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DK2094240T3 - Stabil pulverformulering indeholdende et anticholinergikum - Google Patents

Stabil pulverformulering indeholdende et anticholinergikum Download PDF

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Publication number
DK2094240T3
DK2094240T3 DK07847111.7T DK07847111T DK2094240T3 DK 2094240 T3 DK2094240 T3 DK 2094240T3 DK 07847111 T DK07847111 T DK 07847111T DK 2094240 T3 DK2094240 T3 DK 2094240T3
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Denmark
Prior art keywords
acid
spray
powder formulation
group
organic
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DK07847111.7T
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English (en)
Inventor
Michael Trunk
Claudius Weiler
Werner Pieroth
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Boehringer Ingelheim Int
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Publication of DK2094240T3 publication Critical patent/DK2094240T3/da

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    • 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
    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/1682—Processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61P11/06—Antiasthmatics
    • 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
    • A61P11/16—Central respiratory analeptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D451/00—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof
    • C07D451/02—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof
    • C07D451/04—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof with hetero atoms directly attached in position 3 of the 8-azabicyclo [3.2.1] octane or in position 7 of the 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring system
    • C07D451/06—Oxygen atoms
    • C07D451/12—Oxygen atoms acylated by aromatic or heteroaromatic carboxylic acids, e.g. cocaine

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

Claims (16)

1. Sprøjtetørret pulverformulering omfattende partikler, som indeholder følgende bestanddele i) til iii): i) en forbindelse med formlen 1.
χ- 1, hvor X" betegner en negativt ladet anion, ii) mindst et indlejringsmateriale udvalgt fra gruppen bestående af mono- eller di- saccharider, oligosaccharider, polymerer, sukkeralkoholer og kolesterin, iii) en organisk, fysiologisk acceptabel syre udvalgt fra gruppen bestående af askorbinsyre, en monovalent carboxylsyre, en divalent carboxylsyre og en trivalent carboxylsyre, med undtagelse af aminocarboxylsyrer.
2. Sprøjtetørret pulverformulering ifølge krav 1, hvor den organiske, fysiologisk acceptable syre ifølge iii) er en mono-, di- eller trivalent carboxylsyre udvalgt fra gruppen bestående af citronsyre, vinsyre, æblesyre, mælkesyre, eddikesyre, a-hydroxycaprylsyre og glukonsyre.
3. Sprøjtetørret pulverformulering ifølge et af kravene 1 eller 2, hvor den sprøjtetørrede pulverformulering yderligere indeholder saltet af en organisk, fysiologisk acceptabel syre ifølge iii).
4. Sprøjtetørret pulverformulering ifølge krav 3, hvor saltet af den organiske, fysiologisk acceptable syre ifølge iii) er udvalgt fra gruppen bestående af fumarat, oxalat, succi-nat, citrat, tartrat, malat, lactat, acetat, α-hydroxycapronat og glukonat.
5. Sprøjtetørret pulverformulering ifølge et af kravene 1 til 4, hvor X' i forbindelsen med formlen i ifølge i) betegner en anion udvalgt fra gruppen bestående af chlorid, bromid, iodid, sulfat, phosphat, methansulfonat, nitrat, maleat, acetat, citrat, fumarat, tartrat, oxalat, succinat, benzoat og p-toluensulfonat.
6. Sprøjtetørret pulverformulering ifølge et af kravene 1 til 5, hvor forbindelsen med formlen 1. foreligger i en koncentration på mellem 0,01 og 5 % på basis af faststoffet.
7. Sprøjtetørret pulverformulering ifølge et af kravene 1 til 6, hvor indlejringsmaterialet ifølge ii) er udvalgt fra gruppen bestående af a) et mono- eller disaccharid udvalgt fra gruppen glukose, saccharose, fruktose, mal tose, laktose, cellobiose og trehalose, b) et oligosaccharid udvalgt fra gruppen oligomaltose, oligofruktose, cyklodextrin, dextrin og oligosaccharose, c) en polymer udvalgt fra gruppen inulin, alginat, maltodextrin, stivelse, stivelsesderivater, cellulose, cellulosederivater, PVP, gelatine, chitosan, dextran, pektin, gummi arabi-cum, polylaktider, poly(laktid-coglykolider) og polyvinylalkoholer og d) en sukkeralkohol udvalgt fra gruppen mannitol, xylitol og sorbitol.
8. Sprøjtetørret pulverformulering ifølge et af kravene 1 til 7, hvor den organiske, fysiologisk acceptable syre ifølge iii) er citronsyre, og citronsyren tilsættes i en sådan koncentration til den sprøjtefærdige opløsning indeholdende anticholinergikummet ifølge i), fortrinsvis en forbindelse med formlen og det mindst ene indlejringsmateriale ifølge ii), at pH-værdien i opløsningen indstiller sig til < 5.
9. Sprøjtetørret pulverformulering ifølge et af kravene 1 til 8, hvor partiklerne besidder et aerodynamisk middelmål på maksimalt 15 pm, fortrinsvist maksimalt 10 pm.
10. Fremgangsmåde til fremstilling af en pulverformulering, som indeholder partikler, hvilken fremgangsmåde omfatter følgende trin: a) tilvejebringelse af en opløsning omfattende bestanddelene i) til iii): i) en forbindelse med formlen 1.
X i, hvor X' betegner en negativt ladet anion, ii) mindst et indlejringsmateriale udvalgt fra gruppen bestående af mono- eller disac-charider, oligosaccharider, polymerer, sukkeralkoholer og kolesterin, og iii) en organisk, fysiologisk acceptabel syre udvalgt fra gruppen bestående af askorbinsyre, en monovalent carboxylsyre, en divalent carboxylsyre og en trivalent carboxylsyre, med undtagelse af aminocarboxylsyrer, i et egnet opløsningsmiddel; b) forstøvning af opløsningen fra trin a) i en varmluftstrøm; c) tørring af den forstøvede opløsning fra trin b) til et pulver indeholdende partikler; d) separation af pulveret fra trin c) ved hjælp af cyklon eller filter.
11. Fremgangsmåde ifølge krav 10, hvor der i trin a) tilvejebringes en opløsning, der som organisk, fysiologisk acceptabel syre ifølge iii) gør brug af en mono-, di- eller trivalent carboxylsyre udvalgt fra gruppen bestående af citronsyre, vinsyre, æblesyre, mælkesyre, eddikesyre, α-hydroxycaprylsyre og glukonsyre.
12. Fremgangsmåde ifølge et af kravene 10 eller 11, hvor der i trin a) tilvejebringes en opløsning, som yderligere indeholder saltet af en organisk, fysiologisk acceptabel syre ifølge iii).
13. Fremgangsmåde ifølge et af kravene 10 til 12, hvor varmluftstrømmen i trin b) besidder temperaturer mellem 100 og 350 °C, fortrinsvis mellem 120 og 200 °C.
14. Pulverformulering, der kan opnås ved en fremgangsmåde ifølge et af kravene 10 til 13.
15. Anvendelse af en organisk, fysiologisk acceptabel syre udvalgt fra gruppen bestående af askorbinsyre, en monovalent carboxylsyre, en divalent carboxylsyre og en trivalent carboxylsyre, med undtagelse af aminocarboxylsyrer, til stabilisering af en ved hjælp af sprøjtetørring fremstillet pulverformulering indeholdende følgende bestanddele i) og ii): i) en forbindelse med formlen 1.
X* i* hvor X" betegner en negativt ladet anion, ii) mindst et indlejringsmateriale udvalgt fra gruppen bestående af mono- eller disac-charider, oligosaccharider, polymerer, sukkeralkoholer og kolesterin.
16. Anvendelse ifølge krav 15, hvor den organiske, fysiologisk acceptable syre er en mono-, di- eller trivalent carboxylsyre udvalgt fra gruppen bestående af citronsyre, vinsyre, æblesyre, mælkesyre, eddikesyre, α-hydroxycaprylsyre og glukonsyre.
DK07847111.7T 2006-11-22 2007-11-06 Stabil pulverformulering indeholdende et anticholinergikum DK2094240T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06124580A EP1925295A1 (de) 2006-11-22 2006-11-22 Stabile Pulverformulierung enthaltend ein Anticholinergikum
PCT/EP2007/061911 WO2008061874A2 (de) 2006-11-22 2007-11-06 Stabile pulverformulierung enthaltend ein anticholinergikum

Publications (1)

Publication Number Publication Date
DK2094240T3 true DK2094240T3 (da) 2018-01-22

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DK07847111.7T DK2094240T3 (da) 2006-11-22 2007-11-06 Stabil pulverformulering indeholdende et anticholinergikum

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US (4) US20100055193A1 (da)
EP (3) EP1925295A1 (da)
JP (1) JP5906003B2 (da)
CA (1) CA2670155C (da)
DK (1) DK2094240T3 (da)
ES (1) ES2657482T3 (da)
HU (1) HUE036427T2 (da)
PL (1) PL2094240T3 (da)
PT (1) PT2094240T (da)
SI (1) SI2094240T1 (da)
WO (1) WO2008061874A2 (da)

Families Citing this family (4)

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JP5440934B2 (ja) 2006-05-24 2014-03-12 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 置換プテリジン
FR2938433B1 (fr) * 2008-11-19 2011-09-09 Francois Fauran Compositions pharmaceutiques utilisant l'inuline comme excipient de granulation
PT107312B (pt) * 2013-11-25 2022-05-10 Advanced Cyclone Systems S A Ciclone aglomerador de fluxo invertido e respectivo processo
CN119278026A (zh) 2022-03-31 2025-01-07 好利安科技有限公司 吸入复合材料和基于载体的制剂组合

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Also Published As

Publication number Publication date
US20100055193A1 (en) 2010-03-04
JP5906003B2 (ja) 2016-04-20
PL2094240T3 (pl) 2018-03-30
ES2657482T3 (es) 2018-03-05
CA2670155C (en) 2017-03-21
JP2011502102A (ja) 2011-01-20
PT2094240T (pt) 2018-01-17
US20160263121A1 (en) 2016-09-15
EP2932962B1 (de) 2021-10-13
WO2008061874A3 (de) 2008-08-21
EP1925295A1 (de) 2008-05-28
CA2670155A1 (en) 2008-05-29
WO2008061874A2 (de) 2008-05-29
HUE036427T2 (hu) 2018-07-30
EP2094240B1 (de) 2017-10-25
US20130164344A1 (en) 2013-06-27
EP2932962A1 (de) 2015-10-21
SI2094240T1 (en) 2018-02-28
US20170326150A1 (en) 2017-11-16
EP2094240A2 (de) 2009-09-02

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