DK3006045T3 - Farmaceutiske formuleringer til oral indgivelse af peptid- eller proteinlægemidler - Google Patents

Farmaceutiske formuleringer til oral indgivelse af peptid- eller proteinlægemidler Download PDF

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DK3006045T3
DK3006045T3 DK14187885.0T DK14187885T DK3006045T3 DK 3006045 T3 DK3006045 T3 DK 3006045T3 DK 14187885 T DK14187885 T DK 14187885T DK 3006045 T3 DK3006045 T3 DK 3006045T3
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sodium
complex
acid
dodecanoyl
peptide
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DK14187885.0T
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Florian Föger
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Cyprumed Gmbh
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    • A61K38/22—Hormones
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
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    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
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    • 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
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Claims (15)

  1. PATE N TKRAV
    1. Peptid- eller proteinlægemiddel med en molekylvægt på lig med eller mindre end omkring 50 kDa til anvendelse som et medikament, hvor peptid- eller proteinlægemidlet skal indgives oralt i kombination med: et farmaceutiske acceptabelt kobbersalt/-kompleks og/eller et farmaceutisk acceptabelt zinksalt/-kompleks; og et farmaceutisk acceptabelt reduktionsmiddel.
  2. 2. Farmaceutisk acceptabelt kobbersalt/-kompleks til terapeutisk anvendelse, hvor det nævnte kobbersalt/-kompleks skal indgives oralt i kombination med: et farmaceutisk acceptabelt reduktionsmiddel; og et peptid- eller proteinlægemiddel med molekylvægt på lig med eller mindre end 50 kDa.
  3. 3. Farmaceutisk acceptabelt zinksalt/-kompleks til terapeutisk anvendelse, hvor det nævnte zinksalt/-kompleks skal indgives oralt i kombination med: et farmaceutisk acceptabelt reduktionsmiddel; og et peptid- eller proteinlægemiddel med en molekylvægt på lig med eller mindre end 50 kDa.
  4. 4. Farmaceutisk acceptabelt reduktionsmiddel til terapeutisk anvendelse, hvor reduktionsmidlet skal indgives oralt i kombination med: et farmaceutisk acceptabelt kobbersalt/-kompleks og/eller et farmaceutisk acceptabelt zinksalt/-kompleks; og et peptid- eller proteinlægemiddel, som har en molekylvægt på lig med eller mindre end 50 kDa.
  5. 5. Farmaceutisk sammensætning omfattende: et peptid- eller proteinlægemiddel med en molekylvægt på lig med eller mindre end 50 kDa; et farmaceutisk acceptabelt kobbersalt/-kompleks og/eller et farmaceutisk acceptabelt zinksalt/-kompleks; og et farmaceutisk acceptabelt reduktionsmiddel.
  6. 6. Farmaceutisk doseringsform omfattende: et peptid- eller proteinlægemiddel med en molekylvægt på lig med eller mindre end omkring 50 kDa; et farmaceutisk acceptabelt kobbersalt/-kompleks og/eller et farmaceutisk acceptabelt zinksalt/-kompleks; og et farmaceutisk acceptabelt reduktionsmiddel; hvor peptid- eller proteinlægemidlet er fysisk adskilt fra det farmaceutisk acceptable kobbersalt/-kompleks og det farmaceutisk acceptable zinksalt/-kompleks i den farmaceutiske doseringsform.
  7. 7. Peptid- eller proteinlægemiddel til anvendelse ifølge krav 1 eller kobbersalt/-kompleks til anvendelse ifølge krav 2 eller zinksalt/-kompleks til anvendelse ifølge krav 3 eller reduktionsmiddel til anvendelse ifølge krav 4 eller den farmaceutiske sammensætning ifølge krav 5 eller den farmaceutiske doseringsform ifølge krav 6, hvor peptideller proteinlægemidlet haren molekylvægt på omkring 500 Da til omkring 30 kDa.
  8. 8. Peptid- eller proteinlægemiddel til anvendelse ifølge krav 1 eller kobbersalt/-kompleks til anvendelse ifølge krav 2 eller zinksalt/-kompleks til anvendelse ifølge krav 3 eller reduktionsmiddel til anvendelse ifølge krav 4 eller farmaceutisk sammensætning ifølge krav 5 eller farmaceutisk doseringsform ifølge krav 6, hvor peptid- eller proteinlægemidlet vælges blandt insulin, en insulinanalog, insulinlispro, insulin-PEGIispro, insulinaspart, insulinglulisin, insulinglargin, insulindetemir, NPH-insulin, insulin-degludec, B29K(N(e)hexadecandioyl-y-L-Glu) A14E B25H desB30 humaninsulin, B29K(N(e)octadecandioyl-y-L-Glu-OEG-OEG) desB30 humaninsulin, B29K(N(s)octadecandioyl-y-L-Glu) A14E B25H desB30 humaninsulin, B29K(N(s)eicosandioyl-y-L-Glu) A14E B25H desB30 humaninsulin, B29K(N(s)octadecandioyl-Y-L-Glu-OEG-OEG) A14E B25H desB30 humaninsulin, B29K(N(s)eicosandioyl-y-L-Glu-OEG-OEG) A14E B25H desB30 humaninsulin, B29K(N(s)eicosandioyl-y-L-Glu-OEG-OEG) A14E B16H B25H desB30 humaninsulin, B29K(N(s)hexadecandioyl-y-L-Glu) A14E B16H B25H desB30 humaninsulin, B29K(N(s)eicosandioyl-y-L-Glu-OEG-OEG) A14E B16H B25H desB30 humaninsulin, B29K(N(s)octadecandioyl) A14E B25H desB30 humaninsulin, GLP-1, et GLP-1 analog, et acyleret GLP-1 analog, en diacyleret GLP-1 analog, semaglutid, liraglutid, exenatid, lixizenatid, en dobbelt agonist for GLP-1 receptoren og glucagonreceptoren, amylin, en amylinanalog, pramlintid, en somatostatinanalog, octreotid, lanreotid, pasireotid, goserelin, buserelin, leptin, en leptinanalog, metreleptin, peptid YY, en peptid YY analog, glatiramer, leuprolid, teriparatid, desmopressin, humant væksthormon, en human væksthormonanalog, et glycopeptidantibiotikum, et glycosyleret cyclisk eller polycyclisk nonribosomal peptidantibiotikum, vancomycin, teicoplanin, telavancin, bleomycin, ramoplanin, decaplanin, bortezomib, cosyntropin, chorionic gonadotropin, menotropin, sermorelin, luteiniserende-hormon-frigivende hormon, somatropin, calcitonin, calcitonin-salmon, pentagastrin, oxytocin, neseritid, anakinra, enfuvirtid, pegvisomant, dornase alfa, lepirudin, anidulafungin, eptifibatid, interferon alfacon-1, interferon alfa-2a, interferon alfa-2b, interferon beta-1a, interferon beta-1 b, interferon gamma-1 b, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon beta-1 a, fibrinolysin, vasopressin, aldesleukin, epoetin alfa, darbepoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin zeta, filgrastim, interleukin-11, cyclosporine, glucagon, urokinase, viomycin, thyrotropin-frigivende hormon, leucin-enkephalin, methionin-enkephalin, substans P, adrenocorticotropisk hormon, parathyroid hormon og farmaceutisk acceptable salte deraf.
  9. 9. Peptid- eller proteinlægemiddel til anvendelse ifølge ethvert af kravene 1,7 eller 8 eller kobbersalt/-kompleks til anvendelse ifølge ethvert af kravene 2, 7 eller 8 eller reduktionsmiddel til anvendelse ifølge ethvert af kravene 4, 7 eller 8 eller den farmaceutiske sammensætning ifølge ethvert af kravene 5, 7 eller 8 eller den farmaceutiske doseringsform ifølge ethvert af kravene 6 til 8, hvor kobbersalt/-komplekset er et kobber(ll)salt/-kompleks valgt blandt kobbersulfat, kobbercarbonat, kobber(ll)lysin-kompleks, kobber(ll)citrat og kobber(ll)gluconat, eller kobbersalt/-komplekset er kobber(l)salt/-kompleks valgt blandt kobber(l)chlorid og kobber(l)acetat.
  10. 10. Peptid- eller proteinlægemiddel til anvendelse ifølge ethvert af kravene 1,7 eller 8 eller zinksalt/-kompleks til anvendelse ifølge ethvert af kravene 3, 7 eller 8 eller reduktionsmidlet til anvendelse ifølge ethvert af kravene 4, 7 eller 8 eller den farmaceutiske sammensætning ifølge ethvert af kravene 5, 7 eller 8 eller den farmaceutiske doseringsform ifølge ethvert af kravene 6 til 8, hvor zinksalt/-komplekset er et zink(ll)salt/-kompleks valgt blandt zinksulfat, zinkchlorid, zinkacetat, zinkoxid, zinkascorbat, zinkcaprylat, zinkgluconat, zinkstearat og zinkcarbonat.
  11. 11. Peptid- eller proteinlægemiddel til anvendelse ifølge ethvert af kravene 1 eller 7 til 10 eller kobbersalt/-kompleks til anvendelse ifølge ethvert af kravene 2 eller 7 til 9 eller zinksalt/-kompleks til anvendelse ifølge ethvert af kravene 3, 7, 8 eller 10 eller reduktionsmidlet til anvendelse ifølge ethvert af kravene 4 eller 7 til 10 eller den farmaceutiske sammensætning ifølge ethvert af kravene 5 eller 7 til 10 eller den farmaceutiske doseringsform ifølge ethvert af kravene 6 til 10, hvor reduktionsmidlet er valgt blandt ascorbinsyre, reduceret glutathion, cystein, urinsyre, en reducerende sukker, glucose, glyceraldehyd, galactose, lactose, maltose, mannitol, α-tocopherol, vitamin A, a-liponsyre, dihydro-a-liponsyre, en thiol-bærende forbindelse, en thiomer, og farmaceutisk acceptable salte deraf.
  12. 12. Peptid- eller proteinlægemiddel til anvendelse ifølge ethvert af kravene 1 eller 7 til 11 eller kobbersalt/-kompleks til anvendelse ifølge ethvert af kravene 2, 7 til 9 eller 11 eller zinksalt/-kompleks til anvendelse ifølge ethvert af kravene 3, 7, 8, 10 eller 11 eller reduktionsmidlet til anvendelse ifølge ethvert af kravene 4 eller 7 til 11 eller den farmaceutiske sammensætning ifølge ethvert af kravene 5 eller 7 til 11 eller den farmaceutiske doseringsform ifølge ethvert af kravene 6 til 11, hvor peptid- eller proteinlægemidlet eller kobbersalt/-komplekset eller zinksalt/-komplekset eller reduktionsmidlet skal indgives oralt i kombination med en absorptionsfremmer, eller hvor den farmaceutiske sammensætning eller den farmaceutiske doseringsform yderligere omfatter en absorptionsfremmer.
  13. 13. Peptid- eller proteinlægemiddel til anvendelse ifølge krav 12 eller kobbersalt/-kompleks til anvendelse ifølge krav 12 eller zinksalt/-kompleks til anvendelse ifølge krav 12 eller reduktionsmidlet til anvendelse ifølge krav 12 eller den farmaceutiske sammensætning ifølge krav 12 eller den farmaceutiske doseringsform ifølge krav 12, hvor absorptionsfremmeren er valgt blandt Ce-2o alkanoylcarnitin, salicylsyre, et salicylsyrederivative, 3-methoxysalicylsyre, 5-methoxysalicylsyre, homovanillinsyre, en Ce-2o alkanosyre, citronsyre, en fedtsyre acylated aminosyre, en Cs-20 alkanoyl sarcosinat, et alkylsaccharid, et Ce-io alkylpolysaccharid, n-octyl-beta-D-glucopyranosid, n-dodecyl-beta-D-maltosid, en cyclodextrin, α-cyclodextrin, β-cyclodextrin, y-cyclodextrin, methyl-p-cyclodextrin, hydroxypropyl-p-cyclodextrin, sulfobutylether β-cyclodextrin, natrium-N-[8-(2-hydroxybenzoyl)amino]caprylat, en thiomer, en calciumchelateringsforbindelse, ethylendiamintetraeddikesyre, ethylenglycoltetraeddikesyre, polyacrylsyre, cremophor EL, chitosan, Ν,Ν,Ν-trimethyl chitosan, benzalkoniumchlorid, bestatin, cetylpyridiniumchlorid, cetyltrimethyl-ammoniumbromid, en C2-2o-alkanol, en C8-2o-alkenol, en C8-2o-alkensyre, dextransulfat, diethylenglycolmonoethylether, 1-dodecylazacyclo-heptan-2-on, ethylcaprylat, glycerylmonolaurat, lysophosphatidylcholin, menthol, en C8-2o-alkylamin, en Ce-2o-alkenylamin, phosphatidylcholin, en poloxamer, polyethylenglycolmonolaurat, polyoxyethylen, polypropylenglycolmonolaurat, en polysorbat, en deoxycholat, natriumglycocholat, natriumglycodeoxycholat, natriumlaurylsulfat, en taurocholat, en taurodeoxycholat, sucroselaurate, en sulfoxid, decylmethylsulfoxid, dimethylsulfoxid, cyclopentadecalactone, 8-(N-2-hydroxy-5-chlor-benzoyl)-amino-caprylsyre, dodecyl-2-Ν,Ν-dimethylaminopropionat, D-a-tocopheryl-polyethylenglycol-1000-succinat, og farmaceutisk acceptable salte deraf.
  14. 14. Peptid- eller proteinlægemiddel til anvendelse ifølge krav 13 eller kobbersalt/-kompleks til anvendelse ifølge krav 13 eller zinksalt/-kompleks til anvendelse ifølge krav 13 eller reduktionsmidlet til anvendelse ifølge krav 13 eller den farmaceutiske sammensætning ifølge krav 13 eller den farmaceutiske doseringsform ifølge krav 13, hvor absorptionsfremmeren er en fedtsyre acyleret aminosyre valgt blandt natriumlauroylalaninat, N-dodecanoyl-L-alanin, natriumlauroylasparaginat, N-dodecanoyl-L-asparagin, natriumlauroylasparaginsyre, N-dodecanoyl-L-asparaginsyre, natriumlauroylcysteinat, N-dodecanoyl-L-cystein, natriumlauroylglutaminsyre, N-dodecanoyl-L-glutaminsyre, natriumlauroylglutaminat, N-dodecanoyl-L-glutamin, natriumlauroylglycinat, N-dodecanoyl-L-glycin, natriumlauroylhistidinat, N-dodecanoyl-L-histidin, natriumlauroylisoleucinat, N-dodecanoyl-L-isoleucin, natriumlauroylleucinat, N-dodecanoyl-L-leucin, natriumlauroylmethioninat, N-dodecanoyl-L-methionin, natriumlauroylphenylalaninat, N-dodecanoyl-L-phenylalanin, natriumlauroylprolinat N-dodecanoyl-L-proline, natriumlauroylserinat, N-dodecanoyl-L-serin, natriumlauroyl threoninat, N-dodecanoyl-L-threonine, natriumlauroyltryptophanat, N-dodecanoyl-L-tryptophan, natriumlauroyltyrosinat, N-dodecanoyl-L-tyrosin, natriumlauroylvalinat-N-dodecanoyl-L-valin, natriumlauroylsarcosinat, N-dodecanoyl-L-sarcosin, natriumcaprinsyrealaninat, N-decanoyl-L-alanin, natriumcaprinsyreasparaginat, N-decanoyl-L-asparagin, natriumcaprinsyreasparaginsyre, N-decanoyl-L-asparaginsyre, natriumcaprinsyrecysteinat, N-decanoyl-L-cystein, natriumcaprinsyreglutaminsyre, N-decanoyl-L-glutaminsyre, natriumcaprinsyreglutaminat, N-decanoyl-L-glutamin, natriumcaprinsyreglycinat, N-decanoyl-L-glycin, natriumcaprinsyrehistidinat, N-decanoyl-L-histidine, natriumcaprinsyreisoleucinat, N-decanoyl-L-isoleucin, natrium-caprinsyreleucinat, N-decanoyl-L-leucin, natriumcaprinsyremethioninat, N-decanoyl-L-methionin, natriumcaprinsyrephenylalaninat, N-decanoyl-L-phenylalanin, natrium-caprinsyreprolinat-N-decanoyl-L-prolin, natriumcaprinsyreserinat, N-decanoyl-L-serin, natriumcaprinsyrethreoninat, N-decanoyl-L-threonin, natriumcaprinsyretryptophanat, N-decanoyl-L-tryptophan, natriumcaprinsyretyrosinat, N-decanoyl-L-tyrosin, natrium-caprinsyrevalinat-N-decanoyl-L-valin, natriumcaprinsyresarcosinat, N-decanoyl-L-sarcosin, natriumoleoylsarcosinat, natrium-N-decylleucin, natriumstearoylglutamat, natriummyristoylglutamat, natriumlauroylglutamat, natriumcocoylglutamat, natrium-cocoylglycinat, natrium-N-decyl-leucin, natriumcocoylglycin, natriumcocoylglutamat, natriumlauroylalaninat, N-dodecanoyl-L-alanin, natriumlauroylasparaginat, N-dodecanoyl-L-asparagin, natriumlauroylasparaginsyre, N-dodecanoyl-L-asparaginsyre, natriumlauroylcysteinat, N-dodecanoyl-L-cystein, natriumlauroylglutaminsyre, N-dodecanoyl-L-glutaminsyre, natriumlauroylglutaminat, N-dodecanoyl-L-glutamin, natriumlauroylglycinat, N-dodecanoyl-L-glycine, natriumlauroylhistidinat, N-dodecanoyl-L-histidin, natriumlauroylisoleucinat, N-dodecanoyl-L-isoleucin, natriumlauroylleucinat, N-dodecanoyl-L-leucin, natriumlauroylmethinoninat, N-dodecanoyl-L-methionin, natriumlauroylphenylalaninat, N-dodecanoyl-L-phenylalanin, natriumlauroylprolinat, N-dodecanoyl-L-prolin, natriumlauroylserinat, N-dodecanoyl-L-serin, natriumlauroylthreoninat, N-dodecanoyl-L-threonin, natriumlauroyltryptophanat, N-dodecanoyl-L-tryptophan, natriumlauroyltyrosinat, N-dodecanoyl-L-tyrosin, natriumlauroylvalinat, N-dodecanoyl-L-valin, N-dodecanoyl-L-sarcosin, natriumcaprinsyrealaninat, N-decanoyl-L-alanin, natriumcaprinsyreasparaginat, N-decanoyl-L-aspargin, natriumcaprinasparaginsyre, N-decanoyl-L-asparaginsyre, natriumcaprinsyrecysteinat, N-decanoyl-L-cystein, natriumcaprinsyreglutaminsyre, N-decanoyl-L-glutaminsyre, natriumcaprinsyreglutaminat, N-decanoyl-L-glutamin, natriumcaprinsyreglycinat, N-decanoyl-L-glycin, natriumcaprinsyrehistidinat, N-decanoyl-L-histidin, natriumcaprinsyreisoleucinat, N-decanoyl-L-isoleucin, natriumcaprinsyreleucinat, N-decanoyl-L-leucin, natriumcaprinsyremethioninat, N-decanoyl-L-methionin, natriumcaprinsyrephenylalaninat, N-decanoyl-L-phenylalanin, natriumcaprinsyreprolinat, N-decanoyl-L-prolin, natriumcaprinsyreserinat, N-decanoyl-L-serin, natriumcaprinsyrethreoninat, N-decanoyl-L-threonin, natriumcaprinsyretryptophanat, N-decanoyl-L-tryptophan, natriumcaprinsyretyrosinat, N-decanoyl-L-tyrosin, natriumcaprinsyrevalinat, N-decanoyl-L-valin, natriumcaprinsyresarcosinat, natriumoleoylsarcosinat, og farmaceutisk acceptable salte deraf.
  15. 15. Farmaceutisk sammensætning ifølge ethvert af kravene 12 til 14 eller den farmaceutiske doseringsform ifølge ethvert af kravene 12 til 14, hvor den farmaceutiske sammensætning eller den farmaceutiske doseringsform omfatter: kobbersalt/-komplekset i en mængde på omkring 0,1 mg til omkring 5 mg pr. doseringsenhed og/eller zinksalt/-komplekset i en mængde på omkring 0,1 mg til omkring 50 mg pr. doseringsenhed; reduktionsmidlet i en mængde på omkring 1 mg til omkring 1000 mg pr. doseringsenhed; og absorptionsfremmeren i en mængde på omkring 10 mg til omkring 1000 mg pr. doseringsenhed.
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