DK1485069T3 - Fremgangsmåde til fremstilling af tørre partikler - Google Patents

Fremgangsmåde til fremstilling af tørre partikler Download PDF

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Publication number
DK1485069T3
DK1485069T3 DK03714250.2T DK03714250T DK1485069T3 DK 1485069 T3 DK1485069 T3 DK 1485069T3 DK 03714250 T DK03714250 T DK 03714250T DK 1485069 T3 DK1485069 T3 DK 1485069T3
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mixture
approx
nozzle
liquid
process according
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DK03714250.2T
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DK1485069T5 (da
Inventor
Lloyd P Johnston
Jeffrey D Mintzes
Jean C Sung
Marie Elizabeth Chung
Richard P Batycky
Charles D Blizzard
Blair C Jackson
Ernest E Penachio
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Civitas Therapeutics Inc
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    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • 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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D1/00—Evaporating
    • B01D1/16—Evaporating by spraying
    • B01D1/18—Evaporating by spraying to obtain dry solids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/40—Mixing liquids with liquids; Emulsifying
    • B01F23/405—Methods of mixing liquids with liquids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40—Static mixers
    • B01F25/42—Static mixers in which the mixing is affected by moving the components jointly in changing directions, e.g. in tubes provided with baffles or obstructions
    • B01F25/43—Mixing tubes, e.g. wherein the material is moved in a radial or partly reversed direction
    • B01F25/431—Straight mixing tubes with baffles or obstructions that do not cause substantial pressure drop; Baffles therefor
    • B01F25/4316—Straight mixing tubes with baffles or obstructions that do not cause substantial pressure drop; Baffles therefor the baffles being flat pieces of material, e.g. intermeshing, fixed to the wall or fixed on a central rod
    • B01F25/43161—Straight mixing tubes with baffles or obstructions that do not cause substantial pressure drop; Baffles therefor the baffles being flat pieces of material, e.g. intermeshing, fixed to the wall or fixed on a central rod composed of consecutive sections of flat pieces of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
    • B01J2/04—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops in a gaseous medium
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/10—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic in stationary drums or troughs, provided with kneading or mixing appliances
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Dispersion Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Vaporization, Distillation, Condensation, Sublimation, And Cold Traps (AREA)
  • Nozzles (AREA)
  • Drying Of Solid Materials (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Glanulating (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Detergent Compositions (AREA)

Claims (41)

1. Fremgangsmåde til fremstilling af en tørpulversammensætning, omfattende: - kombinering af en vandig opløsning, der omfatter et hydrofilt, aktivt middel opløst i et vandigt opløsningsmiddel, og en organisk opløsning, der omfatter en hy-drofobisk komponent opløst i et organisk opløsningsmiddel, i en statisk blander til dannelse af en blanding, så nedbrydningsvirkningerne, der resulterer af kontakt mellem det organiske opløsningsmiddel og det aktive middel, derved minimeres, - forstøvning af blandingen til frembringelse af dråber, og - tørring af dråberne til dannelse af tørre partikler, hvori det hydrofile, aktive middel og den hydrofobiske komponent er inkompatible og ved kombinering i den statiske blander danner en homogen blanding.
2. Fremgangsmåde ifølge krav 1, hvori kombineringstrinet omfatter tilføjelse af den vandige opløsning til den organiske opløsning.
3. Fremgangsmåde ifølge krav 1 eller 2, hvori den organiske opløsning omfatter et hjælpestof opløst i det organiske opløsningsmiddel.
4. Fremgangsmåde ifølge ethvert af de foregående krav, hvori den vandige opløsning omfatter et hjælpestof.
5. Fremgangsmåde ifølge ethvert af de foregående krav, hvori det aktive middel er valgt fra gruppen bestående af insulin, albuterolsulfat, L-DOPA, humaniseret monoklonalt antistof (Ig G1), humant væksthormon, epinefrin og salmeterol xina-foat.
6. Fremgangsmåde ifølge ethvert af de foregående krav, hvori det vandige opløsningsmiddel er vand.
7. Fremgangsmåde ifølge krav 1, hvori det aktive middel omfatter et antistof.
8. Fremgangsmåde ifølge krav 1, hvori det aktive middel omfatter et protein.
9. Fremgangsmåde ifølge krav 1, yderligere omfattende sigtning af de tørre partikler.
10. Fremgangsmåde ifølge krav 1, yderligere omfattende afmåling af en enkelt dosis af de tørre partikler og pakning af en enkelt dosis.
11. Fremgangsmåde ifølge ethvert af de foregående krav, hvori tørringstrinet udføres under anvendelse af en spraytørrer.
12. Fremgangsmåde ifølge ethvert af de foregående krav, hvori det hydrofile, aktive middel har en vandig opløselighed over 5 mg/ml.
13. Fremgangsmåde ifølge ethvert af de foregående krav, hvori den hydrofobiske komponent har en opløselighed under 5 mg/ml i vand.
14. Fremgangsmåde ifølge krav 13, hvori den hydrofobiske komponent har en opløselighed under 1 mg/ml i vand.
15. Fremgangsmåde ifølge ethvert af de foregående krav, hvori forstøvningstrinet under anvendelse af en roterende forstøver.
16. Fremgangsmåde ifølge ethvert af de foregående krav, hvori forstøvningstrinet udføres under anvendelse af en ekstern blandedyse.
17. Fremgangsmåde ifølge ethvert af de foregående krav, hvori forstøvningstrinet udføres umiddelbart efter kombineringstrinet.
18. Fremgangsmåde ifølge ethvert af krav 1 til 15, hvori forstøvningstrinet udføres under anvendelse af en intern blandedyse.
19. Fremgangsmåde ifølge krav 18, hvori dysen er en enkelthuldyse.
20. Fremgangsmåde ifølge krav 18, hvori dysen er en sekshulsdyse.
21. Fremgangsmåde ifølge krav 18, hvori dysen omfatter et blandekammer samt et væsketilførselsindløb til blandekammeret, hvori væsketilførselsindløbet er placeret i en vinkel med dysens længdeakse for derved at generere et tyndt lag væske i blandekammeret.
22. Fremgangsmåde ifølge krav 18, hvori dysen er en trykdyse.
23. Fremgangsmåde ifølge ethvert af de foregående krav, yderligere omfattende tilførsel af et afspændingsmiddel til den vandige opløsning, den organiske opløsning eller til blandingen.
24. Fremgangsmåde ifølge krav 23, hvori afspændingsmidlet omfatter et ikke-ionisk afspændingsmiddel.
25. Fremgangsmåde ifølge krav 23, hvori afspændingsmidlet omfatter 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC).
26. Fremgangsmåde ifølge ethvert af de foregående krav, hvori en faststofkoncentration af blandingen er mere end ca. 2 g/l.
27. Fremgangsmåde ifølge krav 26, hvori faststofkoncentrationen af blandingen er mere end ca. 5 g/l.
28. Fremgangsmåde ifølge krav 27, hvori faststofkoncentrationen af blandingen er mindre end ca. 60 g/l.
29. Fremgangsmåde ifølge krav 28, hvori faststofkoncentrationen af blandingen er mindre end ca. 30 g/l.
30. Fremgangsmåde ifølge ethvert af de foregående krav, hvori den organiske opløsning omfatter ca. 60-70 volumen-% vand, og hvori blandingen omfatter ca. 20 volumen-% organisk fase.
31. Fremgangsmåde ifølge krav 30, hvori den organiske opløsning omfatter ca. 60 volumen-% vand, og hvori blandingen omfatter ca. 20 volumen-% organisk fase.
32. Fremgangsmåde ifølge ethvert af de foregående krav, hvori tørretrinet udføres i en tørrer med en udløbstemperatur på 35-70sC.
33. Fremgangsmåde ifølge krav 32, hvori udløbstemperaturen er ca. 40SC.
34. Fremgangsmåde ifølge krav 33, hvori udløbstemperaturen er ca. 60SC.
35. Fremgangsmåde ifølge ethvert af de foregående krav, yderligere omfattende: - sikring af en mængde faste ingredienser, som er nødvendige til at opnå en opløsningskoncentration, - sikring af en mængde væskeformige ingredienser, som er nødvendige til at opnå opløsningskoncentrationen, og - kombinering af de væskeformige og de faste ingredienser til dannelse af den vandige opløsning.
36. Fremgangsmåde ifølge ethvert af de foregående krav, hvori forstøvningstrinet omfatter anvendelse af en forstøvningsgashastighed på ca. 35-120 g/min.
37. Fremgangsmåde ifølge krav 36, hvori forstøvningsgashastigheden er ca. 45-80 g/min.
38. Fremgangsmåde ifølge ethvert af de foregående krav, hvori forstøvningstrinet omfatter anvendelse af en væsketilførselshastighed på ca. 10-75 ml/min.
39. Fremgangsmåde ifølge krav 38, hvori væsketilførselshastigheden er ca. 15-40 ml/min.
40. Fremgangsmåde ifølge ethvert af de foregående krav, hvori tørretrinet udføres under anvendelse af en tørregashastighed på ca. 80-125 kg/t.
41. Fremgangsmåde ifølge ethvert af de foregående krav, hvori forstøvningstrinet udføres under anvendelse af en væsketilførsel, og tørretrinet udføres under anvendelse af en tørregas, hvilket væsketilførsel/tørregas-forhold er ca. 5 til 60 ml væske/kg gas.
DK03714250.2T 2002-03-20 2003-03-19 Fremgangsmåde til fremstilling af tørre partikler DK1485069T5 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/101,563 US7008644B2 (en) 2002-03-20 2002-03-20 Method and apparatus for producing dry particles
PCT/US2003/008398 WO2003080028A2 (en) 2002-03-20 2003-03-19 Method and apparatus for producing dry particles

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Publication Number Publication Date
DK1485069T3 true DK1485069T3 (da) 2015-03-23
DK1485069T5 DK1485069T5 (da) 2015-06-08

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US (4) US7008644B2 (da)
EP (2) EP1485069B1 (da)
JP (2) JP4917739B2 (da)
CA (1) CA2478629C (da)
CY (1) CY1115950T1 (da)
DK (1) DK1485069T5 (da)
ES (2) ES2530774T3 (da)
PT (1) PT1485069E (da)
SI (1) SI1485069T1 (da)
WO (1) WO2003080028A2 (da)

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