HRP20120754T1 - Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak - Google Patents
Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak Download PDFInfo
- Publication number
- HRP20120754T1 HRP20120754T1 HRP20120754TT HRP20120754T HRP20120754T1 HR P20120754 T1 HRP20120754 T1 HR P20120754T1 HR P20120754T T HRP20120754T T HR P20120754TT HR P20120754 T HRP20120754 T HR P20120754T HR P20120754 T1 HRP20120754 T1 HR P20120754T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- pantoprazole
- form according
- pvp
- prophylaxis
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title claims 11
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 title claims 5
- 229960005019 pantoprazole Drugs 0.000 title claims 5
- 239000004480 active ingredient Substances 0.000 title 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 8
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 7
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 7
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims 5
- RDRUTBCDIVCMMX-UHFFFAOYSA-N magnesium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide Chemical compound [Mg+2].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC.COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC RDRUTBCDIVCMMX-UHFFFAOYSA-N 0.000 claims 5
- 238000011321 prophylaxis Methods 0.000 claims 4
- 238000011282 treatment Methods 0.000 claims 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 229940069328 povidone Drugs 0.000 claims 3
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 208000000718 duodenal ulcer Diseases 0.000 claims 2
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims 2
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 241000590002 Helicobacter pylori Species 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 208000007107 Stomach Ulcer Diseases 0.000 claims 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims 1
- 208000025865 Ulcer Diseases 0.000 claims 1
- 201000008629 Zollinger-Ellison syndrome Diseases 0.000 claims 1
- 239000003242 anti bacterial agent Substances 0.000 claims 1
- 229940088710 antibiotic agent Drugs 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 239000008116 calcium stearate Substances 0.000 claims 1
- 238000002648 combination therapy Methods 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 230000002183 duodenal effect Effects 0.000 claims 1
- 230000008029 eradication Effects 0.000 claims 1
- 230000002496 gastric effect Effects 0.000 claims 1
- 201000005917 gastric ulcer Diseases 0.000 claims 1
- 201000000052 gastrinoma Diseases 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 239000011229 interlayer Substances 0.000 claims 1
- 239000010410 layer Substances 0.000 claims 1
- 159000000003 magnesium salts Chemical class 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 1
- 229940117841 methacrylic acid copolymer Drugs 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 229940126409 proton pump inhibitor Drugs 0.000 claims 1
- 239000000612 proton pump inhibitor Substances 0.000 claims 1
- 235000017550 sodium carbonate Nutrition 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 229940083575 sodium dodecyl sulfate Drugs 0.000 claims 1
- 230000009885 systemic effect Effects 0.000 claims 1
- 239000004408 titanium dioxide Substances 0.000 claims 1
- 239000001069 triethyl citrate Substances 0.000 claims 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims 1
- 235000013769 triethyl citrate Nutrition 0.000 claims 1
- 231100000397 ulcer Toxicity 0.000 claims 1
Classifications
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- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- 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
- A61K9/14—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
-
- 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
- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- 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
- A61K9/5078—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 with drug-free core
-
- 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
-
- 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)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (11)
1. Dozirni oblik, naznačen time, da je za oralnu primjenu pantoprazol magnezij dihidrata u obliku tablete koja obuhvaća jezgru tablete, međusloj i gastrorezistentnu oblogu, pri čemu
jezgra tablete sadrži pantoprazol magnezij dihidrat, natrijev karbonat, manitol, krospovidon, PVP 90 (povidon) i kalcijev stearat,
međusloj je oblikovan od HPMC, PVP 25, titan dioksida, žutog željeznog oksida i propilen glikola, i
gastrorezistentna obloga je oblikovana od smjese koja obuhvaća kopolimer metakrilne kiseline, natrijev dodecilsulfat, polisorbat i trietil citrat.
2. Dozirni oblik prema zahtjevu 1, naznačen time, da je PVP 90 (povidon) prisutan u količini u rasponu od oko 0,5 do oko 15 masenih %.
3. Dozirni oblik prema zahtjevu 1, naznačen time, da je PVP 90 (povidon) prisutan u količini u rasponu od oko 1 do oko 5 masenih %.
4. Dozirni oblik prema bilo kojem od zahtjeva 1 do 3, naznačen time, da jezgra sadrži od 5mg do 100mg pantoprazol magnezij dihidrata.
5. Dozirni oblik prema zahtjevu 4, naznačen time, da sadrži jednu količinu magnezijeve soli pantoprazola, koja odgovara za 10, 20, 40, 50, 80 ili 100 mg pantoprazola (slobodna kiselina).
6. Dozirni oblik prema zahtjevu 5, naznačen time, da sadrži jednu količinu pantoprazol magnezij dihidrata, koja odgovara za 40 mg pantoprazola (slobodna kiselina).
7. Dozirni oblik prema zahtjevu 5, naznačen time, da sadrži jednu količinu pantoprazol magnezij dihidrata, koja odgovara za 80 mg pantoprazola (slobodna kiselina).
8. Uporaba dozirnog oblika prema bilo kojem od zahtjeva 1 do 7, naznačena time, da je za proizvodnju lijeka za profilaksu ili liječenje kliničkog stanja kod sisavaca, kao što je čovjek, za koje se upućuje inhibitor protonske pumpe.
9. Uporaba prema zahtjevu 8, naznačena time, da je kliničko stanje odabrano iz skupine koju čine: benigni gastrični ulkus, bolest gastrofagealnog refluksa, Zollinger-Ellison-sindrom, duodenalni ulkus, duodenalni ulkus povezan s bakterijom Helicobacter pylori, profilaksa za gastrični ili duodenalni ulkus povezan s NSAID kod pacijenata s povećanim rizikom za gastroduodenalne komplikacije koje zahtijevaju sustavno NSAID liječenje i kombinacijsku terapiju s antibioticima za eradikaciju bakterije Heliobacter pylori.
10. Uporaba dozirnog oblika prema bilo kojem od zahtjeva 1 do 7, naznačena time, da je za proizvodnju lijeka za profilaksu ili liječenje bolesti gastroezofagealnog refluksa (GERD).
11. Uporaba dozirnog oblika prema bilo kojem od zahtjeva 1 do 7, naznačena time, da je za proizvodnju lijeka za profilaksu ili liječenje bolesti gastroezofagealnog refluksa (GERD) I do III (prema Savary/Miller klasifikaciji).
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03010328 | 2003-05-08 | ||
EP04001754 | 2004-01-28 | ||
PCT/EP2004/050729 WO2004098594A2 (en) | 2003-05-08 | 2004-05-07 | Dosage form containing pantoprazole as active ingredient |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20120754T1 true HRP20120754T1 (hr) | 2012-11-30 |
Family
ID=33436112
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20120754TT HRP20120754T1 (hr) | 2003-05-08 | 2012-09-24 | Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak |
HRP20121005TT HRP20121005T1 (hr) | 2003-05-08 | 2012-12-06 | Dozirani oblik koji sadrži pantoprazol kao aktivni sastojak |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20121005TT HRP20121005T1 (hr) | 2003-05-08 | 2012-12-06 | Dozirani oblik koji sadrži pantoprazol kao aktivni sastojak |
Country Status (27)
Country | Link |
---|---|
US (2) | US20060240100A1 (hr) |
EP (2) | EP2316454B9 (hr) |
JP (2) | JP4878284B2 (hr) |
KR (2) | KR101237742B1 (hr) |
AR (1) | AR044264A1 (hr) |
AU (2) | AU2004237363B2 (hr) |
BR (2) | BRPI0410044B8 (hr) |
CA (1) | CA2489140C (hr) |
CL (1) | CL2004000983A1 (hr) |
CY (2) | CY1113128T1 (hr) |
DK (2) | DK2316454T3 (hr) |
EA (2) | EA027734B1 (hr) |
ES (2) | ES2390342T3 (hr) |
HK (1) | HK1090546A1 (hr) |
HR (2) | HRP20120754T1 (hr) |
IL (2) | IL171365A (hr) |
MX (1) | MXPA05000411A (hr) |
NO (1) | NO337921B1 (hr) |
NZ (1) | NZ543181A (hr) |
PE (1) | PE20050199A1 (hr) |
PL (2) | PL2316454T3 (hr) |
PT (2) | PT1624869E (hr) |
RS (1) | RS53443B (hr) |
SI (2) | SI1624869T1 (hr) |
TW (1) | TW200509992A (hr) |
WO (1) | WO2004098594A2 (hr) |
ZA (1) | ZA200508202B (hr) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PE20050150A1 (es) | 2003-05-08 | 2005-03-22 | Altana Pharma Ag | Una forma de dosificacion que contiene (s)-pantoprazol como ingrediente activo |
TWI372066B (en) * | 2003-10-01 | 2012-09-11 | Wyeth Corp | Pantoprazole multiparticulate formulations |
SI1746980T1 (sl) | 2004-05-07 | 2012-03-30 | Nycomed Gmbh | Farmacevtska dozirna oblika ki obsega pelete kot tudi postopek za njeno pripravo |
AR054358A1 (es) * | 2005-05-13 | 2007-06-20 | Combino Pharm Sl | Formulaciones que contienen pantoprazol libre de acido y sus sales |
EP1747776A1 (en) * | 2005-07-29 | 2007-01-31 | KRKA, tovarna zdravil, d.d., Novo mesto | Pharmaceutical composition comprising granular pantoprazole |
TWI519322B (zh) * | 2008-04-15 | 2016-02-01 | 愛戴爾製藥股份有限公司 | 包含弱鹼性藥物及控制釋放劑型之組合物 |
WO2010018593A2 (en) * | 2008-07-03 | 2010-02-18 | Torrent Pharmaceuticals Ltd. | Gastric acid resistant benzimidazole multiple unit tablet composition |
WO2012010944A2 (en) * | 2010-07-22 | 2012-01-26 | Lupin Limited | Multiple unit tablet composition |
KR101787481B1 (ko) | 2010-10-21 | 2017-10-18 | 롯데정밀화학 주식회사 | 장용성 경질 캡슐용 조성물 및 상기 조성물을 사용하여 제조된 장용성 경질 캡슐 |
ITMI20111168A1 (it) * | 2011-06-27 | 2012-12-28 | Professional Dietetics Srl | Composizioni farmaceutiche comprendenti idrossipropilmetilcellulosa e/o acido ialuronico e loro uso |
US20150209432A1 (en) * | 2012-07-26 | 2015-07-30 | Lupin Limited | Pharmaceutical compositions of proton pump inhibitor |
WO2016174664A1 (en) | 2015-04-29 | 2016-11-03 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
WO2018065952A1 (en) * | 2016-10-06 | 2018-04-12 | Jubilant Generics Limited | Delayed release pharmaceutical composition of pantoprazole and process for preparation thereof |
US12102624B2 (en) | 2020-08-26 | 2024-10-01 | Nivagen Pharmaceuticals, Inc. | Pantoprazole compositions and methods |
WO2023214016A1 (en) * | 2022-05-06 | 2023-11-09 | Evonik Operations Gmbh | Dosage form with drug release at ph 3 to 6 using double coating system with at least one release acceleration agent |
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