AR044264A1 - Una forma de dosificacion que contiene pantoprazol como ingrediente activo - Google Patents
Una forma de dosificacion que contiene pantoprazol como ingrediente activoInfo
- Publication number
- AR044264A1 AR044264A1 ARP040101558A ARP040101558A AR044264A1 AR 044264 A1 AR044264 A1 AR 044264A1 AR P040101558 A ARP040101558 A AR P040101558A AR P040101558 A ARP040101558 A AR P040101558A AR 044264 A1 AR044264 A1 AR 044264A1
- Authority
- AR
- Argentina
- Prior art keywords
- dosage form
- pantoprazole magnesium
- tablet
- pellet
- form according
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title abstract 8
- 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 1
- 239000004480 active ingredient Substances 0.000 title 1
- RDRUTBCDIVCMMX-UHFFFAOYSA-N magnesium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide Chemical class [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 abstract 5
- 239000010410 layer Substances 0.000 abstract 4
- 208000000718 duodenal ulcer Diseases 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 3
- 239000008188 pellet Substances 0.000 abstract 3
- 238000011282 treatment Methods 0.000 abstract 3
- 208000007107 Stomach Ulcer Diseases 0.000 abstract 2
- 239000011230 binding agent Substances 0.000 abstract 2
- 150000001875 compounds Chemical class 0.000 abstract 2
- 239000000945 filler Substances 0.000 abstract 2
- 210000004051 gastric juice Anatomy 0.000 abstract 2
- 201000005917 gastric ulcer Diseases 0.000 abstract 2
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 abstract 2
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 abstract 2
- 238000011321 prophylaxis Methods 0.000 abstract 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 241000590002 Helicobacter pylori Species 0.000 abstract 1
- 241000124008 Mammalia Species 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 201000008629 Zollinger-Ellison syndrome Diseases 0.000 abstract 1
- 239000003242 anti bacterial agent Substances 0.000 abstract 1
- 229940088710 antibiotic agent Drugs 0.000 abstract 1
- 239000012752 auxiliary agent Substances 0.000 abstract 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 238000002648 combination therapy Methods 0.000 abstract 1
- 230000003111 delayed effect Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 239000012055 enteric layer Substances 0.000 abstract 1
- 230000008029 eradication Effects 0.000 abstract 1
- 230000002496 gastric effect Effects 0.000 abstract 1
- 201000000052 gastrinoma Diseases 0.000 abstract 1
- 208000021302 gastroesophageal reflux disease Diseases 0.000 abstract 1
- 229940037467 helicobacter pylori Drugs 0.000 abstract 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- 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 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 150000002484 inorganic compounds Chemical class 0.000 abstract 1
- 229910010272 inorganic material Inorganic materials 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 230000007935 neutral effect Effects 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 abstract 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 229940126409 proton pump inhibitor Drugs 0.000 abstract 1
- 239000000612 proton pump inhibitor Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000007909 solid dosage form Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 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
-
- 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
- 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)
Abstract
Formas de dosificación para la administración oral de la sal de magnesio de pantoprazol. Reivindicación 1: Una forma de dosificación para la administración oral de la sal de magnesio de pantoprazol, caracterizada porque comprende una cantidad terapéuticamente efectiva de la sal de magnesio de pantoprazol conjuntamente con excipientes farmacéuticamente aceptables. Reivindicación 2: Una forma de dosificación de acuerdo con la reivindicación 1, caracterizada porque es una forma de dosificación sólida en forma de tableta o pella. Reivindicación 3: Una forma de dosificación de acuerdo con la reivindicación 1, caracterizada porque es una forma de dosificación de liberación retardada que comprende una capa entérica soluble en condiciones neutras o alcalinas y al menos una capa intermedia (capa de subrecubrimiento). Reivindicación 5: Una forma de dosificación de acuerdo con la reivindicación 1, caracterizada porque es un medicamento oralmente administrable en la forma de pella o tableta que es resistente a jugo gástrico, y donde cada pella o tableta consiste de un núcleo en el cual el compuesto activo o su sal tolerada fisiológicamente se encuentra mezclado con un ligante, relleno y, opcionalmente, un miembro seleccionado del grupo formado por otro agente auxiliar para la formación de tabletas y un compuesto inorgánico básico tolerado fisiológicamente; una capa intermedia inerte soluble en agua que rodea el núcleo y una capa exterior resistente a jugo gástrico, donde el compuesto activo es pantoprazol magnesio dihidrato, el ligante es polivinilpirrolidona y/o hidroxipropilmetilcelulosa y, opcionalmente, el relleno es manitol. Reivindicación 28: Un método para la profilaxis o el tratamiento de una condición clínica en un mamífero, tal como un humano, para la cual está indicada un inhibidor de bomba protónica, método caracterizado porque comprende la administración de una cantidad terapéuticamente efectiva de pantoprazol magnesio en una forma de dosificación de acuerdo con cualquiera de las reivindicaciones 1 a 27. Reivindicación 29: Un método de tratamiento de acuerdo con la reivindicación 28, caracterizado porque la condición clínica se selecciona del grupo formado por úlcera gástrica benigna, enfermedad de reflujo gastro-esofágico, síndrome de Zollinger-Ellison, úlcera duodenal, úlcera duodenal asociada con Helicobacter pylori, profilaxis de úlcera gástrica o duodenal asociado con NSAID en pacientes con un riesgo aumentado de complicación gastroduodenal que requieran un tratamiento continuo con NSAID y una terapia de combinación con antibióticos en la erradicación de Helicobacter pylori.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03010328 | 2003-05-08 | ||
| EP04001754 | 2004-01-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR044264A1 true AR044264A1 (es) | 2005-09-07 |
Family
ID=33436112
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP040101558A AR044264A1 (es) | 2003-05-08 | 2004-05-07 | Una forma de dosificacion que contiene pantoprazol como ingrediente activo |
Country Status (26)
| Country | Link |
|---|---|
| US (2) | US20060240100A1 (es) |
| EP (2) | EP1624869B1 (es) |
| JP (2) | JP4878284B2 (es) |
| KR (2) | KR20110104124A (es) |
| AR (1) | AR044264A1 (es) |
| AU (2) | AU2004237363B2 (es) |
| BR (2) | BR122016006880B8 (es) |
| CA (1) | CA2489140C (es) |
| CL (1) | CL2004000983A1 (es) |
| CY (2) | CY1113128T1 (es) |
| DK (2) | DK1624869T3 (es) |
| EA (2) | EA016824B1 (es) |
| ES (2) | ES2390342T3 (es) |
| HR (2) | HRP20120754T1 (es) |
| IL (2) | IL171365A (es) |
| MX (1) | MXPA05000411A (es) |
| NO (1) | NO337921B1 (es) |
| NZ (1) | NZ543181A (es) |
| PE (1) | PE20050199A1 (es) |
| PL (2) | PL2316454T3 (es) |
| PT (2) | PT1624869E (es) |
| RS (1) | RS53443B (es) |
| SI (2) | SI2316454T1 (es) |
| TW (1) | TW200509992A (es) |
| WO (1) | WO2004098594A2 (es) |
| ZA (1) | ZA200508202B (es) |
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 |
| PT1746980E (pt) | 2004-05-07 | 2012-01-25 | Nycomed Gmbh | Forma de dosagem farmacêutica compreendendo granulados assim como o seu processo de fabrico |
| 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 |
| US10537562B2 (en) * | 2016-10-06 | 2020-01-21 | Jubilant Generics Limited | Delayed release pharmaceutical composition of pantoprazole and process for formulation thereof |
| US12102624B2 (en) | 2020-08-26 | 2024-10-01 | Nivagen Pharmaceuticals, Inc. | Pantoprazole compositions and methods |
| ES3064012T3 (en) * | 2022-05-06 | 2026-04-22 | 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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|---|---|---|---|---|
| SE7804231L (sv) | 1978-04-14 | 1979-10-15 | Haessle Ab | Magsyrasekretionsmedel |
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| JPS6150978A (ja) | 1984-08-16 | 1986-03-13 | Takeda Chem Ind Ltd | ピリジン誘導体およびその製造法 |
| GB2189698A (en) * | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated omeprazole tablets |
| GB2189699A (en) * | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated acid-labile medicaments |
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| JP4988088B2 (ja) | 1998-08-12 | 2012-08-01 | ニコメッド ゲゼルシャフト ミット ベシュレンクテル ハフツング | ピリジン−２−イルメチルスルフィニル−１ｈ−ベンズイミダゾール、もしくはピリジン−２−イルメチルスルフィニル−１ｈ−ベンズイミダゾールの骨格を有する化合物、またはその薬学的に許容される塩の経口投与形組成物を固定的に組み合わせた組成物 |
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| MY137726A (en) * | 2000-11-22 | 2009-03-31 | Nycomed Gmbh | Freeze-dried pantoprazole preparation and pantoprazole injection |
| KR20030072555A (ko) | 2000-12-07 | 2003-09-15 | 알타나 파마 아게 | 산 불안정성 활성 성분을 포함하는 신속 붕해 정제 |
| KR20030059318A (ko) * | 2000-12-07 | 2003-07-07 | 알타나 파마 아게 | 산 불안정성 활성 성분을 포함하는 현탁액 형태의 약학 제제 |
| MY140561A (en) * | 2002-02-20 | 2009-12-31 | Nycomed Gmbh | Dosage form containing pde 4 inhibitor as active ingredient |
| 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 |
| PT1746980E (pt) | 2004-05-07 | 2012-01-25 | Nycomed Gmbh | Forma de dosagem farmacêutica compreendendo granulados assim como o seu processo de fabrico |
| JP4563077B2 (ja) * | 2004-05-28 | 2010-10-13 | 株式会社ロッテ | キャンディ及びその製造方法 |
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2004
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- 2004-05-07 KR KR1020117019680A patent/KR20110104124A/ko not_active Ceased
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2005
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