FI118208B - Monomera insulinanalogpreparat - Google Patents

Monomera insulinanalogpreparat Download PDF

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Publication number
FI118208B
FI118208B FI952932A FI952932A FI118208B FI 118208 B FI118208 B FI 118208B FI 952932 A FI952932 A FI 952932A FI 952932 A FI952932 A FI 952932A FI 118208 B FI118208 B FI 118208B
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FI
Finland
Prior art keywords
protamine
insulin
zinc
human insulin
analog
Prior art date
Application number
FI952932A
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English (en)
Finnish (fi)
Other versions
FI952932A0 (sv
FI952932A (sv
Inventor
Felippis Michael Rosario De
Original Assignee
Lilly Co Eli
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Application filed by Lilly Co Eli filed Critical Lilly Co Eli
Publication of FI952932A0 publication Critical patent/FI952932A0/sv
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins
    • 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
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones

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

Claims (21)

1. Insulinanalog-protamin-komplex, känneteck- J nat av att det innehäller: humant insulin där Pro i stall- '7 5 ningen B28 har ersatts med nägon av följande: Lys, Leu, Vai eller Ala, och Lys i ställningen B29 är Lys eller Pro, des(B28-B30)-humaninsulin eller des(B27)-humaninsulin; pro-tamin; zink och ett fenolderivat.
2. Komplex enligt patentkrav 1, kännetecknat 10 av att det innehäller LysB28ProB29-humaninsulin, ca 0,27 - 0,32 mg protamin/100 IU insulinanalog, ca 0,35-0,9 . vikt-% zink och ett fenolderivat.
3. Komplex enligt nägot av patentkraven 1-2, kännetecknat av att komplexet är kristallint.
4. Parenteral farmaceutisk insulinanalog-protamin- £ formulering, kännetecknad av att den innehäller kom- "f pexet enligt nägot av patentkraven 1, 2 eller 3.
5. Formulering enligt patentkrav 4, känneteck- ^ nad av att den ytterligare innehäller ca 0,2 -1,5 mg pro- | 20 tamin/100 IU insulinanalog; ca 0,35 -0,9 vikt-% zink; och Γ ett f enolderivat. . ?l
• · ·,**: 6. Parenteral farmaceutisk formulering enligt pa- -r ·· · ‘ ' : tentkrav 5, kännetecknad av att den innehäller ♦ * LysB28ProB29-humaninsulin, ca 0,27 - 0,32 mg protamin/100 IU ;*·,· 25 insulinanalog och ca 0,35 - 0,9 vikt-% zink.
• · : 7. Parenteral farmaceutisk formulering kän- netecknad av att den innehäller LysB28ProB29- * * * humaninsulin, ca 0,3 mg protamin/100 IU insulinanalog, ca .. 0,7 vikt-% zink, ca 1,7 mg/ml m-kresol, ca 0,7 mg/ml fenol, * · 30 ca 16 mg/ml glycerin och ca 3,78 mg/ml tväbasiskt natrium- ;1 ’·**' fosfat. : s":
8. Parenteral farmaceutisk formulering enlligt nä- got av kraven 4 - 7 kännetecknad av att den ytterliga- > • · · 1. re innehäller löslig insulinanalog. « · "*[ 35
9. Parenteral farmaceutisk formulering, känne- * · · *· '· tecknat av att den innehäller; en blandning av löslig 118208 insulinanalog och kristaller av insulinanalog-protamin; där viktförhällandet mellan de tvä komponenterna insulinanalog .: och insulinanalog-protaminkristaller är ca 1:99 - 99:1; varvid nämnda insulinanalog är humaninsulin där Pro 5 i ställningen B28 ersatts med nägon av följande: Lys, Leu, Vai eller Ala, och Lys i ställningen B29 är Lys eller Pro, des(B28-B30)-humaninsulin eller des(B27)-humaninsulin.
10. Parenteral farmaceutisk formulering enligt pa- ? tentkrav 9, kännetecknad av att viktförhällandet mel- 1 10 lan de tvä komponenterna ärca 75:25-25:75. ;
11. Parenteral farmaceutisk formulering enligt pa- f: tentkrav 10, kännetecknad av att den innehäller: "·- LysB28ProB29-humaninsulin och LysB28ProB29-humaninsulin-prota-min-kristaller.
12. Parenteral farmaceutisk formulering enligt pa- | tentkrav 11, kännetecknad av att viktförhällandet mellan de tvä komponenterna är 50:50, 75:25 eller 25:75.
13. Parenteral farmaceutisk formulering enligt nä- ‘ r got av patentkraven 4-12 att användas vid behandling av 20 diabetes mellitus.
14. Förfarande för att framställa komplexet enligt • * nägot av patentkraven 1 - 3, kännetecknat av att man: ? * · · • kombinerar en monomer insulinanalog, protamin, zink och ett :: : fenolderivat i en vattenhaltig lösning och läter komplexet :*·,· 25 bildas. • * ‘ i
• 15. Förfarande för framställning av kristaller av Lys Pro -humamnsulm-protamin kännetecknat av att • * · man kombinerar en vattenhaltig lösning som innehäller 30 Lys Pro -humaninsulin ι ett hexamert associationstili- • · *” ständ, och protaminlösning vid en temperatur pä ca 8 - : 22 °C; ' i: ··« :* : varvid den vattenhaltiga lösningen innehäller ca - • * * y·.' 0,35 - 0,9 vikt-% zink, LysB28ProB29-humaninsulin och ett fe- *;··! 35 no 1 der ivat vid ett pH mellan ca 7,1 - 7,6; : ^ • · · V • · · * « I .. : 1 118208 varvid protaminlösningen som innehäller protaminet vid ett pH pä ca 7,1 - 7,6 är sädan att protaminets slutli-ga styrka är ca 0,27 - 0,32 mg protamin/100 IU insulinana-log. 5
16. Förfarande enligt patentkrav kännetecknat av att temperaturen är 15 °C; zinkhalten är 0,7 - 0,9 I; och protaminhalten är 0,3 mg/100 IU insulinanalog.
17. Förfarande för framställning av kristaller av AspB28-humaninsulin-protamin kännetecknat av att man i 10 kombinerar en vattenhaltig lösning som innehäller AspB28-humaninsulin i ett hexamert associationstillständ, och en protaminlösning vid en temperatur pä ca 5 - 22 °C; f varvid den vattenhalting lösningen innerhäller ca 0,35 - 0,9 vikt-% zink, AspB28-humaninsulin och ett fenolde-15 rivat vid ett pH pä ca 7,1 - 7,6; varvid protaminlösningen som innehäller protaminet vid ett pH pä ca 7,1 - 7,6 är sädan att protaminets slutli-ga styrka är ca 0,27 - 0,32 mg protamin/100 IU insulinana-log. > 20
18. Förfarande för att framställa en parenteral farmaceutisk formulering enligt nägot av patentkraven 4 - • · .’·· 12, kännetecknat av att man suspenderar insulinanalog- • protamin-kristallerna i en farmaceutiskt godtagbar diluent. :T:
19. Förfarande enligt patentkrav 17, kän- :1·,· 25 netecknat av att förfarandet utförs vid en temperatur .1 .·. pä ca 8 - 22 °C. • · · « · 1 1
20. Förfarande enligt patentkrav 18, kanne- • t1 tecknat av att förfarandet utförs vid en temperatur pä .. ca 13 - 17 °C. • · *... 30
21. Förfarande enligt patentkrav 19, känne- · *···1 tecknat av att förfarandet utförs under betingelser un- : der ca 4 mg/ml natriumklorid. • · · · • · • 1· · *♦· • · • » · · * · · * · · • ·
FI952932A 1994-06-16 1995-06-14 Monomera insulinanalogpreparat FI118208B (sv)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26063394 1994-06-16
US08/260,633 US5461031A (en) 1994-06-16 1994-06-16 Monomeric insulin analog formulations

Publications (3)

Publication Number Publication Date
FI952932A0 FI952932A0 (sv) 1995-06-14
FI952932A FI952932A (sv) 1995-12-17
FI118208B true FI118208B (sv) 2007-08-31

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (37)

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US (3) US5461031A (sv)
JP (1) JP3812962B2 (sv)
KR (1) KR100386038B1 (sv)
CN (1) CN1145641C (sv)
AT (1) AT408611B (sv)
BE (1) BE1009409A5 (sv)
BR (1) BR9502797A (sv)
CA (1) CA2151564C (sv)
CH (2) CH689934A5 (sv)
CO (1) CO4410204A1 (sv)
CZ (1) CZ294556B6 (sv)
DE (1) DE19521753B4 (sv)
DK (1) DK176213B1 (sv)
ES (1) ES2091728B1 (sv)
FI (1) FI118208B (sv)
FR (1) FR2721215B1 (sv)
GB (1) GB2290294B (sv)
GR (1) GR1002494B (sv)
HU (1) HU218943B (sv)
IE (1) IE68852B1 (sv)
IL (1) IL114153A (sv)
IT (1) IT1276722B1 (sv)
LU (1) LU88627A1 (sv)
MY (1) MY116831A (sv)
NL (2) NL1000565C2 (sv)
NO (1) NO320808B1 (sv)
NZ (1) NZ272360A (sv)
PE (1) PE34496A1 (sv)
PL (1) PL183284B1 (sv)
PT (1) PT101723B (sv)
RO (1) RO115124B1 (sv)
SE (1) SE509295C2 (sv)
SI (1) SI9500199A (sv)
TW (1) TW347334B (sv)
UA (1) UA34468C2 (sv)
YU (1) YU39795A (sv)
ZA (1) ZA954941B (sv)

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TW347334B (en) 1998-12-11
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SE509295C2 (sv) 1999-01-11
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US5650486A (en) 1997-07-22
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