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AR109186A1 - Procedimiento de estabilización de tamaño de partícula de bromuro de glicopirronio - Google Patents

Procedimiento de estabilización de tamaño de partícula de bromuro de glicopirronio

Info

Publication number
AR109186A1
AR109186A1 ARP170102134A ARP170102134A AR109186A1 AR 109186 A1 AR109186 A1 AR 109186A1 AR P170102134 A ARP170102134 A AR P170102134A AR P170102134 A ARP170102134 A AR P170102134A AR 109186 A1 AR109186 A1 AR 109186A1
Authority
AR
Argentina
Prior art keywords
glycopyrronium
salt
particle size
bromide
glycopyrronium salt
Prior art date
Application number
ARP170102134A
Other languages
English (en)
Inventor
Soler Emma Recio
Veln Mara Jos Martnez
Lamarca David Gmez
Garca Silvia Donnici
Oliver Josep Mara Carulla
Camins Josep Terradas
Original Assignee
Lesvi Laboratorios Sl
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 Lesvi Laboratorios Sl filed Critical Lesvi Laboratorios Sl
Publication of AR109186A1 publication Critical patent/AR109186A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • 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
    • A61K31/40—Heterocyclic 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
    • 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
    • A61K31/40—Heterocyclic 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
    • A61K31/4015—Heterocyclic 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 having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (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 proporciona un procedimiento para estabilizar el tamaño de partícula de sal de glicopirronio micronizada (tal como bromuro de glicopirronio) que proporciona un producto micronizado que presenta una estabilidad química y polimórfica mejorada incluso después de un almacenamiento prolongado. También se refiere a composiciones que comprenden dicha sal de glicopirronio estabilizada (tal como bromuro de glicopirronio) y a dispositivos inhaladores de polvo seco y cápsulas o blísteres que comprenden la sal de glicopirronio estabilizada (tal como bromuro de glicopirronio). La sal de glicopirronio (tal como bromuro de glicopirronio) o composiciones de la presente pueden usarse como medicamento, por ejemplo en el tratamiento de asma, enfermedad pulmonar obstructiva crónica o fibrosis quística o enfermedades relacionadas. Reivindicación 1: Procedimiento para obtener una sal de glicopirronio estable caracterizado porque comprende las siguientes etapas: a) micronizar la sal de glicopirronio, opcionalmente en presencia de uno o más principios activos y/o excipientes diferentes, para obtener una distribución de tamaño de partícula (PSD) caracterizada porque un D₉₀ igual a o menor de aproximadamente 10 mm; b) curar la sal de glicopirronio micronizada manteniendo el producto durante al menos 2 horas a una temperatura de entre aproximadamente 125ºC y aproximadamente 160ºC.
ARP170102134A 2016-07-29 2017-07-27 Procedimiento de estabilización de tamaño de partícula de bromuro de glicopirronio AR109186A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP16382374 2016-07-29

Publications (1)

Publication Number Publication Date
AR109186A1 true AR109186A1 (es) 2018-11-07

Family

ID=56842772

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170102134A AR109186A1 (es) 2016-07-29 2017-07-27 Procedimiento de estabilización de tamaño de partícula de bromuro de glicopirronio

Country Status (7)

Country Link
US (1) US10888500B2 (es)
EP (1) EP3490533B1 (es)
AR (1) AR109186A1 (es)
ES (1) ES2805434T3 (es)
PL (1) PL3490533T3 (es)
PT (1) PT3490533T (es)
WO (1) WO2018019803A1 (es)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2956062A (en) 1959-02-26 1960-10-11 Robins Co Inc A H Esters of amino alcohols
GB0409703D0 (en) 2004-04-30 2004-06-02 Vectura Ltd Pharmaceutical compositions
WO2009007666A1 (en) 2007-07-10 2009-01-15 Redcliffe Magtronics Ltd Automatic vehicle guidance protection system
CA2707594C (en) 2007-12-13 2015-08-18 Novartis Ag Process for preparing particulates of crystalline drug substance
EP2234595B1 (en) 2007-12-13 2012-11-28 Novartis AG Process for reducing the tendency of a glycopyyronium salt to aggegate during storage.
ES2712988T5 (es) 2013-03-15 2022-10-21 Pearl Therapeutics Inc Métodos y sistemas para acondicionamiento de materiales cristalinos en partículas
US9393202B2 (en) * 2013-04-26 2016-07-19 Chiesi Farmaceutici S.P.A Particle size reduction of an antimuscarinic compound
ES2700597T3 (es) 2014-12-24 2019-02-18 Lesvi Laboratorios Sl Proceso para la preparación de (3RS) -3 - [(2SR) - (2-ciclopentil-2-hidroxi-2-fenilacetil) oxi] -1,1-dimetilpirrolidinio

Also Published As

Publication number Publication date
PT3490533T (pt) 2020-07-21
PL3490533T3 (pl) 2020-11-02
US10888500B2 (en) 2021-01-12
EP3490533A1 (en) 2019-06-05
US20190175451A1 (en) 2019-06-13
WO2018019803A1 (en) 2018-02-01
EP3490533B1 (en) 2020-05-27
ES2805434T3 (es) 2021-02-12

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