HRP20170591T1 - Farmaceutski sastav koji obuhvaća pantoprazol u obliku granula - Google Patents
Farmaceutski sastav koji obuhvaća pantoprazol u obliku granula Download PDFInfo
- Publication number
- HRP20170591T1 HRP20170591T1 HRP20170591TT HRP20170591T HRP20170591T1 HR P20170591 T1 HRP20170591 T1 HR P20170591T1 HR P20170591T T HRP20170591T T HR P20170591TT HR P20170591 T HRP20170591 T HR P20170591T HR P20170591 T1 HRP20170591 T1 HR P20170591T1
- Authority
- HR
- Croatia
- Prior art keywords
- composition according
- pantoprazole
- mixture
- sodium
- average particle
- Prior art date
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- 229960005019 pantoprazole Drugs 0.000 title claims 13
- 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 12
- 239000008194 pharmaceutical composition Substances 0.000 title claims 3
- 239000000203 mixture Substances 0.000 claims 30
- 239000002245 particle Substances 0.000 claims 14
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 5
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 5
- 150000001875 compounds Chemical class 0.000 claims 5
- 229960000913 crospovidone Drugs 0.000 claims 5
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 5
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 5
- 239000000600 sorbitol Substances 0.000 claims 5
- 235000010356 sorbitol Nutrition 0.000 claims 5
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 4
- 239000000945 filler Substances 0.000 claims 4
- 239000010410 layer Substances 0.000 claims 4
- 239000000126 substance Substances 0.000 claims 4
- 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 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000004480 active ingredient Substances 0.000 claims 3
- 230000003113 alkalizing effect Effects 0.000 claims 3
- 239000002702 enteric coating Substances 0.000 claims 3
- 238000009505 enteric coating Methods 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- 229940117841 methacrylic acid copolymer Drugs 0.000 claims 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 2
- 150000005846 sugar alcohols Chemical class 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
- 229920001800 Shellac Polymers 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- FGBXDQWECLPOGZ-UHFFFAOYSA-N [Na].O.O.O.O.O.[Na] Chemical compound [Na].O.O.O.O.O.[Na] FGBXDQWECLPOGZ-UHFFFAOYSA-N 0.000 claims 1
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 claims 1
- CEGOLXSVJUTHNZ-UHFFFAOYSA-K aluminium tristearate Chemical compound [Al+3].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CEGOLXSVJUTHNZ-UHFFFAOYSA-K 0.000 claims 1
- 229940063655 aluminum stearate Drugs 0.000 claims 1
- 229920006318 anionic polymer Polymers 0.000 claims 1
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 claims 1
- 239000011230 binding agent Substances 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
- 239000008116 calcium stearate Substances 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 claims 1
- 229960002442 glucosamine Drugs 0.000 claims 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 claims 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 1
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Substances [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 150000002734 metacrylic acid derivatives Chemical class 0.000 claims 1
- 125000005397 methacrylic acid ester group Chemical group 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- IWVKTOUOPHGZRX-UHFFFAOYSA-N methyl 2-methylprop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.COC(=O)C(C)=C IWVKTOUOPHGZRX-UHFFFAOYSA-N 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 claims 1
- 239000012188 paraffin wax Substances 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 229940100467 polyvinyl acetate phthalate Drugs 0.000 claims 1
- 229920002744 polyvinyl acetate phthalate Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 239000011591 potassium Substances 0.000 claims 1
- 229910052700 potassium Inorganic materials 0.000 claims 1
- 235000007686 potassium Nutrition 0.000 claims 1
- 238000000926 separation method Methods 0.000 claims 1
- 229940113147 shellac Drugs 0.000 claims 1
- 239000004208 shellac Substances 0.000 claims 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 claims 1
- 235000013874 shellac Nutrition 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 229940083542 sodium Drugs 0.000 claims 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 1
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 159000000000 sodium salts Chemical class 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- NASFKTWZWDYFER-UHFFFAOYSA-N sodium;hydrate Chemical compound O.[Na] NASFKTWZWDYFER-UHFFFAOYSA-N 0.000 claims 1
- 239000008107 starch Substances 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 235000019698 starch Nutrition 0.000 claims 1
- 229940114926 stearate Drugs 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- 238000009736 wetting Methods 0.000 claims 1
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
- A61K9/14—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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (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 (21)
1. Farmaceutski sastav koji obuhvaća pantoprazol kao djelatni sastojak u obliku tablete i obuhvaća sljedeće:
(a) jezgra koja sadrži djelatni sastojak, tvar za alkalizaciju, punilo i dezintegrator;
(b) prema potrebi sloj za odvajanje, koji je topiv u vodi; i
(c) enterička obloga,
naznačen time, da sloj enteričke obloge ima debljinu od 85 μm do 150 μm, te time, da je pantoprazol prisutan u obliku čestica koje imaju prosječnu veličinu čestice unutar raspona od 60 μm do 250 μm, pri čemu se te čestice sastoje od pantoprazola i mogu se dobiti putem postupka koji obuhvaća korake vlaženja pantoprazola s vodom u brzoreznoj mješalici, prolaženja vlažnog pantoprazola kroz sito koje ima veličinu otvora mreže unutar raspona od 0,8 do 2 mm, te sušenja smjese u sušilici s fluidiziranim slojem, pri čemu se poredak za korake prosijavanja i sušenja, namješta prema potrebi.
2. Farmaceutski sastav prema zahtjevu 1, naznačen time, da čestice pantoprazola imaju prosječnu veličinu čestice unutar raspona od 100 μm do 250 μm.
3. Sastav prema zahtjevu 1 ili 2, naznačen time, da čestice pantoprazola imaju prosječnu veličinu čestice unutar raspona od 125 μm do 230 μm.
4. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da čestice pantoprazola imaju prosječnu veličinu čestice unutar raspona od 140 μm do 200 μm.
5. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da je pantoprazol prisutan u obliku natrijeve soli.
6. Sastav prema zahtjevu 5, naznačen time, da je pantoprazol prisutan u obliku pantoprazol-natrij-seskvihidrata.
7. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da sredstvo za alkalizaciju je alkalijski ili zemnoalkalijski hidroksid, alkalijski ili zemnoalkalijski karbonat, alkalijski ili zemnoalkalijski hidrogenkarbonat, fosfat, glukozamin ili mješavina od dva ili više tih spojeva, poželjno je to natrijev hidroksid, natrijev karbonat, natrijev hidrogenkarbonat, natrijev fosfat ili mješavina od dva ili više tih sastojaka, a najpoželjniji je natrijev karbonat.
8. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da punilo je laktoza ili šećerni alkohol, kao što je manitol, sorbitol, maltitol, eritrol, ili mješavina od dva ili više tih spojeva.
9. Sastav prema zahtjevu 8, naznačen time, da punilo je mješavina od manitola i sorbitola.
10. Sastav prema zahtjevu 9, naznačen time, da mješavina obuhvaća jedan maseni udio manitola i jedan do pet masenih udjela sorbitola, poželjno dva do četiri masena udjela sorbitola i još poželjnije od 2,8 do 3,8 masenih udjela sorbitola.
11. Sastav prema bilo kojem od zahtjeva 8 do 10, naznačen time, da šećerni alkohol ima prosječnu veličinu čestice unutar raspona od 30 μm do 500 μm.
12. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da dezintegrator je krospovidon, natrijev škrobni glikolat, kroskarmeloza-natrij, natrij-karboksimetilni škrob, natrij-karboksimetilna celuloza, kalij-karboksimetilna celuloza, ili mješavina od dva ili više tih spojeva.
13. Sastav prema zahtjevu 12, naznačen time, da dezintegrator je mješavina od krospovidona koji ima prosječnu veličinu čestice unutar raspona od 10 μm do 60 μm i krospovidona koji ima prosječnu veličinu čestice unutar raspona od 80 μm do 200 μm.
14. Sastav prema zahtjevu 13, naznačen time, da dezintegrator je mješavina od jednog masenog udjela krospovidona koji ima prosječnu veličinu čestice od 10 μm do 60 μm i od jednog do pet masenih udjela krospovidona koji ima prosječnu veličinu čestice od 80 μm do 200 μm.
15. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da jezgra dodatno obuhvaća lubrikant odabran od stearinske kiseline, hidrogeniziranog biljnog ulja, parafina ili alkalijskog ili zemnoalkalijskog stearata, aluminijevog stearata, natrijevog stearil-fumarata ili mješavine od dva ili više tih spojeva, poželjno magnezijevog ili kalcijevog stearata.
16. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da jezgra dodatno obuhvaća vezivo odabrano od mikrokristalne celuloze, hidroksipropilmetil-celuloze, polivinil-pirolidona ili mješavine od dva ili više tih spojeva.
17. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da jezgra obuhvaća sljedeće:
djelatni sastojak u omjeru od 15 do 50 masenih %,
tvar za alkalizaciju u omjeru od 2 do 25 masenih %,
punilo u omjeru od 10 do 50 masenih %, i
dezintegrator u omjeru od 10 do 50 masenih %.
18. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da opcijski sloj za odvajanje sadrži tvar koja stvara film i topiva je u vodi, što je poželjno hidroksipropilmetil-celuloza.
19. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da opcijski sloj za odvajanje ima debljinu od 20 μm do 120 μm.
20. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da enterička obloga obuhvaća tvari za formiranje filma, poželjno su to celulozni acetat-ftalat, polivinil-acetat-ftalat, hidroksipropilmetil-celuloza-ftalat, hidroksipropilmetil-celuloza-acetat-sukcinat, kopolimer etilakrilat-metakrilne kiseline, kopolimer metilmetakrilat-metakrilne kiseline, šelak, poželjno kopolimeri metakrilne kiseline i esteri metakrilne kiseline kao što su anionski polimer metakrilne kiseline i metakrilati s -COOH-skupinama.
21. Sastav prema zahtjevu 1, naznačen time, da tableta obuhvaća od 20 do 40 mg pantoprazola u obliku hidrata natrijeve soli ili hidrata seskvihidrata natrijeve soli.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05016555A EP1747776A1 (en) | 2005-07-29 | 2005-07-29 | Pharmaceutical composition comprising granular pantoprazole |
| PCT/EP2006/064824 WO2007014928A1 (en) | 2005-07-29 | 2006-07-29 | Pharmaceutical composition comprising granular pantoprazole |
| EP06764269.4A EP1909761B1 (en) | 2005-07-29 | 2006-07-29 | Pharmaceutical composition comprising granular pantoprazole |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20170591T1 true HRP20170591T1 (hr) | 2017-06-30 |
Family
ID=35149583
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20170591TT HRP20170591T1 (hr) | 2005-07-29 | 2017-04-12 | Farmaceutski sastav koji obuhvaća pantoprazol u obliku granula |
Country Status (9)
| Country | Link |
|---|---|
| EP (2) | EP1747776A1 (hr) |
| EA (1) | EA014187B1 (hr) |
| HR (1) | HRP20170591T1 (hr) |
| NO (1) | NO20081010L (hr) |
| PL (1) | PL1909761T3 (hr) |
| PT (1) | PT1909761T (hr) |
| SI (1) | SI1909761T1 (hr) |
| UA (1) | UA86541C2 (hr) |
| WO (1) | WO2007014928A1 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITFI20070253A1 (it) * | 2007-11-09 | 2009-05-10 | Valpharma Internat S P A | Formulazioni farmaceutiche per la somministrazione di ipp. |
| EP2133072A1 (en) | 2008-06-13 | 2009-12-16 | KRKA, D.D., Novo Mesto | Gastro-resistant pharmaceutical oral compositions comprising duloxetine or its pharmaceutically acceptable derivatives |
| AU2013204533B2 (en) * | 2012-04-17 | 2017-02-02 | Astrazeneca Ab | Crystalline forms |
| KR102419769B1 (ko) | 2016-08-11 | 2022-07-13 | 아다미스 파마슈티칼스 코포레이션 | 약물 조성물 |
| US11564910B2 (en) | 2017-12-08 | 2023-01-31 | Adamis Pharmaceuticals Corporation | Drug compositions |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL75400A (en) | 1984-06-16 | 1988-10-31 | Byk Gulden Lomberg Chem Fab | Dialkoxypyridine methyl(sulfinyl or sulfonyl)benzimidazoles,processes for the preparation thereof and pharmaceutical compositions containing the same |
| GB2189699A (en) | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated acid-labile medicaments |
| YU48263B (sh) * | 1991-06-17 | 1997-09-30 | Byk Gulden Lomberg Chemische Fabrik Gmbh. | Postupak za dobijanje farmaceutskog preparata na bazi pantoprazola |
| DK1037607T3 (da) * | 1997-12-08 | 2004-06-21 | Altana Pharma Ag | Hidtil ukendt suppositoriumsform, der omfatter en syrelabil aktiv forbindelse |
| WO2000040224A1 (en) * | 1999-01-07 | 2000-07-13 | Elan Corporation, Plc | Multiparticulate oral dosage forms |
| CA2430824C (en) * | 2000-12-07 | 2012-05-08 | Altana Pharma Ag | Pharmaceutical preparation in the form of a suspension comprising an acid-labile active ingredient |
| TW200410955A (en) * | 2002-07-29 | 2004-07-01 | Altana Pharma Ag | Novel salt of (S)-PANTOPRAZOLE |
| CL2004000983A1 (es) * | 2003-05-08 | 2005-03-04 | Altana Pharma Ag | Composicion farmaceutica oral en forma de tableta que comprende a pantoprazol magnetico dihidratado, en donde la forma de tableta esta compuesto por un nucleo, una capa intermedia y una capa exterior; y uso de la composicion farmaceutica en ulceras y |
| US20050031700A1 (en) * | 2003-07-18 | 2005-02-10 | Sanatarus, Inc. | Pharmaceutical formulation and method for treating acid-caused gastrointestinal disorders |
| TWI372066B (en) * | 2003-10-01 | 2012-09-11 | Wyeth Corp | Pantoprazole multiparticulate formulations |
| HU227317B1 (en) | 2003-11-25 | 2011-03-28 | Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag | Enteric coated tablet containing pantoprazole |
-
2005
- 2005-07-29 EP EP05016555A patent/EP1747776A1/en not_active Withdrawn
-
2006
- 2006-07-29 UA UAA200802687A patent/UA86541C2/ru unknown
- 2006-07-29 SI SI200632163A patent/SI1909761T1/sl unknown
- 2006-07-29 EA EA200800443A patent/EA014187B1/ru not_active IP Right Cessation
- 2006-07-29 EP EP06764269.4A patent/EP1909761B1/en active Active
- 2006-07-29 WO PCT/EP2006/064824 patent/WO2007014928A1/en active Application Filing
- 2006-07-29 PT PT67642694T patent/PT1909761T/pt unknown
- 2006-07-29 PL PL06764269T patent/PL1909761T3/pl unknown
-
2008
- 2008-02-26 NO NO20081010A patent/NO20081010L/no not_active Application Discontinuation
-
2017
- 2017-04-12 HR HRP20170591TT patent/HRP20170591T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PT1909761T (pt) | 2017-04-13 |
| EP1909761A1 (en) | 2008-04-16 |
| EP1909761B1 (en) | 2017-01-18 |
| EP1747776A1 (en) | 2007-01-31 |
| WO2007014928A1 (en) | 2007-02-08 |
| SI1909761T1 (sl) | 2017-07-31 |
| UA86541C2 (ru) | 2009-04-27 |
| EA200800443A1 (ru) | 2008-06-30 |
| PL1909761T3 (pl) | 2017-08-31 |
| EA014187B1 (ru) | 2010-10-29 |
| NO20081010L (no) | 2008-04-16 |
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