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AR128145A1 - Formulación farmacéutica de polvo seco para inhalación y proceso de preparación - Google Patents

Formulación farmacéutica de polvo seco para inhalación y proceso de preparación

Info

Publication number
AR128145A1
AR128145A1 ARP220103630A ARP220103630A AR128145A1 AR 128145 A1 AR128145 A1 AR 128145A1 AR P220103630 A ARP220103630 A AR P220103630A AR P220103630 A ARP220103630 A AR P220103630A AR 128145 A1 AR128145 A1 AR 128145A1
Authority
AR
Argentina
Prior art keywords
ethyl
dry powder
lactose
acid
powder pharmaceutical
Prior art date
Application number
ARP220103630A
Other languages
English (en)
Inventor
Tobias Mundry
Ildiko Terebesi
Annett Richter
Britta Olenik
Birgit Keil
Bernd Rsler
Peter Fey
Heiko Schirmer
Guido Becker
Clemens Bothe
Helene Faber
Julian Egger
Eva Maria Becker-Pelster
Hanna Tinel
Michael Hahn
Dieter Lang
Gerrit Weimann
Johannes Nagelschmitz
Lisa Dietz
Soundos Saleh
David Jung
Mark Parry
David Ward
Cecile Vitre
Original Assignee
Bayer Ag
Bayer Pharma AG
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 Bayer Ag, Bayer Pharma AG filed Critical Bayer Ag
Publication of AR128145A1 publication Critical patent/AR128145A1/es

Links

Classifications

    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4706—4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/145—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 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere a formulaciones farmacéuticas de polvo seco, que comprenden ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4’-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico de fórmula (1), preferiblemente en forma de una de sus sales o solvatos o hidratos, preferiblemente ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4’-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato I de fórmula (1-M-I) o ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4’-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato II de fórmula (1-M-II) en combinación con un portador de lactosa, que comprende lactosa monohidrato como mezcla de lactosa gruesa y lactosa fina, y al proceso de manufactura de dichas formulaciones farmacéuticas de polvo seco y su aplicación para usar en el tratamiento de trastornos cardiopulmonares, tales como hipertensión arterial pulmonar (PAH), hipertensión pulmonar tromboembólica crónica (CTEPH) e hipertensión pulmonar (PH) asociada con enfermedad pulmonar crónica (PH grupo 3) tal como hipertensión pulmonar en la enfermedad pulmonar obstructiva crónica (PH-EPOC) e hipertensión pulmonar con neumonía intersticial idiopática (PH-IIP).
ARP220103630A 2021-12-29 2022-12-28 Formulación farmacéutica de polvo seco para inhalación y proceso de preparación AR128145A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP21218160 2021-12-29

Publications (1)

Publication Number Publication Date
AR128145A1 true AR128145A1 (es) 2024-03-27

Family

ID=79230655

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP220103630A AR128145A1 (es) 2021-12-29 2022-12-28 Formulación farmacéutica de polvo seco para inhalación y proceso de preparación

Country Status (12)

Country Link
US (1) US20250281480A1 (es)
EP (1) EP4456871A1 (es)
JP (1) JP2025501302A (es)
KR (1) KR20240136361A (es)
CN (1) CN118804741A (es)
AR (1) AR128145A1 (es)
AU (1) AU2022427770A1 (es)
CA (1) CA3244896A1 (es)
IL (1) IL313924A (es)
MX (1) MX2024008171A (es)
TW (1) TW202342035A (es)
WO (1) WO2023126438A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023126436A1 (en) 2021-12-29 2023-07-06 Bayer Aktiengesellschaft Process for preparing (5s)-{[2-(4-carboxyphenyl)ethyl] |2-(2-{|3-chloro-4'-(trifluoromethyl)biphenyl-4- yl]methoxy}phenyl)ethyl]aminol-5,6,7,8-tetrahydroquinoline-2-carboxylic acid and its crystalline forms for use as pharmaceutically active compound
AU2022424376A1 (en) 2021-12-29 2024-07-04 Bayer Aktiengesellschaft Treatment of cardiopulmonary disorders
KR20250112022A (ko) * 2024-01-16 2025-07-23 피투케이바이오 주식회사 리바록사반 흡입용 조성물
CN120570867A (zh) * 2024-03-01 2025-09-02 上海欣药智能科技有限公司 一种含sgc受体激动剂的吸入混悬液制剂及其用途

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19834044A1 (de) 1998-07-29 2000-02-03 Bayer Ag Neue substituierte Pyrazolderivate
DE19834047A1 (de) 1998-07-29 2000-02-03 Bayer Ag Substituierte Pyrazolderivate
DE19943635A1 (de) 1999-09-13 2001-03-15 Bayer Ag Neuartige Aminodicarbonsäurederivate mit pharmazeutischen Eigenschaften
AR031176A1 (es) 2000-11-22 2003-09-10 Bayer Ag Nuevos derivados de pirazolpiridina sustituidos con piridina
DE10220570A1 (de) 2002-05-08 2003-11-20 Bayer Ag Carbamat-substituierte Pyrazolopyridine
DE102010021637A1 (de) 2010-05-26 2011-12-01 Bayer Schering Pharma Aktiengesellschaft Substituierte 5-Fluor-1H-Pyrazolopyridine und ihre Verwendung
PH12013500055A1 (en) 2010-07-09 2017-08-23 Bayer Ip Gmbh Ring-fused pyrimidines and triazines and use thereof for the treatment and/or prophylaxis of cardiovascular diseases
DE102010040233A1 (de) 2010-09-03 2012-03-08 Bayer Schering Pharma Aktiengesellschaft Bicyclische Aza-Heterocyclen und ihre Verwendung
DE102010043379A1 (de) 2010-11-04 2012-05-10 Bayer Schering Pharma Aktiengesellschaft Substituierte 6-Fluor-1H-Pyrazolo[4,3-b]pyridine und ihre Verwendung
LT2875003T (lt) 2012-07-20 2017-02-27 Bayer Pharma Aktiengesellschaft Naujos 5-aminotetrahidrochinolin-2-karboksirūgštys ir jų panaudojimas
US9624214B2 (en) 2012-11-05 2017-04-18 Bayer Pharma Aktiengesellschaft Amino-substituted imidazo[1,2-a]pyridinecarboxamides and their use
CA3183771A1 (en) 2020-05-20 2021-11-25 Bayer Aktiengesellschaft Process of preparing butyl-(5s)-5-({2-[4-(butoxycarbonyl)phenyl]ethyl}[2-(2-{[3-chloro-4'-(trifluoromethyl)[biphenyl]-4-yl]methoxy}phenyl)ethyl]amino)-5,6,7,8-tetrahydroquinoline-2-carboxylate

Also Published As

Publication number Publication date
EP4456871A1 (en) 2024-11-06
MX2024008171A (es) 2024-12-06
CN118804741A (zh) 2024-10-18
WO2023126438A1 (en) 2023-07-06
AU2022427770A1 (en) 2024-07-04
KR20240136361A (ko) 2024-09-13
TW202342035A (zh) 2023-11-01
CA3244896A1 (en) 2023-07-06
US20250281480A1 (en) 2025-09-11
IL313924A (en) 2024-08-01
JP2025501302A (ja) 2025-01-17

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