BR112020024768A8 - Método para reduzir o intervalo de penetração cutânea de roflumilaste em um paciente, composição farmacêutica compreendendo roflumilaste e uma mistura emulsificante e composição farmacêutica compreendendo roflumilaste e pelo menos um emulsificante - Google Patents

Método para reduzir o intervalo de penetração cutânea de roflumilaste em um paciente, composição farmacêutica compreendendo roflumilaste e uma mistura emulsificante e composição farmacêutica compreendendo roflumilaste e pelo menos um emulsificante

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Publication number
BR112020024768A8
BR112020024768A8 BR112020024768A BR112020024768A BR112020024768A8 BR 112020024768 A8 BR112020024768 A8 BR 112020024768A8 BR 112020024768 A BR112020024768 A BR 112020024768A BR 112020024768 A BR112020024768 A BR 112020024768A BR 112020024768 A8 BR112020024768 A8 BR 112020024768A8
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BR
Brazil
Prior art keywords
roflumilast
pharmaceutical composition
emulsifier
range
reducing
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Application number
BR112020024768A
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English (en)
Other versions
BR112020024768A2 (pt
Inventor
W Osborne David
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Arcutis Inc
Arcutis Biotherapeutics Inc
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Application filed by Arcutis Inc, Arcutis Biotherapeutics Inc filed Critical Arcutis Inc
Publication of BR112020024768A2 publication Critical patent/BR112020024768A2/pt
Publication of BR112020024768A8 publication Critical patent/BR112020024768A8/pt

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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
    • A61K9/06—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
    • A61K9/0012—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
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • 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
    • A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K31/535—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
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
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    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6903—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being semi-solid, e.g. an ointment, a gel, a hydrogel or a solidifying gel
    • 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
    • A61P17/06—Antipsoriatics
    • 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]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

MÉTODO PARA REDUZIR O INTERVALO DE PENETRAÇÃO CUTÂNEA DE ROFLUMILASTE EM UM PACIENTE, COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO ROFLUMILASTE E UMA MISTURA EMULSIFICANTE E COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO ROFLUMILASTE E PELO MENOS UM EMULSIFICANTE. A redução dos intervalos de penetração cutânea melhorará a biodisponibilidade de uma composição de roflumilaste administrada via tópica. Um intervalo mais curto de penetração cutânea provê início mais rápido de alívio da doença e biodisponibilidade mais consistente, uma vez que há menos transferência à vestimenta ou outras pessoas. O intervalo de penetração cutânea para roflumilaste pode ser reduzido pela formulação de uma composição de roflumilaste para apresentar um pH entre 4,0 e 6,5 e/ou combinando roflumilaste com uma mistura emulsificante compreendendo álcool cetearílico, fosfato de dicetila e fosfato ceteth-10.
BR112020024768A 2018-06-04 2019-05-30 Método para reduzir o intervalo de penetração cutânea de roflumilaste em um paciente, composição farmacêutica compreendendo roflumilaste e uma mistura emulsificante e composição farmacêutica compreendendo roflumilaste e pelo menos um emulsificante BR112020024768A8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862680203P 2018-06-04 2018-06-04
US62/680,203 2018-06-04
US201862742644P 2018-10-08 2018-10-08
US62/742,644 2018-10-08
PCT/US2019/034640 WO2019236374A2 (en) 2018-06-04 2019-05-30 Method and formulation for improving roflumilast skin penetration lag time

Publications (2)

Publication Number Publication Date
BR112020024768A2 BR112020024768A2 (pt) 2021-03-30
BR112020024768A8 true BR112020024768A8 (pt) 2022-12-13

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BR112020024768A BR112020024768A8 (pt) 2018-06-04 2019-05-30 Método para reduzir o intervalo de penetração cutânea de roflumilaste em um paciente, composição farmacêutica compreendendo roflumilaste e uma mistura emulsificante e composição farmacêutica compreendendo roflumilaste e pelo menos um emulsificante

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US (4) US20190365642A1 (pt)
EP (1) EP3801461A2 (pt)
KR (1) KR20210044191A (pt)
CN (1) CN112384199A (pt)
AU (1) AU2019281888B2 (pt)
BR (1) BR112020024768A8 (pt)
CA (1) CA3102689C (pt)
IL (1) IL279158A (pt)
MX (1) MX2020013192A (pt)
WO (1) WO2019236374A2 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9895359B1 (en) 2017-06-07 2018-02-20 Arcutis, Inc. Inhibition of crystal growth of roflumilast
US11129818B2 (en) 2017-06-07 2021-09-28 Arcutis Biotherapeutics, Inc. Topical roflumilast formulation having improved delivery and plasma half life
US20200155524A1 (en) * 2018-11-16 2020-05-21 Arcutis, Inc. Method for reducing side effects from administration of phosphodiesterase-4 inhibitors
AU2021214399A1 (en) * 2020-01-31 2022-08-25 Arcutis Biotherapeutics, Inc. Topical roflumilast formulation having improved delivery and plasma half-life
BR112022007459A2 (pt) * 2020-05-07 2022-11-29 Arcutis Biotherapeutics Inc Método para tratar uma barreira epidérmica com função diminuída, composição farmacêutica, composição e método para reduzir a extração de lipídios epidérmicos e aumentar a função de barreira epidérmica
WO2022169615A1 (en) * 2021-02-05 2022-08-11 Arcutis Biotherapeutics, Inc. Roflumilast formulations with an improved pharmacokinetic profile
WO2023177416A1 (en) * 2022-03-14 2023-09-21 Arcutis Biotherapeutics, Inc. Self-preserving topical pharmaceutical compositions comprising diethylene glycol monoethyl ether

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100331255B1 (ko) 1993-07-02 2002-10-25 빅굴덴 롬베르그 케미쉐 화부리크 게엠베하 플루오로알콕시-치환된벤즈아미드및시클릭뉴클레오티드포스포디에스테라아제억제제로서의그의용도
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

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Publication number Publication date
CN112384199A (zh) 2021-02-19
US20230346690A1 (en) 2023-11-02
WO2019236374A3 (en) 2020-01-16
JP2021527037A (ja) 2021-10-11
MX2020013192A (es) 2021-08-16
AU2019281888B2 (en) 2024-05-02
WO2019236374A2 (en) 2019-12-12
IL279158A (en) 2021-01-31
KR20210044191A (ko) 2021-04-22
US20190365642A1 (en) 2019-12-05
US20230346689A1 (en) 2023-11-02
EP3801461A2 (en) 2021-04-14
AU2019281888A1 (en) 2021-01-14
CA3102689C (en) 2023-08-29
BR112020024768A2 (pt) 2021-03-30
US20230338275A1 (en) 2023-10-26
CA3102689A1 (en) 2019-05-30

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Legal Events

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B25G Requested change of headquarter approved

Owner name: ARCUTIS, INC. (US)

B25D Requested change of name of applicant approved

Owner name: ARCUTIS BIOTHERAPEUTICS, INC. (US)

B25G Requested change of headquarter approved

Owner name: ARCUTIS BIOTHERAPEUTICS, INC. (US)

B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]