FI122016B - Farmaceutiskt flerenhetspreparat innehållande protonpumpinhibitor - Google Patents

Farmaceutiskt flerenhetspreparat innehållande protonpumpinhibitor Download PDF

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Publication number
FI122016B
FI122016B FI961058A FI961058A FI122016B FI 122016 B FI122016 B FI 122016B FI 961058 A FI961058 A FI 961058A FI 961058 A FI961058 A FI 961058A FI 122016 B FI122016 B FI 122016B
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FI
Finland
Prior art keywords
enteric
dosage form
pellets
coating layer
individual
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Application number
FI961058A
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English (en)
Finnish (fi)
Other versions
FI961058A0 (sv
FI961058A (sv
Inventor
Kurt Ingmar Loevgren
Pontus John Arvid Bergstrand
Original Assignee
Astrazeneca Ab
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Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of FI961058A0 publication Critical patent/FI961058A0/sv
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    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (15)

1. Oral farmaceutisk tabletterad flerenhetsdoseringsform innefattande tablett-fyllnadsämnen och individuella enterodragerade skiktförsedda enheter av ett kämmaterial innehällande aktiv substans i form av en syralabil H+K+-ATPas- 5 hämmare eller en av dess enskilda enantiomerer eller ett alkaliskt salt därav, varvid den aktiva substansen eventuellt är blandad med alkaliska föreningar och farmaceutiskt acceptabla fyllnadsämnen, varvid kärnmaterialet är täckt med ett eller Hera skikt av vilka ätminstone ett är ett enterodrageringsskikt, kännetecknad av att enterodrageringsskiktet har en tjocklek av mer än 20 pm och nämnda skikt 10 innefattar ett mjukmedel i en mängd av 15-50 vikt-% av enterodragerings-skiktpolymeren eller -polymererna, enterodrageringsskiktet har sädana mekaniska egenskaper att komprimering av de individuella enheterna blandade med tablett-fyllnadsämnena tili den tabletterade flerenhetsdoseringsformen inte väsentligen päverkar syrabeständigheten hos de individuella enterodragerade skiktförsedda 15 enheterna, de individuella enterodragerade skiktförsedda enheterna är ytterligare täckta med ett ytterdrageringsskikt som innefattar farmaceutiskt acceptabla fyllnadsämnen, och att mängden av de enterodragerade skiktförsedda pelleterna utgör mindre än 60 vikt-% av den totala tablettvikten.
2. Tabletterad doseringsform enligt patentkrav 1, kännetecknad av att den aktiva 20 substansen är en av följande föreningar och2cf3 o kNAcH2_!// I η 9 / <M H x OCH3 CC I Q_ I ^och3
00. V tn ° N-___ s I H OCH2CH2CH2OCH3 k " // η ^N' ^CH2-S-\ H CH3 _ I N-CH2CH(CH3)2 k /k n // η ^NT CH2-S-<S H fy. >=< k _J~\ r\ II / \=y h och3 H3C\t/^^CH3 o N ^n-^\0CH3 4 5 0 ' och3 C\J I 3 X ? \ s k. ^k ? // \ T n O \h,-S-V § H eller ett alkaliskt salt därav eller en av dess enskilda enantiomerer eller ett alkaliskt salt därav.
3. Tabletterad doseringsform enligt patentkrav 1, kännetecknad av att syrabeständigheten hos de individuella enterodragerade skiktförsedda enheterna inte minskar mer än 10 % vid komprimering av de individuella enterodragerade skiktförsedda enheterna till den tabletterade flerenhetsdoseringsformen.
4. Tabletterad doseringsform enigt patentkrav 1, kännetecknad av att det enterodrageringsskikt som applicerats pä kärnmaterialet har en Vickers-härdhet av lägre än 8, uppmätt pä enterodragerad skiktförsedd pellets eller pelletars yta innan komprimering av nämnda pelletar tili tabletter.
5. Tabletterad doseringsform enligt patentkrav 1, kännetecknad av att 10 doseringsformen är delbar.
6. Tabletterad doseringsform enligt patentkrav 1, kännetecknad av att doseringsformen är dispergerbar tili en suspension av individuella enterodragerade skiktförsedda enheter i en vattenhaltig vätska.
7. Tabletterad doseringsform enligt patentkrav 1, kännetecknad av att under 15 enterodrageringsskiktet är beläget ett separerande skikt, som innefattar farmaceu- tiskt acceptabla fyllnadsämnen som är lösliga eller olösliga men som sönderfaller i vatten, vilket separerande skikt eventuellt innefattar alkaliska föreningar.
8. Tabletterad doseringsform enligt patentkrav 1, kännetecknad av att kärnmaterialet är en ymp som är skiktförsett med den aktiva substansen.
9. Tabletterad doseringsform enligt patentkrav 8, kännetecknad av att ymparna har en storlek av 0,1-2 mm. __ 10. Förfarande för framställning av en farmaceutisk tabletterad o flerenhetsdoseringsform innefattande tablettfyllnadsämnen och individuella 4 enterodragerade skiktförsedda enheter av ett kämmaterial innehällande en aktiv o ^ 25 substans säsom definieras i patentkrav 1, eventuellt blandad med alkaliska ^ föreningar och farmaceutiskt acceptabla fyllnadsämnen, kännetecknat av att X £ förfarandet innefattar följande steg: 00 o a) att bilda en mängfald kämmaterial innefattande den aktiva substansen, (j) eventuellt blandad med de(n) alkaliska föreningen (-arna) och fyllnadsämnen, 30 b) att eventuellt täcka kärnmaterialet frän steg (a) med ett eller flera separerande skikt, c) att täcka kärnmaterialet frän steg (a) eller (b) med ett eller flera enterodrageringsskikt innefattande ett mjukmedel i en mängd av 15-50 vikt-% av enterodrageringsskiktpolymeren eller -polymererna, d) att täcka de individuella enterodragerade skiktförsedda enhetema med ett 5 ytterdrageringsskikt, e) att blanda mängfalden av enterodragerade skiktförsedda enheter frän steg (d) med tablettfyllnadsämnen, och f) att komprimera blandningen frän steg (e) till en tabletterad doseringsform, varvid enterodrageringsskiktet har sädana mekaniska egenskaper att komprimerin- 10 gen av de individuella enheterna blandade med tablettfyllnadsämnena till den tabletterade flerenhetsdoseringsformen inte väsentligen päverkar syrabeständigheten hos de individuella enterodragerade skiktförsedda enhetema, varvid vikten av de i steg (e) använda enterodragerade skiktförsedda pelletema och tablettfyllnadsämnena är sädan att vikten av de enterodragerade skiktförsedda pelletema utgör mindre än 15 60 vikt-% av den totala tablettvikten.
11. Förfarande enligt patentkrav 10, kännetecknat av att ett separerande skikt appliceras pä kärnmaterialet.
12. Tabletterad doseringsform enligt nägot av patentkraven 1-9 för användning i terapi.
13. Användning av en tabletterad doseringsforn enligt nägot av patentkraven 1-9 för tillverkning av läkemedel för att hämma magsyrautsöndring i däggdjur och människa.
14. Användning av en tabletterad doseringsform enligt nägot av patentkraven 1-9 4 för tillverkning av ett läkemedel för behandling av gastrointestinala inflammatoriska O ^ 25 sjukdomar i däggdjur och människa.
15. Genomtryckbar blisterförpackning, kännetecknad av att den innefattar en tabletterad flerenhetsdoseringsform enligt nägot av patentkraven 1-9. tn o 5 σ>
FI961058A 1994-07-08 1996-03-07 Farmaceutiskt flerenhetspreparat innehållande protonpumpinhibitor FI122016B (sv)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
SE9402431A SE9402431D0 (sv) 1994-07-08 1994-07-08 New tablet formulation
SE9402431 1994-07-08
SE9500678 1995-06-07
PCT/SE1995/000678 WO1996001624A1 (en) 1994-07-08 1995-06-07 Multiple unit pharmaceutical preparation containing proton pump inhibitor

Publications (3)

Publication Number Publication Date
FI961058A0 FI961058A0 (sv) 1996-03-07
FI961058A FI961058A (sv) 1996-03-07
FI122016B true FI122016B (sv) 2011-07-29

Family

ID=20394685

Family Applications (2)

Application Number Title Priority Date Filing Date
FI961058A FI122016B (sv) 1994-07-08 1996-03-07 Farmaceutiskt flerenhetspreparat innehållande protonpumpinhibitor
FI961059A FI961059A (sv) 1994-07-08 1996-03-07 Tabletterad flerenhetsdoseringsform innehållande protonpumpinhibitor

Family Applications After (1)

Application Number Title Priority Date Filing Date
FI961059A FI961059A (sv) 1994-07-08 1996-03-07 Tabletterad flerenhetsdoseringsform innehållande protonpumpinhibitor

Country Status (36)

Country Link
US (1) US5753265A (sv)
EP (3) EP0723437B1 (sv)
JP (2) JP3878669B2 (sv)
KR (1) KR100384961B1 (sv)
CN (2) CN1134667A (sv)
AT (1) ATE275396T1 (sv)
AU (1) AU695971B2 (sv)
BR (2) BR9506029A (sv)
CA (2) CA2170644C (sv)
CZ (1) CZ294380B6 (sv)
DE (1) DE69533470T2 (sv)
DK (1) DK0723437T3 (sv)
EE (1) EE03292B1 (sv)
ES (1) ES2227556T3 (sv)
FI (2) FI122016B (sv)
HK (1) HK1008298A1 (sv)
HU (2) HUT75934A (sv)
IL (2) IL114447A (sv)
IS (3) IS4326A (sv)
MA (1) MA23608A1 (sv)
MY (1) MY114388A (sv)
NO (2) NO316863B1 (sv)
NZ (1) NZ289949A (sv)
PL (2) PL180598B1 (sv)
PT (1) PT723437E (sv)
RU (2) RU2166935C2 (sv)
SA (1) SA95160092B1 (sv)
SE (1) SE9402431D0 (sv)
SI (1) SI0723437T1 (sv)
SK (1) SK283841B6 (sv)
TN (1) TNSN95076A1 (sv)
TR (2) TR199500826A2 (sv)
TW (1) TW421599B (sv)
UA (1) UA47390C2 (sv)
WO (2) WO1996001625A1 (sv)
ZA (2) ZA955547B (sv)

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