BR112022004216A2 - Formas de dosagem de liberação prolongada para inibidores de tyk2 - Google Patents

Formas de dosagem de liberação prolongada para inibidores de tyk2

Info

Publication number
BR112022004216A2
BR112022004216A2 BR112022004216A BR112022004216A BR112022004216A2 BR 112022004216 A2 BR112022004216 A2 BR 112022004216A2 BR 112022004216 A BR112022004216 A BR 112022004216A BR 112022004216 A BR112022004216 A BR 112022004216A BR 112022004216 A2 BR112022004216 A2 BR 112022004216A2
Authority
BR
Brazil
Prior art keywords
dosage forms
extended
release dosage
tyk2 inhibitors
methyl
Prior art date
Application number
BR112022004216A
Other languages
English (en)
Inventor
S Vig Balvinder
Y Choi Candice
Christoph Gesenberg
A Zordan Christopher
Corey Bloom
Ian Yates
Wynne Jones John
R Brown Jonathan
Ibrahim FARAG BADAWY Sherif
Umesh Kestur
Vivienne Gray
S Yin Xiaotian
Original Assignee
Bristol Myers Squibb Co
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
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of BR112022004216A2 publication Critical patent/BR112022004216A2/pt

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/50Pyridazines; Hydrogenated pyridazines
    • A61K31/501Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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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)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

formas de dosagem de liberação prolongada para inibidores de tyk2. a presente invenção refere-se a formulações de liberação prolongada e formas de dosagem estáveis e biodisponíveis que compreendem uma dispersão (por exemplo, dispersão seca por pulverização) de 6-(ciclopropanamido)-4-((2-metóxi-3-(1-metil-1h-1,2,4-triazol-3-il)fenil)amino)-n-(metil-d3)piridazina-3-carboxamida amorfa sólida (fórmula (i); bms-986165) em uma matriz polimérica sólida para o tratamento de doenças autoimunes e doenças autoinflamatórias, tais como doença inflamatória intestinal (ibd) e psoríase.
BR112022004216A 2019-09-18 2020-09-18 Formas de dosagem de liberação prolongada para inibidores de tyk2 BR112022004216A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962902218P 2019-09-18 2019-09-18
PCT/US2020/051341 WO2021055651A1 (en) 2019-09-18 2020-09-18 Extended release dosage forms for tyk2 inhibitors

Publications (1)

Publication Number Publication Date
BR112022004216A2 true BR112022004216A2 (pt) 2022-05-31

Family

ID=72670853

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112022004216A BR112022004216A2 (pt) 2019-09-18 2020-09-18 Formas de dosagem de liberação prolongada para inibidores de tyk2
BR112022004550A BR112022004550A2 (pt) 2019-09-18 2020-09-18 Formas de dosagem para inibidores de tyk2

Family Applications After (1)

Application Number Title Priority Date Filing Date
BR112022004550A BR112022004550A2 (pt) 2019-09-18 2020-09-18 Formas de dosagem para inibidores de tyk2

Country Status (11)

Country Link
US (2) US20230255964A1 (pt)
EP (2) EP4031110A1 (pt)
JP (2) JP2022548687A (pt)
KR (2) KR20220066310A (pt)
CN (2) CN114727949A (pt)
AU (2) AU2020349524A1 (pt)
BR (2) BR112022004216A2 (pt)
CA (2) CA3151137A1 (pt)
IL (2) IL291452A (pt)
MX (2) MX2022003146A (pt)
WO (2) WO2021055652A1 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023541997A (ja) * 2020-09-18 2023-10-04 ブリストル-マイヤーズ スクイブ カンパニー 膨潤性コアを含むtyk2阻害薬の剤形
WO2022175752A1 (en) 2021-02-19 2022-08-25 Sudo Biosciences Limited Tyk2 inhibitors and uses thereof
CA3232812A1 (en) 2021-09-23 2023-03-30 Ian MacQuarie CATLETT Methods of treating hair-loss disorders with tyk2 inhibitors
WO2023076161A1 (en) 2021-10-25 2023-05-04 Kymera Therapeutics, Inc. Tyk2 degraders and uses thereof
WO2023076515A1 (en) * 2021-10-28 2023-05-04 Bristol-Myers Squibb Company Topical formulations of deucravacitinib
WO2023181075A1 (en) * 2022-03-24 2023-09-28 Dr. Reddy's Laboratories Limited Amorphous solid dispersions of deucravacitinib and processes for the preparation thereof
WO2023183900A1 (en) * 2022-03-25 2023-09-28 Nimbus Lakshmi, Inc. Tyk2 inhibitor formulations and methods of making the same

Family Cites Families (10)

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Publication number Priority date Publication date Assignee Title
PT901786E (pt) * 1997-08-11 2007-08-07 Pfizer Prod Inc Disperções farmacêuticas sólidas com biodisponibilidade melhorada
DE60039377D1 (de) * 1999-02-09 2008-08-21 Pfizer Prod Inc Zusammensetzungen basischer Arzneistoffe mit verbesserter Bioverfügbarkeit
CA2450957A1 (en) 2001-06-22 2003-01-03 Pfizer Products Inc. Pharmaceutical compositions of dispersions of drugs and neutral polymers
WO2013013114A1 (en) 2011-07-21 2013-01-24 Bristol-Myers Squibb Company Bioavailable compositions of amorphous piperidinyl compounds
WO2014042945A1 (en) 2012-09-11 2014-03-20 Bend Research, Inc. Methods for making pharmaceutical solid dosage forms of spray-dried dispersions
TWI673051B (zh) * 2012-09-11 2019-10-01 美商梅維森前列腺療法有限責任公司 恩雜魯它脈(enzalutamide)之調和物
BR112015006537A2 (pt) * 2012-09-28 2017-07-04 Oncoethix Sa dispersão sólida, formulação farmacêutica, cápsula farmacêutica, e, tablete farmacêutico
PL3495358T3 (pl) 2012-11-08 2022-06-27 Bristol-Myers Squibb Company Podstawione amidem związki heterocykliczne przydatne jako modulatory odpowiedzi il-12, il-23 i/lub ifn-alfa
JP7260481B2 (ja) 2017-03-30 2023-04-18 ブリストル-マイヤーズ スクイブ カンパニー 6-(シクロプロパンカルボキサミド)-4-((2-メトキシ-3-(1-メチル-1H-1,2,4-トリアゾール-3-イル)フェニル)アミノ)-N-(メチル-d3)ピリダジン-3-カルボキサミドの結晶形態
EP3810599A1 (en) 2018-05-31 2021-04-28 Bristol-Myers Squibb Company Crystalline form of 6-(cyclopropanecarboxamido)-4-((2-methoxy-3-(1-methyl-1h-1,2,4-triazol-3-yl)phenyl)amino)-n-(methyl-d3) pyridazine-3-carboxamide

Also Published As

Publication number Publication date
CN114727949A (zh) 2022-07-08
EP4031110A1 (en) 2022-07-27
CN114727948A (zh) 2022-07-08
US20230255964A1 (en) 2023-08-17
CA3151137A1 (en) 2021-03-25
IL291453A (en) 2022-05-01
BR112022004550A2 (pt) 2022-05-31
WO2021055652A1 (en) 2021-03-25
AU2020349524A1 (en) 2022-03-31
MX2022003150A (es) 2022-04-06
KR20220066105A (ko) 2022-05-23
WO2021055651A1 (en) 2021-03-25
EP4031109A1 (en) 2022-07-27
JP2022548688A (ja) 2022-11-21
CA3151369A1 (en) 2021-03-25
MX2022003146A (es) 2022-04-06
JP2022548687A (ja) 2022-11-21
IL291452A (en) 2022-05-01
US20220331315A1 (en) 2022-10-20
KR20220066310A (ko) 2022-05-24
AU2020348783A1 (en) 2022-03-31

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