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SI9420048B - Farmacevtske formulacije živčnega rastnega faktorja - Google Patents

Farmacevtske formulacije živčnega rastnega faktorja Download PDF

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Publication number
SI9420048B
SI9420048B SI9420048A SI9420048A SI9420048B SI 9420048 B SI9420048 B SI 9420048B SI 9420048 A SI9420048 A SI 9420048A SI 9420048 A SI9420048 A SI 9420048A SI 9420048 B SI9420048 B SI 9420048B
Authority
SI
Slovenia
Prior art keywords
formulation
water
growth factor
aqueous
nerve growth
Prior art date
Application number
SI9420048A
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English (en)
Other versions
SI9420048A (en
Inventor
M. Victoria Knepp
M. Deborah Lidgate
Richard Maskiewicz
Leo Gu
Original Assignee
Syntex (U.S.A.) Inc.
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
Application filed by Syntex (U.S.A.) Inc. filed Critical Syntex (U.S.A.) Inc.
Publication of SI9420048A publication Critical patent/SI9420048A/sl
Publication of SI9420048B publication Critical patent/SI9420048B/sl

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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
    • A61K38/18—Growth factors; Growth regulators
    • 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
    • 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
    • A61K38/185—Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • Y10S530/839—Nerves; brain

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Psychology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (13)

  1. PATENTNI ZAHTEVKI 1. Vodna farmacevtska formulacija, ki obsega: (a) živčni rastni faktor; (b) biološko sprejemljivo sol v količini, ki zadostuje za vzdrževanje izoto-ničnosti; (c) pufer v količini, ki zadostuje za vzdrževanje pH formulacije od 4,5 do 6,0; in (d) vodo in s pridržkom, da navedena formulacija ne vsebuje vodotopnega polisaharida.
  2. 2. Formulacija po zahtevku 1, označena s tem, da nadalje obsega biološko sprejemljiv vodotopen nosilec.
  3. 3. Formulacija po zahtevku 1 ali 2, označena s tem, da: (a) živčni rastni faktor obsega 0,0001 do 0,125 % glede na maso vodne formulacije; (b) nosilec obsega 0,1 do 1,25 % glede na maso vodne formulacije; (c) sol obsega 0,5 do 1,0 % glede na maso vodne formulacije; in (d) je pufer prisoten v količini, ki zadostuje za vzdrževanje pH vodne formulacije od 4,5 do 6,0.
  4. 4. Formulacija po kateremkoli od prejšnjih zahtevkov, označena s tem, da je pH od 5,0 do 5,4.
  5. 5. Vodna formulacija po kateremkoli od zahtevkov 2 do 4, označena s tem, da obsega 10 do 500 μg NGF, 5 mg/ml HSA, 8,7 mg/ml NaCl, 2,1 mg/ml citronske kisline in vodo, pri čemer je pH formulacije naravnan na 5,2.
  6. 6. Vodna farmacevtska formulacija živčnega rastnega faktorja, prikladna za liofilizacijo, označena s tem, da obsega: (a) od 1 do 1250 /ig/ml živčnega rastnega faktorja; (b) od 30 do 90 mg/ml biološko sprejemljivega pomožnega sredstva; (c) pufer v količini, ki zadostuje za vzdrževanje pH formulacije pri 5,5 do 6,5; in (d) vodo; s pridržkom, da navedena formulacija ne vsebuje vodotopnega polisaharida.
  7. 7. Formulacija po zahtevku 6, označena s tem, da je pomožno sredstvo sladkor.
  8. 8. Formulacija po kateremkoli od zahtevkov 6-7, označena s tem, da pomožno sredstvo obsega zmes saharoze in manitola, pufer je citrat, pH formulacije pa je od 5,8 do 6,2.
  9. 9. Formulacija po kateremkoli od zahtevkov 6-8, označena s tem, da je liofilizirana, da se zniža vsebnost vlage na manj kot 2 %.
  10. 10. Liofiliziran farmacevtski sestavek, označen s tem, da obsega 0,001 do 1,25 delov živčnega rastnega faktorja, 30 do 90 delov sladkorja in manj kot 1 del vode, s pridržkom, da naveden sestavek ne vsebuje vodotopnega polisaharida.
  11. 11. Formulacija ali sestavek po kateremkoli od zahtevkov 6-10, označen s tem, da nadalje obsega biološko sprejemljiv vodotopen nosilec.
  12. 12. Formulacija ali sestavek po kateremkoli od prejšnjih zahtevkov za uporabo pri zdravljenju nevronskih disfunkcij pri ljudeh.
  13. 13. Formulacija ali sestavek po zahtevku 13 v intracerebroventrikularni infuzijski obliki za uporabo pri zdravljenju Alzheimerjeve bolezni pri ljudeh.
SI9420048A 1993-08-20 1994-08-16 Farmacevtske formulacije živčnega rastnega faktorja SI9420048B (sl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/109,798 US6277828B1 (en) 1993-08-20 1993-08-20 Pharmaceutical formulations of nerve growth factor
PCT/US1994/009245 WO1995005845A1 (en) 1993-08-20 1994-08-16 Pharmaceutical formulations of nerve growth factor

Publications (2)

Publication Number Publication Date
SI9420048A SI9420048A (en) 1996-10-31
SI9420048B true SI9420048B (sl) 2003-12-31

Family

ID=22329623

Family Applications (1)

Application Number Title Priority Date Filing Date
SI9420048A SI9420048B (sl) 1993-08-20 1994-08-16 Farmacevtske formulacije živčnega rastnega faktorja

Country Status (31)

Country Link
US (2) US6277828B1 (sl)
EP (1) EP0721343B1 (sl)
JP (2) JP4592830B2 (sl)
KR (1) KR100341193B1 (sl)
CN (1) CN1163265C (sl)
AT (1) ATE226085T1 (sl)
AU (1) AU677699B2 (sl)
BG (1) BG62951B1 (sl)
BR (1) BR9407278A (sl)
CA (1) CA2169834C (sl)
CZ (1) CZ292422B6 (sl)
DE (1) DE69431562T2 (sl)
DK (1) DK0721343T3 (sl)
ES (1) ES2181723T3 (sl)
FI (1) FI113241B (sl)
HU (1) HU228152B1 (sl)
IL (3) IL110725A (sl)
LT (1) LT4051B (sl)
LV (1) LV11279B (sl)
NO (1) NO317627B1 (sl)
NZ (1) NZ271873A (sl)
PL (1) PL176387B1 (sl)
PT (1) PT721343E (sl)
RO (1) RO114742B1 (sl)
RU (1) RU2126265C1 (sl)
SI (1) SI9420048B (sl)
SK (1) SK284064B6 (sl)
TW (1) TW427905B (sl)
UA (1) UA43348C2 (sl)
WO (1) WO1995005845A1 (sl)
ZA (1) ZA946333B (sl)

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ES2181723T3 (es) 2003-03-01
TW427905B (en) 2001-04-01
EP0721343A1 (en) 1996-07-17
CN1133012A (zh) 1996-10-09
US6277828B1 (en) 2001-08-21
LT96011A (en) 1996-07-25
DK0721343T3 (da) 2003-02-17
LT4051B (en) 1996-10-25
IL110725A0 (en) 1994-11-11
DE69431562T2 (de) 2003-06-18
HK1012990A1 (en) 1999-08-13
US7074763B2 (en) 2006-07-11
NZ271873A (en) 1996-10-28
NO960651D0 (no) 1996-02-19
SK284064B6 (sk) 2004-09-08
IL110725A (en) 2004-09-27
LV11279B (en) 1996-10-20
BG62951B1 (bg) 2000-12-29
CN1163265C (zh) 2004-08-25
FI960750A0 (fi) 1996-02-19
SI9420048A (en) 1996-10-31
RU2126265C1 (ru) 1999-02-20
ZA946333B (en) 1996-02-19
IL124941A0 (en) 1999-01-26
NO960651L (no) 1996-02-19
BR9407278A (pt) 1996-10-01
IL124941A (en) 2006-12-10
AU677699B2 (en) 1997-05-01
LV11279A (lv) 1996-06-20
KR100341193B1 (ko) 2002-06-21
BG100371A (bg) 1996-12-31
HUT74728A (en) 1997-02-28
ATE226085T1 (de) 2002-11-15
EP0721343B1 (en) 2002-10-16
JP2007314572A (ja) 2007-12-06
AU7566894A (en) 1995-03-21
CA2169834A1 (en) 1995-03-02
JP4592830B2 (ja) 2010-12-08
PL176387B1 (pl) 1999-05-31
US20010007662A1 (en) 2001-07-12
HU9600371D0 (en) 1996-04-29
CA2169834C (en) 2008-11-04
FI113241B (fi) 2004-03-31
CZ42496A3 (en) 1996-05-15
CZ292422B6 (cs) 2003-09-17
RO114742B1 (ro) 1999-07-30
HU228152B1 (en) 2012-12-28
NO317627B1 (no) 2004-11-29
JPH10508000A (ja) 1998-08-04
PT721343E (pt) 2003-01-31
DE69431562D1 (de) 2002-11-21
WO1995005845A1 (en) 1995-03-02
PL313084A1 (en) 1996-05-27
UA43348C2 (uk) 2001-12-17
FI960750L (fi) 1996-02-20
SK18396A3 (en) 1996-10-02

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