DK1311285T4 - Flydende farmaceutisk præparat indeholdende et erythropoietinderivat - Google Patents

Flydende farmaceutisk præparat indeholdende et erythropoietinderivat Download PDF

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DK1311285T4
DK1311285T4 DK01943331.7T DK01943331T DK1311285T4 DK 1311285 T4 DK1311285 T4 DK 1311285T4 DK 01943331 T DK01943331 T DK 01943331T DK 1311285 T4 DK1311285 T4 DK 1311285T4
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erythropoietin
epo
mmol
pluronic
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DK1311285T3 (da
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Apollon Papadimitriou
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Hoffmann La Roche
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    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics

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Claims (46)

1. Flydende farmaceutisk præparat, som omfatter et pegyleret humant erythropoietinprotein, en flerladet uorganisk anion i en farmaceutisk acceptabel buffer, der er egnet til at holde opløsningens pH inden for området fra 5,5 til 7,0, og eventuelt en eller flere farmaceutisk acceptable excipienser, hvilket flydende præparat er stabilt ved stuetemperatur, hvor anionen er en sulfatanion.
2. Præparat ifølge krav 1, som er en vandig opløsning.
3. Præparat ifølge krav 1 til 2, som er en isotonisk opløsning.
4. Præparat ifølge krav 1 som omfatter fra 10 til 200 mmol/l sulfat.
5. Præparat ifølge krav 1 til 4, hvor pH'en er fra 5,8 til 5,7.
6. Præparat ifølge krav 5, hvor pH'en er fra 6,0 til 6,5.
7. Præparat ifølge krav 6, hvor pH'en er ca. 6,2.
8. Præparat ifølge krav 1 til 7, hvor bufferen er valgt fra gruppen bestående af en phosphatbuffer eller en arginin/H2S04/Na2SC>4-buffer.
9. Præparat ifølge krav 8, hvor bufferen er en fra 10 til 50 mmol/l phosphatbuffer.
10. Præparat ifølge krav 1 til 9, hvor præparatet omfatter en eller flere farmaceutisk acceptable excipienser.
11. Præparat ifølge krav 10, hvor én eller flere farmaceutisk acceptable excipienser er valgt fra gruppen bestående af farmaceutisk acceptable salte, diluenter, opløsningsmidler og konserveringsmidler.
12. Præparat ifølge krav 10 og 11, hvor de farmaceutisk acceptable excipienser er valgt fra gruppen bestående af tonicitetsmidler, polyoler, antioxidanter og ikke-ioniske detergenter.
13. Præparat ifølge krav 10 til 12, hvor den farmaceutisk acceptable excipiens er en polyol.
14. Præparat ifølge krav 13, hvor polyolen er valgt fra gruppen bestående af mannitol, sorbitol, glycerol, trehalose og saccharose.
15. Præparat ifølge krav 14, hvor polyolen er mannitol.
16. Præparat ifølge krav 10 til 15, som omfatter en antioxidant.
17. Præparat ifølge krav 16, hvor antioxidanten er methionin.
18. Præparat ifølge krav 10 til 17, som omfatter op til 1 mmol/l CaCh.
19. Præparat ifølge krav 12 til 18, hvor den ikke-ioniske detergent er polysorbat 80, polysorbat 20 eller Pluronic F68.
20. Præparat ifølge krav 19, hvor den ikke-ioniske detergent er Pluronic F68.
21. Præparat ifølge krav 19 eller 20, hvor præparatet omfatter op til 1 vægt/volumenpercent af den ikke-ioniske detergent.
22. Præparat ifølge et hvilket som helst af kravene 19 til 21, hvor præparatet omfatter op til 0,1 vægt/volumenprocent af den ikke-ioniske detergent.
23. Præparat ifølge et hvilket som helst af kravene 1 til 22, hvor erythropoietinproteinet er et konjugat, hvilket konjugat omfatter et humant erythropoietinglycoprotein, hvilket glycoprotein er kovalent bundet til "n" poly(ethylenglycol)grupper ifølge formlen -CO-(CH2)x-(OCH2CH2)m-OR, idet -CO i hver poly(ethylenglycol)gruppe danner en amidbinding med en af aminogrupperne; hvor R er lavere alkyl; x er 2 eller 3; m er fra ca. 450 til ca. 900; n er fra 1 til 3; og n og m er valgt således, at molekylvægten af konjugatet minus erythropoietinglycoproteinet er fra 20 kilodalton til 100 kilodalton.
24. Præparat ifølge krav 23 med et erythropoietinprotein ifølge formlen: P-[NHCO-(CH2)x-(OCH2CH2)m-OR]n (I) hvor m, n, x og R er som ovenfor, og P er resten af glycoproteinet uden den eller de n aminogrupper, som danner en eller flere amidbindinger med poly(ethylenglycol)gruppen eller poly(ethylenglycol)grupperne.
25. Præparat ifølge krav 24, hvor x i formel (I) er 2, m i formel (I) er fra 650 til 750, n i formel (I) er 1, og R i formel (I) er methyl.
26. Præparat ifølge et hvilket som helst af kravene 1 til 22, hvor erythropoietinproteinet er et konjugat, hvilket konjugat omfatter et humant erythropoietinglycoprotein, hvilket glycoprotein er kovalent bundet til fra én til tre lavere-alkoxy-poly(ethylenglycol)grupper, idet hver poly(ethylenglycol)gruppe er kovalent bundet til glycoproteinet via en linker ifølge formlen -C(0)-X-S-Y-, idet linkerens C(O) danner en amidbinding med en af aminogrupperne, X er -(CH2)k- eller -CH2(0-CH2-CH2)k-, k er fra 1 til 10, Y er
eller
den gennemsnitlige molekylvægt af hver poly(ethylenglycol)gruppe er fra ca. 20 kilodalton til ca. 40 kilodalton, og konjugatets molekylvægt er fra ca. 51 kilodalton til ca. 175 kilodalton.
27. Præparat ifølge krav 26, hvor erythropoietinproteinet er et konjugat ifølge formlen:
hvor n et helt tal fra 1 til 3; m er et helt tal fra 450 til 900; R er lavere alkyl; X er -(CH2)k- eller -CH2(0-CH2-CH2)k-, og P er resten af erythropoietinglycoproteinet uden den aminogruppe eller de aminogrupper, der danner en amidbinding med X.
28. Præparat ifølge krav 27, hvor erythropoietinproteinet er et konjugat ifølge formlen:
hvor n et helt tal fra 1 til 3; m er et helt tal fra 450 til 900; R er lavere alkyl; X er -(CH2)k- eller -CH2(0-CH2-CH2)k-, og P er resten af erythropoietinglycoproteinet uden den aminogruppe eller de aminogrupper, der danner en amidbinding med X.
29. Præparat ifølge krav 1 til 28, som omfatter fra 10 μg til 10.000 μg erythropoietinprotein pr. ml.
30. Præparat ifølge krav 1 til 29, som omfatter fra 10 μg til 10.000 pg erythropoietinprotein pr. ml, 10-200 mmol/l sulfat og fra 10 til 50 mmol/l phosphat, pH 6,0 til 6,5.
31. Præparat ifølge krav 30 som omfatter op til 20 mM methionin, 1-5 vægt/volumenprocent afen polyol, op til 0,1 vægt/volumenprocent Pluronic F68 og eventuelt op til 1 mM CaCl2.
32. Præparat ifølge krav 30 til 31, som omfatter fra 10 pg til 10.000 pg erythropoietinprotein pr. ml, 40 mmol/l sulfat, 10 mmol/l phosphat, 3 vægt/volumenprocent mannitol, 10 mM methionin, 0,01 vægt/volumenprocent Pluronic F68, pH 6,2.
33. Præparat ifølge krav 1 til 29, som omfatter fra 10 μς til 10.000 μς erythropoietinprotein pr. ml, fra 10 til 100 mmol/l NaCI, fra 10 til 50 mmol/l phosphat, pH 6,0 til 7,0, eventuelt 1-5% afen polyol.
34. Præparat ifølge krav 33, som omfatter op til 20 mM methionin, op til 0,1% Pluronic F68 og eventuelt 7,5 μΓηοΙ/Ι CaCL·.
35. Præparat ifølge krav 33 eller 34, som omfatter fra 10 μg til 10.000 μg erythropoietinprotein pr. ml, 100 mmol/l NaCI, 10 mM methionin, 0,01% Pluronic F68; og 10 mmol/l phosphat, pH 7,0.
36. Præparat ifølge krav 1 til 29, som omfatter fra 10 μg til 10.000 μς erythropoietinprotein pr. ml, fra 10 til 50 mmol/l arginin, fra pH 6 til pH 6,5, fra 10 til 100 mmol/l natriumsulfat.
37. Præparat ifølge krav 36, som omfatter op til 20 mM methionin, op til 0,1% Pluronic F68, eventuelt op til 1 mmol/l CaCl2 og eventuelt 1-5% afen polyol.
38. Præparat ifølge krav 36 eller 37, som omfatter fra 10 μg til 10.000 μς erythropoietinprotein pr. ml, 40 mmol/l arginin, pH 6,2, 30 mmol/l natriumsulfat, 3% mannitol, 10 mM methionin, 0,01% Pluronic F68 og eventuelt 1 mmol/l CaCl2.
39. Præparat ifølge krav 1 til 29, som omfatter fra 25 til 2.500 μς/ιτιΙ erythropoietinprotein og a) 10 mM natrium-/kaliumphosphat, 100 mM NaCI, pH 7,0, eller b) 10 mM natriumphosphat, 120 mM natriumsulfat, pH 6,2, eller c) 10 mM natriumphosphat, 40 mM natriumsulfat, 3% mannitol, pH 6,2, eller d) 10 mM natriumphosphat, 40 mM natriumsulfat, 3% mannitol, 10 mM methionin, 0,01% Pluronic F68, pH 6,2, eller e) 40 mM arginin, 30 mM natriumsulfat, 3% mannitol, pH 6,2, eller f) 40 mM arginin, 30 mM natriumsulfat, 3% mannitol, 10 mM methionin, 0,01% Pluronic F68, pH 6,2.
40. Præparat ifølge krav 1 til 39, hvor mængden af erythropoietinprotein er 50, 100, 400, 800 eller 2.500 μg/ml.
41. Præparat ifølge krav 40, som omfatter 10 mM natriumphosphat, 40 mM natriumsulfat, 3% mannitol, 10 mM methionin, 0,01% Pluronic F68, pH 6,2.
42. Præparat ifølge krav 40, som omfatter 40 mM arginin, 30 mM natriumsulfat, 3% mannitol, 10 mM methionin, 0,01% Pluronic F68, pH 6,2.
43. Præparat ifølge krav 1 til 42, hvor erythropoietinproteinet har aminosyresekvensen ifølge SEQ ID NO: 1 eller SEQ ID NO: 2.
44. Fremgangsmåde til fremstilling af et præparat ifølge et hvilket som helst af kravene 1 til 43, hvilken fremgangsmåde omfatter blanding af et pegyleret humant erythropoietinprotein med en opløsning, som omfatter en flerladet anion og eventuelt en eller flere farmaceutisk acceptable excipienser, og justering af pH'en til fra 5,5 til 7,0 under anvendelse af en farmaceutisk acceptabel buffer, hvor anionen er en sulfatanion.
45. Anvendelse af et præparat ifølge et hvilket som helst af kravene 1 til 43 til fremstilling af medikamenter, der er nyttige til behandling og forebyggelse af sygdomme, der er forbundet med anæmi, hos patienter med kronisk nyresvigt (CRF), AIDS og/eller til behandling af cancerpatienter, som undergår kemoterapi.
46. Anordning til lokal og systemisk forlænget frigivelse, hvilken anordning omfatter et præparat ifølge et hvilket som helst af kravene 1 til 43, hvilken anordning er valgt fra gruppen bestående af et implantat, en sprøjte og en inhalationsanordning.
DK01943331.7T 2000-05-15 2001-05-08 Flydende farmaceutisk præparat indeholdende et erythropoietinderivat DK1311285T4 (da)

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EP00110355 2000-05-15
PCT/EP2001/005187 WO2001087329A1 (en) 2000-05-15 2001-05-08 Liquid pharmaceutical composition containing an erythropoietin derivate
EP01943331.7A EP1311285B2 (en) 2000-05-15 2001-05-08 Liquid pharmaceutical composition containing an erythropoietin derivative

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DK1311285T3 DK1311285T3 (da) 2005-06-27
DK1311285T4 true DK1311285T4 (da) 2017-07-24

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EP1311285A2 (en) 2003-05-21
US20040147431A1 (en) 2004-07-29
YU83502A (sh) 2005-11-28
EP1311285B2 (en) 2017-04-12
HK1056683A1 (en) 2004-02-27
AR092919A2 (es) 2015-05-06
DE60109625T2 (de) 2006-03-30
HUP0302114A2 (hu) 2003-10-28
US7169754B2 (en) 2007-01-30
WO2001087329A8 (en) 2002-03-07
ME00673B (me) 2011-12-20
EP1311285B1 (en) 2005-03-23
KR20070032815A (ko) 2007-03-22
NO20025450D0 (no) 2002-11-14
NZ522030A (en) 2004-11-26
UY26704A1 (es) 2001-12-28
NO330934B1 (no) 2011-08-22
BRPI0110914B8 (pt) 2021-05-25
TWI288644B (en) 2007-10-21

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