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MX2019012931A - Proceso para preparar una formulacion de polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico. - Google Patents

Proceso para preparar una formulacion de polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico.

Info

Publication number
MX2019012931A
MX2019012931A MX2019012931A MX2019012931A MX2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A
Authority
MX
Mexico
Prior art keywords
physiologically acceptable
acceptable excipient
weight
mixture
micronized particles
Prior art date
Application number
MX2019012931A
Other languages
English (en)
Other versions
MX379783B (es
Inventor
Schiaretti Francesca
Pivetti Fausto
Cavecchi Alessandro
Merusi Cristiana
Original Assignee
Chiesi Farm Spa
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 Chiesi Farm Spa filed Critical Chiesi Farm Spa
Publication of MX2019012931A publication Critical patent/MX2019012931A/es
Publication of MX379783B publication Critical patent/MX379783B/es

Links

Classifications

    • 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
    • A61K9/145Intimate 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
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/47042-Quinolinones, e.g. carbostyril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/06Organic 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Pain & Pain Management (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención se relaciona con un proceso para preparar una formulación en polvo para inhalación para el uso en un inhalador de polvo seco, en donde el polvo comprende: (A) un vehículo que comprende: (a) 80 a 95 por ciento en peso, basado en el peso total del vehículo, de partículas gruesas de un excipiente fisiológicamente aceptable que tiene un tamaño medio de partículas de por lo menos 175 micrómetros; y (b) 19.6 a 4.9 por ciento en peso, basado en el peso total del vehículo, de partículas micronizadas de un excipiente fisiológicamente aceptable, y (c) 0.1 a 0.4 por ciento en peso, basado en el peso total del vehículo, de una sal de un ácido graso; y (B) partículas micronizadas de bromuro de glicopirronio, un agonista ß2 de acción prolongada (LABA) y un corticosteroide inhalado (ICS), como ingredientes activos, tal proceso comprende: (i) preparar co-molienda micropartículas que consisten de bromuro de glicopirronio y una primera parte de un ICS en una relación que varía de 80:20 a 70:30 en peso, en donde el diámetro de volumen de las micropartículas no es más de 15 micrómetros; (ii) mezclar las partículas gruesas de un excipiente fisiológicamente aceptable, la sal de un ácido graso, una primera parte de tales partículas micronizadas de un excipiente fisiológicamente aceptable, las partículas micronizadas de tal LABA, las micropartículas co-molidas obtenidas en la etapa (i), y la parte restante del ICS en un recipiente de un agitador mezclador a una velocidad de rotación no menor de 16 rpm por un tiempo no menor de 60 minutos, para obtener un primera mezcla; y (iii) adicionar la parte restante de las partículas micronizadas de un excipiente fisiológicamente aceptable a la primera mezcla, para obtener una segunda mezcla, y mezclar la segunda mezcla a una velocidad de rotación no menor de 16 rpm durante un tiempo de por lo menos 120 minutos para obtener una formulación.
MX2019012931A 2017-05-11 2018-05-09 Proceso para preparar una formulación de polvo seco que comprende un anticolinérgico, un corticosteroide y un beta-adrenérgico. MX379783B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17170657 2017-05-11
PCT/EP2018/061953 WO2018206618A1 (en) 2017-05-11 2018-05-09 A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic

Publications (2)

Publication Number Publication Date
MX2019012931A true MX2019012931A (es) 2020-01-20
MX379783B MX379783B (es) 2025-03-04

Family

ID=58707349

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019012931A MX379783B (es) 2017-05-11 2018-05-09 Proceso para preparar una formulación de polvo seco que comprende un anticolinérgico, un corticosteroide y un beta-adrenérgico.

Country Status (11)

Country Link
US (1) US10786450B2 (es)
EP (1) EP3621590B1 (es)
KR (3) KR20220155395A (es)
CN (1) CN110582269B (es)
CA (1) CA3060020A1 (es)
ES (1) ES2891346T3 (es)
MA (1) MA48621A (es)
MX (1) MX379783B (es)
PL (1) PL3621590T3 (es)
RU (1) RU2742376C1 (es)
WO (1) WO2018206618A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4034079A1 (en) * 2019-09-24 2022-08-03 Chiesi Farmaceutici S.p.A. Novel carrier particles for dry powder formulations for inhalation
CN116033893A (zh) * 2020-06-26 2023-04-28 迈兰制药英国有限公司 包含5-[3-(3-羟基苯氧基)氮杂环丁烷-1-基]-5-甲基-2,2-二苯基己酰胺的制剂

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20011227A1 (es) * 2000-04-17 2002-01-07 Chiesi Farma Spa Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros
GB0015043D0 (en) 2000-06-21 2000-08-09 Glaxo Group Ltd Medicament dispenser
DK1658872T4 (da) 2002-07-31 2019-11-11 Chiesi Farm Spa Pulverinhalator
GB0525254D0 (en) * 2005-12-12 2006-01-18 Jagotec Ag Powder compositions for inhalation
GB0613161D0 (en) * 2006-06-30 2006-08-09 Novartis Ag Organic Compounds
PE20121396A1 (es) * 2009-12-23 2012-10-24 Chiesi Farma Spa Composicion farmaceutica que comprende bromuro de glicopirronio y formoterol
RS63759B1 (sr) * 2012-01-25 2022-12-30 Chiesi Farm Spa Formulacija suvog praha koja sadrži kortikosteroid i beta-adrenergik, za primenu inhalacijom
CA2917752C (en) * 2013-07-11 2022-05-03 Chiesi Farmaceutici S.P.A. Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation
MA46776B1 (fr) 2014-06-30 2020-12-31 Chiesi Farm Spa Inhalateur de poudre
GEP20207178B (en) 2015-11-16 2020-11-10 Chiesi Farma Spa Process for preparing dry powder formulation comprising anticholinergic, corticosteroid and beta-adrenergic
PL3628331T3 (pl) * 2015-11-16 2021-11-08 Chiesi Farmaceutici S.P.A. Sposób wytwarzania formulacji w postaci suchego proszku zawierającej środek antycholinergiczny, kortykosteroid i środek beta-adrenergiczny
PL3621589T3 (pl) * 2017-05-11 2021-12-06 Chiesi Farmaceutici S.P.A. Sposób wytwarzania preparatu suchego proszku obejmującego środek antycholinergiczny, kortykosteroid i środek beta-adrenergiczny

Also Published As

Publication number Publication date
EP3621590A1 (en) 2020-03-18
EP3621590B1 (en) 2021-09-01
WO2018206618A1 (en) 2018-11-15
US10786450B2 (en) 2020-09-29
PL3621590T3 (pl) 2022-01-17
KR102637303B1 (ko) 2024-02-20
MA48621A (fr) 2021-04-28
CA3060020A1 (en) 2018-11-15
KR20240104225A (ko) 2024-07-04
MX379783B (es) 2025-03-04
KR20190142770A (ko) 2019-12-27
CN110582269A (zh) 2019-12-17
RU2742376C1 (ru) 2021-02-05
ES2891346T3 (es) 2022-01-27
US20180325816A1 (en) 2018-11-15
KR20220155395A (ko) 2022-11-22
CN110582269B (zh) 2023-02-28
BR112019023378A2 (pt) 2020-06-16

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