CA2362927A1 - Novel albumin-free factor viii formulations - Google Patents

Novel albumin-free factor viii formulations Download PDF

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Publication number
CA2362927A1
CA2362927A1 CA002362927A CA2362927A CA2362927A1 CA 2362927 A1 CA2362927 A1 CA 2362927A1 CA 002362927 A CA002362927 A CA 002362927A CA 2362927 A CA2362927 A CA 2362927A CA 2362927 A1 CA2362927 A1 CA 2362927A1
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CA
Canada
Prior art keywords
factor viii
viii composition
composition according
amount
nacl
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002362927A
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French (fr)
Other versions
CA2362927C (en
Inventor
Marc Besman
Erik Bjornson
Feroz Jameel
Ramesh Kashi
Michael Pikal
Serguei Tchessalov
John Carpenter
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Baxalta GmbH
University of Connecticut
Baxalta Inc
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Individual
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Publication date
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Application filed by Individual filed Critical Individual
Priority to CA2634664A priority Critical patent/CA2634664C/en
Priority to CA002634674A priority patent/CA2634674A1/en
Priority to CA002634663A priority patent/CA2634663C/en
Publication of CA2362927A1 publication Critical patent/CA2362927A1/en
Application granted granted Critical
Publication of CA2362927C publication Critical patent/CA2362927C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K47/08—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
    • 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
    • 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
    • A61K47/26—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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/829—Blood

Abstract

A Factor VIII composition formulated without albumin, comprising the followi ng formulation excipients in addition to Factor VIII: 4 % to 10 % of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1 % to 4 % of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2 % to 6 % hydroxyethyl starch; 1 % to 4 % of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 1 00 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximate ly between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1 % to 4 % of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.

Claims (35)

1. A Factor VIII composition formulated without adding albumin to said composition, comprising the following formulation excipients in addition to Factor VIII:
4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine;
1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine;
1 mM to 5 mM calcium salt;
100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.
2. The Factor VIII composition of Claim 1, additionally comprising a surfactant.
3. The Factor VIII composition of Claim 2, wherein said surfactant is selected from the group consisting of polysorbate 20, polysorbate 80, Pluronic F68, and Brij 35.
4. The Factor VIII composition of Claim 3, wherein said surfactant is polysorbate 80, and wherein said polysorbate 80 is present in an amount of less than 0.1 %.
5. The Factor VIII composition according to Claims 1-4, wherein said surfactant is present in an amount of about 0.03%.
6. The Factor VIII composition according to Claims 1-5, wherein said buffering agent is selected from the group consisting of Tris, BIS-Tris Propane, histidine, PIPES, MOPS, HEPES, MES and ACES.
7. The Factor VIII composition of Claim 6, wherein said buffering agent comprises Tris.
8. The Factor VIII composition of Claim 7, wherein the Tris is present in an amount of about 20 mM.
9. The Factor VIII composition of Claim 6, wherein said buffering agent comprises between about 10 mM and about 50 mM histidine.
10. The Factor VIII composition of claim 9, wherein the histidine is present in an amount of about 25 mM.
11. The Factor VIII composition according to Claims 1-10, further comprising an antioxidant.
12. The Factor VIII composition of Claim 11, wherein said antioxidant is glutathione.
13. The Factor VIII composition of Claim 12, wherein said glutathione is present in an amount of between about 0.05 mg/ml and about 1.0 mg/ml.
14. The Factor VIII composition according to Claims 1-13, wherein said bulking agent is present in an amount of about 8%.
15. The Factor VIII composition according to Claims 1-14, wherein said bulking agent is mannitol.
16. The Factor VIII composition according to Claims 1-14, wherein said bulking agent is glycine.
17. The Factor VIII composition according to Claims 1-16, wherein said stabilizing agent is present in an amount of about 2%.
18. The Factor VIII composition according to Claims 1-17, wherein said stabilizing agent is sucrose.
19. The Factor VIII composition according to Claims 1-17, wherein said stabilizing agent is arginine.
20. The Factor VIII composition according to Claims 1-17, wherein said stabilizing agent is trehalose.
21. The Factor VIII composition according to Claims 1-20, wherein said NaCl is present in an amount of from about 200 mM to about 250 mM.
22. The Factor VIII composition of Claim 21, wherein said NaCl is present in an amount of about 225 mM.
23. The Factor VIII composition according to Claims 1-22, wherein said calcium salt is calcium chloride.
24. The Factor VIII composition according to Claims 1-23, wherein said composition is in lyophilized form.
25. A Factor VIII composition formulated without adding albumin to said composition, comprising the following formulation excipients in addition to Factor VIII:
2% to 6 % hydroxyethyl starch;
1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine;
1 mM to 5 mM calcium salt;
100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.
26. The Factor VIII composition of Claim 25, comprising about 4%
hydroxyethyl starch.
27. The Factor VIII composition according to Claims 25-26, comprising about 200 mM NaCl.
28. The Factor VIII composition according to Claims 25-27, wherein said stabilizing agent is present in an amount of about 2%.
29. The Factor VIII composition according to Claims 25-28, wherein said stabilizing agent is sucrose.
30. The Factor VIII composition according to Claims 25-28, wherein said stabilizing agent is arginine.
31. The Factor VIII composition according to Claims 25-28, wherein said stabilizing agent is trehalose.
32. A Factor VIII composition formulated without adding albumin to said composition, comprising the following formulation excipients in addition to Factor VIII:
300 mM to 500 mM NaCl;
1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine;
1 mM to 5 mM calcium salt; and a buffering agent for maintaining a pH of approximately between 6 and 8.
33. The composition of Claim 32, wherein the NaCl is present in an amount of about 400 mM.
34. Use of a Factor VIII composition according to any of Claims 1-33 for the preparation of a medicament for the treatment of hemophilia.
35. An improved method of lyophilizing an aqueous pharmaceutical formulation containing a crystallizable bulking agent and NaCl, wherein said method comprises the steps of:
(a) freezing the aqueous pharmaceutical formulation at a temperature of less than about -35ÀC;
(b) annealing the pharmaceutical formulation at between about -30À
and -19ÀC;
(c) lowering the temperature of the pharmaceutical formulation to less than about -50ÀC;
(d) annealing the pharmaceutical formulation at between about -30ÀC and -39ÀC; and then (e) freeze-drying the pharmaceutical formulation.
CA2362927A 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations Expired - Lifetime CA2362927C (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA2634664A CA2634664C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634674A CA2634674A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634663A CA2634663C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US25527999A 1999-02-22 1999-02-22
US09/255,279 1999-02-22
US45275299A 1999-12-01 1999-12-01
US09/452,752 1999-12-01
PCT/US2000/040068 WO2000048635A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Related Child Applications (3)

Application Number Title Priority Date Filing Date
CA2634664A Division CA2634664C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634674A Division CA2634674A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634663A Division CA2634663C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Publications (2)

Publication Number Publication Date
CA2362927A1 true CA2362927A1 (en) 2000-08-24
CA2362927C CA2362927C (en) 2011-07-12

Family

ID=26944588

Family Applications (4)

Application Number Title Priority Date Filing Date
CA2634664A Expired - Lifetime CA2634664C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634674A Abandoned CA2634674A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634663A Expired - Lifetime CA2634663C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA2362927A Expired - Lifetime CA2362927C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Family Applications Before (3)

Application Number Title Priority Date Filing Date
CA2634664A Expired - Lifetime CA2634664C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634674A Abandoned CA2634674A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634663A Expired - Lifetime CA2634663C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Country Status (19)

Country Link
US (8) US6586573B1 (en)
EP (5) EP1154796B1 (en)
JP (9) JP5149470B2 (en)
CN (3) CN101683522B (en)
AT (1) ATE365052T1 (en)
AU (1) AU777972B2 (en)
BR (1) BR0008405B1 (en)
CA (4) CA2634664C (en)
CY (2) CY1108030T1 (en)
CZ (3) CZ307715B6 (en)
DE (1) DE60035260T2 (en)
DK (4) DK1820516T3 (en)
ES (4) ES2435141T3 (en)
HK (4) HK1139862A1 (en)
MX (1) MXPA01008515A (en)
PL (4) PL198123B1 (en)
PT (4) PT2193809E (en)
RU (1) RU2244556C2 (en)
WO (1) WO2000048635A1 (en)

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