MD1472G2 - Microgranule de omeprazol gastro-rezistente şi procedeu de obţinere a lor - Google Patents
Microgranule de omeprazol gastro-rezistente şi procedeu de obţinere a lor Download PDFInfo
- Publication number
- MD1472G2 MD1472G2 MD96-0332A MD960332A MD1472G2 MD 1472 G2 MD1472 G2 MD 1472G2 MD 960332 A MD960332 A MD 960332A MD 1472 G2 MD1472 G2 MD 1472G2
- Authority
- MD
- Moldova
- Prior art keywords
- omeprazol
- mannitol
- gastro
- microgranules
- active layer
- Prior art date
Links
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 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 abstract 4
- 229930195725 Mannitol Natural products 0.000 abstract 4
- 239000000594 mannitol Substances 0.000 abstract 4
- 235000010355 mannitol Nutrition 0.000 abstract 4
- 230000007935 neutral effect Effects 0.000 abstract 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 2
- 239000011230 binding agent Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 229920002472 Starch Polymers 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 239000003814 drug Substances 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
- 235000019698 starch Nutrition 0.000 abstract 1
- 239000008107 starch Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- 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
- A61K31/415—1,2-Diazoles
-
- 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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
- A61K9/48—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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
- Plural Heterocyclic Compounds (AREA)
- Epoxy Resins (AREA)
- Sampling And Sample Adjustment (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
Abstract
Invenţia se referă la medicină şi anume la farmacologie.Esenţa invenţiei constă în aceea că microgranulele de omeprazol conţin miez neutru, constituit din zahăr şi amidon, strat activ de omeprazol combinat cu manitol şi înveliş polimeric gastro-rezistent, totodată raportul omeprazolului şi manitolului în stratul activ constituie 1:1.Procedeul solicitat de obţinere a microgranulelor de omeprazol include amestecarea omeprazolului şi manitolului în prezenţa unui liant coloidal polimeric, aplicarea amestecului obţinut pe miezurile neutre şi aplicarea ulterioară a stratului de polimer gastro-rezistent, după care fulgii obţinuţi se extrag, se usucă şi se calibrează. Aplicarea omeprazolului şi manitolului pe miezul neutru se realizează în stare uscată cu ajutorul unei soluţii liante polimerice de tipul hidroxipropilmetilcelulozei cu o viscozitate înaltă în amestecul din 80% mas. etanol şi 20% mas. apă.Rezultatul este ameliorarea stabilităţii stratului activ.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9207249A FR2692146B1 (fr) | 1992-06-16 | 1992-06-16 | Compositions stables de microgranules d'omeprazole gastro-protégés et leur procédé d'obtention. |
| PCT/FR1993/000582 WO1993025204A1 (fr) | 1992-06-16 | 1993-06-16 | Compositions stables de microgranules d'omeprazole gastro-proteges et leur procede d'obtention |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| MD960332A MD960332A (ro) | 1998-03-31 |
| MD1472F2 MD1472F2 (ro) | 2000-05-31 |
| MD1472G2 true MD1472G2 (ro) | 2001-01-31 |
Family
ID=9430771
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MD96-0332A MD1472G2 (ro) | 1992-06-16 | 1993-06-16 | Microgranule de omeprazol gastro-rezistente şi procedeu de obţinere a lor |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US5385739A (ro) |
| EP (1) | EP0646006B1 (ro) |
| JP (1) | JP3568950B2 (ro) |
| KR (1) | KR100193966B1 (ro) |
| CN (1) | CN1051225C (ro) |
| AT (1) | ATE149835T1 (ro) |
| AU (1) | AU669719B2 (ro) |
| CA (1) | CA2138149C (ro) |
| CZ (1) | CZ287260B6 (ro) |
| DE (1) | DE69308849T2 (ro) |
| DK (1) | DK0646006T3 (ro) |
| ES (1) | ES2052458B1 (ro) |
| FI (1) | FI111220B (ro) |
| FR (1) | FR2692146B1 (ro) |
| GE (1) | GEP20002015B (ro) |
| GR (2) | GR1001535B (ro) |
| MD (1) | MD1472G2 (ro) |
| MX (1) | MX9303612A (ro) |
| NZ (1) | NZ253179A (ro) |
| PL (1) | PL172706B1 (ro) |
| RU (1) | RU2103995C1 (ro) |
| SK (1) | SK280198B6 (ro) |
| TJ (1) | TJ230B (ro) |
| WO (1) | WO1993025204A1 (ro) |
| ZA (1) | ZA934266B (ro) |
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|---|---|---|---|---|
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| DE69502709T2 (de) * | 1994-10-18 | 1998-12-24 | Philips Electronics N.V., Eindhoven | Verfahren und herstellung einer dünnen silizium-oxid-schicht |
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| US6379651B1 (en) | 1995-02-07 | 2002-04-30 | Josman Laboratories | Oral-topical dosage forms for delivering antibacterials/antibiotics to oral cavity to eradicate H. pylori as a concomitant treatment for peptic ulcers and other gastro-intestinal diseases |
| US6372784B1 (en) | 1995-02-07 | 2002-04-16 | Josman Laboratories, Inc. | Bismuth-containing compounds in topical dosage forms for treatment of corneal and dermal wounds |
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| US5547844A (en) * | 1995-02-23 | 1996-08-20 | The Regents Of The University Of California | Helicobacter pylori bacterial derived factor |
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| US6645988B2 (en) | 1996-01-04 | 2003-11-11 | Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
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| SI9700186B (sl) | 1997-07-14 | 2006-10-31 | Lek, Tovarna Farmacevtskih In Kemicnih Izdelkov, D.D. | Nova farmacevtska oblika z nadzorovanim sproscanjem zdravilnih ucinkovin |
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| US6174548B1 (en) * | 1998-08-28 | 2001-01-16 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
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| WO2013122553A1 (en) * | 2012-02-14 | 2013-08-22 | Mahmut Bilgic | A pharmaceutical formulation comprising an atp-ase inhibitor and method for this formulation |
| KR101340733B1 (ko) * | 2012-12-31 | 2013-12-12 | (주) 에프엔지리서치 | 신규한 마이크로그래뉼 제형 |
| US20170042806A1 (en) * | 2015-04-29 | 2017-02-16 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| EP3292862A1 (en) | 2016-09-07 | 2018-03-14 | Sandoz Ag | Omeprazole formulations |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE7804231L (sv) * | 1978-04-14 | 1979-10-15 | Haessle Ab | Magsyrasekretionsmedel |
| EP0247983A2 (en) * | 1986-04-30 | 1987-12-02 | Aktiebolaget Hässle | New pharmaceutical preparation for oral use |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE457326B (sv) * | 1986-02-14 | 1988-12-19 | Lejus Medical Ab | Foerfarande foer framstaellning av en snabbt soenderfallande kaerna innehaallande bl a mikrokristallin cellulosa |
| IT1215726B (it) * | 1988-01-18 | 1990-02-22 | Alfa Wassermann Spa | Formulazioni galeniche a cessione programmata. |
| US5188836A (en) * | 1990-07-27 | 1993-02-23 | Warner-Lambert Company | Sustained release formulations |
| ES2024993A6 (es) * | 1990-12-31 | 1992-03-01 | Genesis Para La Investigacion | Procedimiento de obtencion de un preparado farmaceutico oral conteniendo omeprazol. |
-
1992
- 1992-06-16 FR FR9207249A patent/FR2692146B1/fr not_active Expired - Lifetime
- 1992-07-16 KR KR1019920012770A patent/KR100193966B1/ko not_active Expired - Lifetime
- 1992-10-08 GR GR920100433A patent/GR1001535B/el not_active IP Right Cessation
-
1993
- 1993-06-15 ES ES09301319A patent/ES2052458B1/es not_active Expired - Fee Related
- 1993-06-16 TJ TJ96000409A patent/TJ230B/xx unknown
- 1993-06-16 PL PL93306773A patent/PL172706B1/pl not_active IP Right Cessation
- 1993-06-16 WO PCT/FR1993/000582 patent/WO1993025204A1/fr not_active Ceased
- 1993-06-16 CZ CZ19943165A patent/CZ287260B6/cs not_active IP Right Cessation
- 1993-06-16 EP EP93913137A patent/EP0646006B1/fr not_active Expired - Lifetime
- 1993-06-16 DK DK93913137.1T patent/DK0646006T3/da active
- 1993-06-16 RU RU94046268A patent/RU2103995C1/ru not_active IP Right Cessation
- 1993-06-16 AT AT93913137T patent/ATE149835T1/de active
- 1993-06-16 ZA ZA934266A patent/ZA934266B/xx unknown
- 1993-06-16 GE GEAP19932604A patent/GEP20002015B/en unknown
- 1993-06-16 AU AU43321/93A patent/AU669719B2/en not_active Ceased
- 1993-06-16 US US08/078,548 patent/US5385739A/en not_active Expired - Lifetime
- 1993-06-16 JP JP50119994A patent/JP3568950B2/ja not_active Expired - Fee Related
- 1993-06-16 MD MD96-0332A patent/MD1472G2/ro not_active IP Right Cessation
- 1993-06-16 MX MX9303612A patent/MX9303612A/es not_active IP Right Cessation
- 1993-06-16 NZ NZ253179A patent/NZ253179A/xx not_active IP Right Cessation
- 1993-06-16 DE DE69308849T patent/DE69308849T2/de not_active Expired - Lifetime
- 1993-06-16 CA CA002138149A patent/CA2138149C/fr not_active Expired - Lifetime
- 1993-06-16 SK SK1551-94A patent/SK280198B6/sk not_active IP Right Cessation
- 1993-06-16 CN CN93108926A patent/CN1051225C/zh not_active Expired - Fee Related
-
1994
- 1994-12-15 FI FI945904A patent/FI111220B/fi not_active IP Right Cessation
-
1997
- 1997-05-09 GR GR970401044T patent/GR3023391T3/el unknown
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE7804231L (sv) * | 1978-04-14 | 1979-10-15 | Haessle Ab | Magsyrasekretionsmedel |
| EP0247983A2 (en) * | 1986-04-30 | 1987-12-02 | Aktiebolaget Hässle | New pharmaceutical preparation for oral use |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PD99 | Pending application | ||
| KA4A | Patent for invention lapsed due to non-payment of fees (with right of restoration) |