FI70794B - Foerfarande foer stabilisering av en lyofiliserad farmaceutiskinterferonblandning - Google Patents

Foerfarande foer stabilisering av en lyofiliserad farmaceutiskinterferonblandning Download PDF

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Publication number
FI70794B
FI70794B FI824366A FI824366A FI70794B FI 70794 B FI70794 B FI 70794B FI 824366 A FI824366 A FI 824366A FI 824366 A FI824366 A FI 824366A FI 70794 B FI70794 B FI 70794B
Authority
FI
Finland
Prior art keywords
interferon
amino acid
buffer system
mixture
approx
Prior art date
Application number
FI824366A
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English (en)
Finnish (fi)
Other versions
FI70794C (fi
FI824366A0 (fi
FI824366L (fi
Inventor
Henry King Hong Kwan
Original Assignee
Schering Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26989028&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=FI70794(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from ZA828580A external-priority patent/ZA828580B/xx
Application filed by Schering Corp filed Critical Schering Corp
Publication of FI824366A0 publication Critical patent/FI824366A0/fi
Publication of FI824366L publication Critical patent/FI824366L/fi
Application granted granted Critical
Publication of FI70794B publication Critical patent/FI70794B/fi
Publication of FI70794C publication Critical patent/FI70794C/fi

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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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Claims (9)

1. Förfarande för stabilisering av en lyofiliserad farmaceu-tisk blandning av interferon och ett buffertsystem för att rekonstitueras med sterilt vatten, kännetecknat därav, att en stabiliserande mängd av aminosyra eller dess derivat, som är glycin, cf-alanin eller deras farmaceutiskt godtagbara salter, tillsättes i blandningen före lyofili-sering, varvid blandningen innehäller 1 x 10^ - 5 x 10® inter-nationella enheter (I.U) interferon per varje 5 - 150 mg aminosyra eller dess derivat, varvid vikten av aminosyrans derivat är beräknad pä fri aminosyra.
2. Förfarande enligt patentkravet 1, kännetecknat därav, att i blandningen dessutom tillsatts högst ca. 10 mg, fördelaktigt ca. 1 mg, människoalbumin per varje 5 - 150 mg aminosyra eller dess farmaceutiskt godtagbara sait.
3. Förfarande enligt patentkravet 1 eller 2, kännetecknat därav, att buffertsystemet uppgjorts att hälla pH vid ett värde av ca. 6,5 - 8,0, fördelaktigt 7,0 - 7,4 efter rekonstitueringen.
4. Förfarande enligt nägot av patentkraven 1-3, kännetecknat därav, att buffertsystemet innehäller dinat-riumvätefosfat och mononatriumdivätefosfat.
5. Förfarande enligt patentkravet 1 eller 4, kännetecknat därav, att interferonet är människointerferon, fördelaktigt leukocyt- eller fibroblastinterferon, i synnerhet «-interferon eller /3-interferon, speciellt a-2 inteferon eller o(-l interferon.
6. Förfarande enligt nägot av patentkraven 1-5, känne-
FI824366A 1981-12-23 1982-12-20 Foerfarande foer stabilisering av en lyofiliserad farmaceutiskinterferonblandning FI70794C (fi)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US33405281A 1981-12-23 1981-12-23
US33405281 1981-12-23
ZA828580A ZA828580B (en) 1981-12-23 1982-11-19 Interferon formulations
ZA8208580 1982-11-19

Publications (4)

Publication Number Publication Date
FI824366A0 FI824366A0 (fi) 1982-12-20
FI824366L FI824366L (fi) 1983-06-24
FI70794B true FI70794B (fi) 1986-07-18
FI70794C FI70794C (fi) 1986-10-27

Family

ID=26989028

Family Applications (1)

Application Number Title Priority Date Filing Date
FI824366A FI70794C (fi) 1981-12-23 1982-12-20 Foerfarande foer stabilisering av en lyofiliserad farmaceutiskinterferonblandning

Country Status (18)

Country Link
US (1) US4496537A (sv)
EP (1) EP0082481B2 (sv)
AU (1) AU558966B2 (sv)
CA (1) CA1207665A (sv)
DE (1) DE3262575D1 (sv)
DK (1) DK158873C (sv)
FI (1) FI70794C (sv)
HK (1) HK94487A (sv)
HU (1) HU190649B (sv)
IE (1) IE54468B1 (sv)
IL (1) IL67517A (sv)
MY (1) MY8700705A (sv)
NO (1) NO161036C (sv)
NZ (1) NZ202856A (sv)
OA (1) OA07282A (sv)
PH (1) PH19869A (sv)
PT (1) PT76013B (sv)
SG (1) SG70687G (sv)

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Also Published As

Publication number Publication date
DE3262575D1 (en) 1985-04-18
IE54468B1 (en) 1989-10-25
AU558966B2 (en) 1987-02-19
IL67517A0 (en) 1983-05-15
FI70794C (fi) 1986-10-27
HK94487A (en) 1987-12-18
DK158873C (da) 1990-12-31
FI824366A0 (fi) 1982-12-20
NO161036B (no) 1989-03-20
CA1207665A (en) 1986-07-15
MY8700705A (en) 1987-12-31
US4496537A (en) 1985-01-29
DK158771B (da) 1990-07-16
DK565882A (da) 1983-06-24
PT76013A (en) 1983-01-01
NO161036C (no) 1989-06-28
OA07282A (fr) 1984-11-30
EP0082481A1 (en) 1983-06-29
HU190649B (en) 1986-09-29
EP0082481B1 (en) 1985-03-13
NO824285L (no) 1983-06-24
AU9168882A (en) 1983-06-30
FI824366L (fi) 1983-06-24
SG70687G (en) 1988-02-19
PH19869A (en) 1986-08-13
NZ202856A (en) 1985-12-13
IL67517A (en) 1988-11-30
PT76013B (en) 1986-03-11
IE823046L (en) 1983-06-23
EP0082481B2 (en) 1990-09-12
DK158873B (da) 1990-07-30

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