FI94024B - Förfarande för framställning av nasalpreparat - Google Patents

Förfarande för framställning av nasalpreparat Download PDF

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Publication number
FI94024B
FI94024B FI883783A FI883783A FI94024B FI 94024 B FI94024 B FI 94024B FI 883783 A FI883783 A FI 883783A FI 883783 A FI883783 A FI 883783A FI 94024 B FI94024 B FI 94024B
Authority
FI
Finland
Prior art keywords
oil
insulin
process according
preparation
phospholipid
Prior art date
Application number
FI883783A
Other languages
English (en)
Finnish (fi)
Other versions
FI883783A0 (sv
FI94024C (sv
FI883783A (sv
Inventor
Philip Edgar Hansen
Anders Robert Soerensen
Original Assignee
Novo Nordisk As
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
Priority claimed from DK604286A external-priority patent/DK604286D0/da
Priority claimed from DK370087A external-priority patent/DK370087D0/da
Application filed by Novo Nordisk As filed Critical Novo Nordisk As
Publication of FI883783A0 publication Critical patent/FI883783A0/sv
Publication of FI883783A publication Critical patent/FI883783A/sv
Application granted granted Critical
Publication of FI94024B publication Critical patent/FI94024B/sv
Publication of FI94024C publication Critical patent/FI94024C/sv

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Classifications

    • 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
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (11)

1. Förfarande för framställning av ett preparat för int-ranasal administration av en farmaceutiskt aktiv polypep-tid, kannetecknat av att det omfattar följande steg: 5 a) dispergering av minst en fosfolipid med den allmänna formeln I H-CH-OR'
10 CH-OR" (I) H-CH-O-P(O) (OH)-OR"' väri R' och R" är desamma eller oiikä och vardera repre-15 senterar väte, alkyl, alkenyl, alkylkarbonyl, alkenylkar-bonyl, alkadienylkarbonyl, alkatrienylkarbonyl eller alka-tetraenylkarbonyl innehällande ej mera än 14 kolatomer, med det förbehället att R' och R" ej bäda är väte, och R"' representerar en hydrofil grupp vald ur gruppen bestäende 20 av 2-(trimetylammonio)etyl, 2-aminoetyl och 2,3-dihydro-xipropyl i ett flytande eller fast utspädningsmedel som 9 dessutom kan innehälla en eller flera av följande kompo-nenter: fettolja i en mängd av 0,01-50 % (vikt/volym), en pH-buffert, ett konserveringsmedel och ett osmotiskt tryck 25 reglerande medel, b) tillsättning av den farmaceutiskt aktiva polypepti-den, och c) eventuellt justering av blandningens pH-värde, varvid innehället av fosfolipid med formeln I är ätminstone 0,5 % 30 (vikt/volym).
2. Förfarande enligt patentkrav 1, kännetecknat av att R"' är 2-(trimetylammonio)etyl. 35
3. Förfarande enligt patentkrav 2, kännetecknat av att vardera av R' och R" är alkyl eller alkylkarbonyl innehäl-lande frän 4 tili 12 kolatomer, företrädesvis alkylkarbonyl . I; 94024
4. Förfarande enligt patentkrav 3, kännetecknat av att R' och R" vardera representerar nonylkarbonyl.
5. Förfarande enligt patentkrav 2, kännetecknat av att 5 antingen R' eller R" är väte.
6. Förfarande enligt patentkrav 1, kännetecknat av att preparatet innehäller en fettolja, som är en vegetabilisk oija, vilken företrädesvis är vald ur gruppen bestäende av 10 sojaolja, jordnötsolja, kokosolja, majsolja, olivolja och solrosolja.
7. Förfarande enligt nägot av patentkraven 1-6, kännetecknat av att innehället av fosfolipid med formel I lig- 15 ger inom omrädet 0,5-5 % (vikt/vol.).
8. Förfarande enligt patentkrav l, kännetecknat av att preparatet innehäller en fettolja, vars innehäll ligger inom omrädet 0,1-10 % (vikt/vol.). 20
9. Förfarande enligt nägot av patentkraven 1-8, kännetecknat av att polypeptiden är insulin, ett insulinderi-vat, en blandning av insulin och minst ett insulinderivat eller en blandning av insulinderivat. 25
: 10. Förfarande enligt patentkrav 9, kännetecknat av att insulininnehället ligger inom omrädet 5-1000, företrädesvis 50-500, internationella enheter per ml av preparatet. 30
11. Förfarande enligt nägot av patentkraven 1-8, känne tecknat av att polypeptiden är glukagon.
FI883783A 1986-12-16 1988-08-15 Förfarande för framställning av nasalpreparat FI94024C (sv)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DK604286A DK604286D0 (da) 1986-12-16 1986-12-16 Praeparat
DK604286 1986-12-16
DK370087A DK370087D0 (da) 1987-07-16 1987-07-16 Produkt med forbedrede egenskaber
DK370087 1987-07-16
DK8700158 1987-12-15
PCT/DK1987/000158 WO1988004556A1 (en) 1986-12-16 1987-12-15 Nasal formulations and a process for preparation thereof

Publications (4)

Publication Number Publication Date
FI883783A0 FI883783A0 (sv) 1988-08-15
FI883783A FI883783A (sv) 1988-08-15
FI94024B true FI94024B (sv) 1995-03-31
FI94024C FI94024C (sv) 1995-07-10

Family

ID=26067181

Family Applications (1)

Application Number Title Priority Date Filing Date
FI883783A FI94024C (sv) 1986-12-16 1988-08-15 Förfarande för framställning av nasalpreparat

Country Status (22)

Country Link
EP (1) EP0272097B1 (sv)
JP (1) JPH0768149B2 (sv)
KR (1) KR890700036A (sv)
CN (1) CN1034105C (sv)
AT (1) ATE79039T1 (sv)
AU (1) AU606121B2 (sv)
CA (1) CA1326210C (sv)
CS (1) CS273139B1 (sv)
DE (1) DE3780925T2 (sv)
ES (1) ES2044957T3 (sv)
FI (1) FI94024C (sv)
GR (1) GR3005381T3 (sv)
HU (1) HU209247B (sv)
IE (1) IE61110B1 (sv)
IL (1) IL84835A (sv)
MX (1) MX9203640A (sv)
NO (1) NO175566C (sv)
NZ (1) NZ222907A (sv)
PT (1) PT86370B (sv)
RU (1) RU1837869C (sv)
WO (1) WO1988004556A1 (sv)
YU (1) YU46978B (sv)

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Also Published As

Publication number Publication date
ES2044957T3 (es) 1994-01-16
CS273139B1 (en) 1991-03-12
HUT57592A (en) 1991-12-30
EP0272097A3 (en) 1988-08-24
CN87108340A (zh) 1988-07-13
EP0272097B1 (en) 1992-08-05
NO175566C (no) 1994-11-02
NO175566B (no) 1994-07-25
KR890700036A (ko) 1989-03-02
DE3780925T2 (de) 1992-12-24
HU209247B (en) 1994-04-28
IE61110B1 (en) 1994-10-05
YU228487A (en) 1988-12-31
FI883783A0 (sv) 1988-08-15
IE873408L (en) 1988-06-16
JPH0768149B2 (ja) 1995-07-26
JPH01501550A (ja) 1989-06-01
EP0272097A2 (en) 1988-06-22
FI94024C (sv) 1995-07-10
NZ222907A (en) 1990-08-28
PT86370A (en) 1988-01-01
GR3005381T3 (sv) 1993-05-24
RU1837869C (ru) 1993-08-30
NO883627D0 (no) 1988-08-15
NO883627L (no) 1988-08-15
MX9203640A (es) 1992-09-01
CN1034105C (zh) 1997-02-26
CA1326210C (en) 1994-01-18
PT86370B (pt) 1990-11-20
DE3780925D1 (de) 1992-09-10
WO1988004556A1 (en) 1988-06-30
AU606121B2 (en) 1991-01-31
AU1085888A (en) 1988-07-15
ATE79039T1 (de) 1992-08-15
CS930487A1 (en) 1990-07-12
FI883783A (sv) 1988-08-15
IL84835A0 (en) 1988-06-30
YU46978B (sh) 1994-09-09
IL84835A (en) 1994-01-25

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