DK2621488T3 - Kationiske tørre pulvere - Google Patents

Kationiske tørre pulvere Download PDF

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Publication number
DK2621488T3
DK2621488T3 DK11767877.1T DK11767877T DK2621488T3 DK 2621488 T3 DK2621488 T3 DK 2621488T3 DK 11767877 T DK11767877 T DK 11767877T DK 2621488 T3 DK2621488 T3 DK 2621488T3
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DK
Denmark
Prior art keywords
less
dry powder
particles
respirable dry
respirable
Prior art date
Application number
DK11767877.1T
Other languages
English (en)
Inventor
Michael M Lipp
Jean C Sung
Original Assignee
Pulmatrix Operating Co Inc
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
Priority claimed from PCT/US2011/049435 external-priority patent/WO2012030664A1/en
Application filed by Pulmatrix Operating Co Inc filed Critical Pulmatrix Operating Co Inc
Application granted granted Critical
Publication of DK2621488T3 publication Critical patent/DK2621488T3/da

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Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic 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
    • A61K9/1611—Inorganic compounds
    • 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
    • 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
    • A61P11/10—Expectorants

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

Claims (11)

1. Respirabelt tørt pulver, der omfatter sprøjtetørrede respirable tørre partikler, der omfatter a) et calciumsalt med en opløselighed på >0,5 g/1 i vand; hvor calciumsaltet tilvejebringer calcium-ion i en mængde på mellem 0,1 og 2,9 vægt-% af den tørre partikel, og b) et farmaceutisk aktivt middel, hvor det respirable tørre pulver ikke indeholder et phospholipid, og hvor de respirable tørre partikler er sprøjtetørret, har en volumen median geometrisk diameter (VMGD) på 10 mikrometer (mikron) eller mindre og et dispergerbarhedsforhold (1 bar/4 bar) på mindre end 1,5 målt ved dispersionsbetingelserne 1 bar og 4 bar ved hjælp af laserdiffraktion (RODOS/HELOS-system) som målt i afsnit [0274], og hvor de respirable tørre partikler har en tapdensitet på mere end 0,4 g/ml som målt i afsnit [0273] ved hjælp af en SOTAX-tapdensitetstester.
2. Respirabelt tørt pulver ifølge krav 1, hvor (i) det respirable tørre pulver har en volumen median geometrisk diameter (VMGD) på 5,0 mikrometer (mikron) eller mindre, eller (ii) det respirable tørre pulver har en finpartikelfraktion (FPF) på mindre end 5,6 mikrometer (mikron) på mindst 45 % som målt i afsnittene [0258-259], eller (iii) det respirable tørre pulver har en masse median aerodynamisk diameter (MMAD) på 5 mikrometer (mikron) som målt i afsnit [0247], eller (iv) molekylvægtforholdet mellem calcium-ion og calciumsaltet er større end 0,1.
3. Respirabelt tørt pulver ifølge et hvilket som helst af kravene 1 eller 2, hvor det tørre pulver består af sprøjtetørrede respirable tørre partikler.
4. Respirabelt tørt pulver ifølge et hvilket som helst af ovennævnte krav, hvor det respirable tørre pulver yderligere omfatter mindst ét farmaceutisk acceptabelt excipiens, eventuelt hvor det mindst ene farmaceutisk acceptable excipiens er til stede i en mængde på < 50 vægt-%, eller hvor det mindst ene farmaceutisk acceptable excipiens er til stede i en mængde på < 50 vægt-% og omfatter leucin, eller hvor det mindst ene farmaceutisk acceptable excipiens er til stede i en mængde på < 50 vægt-% og omfatter maltodextrin eller mannitol.
5. Respirabelt tørt pulver ifølge et hvilket som helst af ovennævnte krav, hvor (i) det farmaceutisk aktive middel er et antibiotikum, en langtidsvirkende beta-2-agonist (LABA), en langtidsvirkende muscarin-antagonist (LAMA), et kortikosteroid eller en hvilken som helst kombination deraf, eller (ii) det farmaceutisk aktive middel er et makromolekyle, eller (iii) det farmaceutisk aktive middel er et antistof.
6. Respirabelt tørt pulver ifølge et hvilket som helst af ovennævnte krav, hvor de respirable tørre partikler yderligere er kendetegnet ved en kapseludsendt pulvermasse (CEPM) på mindst 70 %, når den udsendes fra en tørpulverinhalator under følgende betingelser: en samlet inhalationsenergi på mindre end 0,28 Joule ved anvendelse af en kapsel, der består af 50 mg respirabelt tørt pulver.
7. Respirabelt tørt pulver ifølge et hvilket som helst af ovennævnte krav, hvor calciumsaltet er calciumlactat.
8. Respirabelt tørt pulver ifølge et hvilket som helst af kravene 1-7 til anvendelse til terapi.
9. Effektiv mængde af et respirabelt tørt pulver ifølge et hvilket som helst af kravene 1-7 til anvendelse til behandling af en luftvejssygdom, hvor luftvejssygdommen er astma, overreaktion i luftvejene, sæsonbetinget allergisk allergi, bronkiektasi, kronisk bronkitis, emfysem, kronisk obstruktiv lungesygdom eller cystisk fibrose.
10. Effektiv mængde af et respirabelt tørt pulver ifølge et hvilket som helst af kravene 1-7 til anvendelse til behandling eller forebyggelse af en akut eksacerbation af en luftvejssygdom, hvor luftvejssygdommen er astma, overreaktion i luftvejene, sæsonbetinget allergisk allergi, bronkiektasi, kronisk bronkitis, emfysem, kronisk obstruktiv lungesygdom eller cystisk fibrose.
11. Effektiv mængde af et respirabelt tørt pulver ifølge et hvilket som helst af kravene 1-7 til anvendelse til behandling eller forebyggelse af en infektionssygdom i luftvejene.
DK11767877.1T 2010-09-29 2011-09-29 Kationiske tørre pulvere DK2621488T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US38785510P 2010-09-29 2010-09-29
PCT/US2011/049435 WO2012030664A1 (en) 2010-08-30 2011-08-26 Dry powder formulations and methods for treating pulmonary diseases
PCT/US2011/053833 WO2012050945A1 (en) 2010-09-29 2011-09-29 Cationic dry powders

Publications (1)

Publication Number Publication Date
DK2621488T3 true DK2621488T3 (da) 2019-03-04

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
DK11767877.1T DK2621488T3 (da) 2010-09-29 2011-09-29 Kationiske tørre pulvere
DK18201700.4T DK3470057T3 (da) 2010-09-29 2011-09-29 Kationiske tørpulvere omfattende magnesiumsalt

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK18201700.4T DK3470057T3 (da) 2010-09-29 2011-09-29 Kationiske tørpulvere omfattende magnesiumsalt

Country Status (9)

Country Link
US (2) US9433576B2 (da)
EP (2) EP3470057B1 (da)
AU (1) AU2011314007B2 (da)
CA (1) CA2812417C (da)
DK (2) DK2621488T3 (da)
ES (2) ES2710537T3 (da)
IL (1) IL225399B (da)
PT (2) PT3470057T (da)
WO (1) WO2012050945A1 (da)

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