DK1754469T3 - Injicérbare opslemninger med forbedrede injektionsegenskaber - Google Patents

Injicérbare opslemninger med forbedrede injektionsegenskaber Download PDF

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Publication number
DK1754469T3
DK1754469T3 DK06010734.9T DK06010734T DK1754469T3 DK 1754469 T3 DK1754469 T3 DK 1754469T3 DK 06010734 T DK06010734 T DK 06010734T DK 1754469 T3 DK1754469 T3 DK 1754469T3
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injection
viscosity
microparticles
suspension
polysorbate
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DK06010734.9T
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English (en)
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Stephan E Zale
Joyce M Hotz
J Michael Ramstack
M Gary Riley
Olufunmi L Johnson
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Alkermes Controlled Therapeutics Inc
Alkermes Pharma Ireland Ltd
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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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (18)

1. Sammensætning egnet til injektion gennem en nål med en diameter i området fra 0,838 mm til 0,412 mm (str. 18-22) i en vært, omfattende mikropartikler, der omfatter et biologisk aktivt middel spredt eller opløst inde i et polymerbindemid-del i et vandigt injektionsbæremedium, hvori (a) mikropartiklerne er opslemmet i injektionsbæremediet i en koncentration større end 30 mg/ml til dannelse af en opslemning og med en middel massediameter på mindst 10 pm og mindre end 250 pm, (b) en flydende fase af opslemningen har en viskositet på mindst 50 cP ved 20s C, (c) det biologisk aktive middel er et peptid, (d) polymerbindemidlet er valgt fra gruppen bestående af poly(glykolsyre), poly-D,L-mælkesyre, poly-L-mælkesyre, og copolymerer af de foregående, og (e) det vandige injektionsbæremedium omfatter (i) et viskositetsforhøjende middel valgt blandt natriumkarboxymetylcellulose, polyvinylpyrrolidon og hydro-xypropylmetylcellulose; (ii) en tonicitetsjusteringsmiddel omfattende natriumklorid; og (iii) et befugtningsmiddel valgt blandt polysorbat 20, polysorbat 40 og po-lysorbat 80, men er ikke det vandige bæremedium bestående af 3 vol-% natriumkarboxymetylcellulose, 1 vol-% polysorbat 20, 0,9 vol-% natriumklorid, og en resterende volumenprocentdel vand.
2. Sammensætning ifølge krav 1, hvori mikropartiklerne har en middel massediameter i området fra 20 pm til 150 pm.
3. Sammensætning ifølge ethvert foregående krav, hvori injektionsbæremediet omfatter sorbitol som et tæthedsforhøjende element.
4. Sammensætning ifølge ethvert foregående krav, hvori viskositeten af opslem-ningens flydende fase er større end 50 cP og mindre end 60 cP ved 20°C.
5. Sammensætning ifølge ethvert foregående krav, hvori injektionsbæremediet omfatter 1,5% natriumkarboxymetylcellulose, 30% sorbitol og 0,2% polysorbat 20.
6. Sammensætning ifølge ethvert foregående krav, hvori injektionsbæremediet omfatter 3% natriumkarboxymetylcellulose, 0,9% saltvand og 0,1% polysorbat 20.
7. Sammensætning ifølge ethvert foregående krav, hvori polymerbindemidlet er poly (D, L-lakt id-co-gly kolid).
8. Sammensætning ifølge krav 7, hvori polymerbindemidlet er poly(D,L-laktid-co-glykolid) med et molforhold af laktid til glykolid i intervallet fra 85:15 til 50:50.
9. Anvendelse af en sammensætning ifølge ethvert foregående krav til fremstilling af et medikament til injektion i en vært gennem en nål med diameter i området fra 0,838 mm til 0,412 mm (str. 18-22).
10. Sammensætning ifølge ethvert foregående krav til injektion i en vært gennem en nål med diameter i området fra 0,838 mm til 0,412 mm (str. 18-22).
11. Fremgangsmåde til fremstilling af en sammensætning egnet til injektion gennem en nål med en diameter i området fra 0,838 mm til 0,412 mm (str. 18-22) i en vært, omfattende: (a) tilvejebringelse af mikropartikler omfattende et biologisk aktivt middel spredt eller opløst i et polymerbindemiddel, hvilke mikropartikler har en middel massediameter på mindst 10 pm og mindre end 250 pm, (b) tilvejebringelse af et vandigt injektionsbæremedium med en viskositet på mindst 50 cP ved 20SC, og (c) opslemning af mikropartiklerne i det vandige injektionsbæremedium i en koncentration større end 30 mg/ml til dannelse af en opslemning, hvori (i) det biologisk aktive middel er et peptid, (ii) polymerbindemidlet er valgt fra gruppen bestående af po-ly(glykolsyre), poly-D,L-mælkesyre, poly-L-mælkesyre, og copolymerer af de foregående, og (iii) det vandige injektionsbæremedium omfatter (i) et viskositetsforhøjende middel valgt blandt natriumkarboxymetylcellulose, polyvinylpyrroli-don og hydroxypropylmetylcellulose; (ii) en tonicitetsjusteringsmiddel omfattende natriumklorid; og (iii) et befugtningsmiddel valgt blandt poly-sorbat 20, polysorbat 40 og polysorbat 80, men er ikke det vandige bæremedium bestående af 3 vol-% natriumkarboxymetylcellulose, 1 vol-% polysorbat 20, 0,9 vol-% natriumklorid, og en resterende volumenprocentdel vand.
12. Fremgangsmåde ifølge krav 11, hvori mikropartiklerne har en middel massediameter i området fra 20 gm til 150 gm.
13. Fremgangsmåde ifølge krav 11 eller 12, hvori injektionsbæremediet omfatter sorbitol som et tæthedsforhøjende element.
14. Fremgangsmåde ifølge ethvert af krav 11-13, hvori viskositeten af opslemnin-gens flydende fase er større end 50 cP og mindre end 60 cP ved 20°C.
15. Fremgangsmåde ifølge ethvert af krav 11-14, hvori injektionsbæremediet omfatter 1,5% natriumkarboxymetylcellulose, 30% sorbitol og 0,2% polysorbat 20.
16. Fremgangsmåde ifølge ethvert af krav 11-14, hvori injektionsbæremediet omfatter 3% natriumkarboxymetylcellulose, 0,9% saltvand og 0,1% polysorbat 20.
17. Fremgangsmåde ifølge ethvert af krav 11-16, hvori polymerbindemidlet er poly (D, L- lakt id-co-gly kolid).
18. Fremgangsmåde ifølge krav 17, hvori polymerbindemidlet er poly(D,L-laktid-co-glykolid) med et molforhold af laktid til glykolid i intervallet fra 85:15 til 50:50.
DK06010734.9T 2000-05-25 2001-04-19 Injicérbare opslemninger med forbedrede injektionsegenskaber DK1754469T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/577,875 US6495164B1 (en) 2000-05-25 2000-05-25 Preparation of injectable suspensions having improved injectability
EP01928628A EP1283699B1 (en) 2000-05-25 2001-04-19 Injectable suspensions having improved injectability properties

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DK1754469T3 true DK1754469T3 (da) 2016-06-27

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DK10174743.4T DK2269577T3 (da) 2000-05-25 2001-04-19 Injicerbare suspensioner med forbedrede injiceringsegenskaber.
DK06010734.9T DK1754469T3 (da) 2000-05-25 2001-04-19 Injicérbare opslemninger med forbedrede injektionsegenskaber
DK01928628T DK1283699T3 (da) 2000-05-25 2001-04-19 Fremstilling af injicerbare suspensioner med forbedrede indspröjtningsegenskaber

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EP (4) EP2269577B1 (da)
JP (1) JP4502355B2 (da)
KR (1) KR100810480B1 (da)
CN (1) CN100453067C (da)
AT (1) ATE363891T1 (da)
AU (2) AU5546301A (da)
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HK (4) HK1103346A1 (da)
HU (1) HU228587B1 (da)
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NO334660B1 (no) 2014-05-12
AU2001255463B2 (en) 2004-11-04
CZ301359B6 (cs) 2010-01-27
DE60128798D1 (de) 2007-07-19
PT2269577E (pt) 2016-06-14
US6667061B2 (en) 2003-12-23

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