FI90393B - Förfarande för framställning av en oral farmaceutisk beredning som är stabil mot missfärgning - Google Patents
Förfarande för framställning av en oral farmaceutisk beredning som är stabil mot missfärgning Download PDFInfo
- Publication number
- FI90393B FI90393B FI871913A FI871913A FI90393B FI 90393 B FI90393 B FI 90393B FI 871913 A FI871913 A FI 871913A FI 871913 A FI871913 A FI 871913A FI 90393 B FI90393 B FI 90393B
- Authority
- FI
- Finland
- Prior art keywords
- omeprazole
- alkaline
- pills
- process according
- magnesium
- Prior art date
Links
Classifications
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (9)
1. Förfarande för framstäilning av en oral, farmaceutisk be-redning som är stabil mot missfärgning och som innehäller omeprazol som den aktiva ingrediensen, kännetecknat av att omeprazol blandad med en aikaiiskt reagerande förening, el-ler ett alkaliskt sait av omeprazol eventuellt blandat med en alkaliskt reagerande förening, formas till kärnor och dessa kärnor, vilka är i form av smä pärlor eller tabletter, drageras med ett eller flera inert reagerande underskyddande drageringsskikt innehällande tablettfyllnadsmedel, vilka är lösliga eller snabbt sönderfallande i vatten eller polymera, vattenlösliga, filmbildande föreningar eventuellt innehällande pH-buffrande alkaliska föreningar mellan den alkaliskt reagerande kärnan och ett yttre skikt, som är ett magsaft-resistent drageringsskikt, varefter de underskyddsdragerade kärnorna drageras ytterligare med nämnda yttre magsaftresis-tenta drageringsskikt.
2. Förfarande enligt patentkravet 1, kännetecknat av att den använda underskyddande drageringen innehäller hydroxi-propylmetylcellulosa, hydroxipropylcellulosa eller poly-vinylpyrrolidon.
3. Förfarande enligt patentkravet 1, kännetecknat av att den använda underskyddande drageringen innefattar tvä eller flera underskikt och att det inre underskiktet innehäller en eller flera av magnesiumoxid, magnesiumhydroxid eller kom-positsubstans AI203 · 6MgO · C02· 121^0 eller MgO· A1203· 2Si02-nH20, väri n inte är ett heltal och mindre än 2.
4. Förfarande enligt patentkravet 1, kännetecknat av att omeprazol är blandad med pH-buffrande aikaiisk förening, vilken ger omeprazolens mikroomgivning ett pH av 7-12 för bildande av den alkaliska kärnan.
5. Förfarande enligt patentkravet 4, kännetecknat av att den alkaliska föreningen med vilken omeprazol är blandad innefattar en eller flera av magnesiumoxid, -hydroxid el- si 90395 ler -karbonat, aluminiumhydroxid, aluminium-, kalcium-, natrium- eller kaliumkarbonat, -fosfat eller -citrat, alu-minium/magnesiumkompositföreningarna Α1203· 6Mg0-C02· 12H20 eller Mg0-Al203-Si02-nH20, där n inte är ett heltal och mindre an 2 .
6. Förfarande enligt patentkravet 1, kännetecknat av att ett alkaliskt salt av omeprazol, säsom natrium-, kalium-, magnesium-, kalcium- eller ammoniumsaltet, är bildat och inkluderat i den alkaliska kärnan.
7. Förfarande enligt patentkravet 6, kannetecknat av att det alkaliska saltet av omeprazol är blandat med en aikaiisk förening för bildande av den alkaliska kärnan.
8. Förfarande enligt patentkravet 1, kannetecknat av att man använder en magsaftsresistent dragering innefattande hydroxipropylmetylcellulosaftaiat, cellulosaacetatftaiat, sampolymeriserad metakrylsyra/metakrylsyrametylester eller polyvinylacetatftaiat, eventuellt innehällande en mjukgöra-re.
9. Förfarande enligt patentkravet 1, kännetecknat av att man framställer en omeprazolinnehällande doseringsform, vars vatteninnehäll inte överstiger 1,5 vikts-%.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB8610572 | 1986-04-30 | ||
GB08610572A GB2189698A (en) | 1986-04-30 | 1986-04-30 | Coated omeprazole tablets |
SG154294 | 1994-10-21 | ||
SG154294A SG154294G (en) | 1986-04-30 | 1994-10-21 | New pharmaceutical preparation for oral use |
Publications (4)
Publication Number | Publication Date |
---|---|
FI871913A0 FI871913A0 (sv) | 1987-04-29 |
FI871913A FI871913A (sv) | 1987-10-31 |
FI90393B true FI90393B (sv) | 1993-10-29 |
FI90393C FI90393C (sv) | 1994-02-10 |
Family
ID=26290693
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
FI871913A FI90393C (sv) | 1986-04-30 | 1987-04-29 | Förfarande för framställning av en oral farmaceutisk beredning som är stabil mot missfärgning |
Country Status (35)
Country | Link |
---|---|
US (1) | US4786505A (sv) |
EP (3) | EP0567201B1 (sv) |
JP (2) | JPS62258320A (sv) |
KR (1) | KR910004579B1 (sv) |
CN (1) | CN1020852C (sv) |
AR (1) | AR240250A1 (sv) |
AT (3) | ATE184482T1 (sv) |
CA (1) | CA1292693C (sv) |
CY (1) | CY1810A (sv) |
DD (1) | DD273197A5 (sv) |
DE (3) | DE3783394T2 (sv) |
DK (1) | DK169988B1 (sv) |
DZ (1) | DZ1077A1 (sv) |
ES (3) | ES2091971T3 (sv) |
FI (1) | FI90393C (sv) |
GB (1) | GB2189698A (sv) |
GR (4) | GR890300058T1 (sv) |
HK (2) | HK135294A (sv) |
HR (1) | HRP920854B1 (sv) |
HU (1) | HU196708B (sv) |
IE (1) | IE61416B1 (sv) |
IL (1) | IL82911A (sv) |
IS (1) | IS1917B (sv) |
LT (1) | LT3699B (sv) |
LV (2) | LV10357B (sv) |
NO (1) | NO174239C (sv) |
NZ (1) | NZ220096A (sv) |
PH (1) | PH25701A (sv) |
PL (1) | PL151631B1 (sv) |
PT (1) | PT84785B (sv) |
RU (2) | RU1820837C (sv) |
SG (1) | SG154294G (sv) |
SI (1) | SI8710681A8 (sv) |
YU (1) | YU46192B (sv) |
ZA (1) | ZA872378B (sv) |
Families Citing this family (356)
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1993
- 1993-03-23 GR GR930400621T patent/GR3007434T3/el unknown
- 1993-06-28 LV LVP-93-694A patent/LV10357B/en unknown
- 1993-12-28 LT LTIP1683A patent/LT3699B/lt not_active IP Right Cessation
-
1994
- 1994-10-21 SG SG154294A patent/SG154294G/en unknown
- 1994-12-01 HK HK135294A patent/HK135294A/xx not_active IP Right Cessation
-
1995
- 1995-10-20 CY CY181095A patent/CY1810A/xx unknown
-
1996
- 1996-07-17 LV LV960264A patent/LV5760B4/xx unknown
- 1996-08-07 GR GR960402099T patent/GR3020734T3/el unknown
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1997
- 1997-04-24 HK HK52897A patent/HK52897A/xx not_active IP Right Cessation
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1999
- 1999-12-10 GR GR990403191T patent/GR3032101T3/el unknown
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FG | Patent granted |
Owner name: AKTIEBOLAGET HAESSLE |
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MA | Patent expired |