DK2265261T3 - Medicinindgivelsessystemer omfattende svagt basiske lægemidler og organiske syrer - Google Patents
Medicinindgivelsessystemer omfattende svagt basiske lægemidler og organiske syrer Download PDFInfo
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- DK2265261T3 DK2265261T3 DK09718989.8T DK09718989T DK2265261T3 DK 2265261 T3 DK2265261 T3 DK 2265261T3 DK 09718989 T DK09718989 T DK 09718989T DK 2265261 T3 DK2265261 T3 DK 2265261T3
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- drug
- pharmaceutically acceptable
- layer
- tpr
- pharmaceutical composition
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- 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
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/14—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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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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
- A61K9/14—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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/14—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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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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
- A61K9/14—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
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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
- A61K9/2072—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
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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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
- A61K9/48—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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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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
- A61K9/48—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
- 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
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
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- 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
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Hospice & Palliative Care (AREA)
- Otolaryngology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (18)
1. Farmaceutisk sammensætning omfattende en flerhed af (TPR)-partikler med reguleret pulserende frigivelse og (RR)-partikler med hurtig frigivelse, hvor: TPR-partiklerne hver omfatter en kerne coatet med et TPR-lag; kernen omfatter et svagt basisk, tungt opløseligt lægemiddel og en farmaceutisk acceptabel organisk syre adskilt fra hinanden ved et (SR)-lag med langvarig frigivelse; RR-partiklerne hver omfatter det svagt basiske, tungt opløselige lægemiddel, granuleret i nærvær af et farmaceutisk acceptabelt polymerisk bindingsmiddel, en farmaceutisk acceptabel organisk syre og mindst et hjælpestof.
2. Farmaceutisk sammensætning ifølge krav 1, hvor kernen omfatter et første inert bead, et organisk syrelag, SR-laget og et lægemiddellag; hvor: det organiske syrelag omfatter den farmaceutisk acceptable organiske syre og et første farmaceutisk acceptabelt polymerisk bindingsmiddel; SR-laget omfatter en første farmaceutisk acceptabel vanduopløselig polymer; og lægemiddellaget omfatter det svagt, basiske, tungt opløselige lægemiddel og et andet farmaceutisk acceptabelt polymerisk bindingsmiddel.
3. Farmaceutisk sammensætning ifølge krav 1, hvor TPR-laget omfatter en farmaceutisk acceptabel vanduopløselig polymer og en enterisk polymer.
4. Farmaceutisk sammensætning ifølge krav 1, hvor RR-partiklerne hver omfatter et granulat, som omfatter det svagt basiske, tungt opløselige lægemiddel, et farmaceutisk acceptabelt polymerisk bindingsmiddel, mindst et hjæl- pestof og mindst et opløsningsmiddel.
5. Farmaceutisk sammensætning ifølge krav 2, hvor RR-partiklerne hver omfatter et granulat omfattende det svagt basiske, tungt opløselige lægemiddel, en farmaceutisk acceptabel organisk syre, et farmaceutisk acceptabelt poly-merisk bindingsmiddel og mindst et hjælpestof.
6. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor det svagt basiske, tungt opløselige lægemiddel omfatter en serotonin-5-HT3-receptorantagonist.
7. Farmaceutisk sammensætning ifølge krav 6, hvor serotonin-5-HT3-receptorantagonisten er udvalgt fra gruppen bestående af ondansetron, tropisetron, granisetron, dolasetron og palonosetron.
8. Farmaceutisk sammensætning ifølge krav 2, hvor den farmaceutisk acceptable vanduopløselige polymer er udvalgt fra gruppen bestående af ethylcel-lulose, celluloseacetat, polyvinylacetat, neutrale copolymerer af ethylacrylat og methylmethacrylat, copolymerer af acryl- og methacrylestere, som indeholder kvaternære ammoniumgrupper og vokser.
9. Farmaceutisk sammensætning ifølge krav 3, hvor den enteriske polymer er udvalgt fra gruppen bestående af celluloseacetat-phthalat, hydroxypropyl-methylcellulose- phthalat, hydroxypropylmethylcellulose-acetatsuccinat, poly-vinylacetat-phthalat, pH-sensitive copolymerer af methacrylsyre og methyl-methacrylat og shellak.
10. Farmaceutisk sammensætning ifølge krav 5, hvor TPR-partiklerne hver omfatter en 25-30 mesh-sukker-bead, sekventielt coatet med det organiske syrelag, et første SR-lag; lægemiddellaget; et eventuelt forseglingslag; og et eventuelt andet SR-lag.
11. Farmaceutisk sammensætning ifølge krav 10, hvor det organiske syrelag omfatter fumarsyre og hydroxypropylcellulose.
12. Farmaceutisk sammensætning ifølge krav 10, hvor det første SR-lag omfatter ethylcellulose og en farmaceutisk acceptabel blødgører,
13. Farmaceutisk sammensætning ifølge krav 10, hvor det første SR-lag omfatter ethylcellulose og en farmaceutisk acceptabel blødgører, og det andet SR-lag ikke er til stede.
14. Farmaceutisk sammensætning ifølge krav 10, hvor det eventuelle forseglingslag er til stede og omfatter hydroxypropylmethylcellulose.
15. Farmaceutisk sammensætning ifølge krav 10, hvor det svagt basiske tungt opløselige lægemiddel i TPR- og RR-bead omfatter ondansetron eller et farmaceutisk acceptabelt salt, solvat og/eller ester deraf.
16. Farmaceutisk sammensætning ifølge krav 10, hvor: TPR-partiklerne hver omfatter: det organiske syrelag omfatter fumarsyre og hydroxypropylcellulose; det første SR-lag omfatter ethylcellulose og en første farmaceutisk acceptabel blødgører; lægemiddellaget omfatter hydroxypropylcellulose og ondansetron eller et farmaceutisk acceptabelt salt, solvat og/eller ester deraf; det eventuelle forseglingslag er til stede og omfatter hydroxypropylmethylcellulose; TPR-laget omfatter ethylcellulose, hydroxypropylmethylcellulose-phthalat og en anden farmaceutisk acceptabel blødgører; RR-partiklerne hver omfatter et granulat omfattende: ondansetron eller et farmaceutisk acceptabelt salt, solvat og/eller ester deraf; fumarsyre; lactose; mikrokrystallinsk cellulose; og crospovidon.
17. Kapsel, som omfatter den farmaceutiske sammensætning ifølge krav 1 eller 16.
18. Farmaceutisk sammensætning ifølge krav 1 til anvendelse i en fremgangsmåde til behandling af emesis, hvilken fremgangsmåde omfatter indgivelse af sammensætningen til en patient med behov herfor.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US3584008P | 2008-03-12 | 2008-03-12 | |
| US12/209,285 US8133506B2 (en) | 2008-03-12 | 2008-09-12 | Drug delivery systems comprising weakly basic drugs and organic acids |
| PCT/US2009/036787 WO2009114606A1 (en) | 2008-03-12 | 2009-03-11 | Drug delivery systems comprising weakly basic drugs and organic acids |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2265261T3 true DK2265261T3 (da) | 2016-10-03 |
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ID=41063296
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09718989.8T DK2265261T3 (da) | 2008-03-12 | 2009-03-11 | Medicinindgivelsessystemer omfattende svagt basiske lægemidler og organiske syrer |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US8133506B2 (da) |
| EP (1) | EP2265261B1 (da) |
| JP (1) | JP5634882B2 (da) |
| KR (1) | KR101660927B1 (da) |
| CN (1) | CN101977593B (da) |
| AR (1) | AR071562A1 (da) |
| AU (1) | AU2009223019C1 (da) |
| BR (1) | BRPI0908942A2 (da) |
| CA (1) | CA2718257C (da) |
| CL (1) | CL2009000598A1 (da) |
| DK (1) | DK2265261T3 (da) |
| ES (1) | ES2590479T3 (da) |
| HU (1) | HUE029680T2 (da) |
| IL (1) | IL208089A0 (da) |
| MX (1) | MX2010010052A (da) |
| NZ (1) | NZ587897A (da) |
| PL (1) | PL2265261T3 (da) |
| PT (1) | PT2265261T (da) |
| RU (1) | RU2504362C2 (da) |
| SA (1) | SA109300166B1 (da) |
| SG (1) | SG10201405929UA (da) |
| TW (1) | TWI440480B (da) |
| WO (1) | WO2009114606A1 (da) |
| ZA (1) | ZA201006557B (da) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070190145A1 (en) * | 2006-01-27 | 2007-08-16 | Eurand, Inc. | Drug delivery systems comprising weakly basic selective serotonin 5-ht3 blocking agent and organic acids |
| KR20140088230A (ko) * | 2006-01-27 | 2014-07-09 | 앱탈리스 파마테크, 인코포레이티드 | 약 염기성 약물과 유기산을 포함하는 약물 전달 시스템 |
| DK2300475T3 (da) | 2008-06-11 | 2014-12-08 | Genentech Inc | Diazacarbazoler og fremgangsmåder til anvendelse |
| CN105581984A (zh) * | 2009-04-09 | 2016-05-18 | 阿尔科米斯制药爱尔兰有限公司 | 药物递送组合物 |
| US20110003005A1 (en) * | 2009-07-06 | 2011-01-06 | Gopi Venkatesh | Methods of Treating PDNV and PONV with Extended Release Ondansetron Compositions |
| CN102048705B (zh) * | 2009-11-10 | 2012-07-18 | 齐鲁制药有限公司 | 盐酸帕洛诺司琼口腔崩解片制剂及其制备方法 |
| SG10201407947WA (en) | 2009-11-30 | 2015-01-29 | Aptalis Pharmatech Inc | Compressible-coated pharmaceutical compositions and tablets and methods of manufacture |
| US20110256218A1 (en) * | 2010-01-04 | 2011-10-20 | Eurand, Inc. | Controlled release compositions comprising meclizine or related piperazine derivatives |
| US20120164233A1 (en) * | 2010-07-30 | 2012-06-28 | Ranbaxy Laboratories Limited | Pulsatile release pharmaceutical formulation of dexlansoprazole |
| MX355644B (es) * | 2010-08-13 | 2018-04-26 | Euro Celtique S A Star | Uso de aglutinantes para fabricar formulaciones estables al almacenamiento. |
| US9011912B2 (en) | 2010-10-07 | 2015-04-21 | Abon Pharmaceuticals, Llc | Extended-release oral dosage forms for poorly soluble amine drugs |
| AU2011336300B2 (en) | 2010-12-02 | 2015-05-21 | Adare Pharmaceuticals, Inc. | Rapidly dispersing granules, orally disintegrating tablets and methods |
| CN103327969A (zh) | 2010-12-23 | 2013-09-25 | 普渡制药公司 | 抗篡改固体口服剂型 |
| RS59365B1 (sr) * | 2012-06-15 | 2019-11-29 | Pharmathen Sa | Farmaceutska kompozicija koja sadrži polimer koji vezuje fosfat |
| EA201500742A1 (ru) * | 2013-02-05 | 2015-12-30 | Пердью Фарма Л.П. | Защищенные от нецелевого использования фармацевтические композиции |
| US10751287B2 (en) | 2013-03-15 | 2020-08-25 | Purdue Pharma L.P. | Tamper resistant pharmaceutical formulations |
| JP6392355B2 (ja) * | 2013-09-13 | 2018-09-19 | アール．ピー．シェーラー テクノロジーズ、エルエルシー | ペレット包含錠剤 |
| CN105797162B (zh) * | 2014-12-31 | 2022-10-25 | 昆明积大制药股份有限公司 | 药用辅料表面改性方法 |
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