MX375427B - Composicion que comprende al menos un polvo seco obtenido por secado por atomizacion para aumentar la estabilidad de la formulacion - Google Patents

Composicion que comprende al menos un polvo seco obtenido por secado por atomizacion para aumentar la estabilidad de la formulacion

Info

Publication number
MX375427B
MX375427B MX2017004476A MX2017004476A MX375427B MX 375427 B MX375427 B MX 375427B MX 2017004476 A MX2017004476 A MX 2017004476A MX 2017004476 A MX2017004476 A MX 2017004476A MX 375427 B MX375427 B MX 375427B
Authority
MX
Mexico
Prior art keywords
powder
composition
weight
stability
dry powder
Prior art date
Application number
MX2017004476A
Other languages
English (en)
Other versions
MX2017004476A (es
Inventor
Cristina Veneziani
Giovanni Caponetti
Heike Butti
Laura Zanellotti
Loretta Maggi
Original Assignee
Zambon 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 Zambon Spa filed Critical Zambon Spa
Publication of MX2017004476A publication Critical patent/MX2017004476A/es
Publication of MX375427B publication Critical patent/MX375427B/es

Links

Classifications

    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/439Heterocyclic 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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Cosmetics (AREA)

Abstract

La presente invencion se refiere a formulaciones de inhalacion de farmacos en forma de polvo seco para administracion por inhalacion, que se pueden suministrar como tales con un inhalador y proporcionan alta capacidad de liberacion, respirabilidad y estabilidad. En particular, la invencion se refiere a una composicion farmaceutica para uso por inhalacion en forma de polvo que comprende un primer polvo que comprende al menos un polvo (a1) que comprende un agente activo o una sal farmacéuticamente aceptable del mismo, n una cantidad mayor a 1% en peso del polvo, leucina en una cantidad del 5 al 70% en peso de dicho polvo, un azucar en una cantidad del 20 al 90% en peso del polvo; y un segundo polvo que comprende una mezcla de una primera lactosa que tiene un X50 de 35 a 75 um, con una segunda lactosa que tiene un X50 de 1.5 a 10 um, el contenido de las primera y segunda lactosas en la mezcla es del 85% al 96% y del 4% al 15% respectivamente. La relación en peso entre el primer polvo y el segundo polvo es de 1/5 a 1/100, y la composicion tiene una fraccion de partículas finas (FPF) superior al 60% y una fraccion entregada (DF) superior al 85%.
MX2017004476A 2014-10-08 2015-10-07 Composicion que comprende al menos un polvo seco obtenido por secado por atomizacion para aumentar la estabilidad de la formulacion MX375427B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI20141761 2014-10-08
PCT/EP2015/073188 WO2016055544A1 (en) 2014-10-08 2015-10-07 Composition comprising at least one dry powder obtained by spray drying to increase the stability of the formulation

Publications (2)

Publication Number Publication Date
MX2017004476A MX2017004476A (es) 2017-11-20
MX375427B true MX375427B (es) 2025-03-06

Family

ID=51904067

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017004476A MX375427B (es) 2014-10-08 2015-10-07 Composicion que comprende al menos un polvo seco obtenido por secado por atomizacion para aumentar la estabilidad de la formulacion

Country Status (14)

Country Link
US (1) US10517828B2 (es)
EP (1) EP3203983A1 (es)
JP (1) JP6919093B2 (es)
KR (1) KR102462058B1 (es)
CN (1) CN107205936B (es)
AU (2) AU2015330010A1 (es)
CA (1) CA2962531C (es)
CO (1) CO2017004504A2 (es)
EA (1) EA035740B1 (es)
IL (1) IL251472B (es)
MX (1) MX375427B (es)
MY (1) MY191712A (es)
WO (1) WO2016055544A1 (es)
ZA (1) ZA201703125B (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3962455B1 (en) 2020-05-18 2022-08-31 Orexo AB New pharmaceutical composition for drug delivery
MX2023002285A (es) * 2020-08-26 2023-05-16 Cila Therapeutic Inc Agentes terapeuticos inhalables.
CN112125818A (zh) * 2020-09-23 2020-12-25 山东瑞博龙化工科技股份有限公司 一种制备n,n-二乙基丙烯酰胺的系统及工艺
IT202000030437A1 (it) * 2020-12-10 2022-06-10 Zambon Spa Metodo per la realizzazione di una polvere inalabile comprendente voriconazolo
GB202117016D0 (en) 2021-11-25 2022-01-12 Orexo Ab New pharmaceutical device
WO2023094826A1 (en) 2021-11-25 2023-06-01 Orexo Ab Pharmaceutical composition comprising adrenaline
CN115400103B (zh) * 2022-09-22 2023-11-24 苏州易合医药有限公司 一种多孔性呼吸颗粒及其制备方法

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9826783D0 (en) * 1998-12-04 1999-01-27 Scherer Ltd R P Inhalation powders
GB0009584D0 (en) * 2000-04-18 2000-06-07 Glaxo Group Ltd Pharmaceutical compositions
IL153705A0 (en) * 2000-06-27 2003-07-06 Vectura Ltd Method of making particles for use in a pharmaceutical composition
US8337816B2 (en) * 2001-09-17 2012-12-25 Glaxo Group Limited Dry powder medicament formulations
US20040204439A1 (en) * 2003-04-14 2004-10-14 Staniforth John Nicholas Composition, device, and method for treating sexual dysfunction via inhalation
ITMI20051999A1 (it) * 2005-10-21 2007-04-22 Eratech S R L Formulazioni inalatorie di farmaci in fora di polvere secca per somministrazione come tale o con nebulizzatore e dotate di elevata erogabilita' respirabilita' e stabilita'
WO2008097233A1 (en) * 2007-02-09 2008-08-14 Schering Corporation Stable pharmaceutical drug aerosols
CN102811715A (zh) * 2009-12-08 2012-12-05 悉尼大学 可吸入制剂
GB201102237D0 (en) * 2011-02-09 2011-03-23 Kuecept Ltd Particle formulation
RU2537833C1 (ru) * 2011-03-02 2015-01-10 Джапан Тобакко Инк. Способ получения содержащего ароматизатор листа для изделия для курения, лист для изделия для курения, содержащий ароматизатор, полученный данным способом, и содержащее его изделие для курения
EP2804585A1 (en) * 2012-01-16 2014-11-26 Mahmut Bilgic Dry powder formulations comprising tiotropium, formoterol and budesonide
DK3527199T3 (da) 2012-01-25 2022-10-24 Chiesi Farm Spa Tørpulverformulering omfattende et kortikosteroid og et beta-adrenergikum til indgivelse via inhalation
EA036153B1 (ru) * 2012-07-05 2020-10-06 Арвен Айлак Санайи Ве Тиджарет А.С. Фармацевтическая композиция для ингаляции, упакованная дозированная форма, капсула, способ лечения обструктивных заболеваний дыхательных путей и фармацевтический набор

Also Published As

Publication number Publication date
EP3203983A1 (en) 2017-08-16
KR20170093114A (ko) 2017-08-14
CO2017004504A2 (es) 2017-10-20
JP6919093B2 (ja) 2021-08-18
WO2016055544A1 (en) 2016-04-14
AU2021200503A1 (en) 2021-02-25
KR102462058B1 (ko) 2022-11-01
JP2017530993A (ja) 2017-10-19
CA2962531C (en) 2023-05-23
IL251472A0 (en) 2017-05-29
US20170333349A1 (en) 2017-11-23
EA035740B1 (ru) 2020-08-03
MY191712A (en) 2022-07-09
AU2015330010A1 (en) 2017-04-27
EA201700182A1 (ru) 2017-09-29
CN107205936A (zh) 2017-09-26
CA2962531A1 (en) 2016-04-14
IL251472B (en) 2021-08-31
ZA201703125B (en) 2020-05-27
AU2021200503B2 (en) 2023-01-12
US10517828B2 (en) 2019-12-31
MX2017004476A (es) 2017-11-20
BR112017007182A2 (pt) 2017-12-19
CN107205936B (zh) 2021-07-16

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Legal Events

Date Code Title Description
FG Grant or registration
PD Change of proprietorship

Owner name: ZAMBON S.P.A.