CN114727949A - Tyk2抑制剂的剂型 - Google Patents

Tyk2抑制剂的剂型 Download PDF

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Publication number
CN114727949A
CN114727949A CN202080078646.5A CN202080078646A CN114727949A CN 114727949 A CN114727949 A CN 114727949A CN 202080078646 A CN202080078646 A CN 202080078646A CN 114727949 A CN114727949 A CN 114727949A
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CN
China
Prior art keywords
dosage form
bms
amorphous
dispersion
methyl
Prior art date
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Withdrawn
Application number
CN202080078646.5A
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English (en)
Chinese (zh)
Inventor
S·I·F·巴达维
J·R·布朗
C·Y·崔
C·格森伯格
V·格雷
J·W·琼斯
U·凯斯特
B·S·维格
X·S·尹
C·A·佐丹
C·布鲁姆
I·耶茨
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Bristol Myers Squibb Co
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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
Priority to CN202411436266.0A priority Critical patent/CN119424434A/zh
Priority to CN202411443114.3A priority patent/CN119424435A/zh
Priority to CN202411436265.6A priority patent/CN119424433A/zh
Publication of CN114727949A publication Critical patent/CN114727949A/zh
Withdrawn legal-status Critical Current

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate 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
    • A61K9/146—Intimate 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
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    • 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
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A61K31/501—Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
    • 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
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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
    • A61K47/02—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • 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]
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN202080078646.5A 2019-09-18 2020-09-18 Tyk2抑制剂的剂型 Withdrawn CN114727949A (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN202411436266.0A CN119424434A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411443114.3A CN119424435A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411436265.6A CN119424433A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962902218P 2019-09-18 2019-09-18
US62/902,218 2019-09-18
PCT/US2020/051342 WO2021055652A1 (en) 2019-09-18 2020-09-18 Dosage forms for tyk2 inhibitors

Related Child Applications (3)

Application Number Title Priority Date Filing Date
CN202411436266.0A Division CN119424434A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411436265.6A Division CN119424433A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411443114.3A Division CN119424435A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型

Publications (1)

Publication Number Publication Date
CN114727949A true CN114727949A (zh) 2022-07-08

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ID=72670853

Family Applications (8)

Application Number Title Priority Date Filing Date
CN202080078646.5A Withdrawn CN114727949A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411436266.0A Pending CN119424434A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411691316.XA Pending CN119745885A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型
CN202411662444.1A Pending CN119700772A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型
CN202411436265.6A Pending CN119424433A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202080078644.6A Withdrawn CN114727948A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型
CN202411443114.3A Pending CN119424435A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411670975.5A Pending CN119700773A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型

Family Applications After (7)

Application Number Title Priority Date Filing Date
CN202411436266.0A Pending CN119424434A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411691316.XA Pending CN119745885A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型
CN202411662444.1A Pending CN119700772A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型
CN202411436265.6A Pending CN119424433A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202080078644.6A Withdrawn CN114727948A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型
CN202411443114.3A Pending CN119424435A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的剂型
CN202411670975.5A Pending CN119700773A (zh) 2019-09-18 2020-09-18 Tyk2抑制剂的延长释放剂型

Country Status (20)

Country Link
US (4) US12521390B2 (https=)
EP (3) EP4031109B1 (https=)
JP (3) JP7812785B2 (https=)
KR (2) KR20220066310A (https=)
CN (8) CN114727949A (https=)
AU (1) AU2020348783B2 (https=)
BR (2) BR112022004216A2 (https=)
CA (2) CA3151137A1 (https=)
DK (1) DK4031110T3 (https=)
ES (1) ES3060149T3 (https=)
FI (1) FI4031110T3 (https=)
HR (1) HRP20260058T1 (https=)
IL (2) IL291452A (https=)
LT (1) LT4031110T (https=)
MX (4) MX2022003150A (https=)
PL (1) PL4031110T3 (https=)
PT (1) PT4031110T (https=)
RS (1) RS67803B1 (https=)
SI (1) SI4031110T1 (https=)
WO (2) WO2021055651A1 (https=)

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IL301389A (en) * 2020-09-18 2023-05-01 Bristol Myers Squibb Co Dosage forms for tyk2 inhibitors comprising swellable cores
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EP4404930A1 (en) 2021-09-23 2024-07-31 Bristol-Myers Squibb Company Methods of treating hair-loss disorders with tyk2 inhibitors
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JP2024539703A (ja) * 2021-10-28 2024-10-29 ブリストル－マイヤーズ スクイブ カンパニー デュークラバシチニブの局所製剤
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AR128868A1 (es) * 2022-03-25 2024-06-19 Nimbus Lakshmi Inc Formulaciones de inhibidor de tyk2 y métodos para elaborarlas
WO2024176263A1 (en) * 2023-02-22 2024-08-29 Cipla Limited Deucravacitinib amorphous solid dispersions and polymorphs thereof

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