NO334743B1 - Pumpevirkende væskesprayformulering - Google Patents

Pumpevirkende væskesprayformulering Download PDF

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Publication number
NO334743B1
NO334743B1 NO20033556A NO20033556A NO334743B1 NO 334743 B1 NO334743 B1 NO 334743B1 NO 20033556 A NO20033556 A NO 20033556A NO 20033556 A NO20033556 A NO 20033556A NO 334743 B1 NO334743 B1 NO 334743B1
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NO
Norway
Prior art keywords
liquid spray
pump
spray formulation
formulation according
acting liquid
Prior art date
Application number
NO20033556A
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English (en)
Other versions
NO20033556L (no
NO20033556D0 (no
Inventor
Brian Anthony Whittle
Geoffrey Guy
Original Assignee
Gw Pharma Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27546617&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO334743(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GB0103638A external-priority patent/GB0103638D0/en
Priority claimed from US09/827,158 external-priority patent/US6730330B2/en
Priority claimed from GB0111597A external-priority patent/GB2377633A/en
Priority claimed from GB0121715A external-priority patent/GB2381194A/en
Priority claimed from US09/951,022 external-priority patent/US7025992B2/en
Application filed by Gw Pharma Ltd filed Critical Gw Pharma Ltd
Publication of NO20033556D0 publication Critical patent/NO20033556D0/no
Publication of NO20033556L publication Critical patent/NO20033556L/no
Publication of NO334743B1 publication Critical patent/NO334743B1/no

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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
    • A61K9/0012—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
    • 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
    • A61K9/0031—Rectum, anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P25/04—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • A61K9/10—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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • 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
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Cardiology (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Oppfinnelsen angår farmasøytiske formuleringer til anvendelse ved administrering av lipofile legemidler via slimhinneoverflater. Spesielt tilveiebringer oppfinnelsen farmasøytiske formuleringer for anvendelse ved administrering av et lipofilt legemiddel via en slimhinneoverflate som ved hydrering danner en emulsjon som inneholder det lipofile legemiddel som er i stand til å klebes til en slimhinneoverflate og tillate kontrollert frigjøring av legemidlet. Oppfinnelsen tilveiebringer videre farmasøytiske formuleringer som inneholder, som aktive ingredienser, spesifikke kombinasjoner av cannabinoider i forutbestemte forhold.

Claims (17)

1. Pumpevirkende væskesprayformulering som ikke er en drivmiddeldrevet aerosolformulering, omfattende løsninger eller emulgerbare formuleringer inneholdende i det minste 1.0 mg cannabinoider per 0,1 ml væskesprayformulering for bukkal levering, hvor væskesprayformuleringen omfatter: tetrahydrocannabinol og cannabidiol i et på forhånd definert vektforhold, - et løsemiddel og - et samoppløsningsmiddel, hvori løsemiddelet er etanol og samoppløsningsmiddelet er enten: (i) et samoppløsningsmiddel som virker som en oppløselighetsforsterker som er et polyoksyetylenlakseroljederivat, eller ii) et samoppløsningsmiddel som er propylenglykol eller glyserol, og i hvilken væskesprayformuleringen avgis gjennom en avbrekkbar kork og leveres gjennom en dyse slik at den gjennomsnittlige aerodynamiske diameter på de produserte partiklene er mellom 15 og 45 mikron.
2. Pumpevirkende væskesprayformulering i følge krav 1, hvori samoppløsningsmiddelet er propylenglykol og forholdet mellom etanol:propylenglykol er mellom 4:1 og 1:4.
3. Pumpevirkende væskesprayformulering i følge krav 1, hvori forholdet mellom THC:CBD er større enn 95:5
4. Pumpevirkende væskesprayformulering i følge krav 1, hvori forholdet mellom THC:CBD is tilnærmet 50:50.
5. Pumpevirkende væskesprayformulering i følge krav 1, hvori forholdet mellom THC:CBD er mindre enn 25:75.
6. Pumpevirkende væskesprayformulering i følge krav 1, hvori forholdet mellom THC:CBD er mindre enn 5:95.
7. Pumpevirkende væskesprayformulering i følge krav 1, hvori den farmasøytiske formuleringen er vesentlig fri for cannabinoider andre enn CBD and THC.
8. Pumpevirkende væskesprayformulering i følge krav 1, hvori nevnte CBD and THC er i vesentlig ren form.
9. Pumpevirkende væskesprayformulering i følge krav 1, hvori den farmasøytiske formuleringen ytterligere omfatter en eller flere andre cannabinoider.
10. Pumpevirkende væskesprayformulering i følge krav 1, hvori den ene eller andre cannabinoiden er tetrahydrocannabinovarin (THCV) og/eller cannabidivarin (CBDV).
11. Pumpevirkende væskesprayformulering i følge krav 1, hvori CBD and THC er utledet fra I det minste et ekstrakt fra i et minste en Cannabisplante, hvori nevnte i et minste ene ekstrakt omfatter alle de naturlige forekommende cannabinoider i nevnte plante.
12. Pumpevirkende væskesprayformulering i følge krav 11, hvori nevnte ekstrakt er fremstilt ved superkritisk eller subkritisk fluidekstraksjon av tørket Cannabisplante.
13. Pumpevirkende væskesprayformulering i følge krav 11, hvori hvert ekstrakt er utledet fra en spesifikk kjemovar.
14. Pumpevirkende væskesprayformulering i følge krav 11, hvori Cannabisplanten er valgt fra Cannabis sativa, Cannabis indica, en genetisk kryssing mellom disse, en selv-krysning eller en hybrid derav.
15. Pumpevirkende væskesprayformulering i følge krav 14, hvori Cannabisplanten er Cannabis sativa, subspecies indica og er valgt fra var. indica og var. kafiristanica.
16. Pumpevirkende væskesprayformulering i følge krav 15, som omfatter ekstrakter fra to eller flere ulike Cannabissorter.
17. Pumpevirkende væskesprayformulering i følge krav 11, hvori den farmasøytiske formuleringen er et botanisk legemiddelprodukt fremstilt fra en botanisk legemiddelforbindelse.
NO20033556A 2001-02-14 2003-08-11 Pumpevirkende væskesprayformulering NO334743B1 (no)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GB0103638A GB0103638D0 (en) 2001-02-14 2001-02-14 Pharmaceutical formulations
US28004401P 2001-03-30 2001-03-30
US09/827,158 US6730330B2 (en) 2001-02-14 2001-04-05 Pharmaceutical formulations
GB0111597A GB2377633A (en) 2001-05-11 2001-05-11 Pharmaceutical compositions comprising the cannabinoids THC and CBD
GB0121715A GB2381194A (en) 2001-09-07 2001-09-07 Pharmaceutical formulations
US09/951,022 US7025992B2 (en) 2001-02-14 2001-09-12 Pharmaceutical formulations
PCT/GB2002/000620 WO2002064109A2 (en) 2001-02-14 2002-02-14 Mucoadhesive pharmaceutical formulations

Publications (3)

Publication Number Publication Date
NO20033556D0 NO20033556D0 (no) 2003-08-11
NO20033556L NO20033556L (no) 2003-10-09
NO334743B1 true NO334743B1 (no) 2014-05-19

Family

ID=27546617

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20033556A NO334743B1 (no) 2001-02-14 2003-08-11 Pumpevirkende væskesprayformulering

Country Status (20)

Country Link
EP (5) EP1361864B9 (no)
JP (1) JP4467883B2 (no)
KR (1) KR100886668B1 (no)
AU (1) AU2002231970B2 (no)
CA (1) CA2438097C (no)
CZ (1) CZ306277B6 (no)
DE (1) DE10296335T5 (no)
DK (1) DK1361864T3 (no)
ES (1) ES2444641T3 (no)
GB (1) GB2388543A (no)
HK (1) HK1056509A1 (no)
HU (1) HU227452B1 (no)
IL (1) IL157130A0 (no)
MX (1) MXPA03007215A (no)
NO (1) NO334743B1 (no)
NZ (1) NZ527289A (no)
PT (1) PT1361864E (no)
SI (1) SI1361864T1 (no)
WO (1) WO2002064109A2 (no)
ZA (1) ZA200306074B (no)

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