LV10357B - New pharmaceutical preparation, a method for the manufacture of the same and use of them for treatment of gastrointestinal diseases - Google Patents

New pharmaceutical preparation, a method for the manufacture of the same and use of them for treatment of gastrointestinal diseases Download PDF

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Publication number
LV10357B
LV10357B LVP-93-694A LV930694A LV10357B LV 10357 B LV10357 B LV 10357B LV 930694 A LV930694 A LV 930694A LV 10357 B LV10357 B LV 10357B
Authority
LV
Latvia
Prior art keywords
omeprazole
alkaline
composition
compounds
pellets
Prior art date
Application number
LVP-93-694A
Other languages
English (en)
Other versions
LV10357A (lv
Inventor
Livgren Kurt Ingemar
Pilbrant Ake Gunnar
Mitsuru Yasumura
Morigaki Satoshi
Oda Minoru
Ohishi Naohiro
Original Assignee
Haessle Ab
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26290693&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=LV10357(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Haessle Ab filed Critical Haessle Ab
Publication of LV10357A publication Critical patent/LV10357A/lv
Publication of LV10357B publication Critical patent/LV10357B/en

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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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (13)

  1. LV 10357 PATENTA FORMULA 1. Farmaceitiska kompozīcija orālai lietošanai, kas satur omeprazolu kā aktīvo vielu, atšķirīga ar to, ka tā izgatavota no kodola materiāla, kas satur omeprazolu kopā ar sārmainu savienojumu vai omeprazola sārmainu sāli neobligāti kopā ar sārmainu savienojumu un vienu vai vairākus inertus starpapvalkus ap minēto kodola materiālu, kas satur tablešu palīgvielas, kuras šķīst vai ātri sadalās ūdenī, vai polimērus, ūdenī šķīstošus plēvi veidojošus materiālus, neobligāti saturošus pH buferējošus sārmainus savienojumus starp sārmaino kodolu un ārējo slāni, kurš ir zarnās šķīstošs apvalks.
  2. 2. Kompozīcija saskaņā ar 1. punktu, kur starpapvalks satur vienu vai vairākus savienojumus no magnija oksīda, magnija hidroksīda vai salikta savienojuma [AI203*6Mg0»C02»12H20 vai MgO*AI203*2Si02*nH20], kur n nav vesels skaitlis un ir mazāks par 2.
  3. 3. Kompozīcija saskaņā ar 1. punktu, kur starpapvalks satur divus vai vairākus starpslāņus.
  4. 4. Kompozīcija saskaņā ar 3. punktu, kur starpapvalks satur hidroksipropilmetilcelulozi, hidroksipropilcelulozi vai polivinilpirolidonu.
  5. 5. Kompozīcija saskaņā ar 1. punktu, kur sārmainais kodols satur omeprazolu un pH buferējošu sārmainu savienojumu, kas nodrošina omeprazola mikrovidē pH no 7 līdz 12.
  6. 6. Kompozīcija saskaņā ar 5. punktu, kur sārmainais savienojums satur vienu vai vairākus savienojumus no magnija oksīda, hidroksīda vai karbonāta, alumīnija hidroksīda, alumīnija, kalcija nātrija vai kālija karbonāta, fosfāta vai citrāta, salikta alumīnija/magnija savienojuma AI203*6Mg0*C02*12H20 vai Mg0«AI203*2Si02*nH20, kur n nav vesels skaitlis un ir mazāks par 2. 2
  7. 7. Kompozīcija saskaņā ar 1. punktu, kur sārmainais kodols satur omeprazola sārmainu sāli, tādu kā nātrija, kālija, magnija, kalcija vai amonija sāli.
  8. 8. Kompozīcija saskaņā ar 7. punktu, kur sārmainais kodols satur omeprazola sārmainu sāli, kas sajaukts ar inertu, sārmainu savienojumu.
  9. S: Kompozīcija saskaņā ar 1. punktu, kur zarnās šķīstošais apvalks satur hidroksipropilmetilcelulozes ftalātu, acetātcelulozes ftalātu, met-akrilskābes/metakrilskābes metilestera kopolimēru vai polivinilacetāta ftalātu, neobligāti ietverot plastifikatoru.
  10. 10. Kompozīcija saskaņā ar 1. punktu, kur ūdens saturs gatavajā ārstnieciskajā formā, kas satur omeprazolu, nepārsniedz 1,5 masas %.
  11. 11. Paņēmiens orālas lietošanas farmaceitiskas kompozīcijas, kas satur omeprazolu, iegūšanai, kurā kodols, kas satur omeprazolu kopā ar sārmainu savienojumu vai savienojumus, vai omeprazola sārmainu sāli neobligāti kopā ar sārmainu savienojumu vai savienojumiem, ir pārklāts ar vienu vai vairākiem inertiem starpapvalkiem un pēc tam ar starpapvalku apvilktais kodols tiek apvilkts ar zarnās šķīstošu apvalku.
  12. 12. Paņēmiens kuņģa un zarnu trakta slimību ārstēšanai, atšķirīga ar to, ka kompozīcija saskaņā ar 1. punktu tiek pielietota slimniekam terapeitiski efektīvā daudzumā.
  13. 13. Kompozīcijas saskaņā ar 1. punktu izmantošana zāļu ražošanai kuņģa un zarnu trakta slimību ārstēšanai.
LVP-93-694A 1986-04-30 1993-06-28 New pharmaceutical preparation, a method for the manufacture of the same and use of them for treatment of gastrointestinal diseases LV10357B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB08610572A GB2189698A (en) 1986-04-30 1986-04-30 Coated omeprazole tablets
SG154294A SG154294G (en) 1986-04-30 1994-10-21 New pharmaceutical preparation for oral use

Publications (2)

Publication Number Publication Date
LV10357A LV10357A (lv) 1995-02-20
LV10357B true LV10357B (en) 1996-04-20

Family

ID=26290693

Family Applications (2)

Application Number Title Priority Date Filing Date
LVP-93-694A LV10357B (en) 1986-04-30 1993-06-28 New pharmaceutical preparation, a method for the manufacture of the same and use of them for treatment of gastrointestinal diseases
LV960264A LV5760B4 (lv) 1986-04-30 1996-07-17 Jauns farmaceitisks preparats peroralai lietosanai

Family Applications After (1)

Application Number Title Priority Date Filing Date
LV960264A LV5760B4 (lv) 1986-04-30 1996-07-17 Jauns farmaceitisks preparats peroralai lietosanai

Country Status (35)

Country Link
US (1) US4786505A (lv)
EP (3) EP0496437B1 (lv)
JP (2) JPS62258320A (lv)
KR (1) KR910004579B1 (lv)
CN (1) CN1020852C (lv)
AR (1) AR240250A1 (lv)
AT (3) ATE184482T1 (lv)
CA (1) CA1292693C (lv)
CY (1) CY1810A (lv)
DD (1) DD273197A5 (lv)
DE (3) DE3783394T2 (lv)
DK (1) DK169988B1 (lv)
DZ (1) DZ1077A1 (lv)
ES (3) ES2135443T3 (lv)
FI (1) FI90393C (lv)
GB (1) GB2189698A (lv)
GR (4) GR890300058T1 (lv)
HK (2) HK135294A (lv)
HR (1) HRP920854B1 (lv)
HU (1) HU196708B (lv)
IE (1) IE61416B1 (lv)
IL (1) IL82911A (lv)
IS (1) IS1917B (lv)
LT (1) LT3699B (lv)
LV (2) LV10357B (lv)
NO (1) NO174239C (lv)
NZ (1) NZ220096A (lv)
PH (1) PH25701A (lv)
PL (1) PL151631B1 (lv)
PT (1) PT84785B (lv)
RU (2) RU1820837C (lv)
SG (1) SG154294G (lv)
SI (1) SI8710681A8 (lv)
YU (1) YU46192B (lv)
ZA (1) ZA872378B (lv)

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