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AR134222A2 - Un proceso para preparar una composición de comprimido adecuada para el tratamiento de trastornos mediados por la actividad de la tirosina cinasa de bruton - Google Patents

Un proceso para preparar una composición de comprimido adecuada para el tratamiento de trastornos mediados por la actividad de la tirosina cinasa de bruton

Info

Publication number
AR134222A2
AR134222A2 ARP240103027A ARP240103027A AR134222A2 AR 134222 A2 AR134222 A2 AR 134222A2 AR P240103027 A ARP240103027 A AR P240103027A AR P240103027 A ARP240103027 A AR P240103027A AR 134222 A2 AR134222 A2 AR 134222A2
Authority
AR
Argentina
Prior art keywords
bruton
preparing
treatment
tablet composition
tyrosine kinase
Prior art date
Application number
ARP240103027A
Other languages
English (en)
Inventor
Chen Mao
Dawen Kou
Po-Chang Chiang
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of AR134222A2 publication Critical patent/AR134222A2/es

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    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • 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
    • 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
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
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    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
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    • 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
    • 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
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C309/00—Sulfonic acids; Halides, esters, or anhydrides thereof
    • C07C309/01—Sulfonic acids
    • C07C309/02—Sulfonic acids having sulfo groups bound to acyclic carbon atoms
    • C07C309/03—Sulfonic acids having sulfo groups bound to acyclic carbon atoms of an acyclic saturated carbon skeleton
    • C07C309/04—Sulfonic acids having sulfo groups bound to acyclic carbon atoms of an acyclic saturated carbon skeleton containing only one sulfo group
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed systems
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
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Abstract

Un proceso para preparar una composición de comprimido adecuada para el tratamiento de trastornos mediados por la actividad de la tirosina cinasa de Bruton, que comprende: (1) formar una mezcla intragranular que comprende de 25 mg a 300 mg de una base libre de compuesto (I); (2) granular y separar por tamaño la mezcla intragranular para formar intragránulos de base libre de compuesto (I); (3) mezclar los intragránulos con un componente extragranular para formar una mezcla de comprimido, en donde el componente extragranular comprende ácido fumárico, y en donde la relación en peso de la base libre de estructura (I) a ácido fumárico es de 1:5 a 3:1; y (4) comprimir la mezcla de comprimido para formar la composición de comprimido.
ARP240103027A 2016-02-29 2024-11-05 Un proceso para preparar una composición de comprimido adecuada para el tratamiento de trastornos mediados por la actividad de la tirosina cinasa de bruton AR134222A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662301373P 2016-02-29 2016-02-29

Publications (1)

Publication Number Publication Date
AR134222A2 true AR134222A2 (es) 2025-12-10

Family

ID=58162610

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP170100492A AR107751A1 (es) 2016-02-29 2017-03-01 Composiciones de forma de dosificación que comprenden un inhibidor de tirosina cinasa de bruton
ARP240103027A AR134222A2 (es) 2016-02-29 2024-11-05 Un proceso para preparar una composición de comprimido adecuada para el tratamiento de trastornos mediados por la actividad de la tirosina cinasa de bruton

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP170100492A AR107751A1 (es) 2016-02-29 2017-03-01 Composiciones de forma de dosificación que comprenden un inhibidor de tirosina cinasa de bruton

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US (6) US10246461B2 (es)
EP (3) EP4049660B1 (es)
JP (4) JP6577143B2 (es)
KR (3) KR102451106B1 (es)
CN (2) CN108367005B (es)
AR (2) AR107751A1 (es)
AU (2) AU2017227929B2 (es)
BR (1) BR112018069530B1 (es)
CA (2) CA3236518A1 (es)
ES (2) ES2913494T3 (es)
IL (2) IL300209A (es)
MX (2) MX391723B (es)
PL (2) PL4049660T3 (es)
WO (1) WO2017148837A1 (es)

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BR112018069530B1 (pt) 2021-02-17
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AU2017227929A1 (en) 2018-03-15
CN113925833A (zh) 2022-01-14
HK1258699A1 (zh) 2019-11-15
EP3423059A1 (en) 2019-01-09
IL300209A (en) 2023-03-01
MX391723B (es) 2025-03-21
MX2022000826A (es) 2022-02-16
EP4049660A1 (en) 2022-08-31
US20220267340A1 (en) 2022-08-25
JP2021073284A (ja) 2021-05-13
US11365197B2 (en) 2022-06-21
US20250109136A1 (en) 2025-04-03
KR102246124B1 (ko) 2021-04-30
JP7258924B2 (ja) 2023-04-17
EP4049660B1 (en) 2025-02-19
IL261249B2 (en) 2023-07-01
WO2017148837A1 (en) 2017-09-08
CN108367005B (zh) 2022-01-07
KR20200118508A (ko) 2020-10-15
IL261249B1 (en) 2023-03-01
KR20200118507A (ko) 2020-10-15
CA2997859A1 (en) 2017-09-08
ES2913494T3 (es) 2022-06-02
ES3022188T3 (en) 2025-05-28
JP2019214605A (ja) 2019-12-19
KR20180104125A (ko) 2018-09-19
PL4049660T3 (pl) 2025-06-09
AU2022241561A1 (en) 2022-10-27
IL261249A (en) 2018-10-31
US10246461B2 (en) 2019-04-02
AU2022241561B2 (en) 2024-06-20
CN108367005A (zh) 2018-08-03
BR112018069530A2 (pt) 2019-01-22
US20170247381A1 (en) 2017-08-31
MX2018008754A (es) 2018-09-28
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CA3236518A1 (en) 2017-09-08
US20190177331A1 (en) 2019-06-13
AU2017227929B2 (en) 2022-06-30
US20180251462A2 (en) 2018-09-06
PL3423059T3 (pl) 2022-08-08
US20230339957A1 (en) 2023-10-26
AR107751A1 (es) 2018-05-30
JP6577143B2 (ja) 2019-09-18
EP4529956A3 (en) 2025-04-23
EP4049660C0 (en) 2025-02-19
EP3423059B1 (en) 2022-03-23
JP2023036772A (ja) 2023-03-14
CA2997859C (en) 2024-06-04

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