PE12272001A1 - Pharmaceutical formulations for DPIs in the form of hard agglomerates - Google Patents

Pharmaceutical formulations for DPIs in the form of hard agglomerates

Info

Publication number
PE12272001A1
PE12272001A1 PE2001000338A PE0003382001A PE12272001A1 PE 12272001 A1 PE12272001 A1 PE 12272001A1 PE 2001000338 A PE2001000338 A PE 2001000338A PE 0003382001 A PE0003382001 A PE 0003382001A PE 12272001 A1 PE12272001 A1 PE 12272001A1
Authority
PE
Peru
Prior art keywords
particle
magnesium stearate
carrier
vehicle
thick
Prior art date
Application number
PE2001000338A
Other languages
Spanish (es)
Inventor
Gaetano Brambilla
Lorenzo Ferrarini
Morton David Alexander Vodden
Rossella Musa
John Nicholas Staniforth
Rajbir Gill
Original Assignee
Chiesi Farma 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
Family has litigation
Priority to GB0009469A priority Critical patent/GB0009469D0/en
Priority to EP00113608 priority
Application filed by Chiesi Farma Spa filed Critical Chiesi Farma Spa
Publication of PE12272001A1 publication Critical patent/PE12272001A1/en
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26071084&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE12272001(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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 TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, 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 TOILET 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
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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

Abstract

SE REFIERE A UNA FORMULACION PARA INHALADOR DE POLVO SECO QUE COMPRENDE: a) UNA FRACCION DE PARTICULAS DE TAMANO FINO CONSTITUIDAS POR UNA MEZCLA DE ESTEARATO DE MAGNESIO CON UN TAMANO PROMEDIO MENOR A 35 um; It refers to a formulation for dry powder inhaler comprising: a) a fraction of FINO sized particles composed of a mixture of magnesium stearate with a size less than 35 um AVERAGE; b) UNA FRACCION DE PARTICULAS GRUESAS CONSTITUIDAS POR UN VEHICULO FISIOLOGICAMENTE ACEPTABLE CON UN TAMANO DE PARTICULA DE AL MENOS 100 um. b) a fraction of coarse particles consist of a physiologically acceptable carrier with a particle size of at least 100 um. LA MEZCLA ESTA COMPUESTA DE 90% A 99% DE PARTICULAS DEL EXCIPIENTE Y DE 1% A 10% DE ESTEARATO DE MAGNESIO CON UN COCIENTE DE PARTICULAS FINAS DEL EXCIPIENTE Y PARTICULAS GRUESAS DEL VEHICULO ENTRE 1:99 Y 40:60 POR CIENTO EN PESO, SIENDO A LA VEZ MEZCLADA CON INGREDIENTES ACTIVOS EN FORMA MICRONIZADA COMO UN CORTICOESTEROIDE TAL COMO BUDESONIDA Y SUS EPIMEROS, DIPROPIONATO DE BECLOMETASONA, FORMOTEROL Y SUS ESTEREOISOMEROS. ESTA mixture of 90% to 99% particulate carrier and from 1% to 10% of magnesium stearate WITH A PARTICLE RATIO THIN THICK PARTICLE carrier and the vehicle between 1:99 and 40:60 weight percent , while being mixed with active ingredients in micronized form AS A corticosteroid such as budesonide and epimers, beclomethasone dipropionate, formoterol and stereoisomers. LAS PARTICULAS DE ESTEARATO DE MAGNESIO CUBREN PARCIALMENTE LAS SUPERFICIES TANTO DEL EXCIPIENTE COMO LAS DEL VEHICULO. PARTICLE magnesium stearate partially cover the surfaces of both the excipient AS THE VEHICLE. LAS PARTICULAS GRUESAS DEL VEHICULO TIENEN UN INDICE DE FISURA DE AL MENOS 1,25. THICK PARTICLE VEHICLE HAS A CRACK RATE OF AT LEAST 1.25. SE REFIERE TAMBIEN A UN PROCESO PARA ELABORAR UN POLVO QUE COMPRENDE: i) COMICRONIZAR LAS PARTICULAS DEL EXCIPIENTE Y DE ESTEARATO DE MAGNESIO Y REDUCIR SIGNIFICATIVAMENTE SUS TAMANOS Y ii) ESFEREONIZACION POR MEZCLADO CON LAS PARTICULAS GRUESAS DEL VEHICULO It also relates to a process for making a powder comprising: comicronizing the excipient particles and magnesium stearate i) and significantly reduce their sizes and ii) ESFEREONIZACION BY MIXING WITH THICK carrier particles
PE2001000338A 2000-04-17 2001-04-11 Pharmaceutical formulations for DPIs in the form of hard agglomerates PE12272001A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB0009469A GB0009469D0 (en) 2000-04-17 2000-04-17 Improvements in or relating to formalities for use in inhaler devices
EP00113608 2000-06-27

Publications (1)

Publication Number Publication Date
PE12272001A1 true PE12272001A1 (en) 2002-01-07

Family

ID=26071084

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2001000338A PE12272001A1 (en) 2000-04-17 2001-04-11 Pharmaceutical formulations for DPIs in the form of hard agglomerates

Country Status (32)

Country Link
US (4) US6884794B2 (en)
EP (6) EP1276472B1 (en)
JP (2) JP2003530425A (en)
KR (1) KR20030069047A (en)
CN (1) CN1424909A (en)
AT (5) AT513542T (en)
AU (3) AU784719B2 (en)
BR (3) BR0110141A (en)
CA (3) CA2406201C (en)
CY (1) CY1107315T1 (en)
CZ (1) CZ301904B6 (en)
DE (3) DE60125344T2 (en)
DK (3) DK1274406T3 (en)
DZ (1) DZ3315A1 (en)
EE (1) EE05257B1 (en)
ES (3) ES2272473T3 (en)
GB (2) GB2363987A (en)
HU (4) HU230464B1 (en)
IL (1) IL152306D0 (en)
MA (1) MA26892A1 (en)
MX (3) MXPA02010218A (en)
MY (1) MY129384A (en)
NO (4) NO342999B1 (en)
NZ (1) NZ521887A (en)
PE (1) PE12272001A1 (en)
PL (3) PL358640A1 (en)
PT (3) PT1274406E (en)
SA (1) SA1522B1 (en)
SI (2) SI1274406T1 (en)
SK (1) SK284248B6 (en)
TN (1) TNSN01060A1 (en)
WO (3) WO2001078693A2 (en)

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