruppen bestående af thioler, sulfoximiner, metalchelatorer, natriummetabisulfit, vitaminer, phenoler, benzoater, urinsyre, mannose, propylgallat, selen, stilbener og kombinationer deraf.
4. Farmaceutisk præparat ifølge et hvilket som helst af kravene 1-3, hvor den første portion omfatter apomorfinpartikler, som har en effektiv partikelstørrelse på fra 1 pm til 10 pm.
5. Farmaceutisk præparat ifølge et hvilket som helst af kravene 1-4, hvor det farmaceutiske præparat er i en enhedsdosisform valgt blandt en pastil, en pille, en tablet, en film eller en strimmel.
6. Farmaceutisk præparat ifølge et hvilket som helst af kravene 1-5, hvor enhedsdosisformen omfatter fra 2 til 40 mg af et syreadditionssalt af apomorfin.
7. Farmaceutisk præparat ifølge et hvilket som helst af kravene 1-6, hvor syreadditionssaltet af apomorfin er apomorfinhydrochlorid.
8. Farmaceutisk præparat ifølge et hvilket som helst af kravene 1-7, hvor enhedsdosisformen er en film eller en strimmel, og hvor den første portion er et første lag omfattende apomorfinpartikler, som omfatter et syreadditionssalt af apomorfin, og den anden portion er et andet lag omfattende et pH-neutraliserende middel.
9. Farmaceutisk præparat ifølge krav 8, som desuden omfatter et tredje barrierelag, som er anbragt mellem det første lag og det andet lag.
10. Farmaceutisk præparat ifølge krav 8 eller 9, hvor filmen eller strimlen omfatter en mucoadhæsiv polymer.
11. Farmaceutisk præparat ifølge et hvilket som helst af kravene 1-10 til anvendelse til behandling af Parkinsons sygdom i et individ, hvor enhedsdosisformen administreres sublingualt.
DK15175258.1T 2009-06-12 2010-06-11 Sublingual apomorfin DK2952191T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18644509P 2009-06-12 2009-06-12
EP10786915.8A EP2442650B2 (en) 2009-06-12 2010-06-11 Sublingual apomorphine

Publications (1)

Publication Number Publication Date
DK2952191T3 true DK2952191T3 (da) 2018-12-10

Family

ID=43309244

Family Applications (2)

Application Number Title Priority Date Filing Date
DK15175258.1T DK2952191T3 (da) 2009-06-12 2010-06-11 Sublingual apomorfin
DK10786915.8T DK2442650T4 (en) 2009-06-12 2010-06-11 Sublingualt apomorfin

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK10786915.8T DK2442650T4 (en) 2009-06-12 2010-06-11 Sublingualt apomorfin

Country Status (20)

Country Link
US (10) US9044475B2 (da)
EP (3) EP2952191B1 (da)
JP (6) JP5760295B2 (da)
KR (5) KR102017009B1 (da)
CN (1) CN102480958B (da)
AU (4) AU2010259971C1 (da)
BR (1) BR112012000204B8 (da)
CA (1) CA2765291C (da)
DK (2) DK2952191T3 (da)
EA (1) EA025054B1 (da)
ES (2) ES2699077T3 (da)
FI (1) FI2442650T4 (da)
HU (1) HUE028121T2 (da)
IL (2) IL216923A (da)
MX (1) MX2011013260A (da)
NZ (1) NZ597237A (da)
PL (2) PL2442650T5 (da)
PT (2) PT2442650E (da)
WO (1) WO2010144817A1 (da)
ZA (1) ZA201109208B (da)

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