CA3166300A1 - Formulation de roflumilast topique ayant une administration et une demi-vie plasmatique ameliorees - Google Patents

Formulation de roflumilast topique ayant une administration et une demi-vie plasmatique ameliorees Download PDF

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Publication number
CA3166300A1
CA3166300A1 CA3166300A CA3166300A CA3166300A1 CA 3166300 A1 CA3166300 A1 CA 3166300A1 CA 3166300 A CA3166300 A CA 3166300A CA 3166300 A CA3166300 A CA 3166300A CA 3166300 A1 CA3166300 A1 CA 3166300A1
Authority
CA
Canada
Prior art keywords
roflumilast
phosphate
formulation
ceteth
topical
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA3166300A
Other languages
English (en)
Inventor
David W. Osborne
Bhaskar Chaudhuri
Archie W. Thurston
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arcutis Biotherapeutics Inc
Original Assignee
Arcutis Biotherapeutics Inc
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.)
Filing date
Publication date
Priority claimed from US16/778,845 external-priority patent/US11129818B2/en
Application filed by Arcutis Biotherapeutics Inc filed Critical Arcutis Biotherapeutics Inc
Publication of CA3166300A1 publication Critical patent/CA3166300A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/0014—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
    • 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
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Abstract

La présente invention concerne des procédés pour améliorer le résultat thérapeutique du traitement par le roflumilast. Le résultat thérapeutique est amélioré par une administration cohérente et/ou une demi-vie plasmatique plus longue d'une composition de roflumilast administrée par voie topique. La composition de roflumilast comprend de préférence du phosphate de dicétyle, du phosphate de cététh-10, de l'éther monoéthylique de diéthylène glycol et/ou de l'hexylène glycol.
CA3166300A 2020-01-31 2021-01-29 Formulation de roflumilast topique ayant une administration et une demi-vie plasmatique ameliorees Pending CA3166300A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16/778,845 US11129818B2 (en) 2017-06-07 2020-01-31 Topical roflumilast formulation having improved delivery and plasma half life
US16/778,845 2020-01-31
PCT/US2021/015740 WO2021155173A1 (fr) 2020-01-31 2021-01-29 Formulation de roflumilast topique ayant une administration et une demi-vie plasmatique améliorées

Publications (1)

Publication Number Publication Date
CA3166300A1 true CA3166300A1 (fr) 2021-08-05

Family

ID=74759470

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3166300A Pending CA3166300A1 (fr) 2020-01-31 2021-01-29 Formulation de roflumilast topique ayant une administration et une demi-vie plasmatique ameliorees

Country Status (10)

Country Link
EP (1) EP4096630A1 (fr)
JP (1) JP2023513092A (fr)
KR (1) KR20220134617A (fr)
CN (1) CN115551478A (fr)
AU (1) AU2021214399A1 (fr)
BR (1) BR112022015104A2 (fr)
CA (1) CA3166300A1 (fr)
IL (1) IL295172A (fr)
MX (1) MX2022009399A (fr)
WO (1) WO2021155173A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240108609A1 (en) * 2022-09-15 2024-04-04 Arcutis Biotherapeutics, Inc. Pharmaceutical compositions of roflumilast and solvents capable of dissolving high amounts of the drug

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ290266B6 (cs) 1993-07-02 2002-06-12 Byk Gulden Lomberg Chemische Fabrik Gmbh Substituované benzamidy, způsob jejich výroby a farmaceutické prostředky s jejich obsahem
US5863560A (en) 1996-09-11 1999-01-26 Virotex Corporation Compositions and methods for topical application of therapeutic agents
EP1511516B1 (fr) 2002-05-28 2008-12-17 Nycomed GmbH Preparation pharmaceutique topique
DE102004046235A1 (de) 2004-09-22 2006-03-30 Altana Pharma Ag Arzneimittelzubereitung
US9895359B1 (en) 2017-06-07 2018-02-20 Arcutis, Inc. Inhibition of crystal growth of roflumilast
US11534493B2 (en) * 2017-09-22 2022-12-27 Arcutis Biotherapeutics, Inc. Pharmaceutical compositions of roflumilast in aqueous blends of water-miscible, pharmaceutically acceptable solvents
AU2019281888B2 (en) * 2018-06-04 2024-05-02 Arcutis Biotherapeutics Inc Method and formulation for improving roflumilast skin penetration lag time
US20200155524A1 (en) * 2018-11-16 2020-05-21 Arcutis, Inc. Method for reducing side effects from administration of phosphodiesterase-4 inhibitors

Also Published As

Publication number Publication date
BR112022015104A2 (pt) 2022-09-27
CN115551478A (zh) 2022-12-30
MX2022009399A (es) 2022-09-19
IL295172A (en) 2022-09-01
JP2023513092A (ja) 2023-03-30
EP4096630A1 (fr) 2022-12-07
AU2021214399A1 (en) 2022-08-25
WO2021155173A1 (fr) 2021-08-05
KR20220134617A (ko) 2022-10-05

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EEER Examination request

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EEER Examination request

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