CO4700482A1 - Formulaciones de un analogo monomero de insulina - Google Patents

Formulaciones de un analogo monomero de insulina

Info

Publication number
CO4700482A1
CO4700482A1 CO96015449A CO96015449A CO4700482A1 CO 4700482 A1 CO4700482 A1 CO 4700482A1 CO 96015449 A CO96015449 A CO 96015449A CO 96015449 A CO96015449 A CO 96015449A CO 4700482 A1 CO4700482 A1 CO 4700482A1
Authority
CO
Colombia
Prior art keywords
physiologically acceptable
insulin analog
solution
analog
ppm
Prior art date
Application number
CO96015449A
Other languages
English (en)
Inventor
Felippis Michael Rosario De
Hill Frank Bruce
Original Assignee
Lilly Co Eli
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 Lilly Co Eli filed Critical Lilly Co Eli
Publication of CO4700482A1 publication Critical patent/CO4700482A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/62Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Endocrinology (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

Una formulación farmacéutica parenteral que tiene un efectoprolongado, que consiste esencialmente en una suspensión acuosa estéril de aproximadamente 20 U/ml a aproximadamente 500 U/ml de un análogo de insulina, aproximadamente de 5 mg/ml a aproximadamente 10 mg/ml de cloruro sódico, aproximadamente 0,2 a aproximadamente 2,0 mg/ml de un tampón fisiológicamente aceptable, un contenido de iones zinc de aproximadamente 0,04 mg/ml a aproximadamente 20,0 mg/ml y un conservante fisiológicamente aceptable, a un pH de aproximadamente 6,5 a aproximadamente 7,8; tal que menos de 5% del análogo presente en la suspensión está en estado disuelto. 1Un procedimiento para preparar cristales de insulina humana-LysB28 ProB29 , que comprende combinar: una primera solución que comprende aproximadamente 300 U/ml a aproximadamente 2.000 U/ml del análogo de insulina, aproximadamente 500 ppm a aproximadamente 3.000 ppm de fenol y un exceso molar de iones zinc, a un pH de aproximadamente 2,0 a aproximadamente 3,0, y una segunda solución que comprende aproximadamente 130 mg/ml a aproximadamente 270 mg/ml de cloruro sódico y aproximadamente 5,0 a aproximadamente 55,0 mg/ml de un tampón fisiológicamente aceptable, a un pH de aproximadamente 10,5 a 12,5, de modo que el pH de la solución combinada sea de 5,0 a 6,0.
CO96015449A 1995-03-31 1996-03-28 Formulaciones de un analogo monomero de insulina CO4700482A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US41488095A 1995-03-31 1995-03-31

Publications (1)

Publication Number Publication Date
CO4700482A1 true CO4700482A1 (es) 1998-12-29

Family

ID=23643384

Family Applications (1)

Application Number Title Priority Date Filing Date
CO96015449A CO4700482A1 (es) 1995-03-31 1996-03-28 Formulaciones de un analogo monomero de insulina

Country Status (23)

Country Link
US (1) US5952297A (es)
EP (1) EP0735048A1 (es)
JP (1) JPH11502856A (es)
KR (1) KR19980703425A (es)
CN (1) CN1185114A (es)
AR (1) AR002976A1 (es)
AU (1) AU720300B2 (es)
BR (1) BR9607935A (es)
CA (1) CA2216516A1 (es)
CO (1) CO4700482A1 (es)
CZ (1) CZ305297A3 (es)
EA (1) EA000970B1 (es)
HU (1) HUP9801700A3 (es)
IL (1) IL117696A (es)
MX (1) MX9707428A (es)
NO (1) NO974498L (es)
NZ (1) NZ305719A (es)
PE (1) PE38797A1 (es)
PL (1) PL322626A1 (es)
TR (1) TR199701078T1 (es)
WO (1) WO1996030040A1 (es)
YU (1) YU18596A (es)
ZA (1) ZA962502B (es)

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Also Published As

Publication number Publication date
EP0735048A1 (en) 1996-10-02
TR199701078T1 (xx) 1998-01-21
NO974498D0 (no) 1997-09-29
KR19980703425A (ko) 1998-11-05
EA199700285A1 (ru) 1998-02-26
AU5381296A (en) 1996-10-16
ZA962502B (en) 1997-09-29
CA2216516A1 (en) 1996-10-03
NO974498L (no) 1997-10-08
AU720300B2 (en) 2000-05-25
EA000970B1 (ru) 2000-08-28
IL117696A (en) 2000-01-31
PL322626A1 (en) 1998-02-02
CN1185114A (zh) 1998-06-17
IL117696A0 (en) 1996-07-23
BR9607935A (pt) 1998-06-02
CZ305297A3 (cs) 1998-02-18
MX9707428A (es) 1997-12-31
HUP9801700A2 (hu) 1998-11-30
JPH11502856A (ja) 1999-03-09
PE38797A1 (es) 1997-10-04
YU18596A (sh) 1998-07-10
WO1996030040A1 (en) 1996-10-03
US5952297A (en) 1999-09-14
HUP9801700A3 (en) 1998-12-28
NZ305719A (en) 1998-09-24
AR002976A1 (es) 1998-05-27

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