CO6280463A2 - Formulaciones farmaceuticas solidas que comprenden bibw 2992 - Google Patents

Formulaciones farmaceuticas solidas que comprenden bibw 2992

Info

Publication number
CO6280463A2
CO6280463A2 CO10152537A CO10152537A CO6280463A2 CO 6280463 A2 CO6280463 A2 CO 6280463A2 CO 10152537 A CO10152537 A CO 10152537A CO 10152537 A CO10152537 A CO 10152537A CO 6280463 A2 CO6280463 A2 CO 6280463A2
Authority
CO
Colombia
Prior art keywords
bibw
active substance
compacted
prepared
immediate release
Prior art date
Application number
CO10152537A
Other languages
English (en)
Inventor
Roman Messerschmid
Thomas Friedl
Original Assignee
Boehringer Ingelheim Int
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40941955&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO6280463(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of CO6280463A2 publication Critical patent/CO6280463A2/es

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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • 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
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • 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
    • 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
    • A61K9/143—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 inorganic 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
    • A61K9/14—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
    • 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
    • A61K9/16—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/16—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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P35/00—Antineoplastic 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

La presente invención se refiere a una forma de dosificación farmacéutica que contiene la sustancia activa BIBW 2992 en forma de la sal dimaleato, que proporciona un perfil de liberación inmediata de la sustancia activa, además, la invención se refiere a productos intermedios compactados que comprenden sal dimaleato de BIBW 2992 (BIBW 2992 MA2) en forma de un polvo preparado al utilizar una etapa de compactación por rodillos y de tamizado combinada a partir de BIBW 2992 MA2, a mezclas intermedias preparadas a partir de dicho producto intermedio compactado, así como en forma de formulaciones orales sólidas que proporcionan un perfil de liberación inmediata de la sustancia activa, hechas a partir de dicho producto intermedio compactado o a partir de dichas mezclas intermedias listas para su uso/ingesta, p. ej. formulaciones de cápsula y comprimido, tales como comprimidos no revestidos o revestidos con película preparados mediante compresión directa, y a métodos para su producción.
CO10152537A 2008-06-06 2010-12-03 Formulaciones farmaceuticas solidas que comprenden bibw 2992 CO6280463A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08157800 2008-06-06
EP09160297 2009-05-14

Publications (1)

Publication Number Publication Date
CO6280463A2 true CO6280463A2 (es) 2011-05-20

Family

ID=40941955

Family Applications (1)

Application Number Title Priority Date Filing Date
CO10152537A CO6280463A2 (es) 2008-06-06 2010-12-03 Formulaciones farmaceuticas solidas que comprenden bibw 2992

Country Status (34)

Country Link
US (1) US8545884B2 (es)
EP (1) EP2299971B1 (es)
JP (1) JP5632367B2 (es)
KR (1) KR101641517B1 (es)
CN (1) CN102056589B (es)
AR (1) AR072062A1 (es)
AU (1) AU2009254574B2 (es)
BR (1) BRPI0913379C1 (es)
CA (1) CA2726472C (es)
CL (1) CL2010001275A1 (es)
CO (1) CO6280463A2 (es)
CY (1) CY1117895T1 (es)
DK (1) DK2299971T3 (es)
EA (1) EA022168B1 (es)
EC (1) ECSP10010650A (es)
ES (1) ES2588031T3 (es)
HK (1) HK1152478A1 (es)
HR (1) HRP20161061T1 (es)
HU (1) HUE029863T2 (es)
IL (1) IL209054A (es)
MA (1) MA34030B1 (es)
ME (1) ME02478B (es)
MX (1) MX2010012939A (es)
MY (1) MY151240A (es)
NZ (1) NZ589568A (es)
PE (1) PE20100252A1 (es)
PL (1) PL2299971T3 (es)
PT (1) PT2299971T (es)
RS (1) RS54943B1 (es)
SI (1) SI2299971T1 (es)
TW (1) TWI453203B (es)
UY (1) UY31867A (es)
WO (1) WO2009147238A1 (es)
ZA (1) ZA201007805B (es)

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CN105801568B (zh) 2015-01-15 2019-07-30 杭州普晒医药科技有限公司 阿法替尼一马来酸盐晶型及其制备方法和药物组合物
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WO2017033107A1 (en) 2015-08-21 2017-03-02 Fresenius Kabi Oncology Ltd. Pharmaceutical compositions comprising afatinib
EP3156047A1 (en) 2015-10-12 2017-04-19 Sandoz Ag Afatinib-containing formulation
CN105456222B (zh) * 2015-12-22 2019-03-26 河南润弘制药股份有限公司 马来酸阿法替尼片及其制备方法
EP3260115A1 (en) * 2016-06-21 2017-12-27 Omya International AG Method for the production of a dosage form
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CN106074427A (zh) * 2016-07-31 2016-11-09 合肥远志医药科技开发有限公司 一种马来酸阿法替尼片剂及其制备方法
EP3541832A4 (en) 2016-11-17 2020-09-30 Board of Regents, The University of Texas System COMPOUNDS WITH ANTI-TUMOR ACTIVITY AGAINST CANCER CELLS CARRIER OF EGFR OR HER2 MUTATIONS EXON 20
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JP2020513006A (ja) * 2017-04-06 2020-04-30 ジョンソン、マッセイ、パブリック、リミテッド、カンパニーＪｏｈｎｓｏｎ Ｍａｔｔｈｅｙ Ｐｕｂｌｉｃ Ｌｉｍｉｔｅｄ Ｃｏｍｐａｎｙ アファチニブジマレアートの新規形態
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DE10349113A1 (de) 2003-10-17 2005-05-12 Boehringer Ingelheim Pharma Verfahren zur Herstellung von Aminocrotonylverbindungen
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JP2009515852A (ja) 2005-11-11 2009-04-16 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Ｅｇｆｒ／ｈｅｒ２インヒビターを含む癌の組み合わせ治療
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LT2451445T (lt) 2009-07-06 2019-06-25 Boehringer Ingelheim International Gmbh Bibw2992, jo druskų ir kietų farmacinių kompozicijų, apimančių šį aktyvųjį ingredientą, džiovinimo būdas
EP2509592A1 (en) 2009-12-07 2012-10-17 Boehringer Ingelheim International GmbH Bibw 2992 for use in the treatment of triple negative breast cancer

Also Published As

Publication number Publication date
HK1152478A1 (en) 2012-03-02
CN102056589A (zh) 2011-05-11
PT2299971T (pt) 2016-07-29
MA34030B1 (fr) 2013-03-05
BRPI0913379B1 (pt) 2020-03-31
MX2010012939A (es) 2010-12-15
IL209054A0 (en) 2011-01-31
CY1117895T1 (el) 2017-05-17
BRPI0913379A2 (pt) 2015-11-24
EP2299971A1 (en) 2011-03-30
BRPI0913379C1 (pt) 2021-05-25
TWI453203B (zh) 2014-09-21
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CA2726472A1 (en) 2009-12-10
EA201001852A1 (ru) 2011-06-30
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AU2009254574B2 (en) 2014-07-03
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