DK3086782T3 - Optimeret farmaceutisk formulering til behandling af inflammatoriske ændringer af øsofagus - Google Patents
Optimeret farmaceutisk formulering til behandling af inflammatoriske ændringer af øsofagus Download PDFInfo
- Publication number
- DK3086782T3 DK3086782T3 DK14814872.9T DK14814872T DK3086782T3 DK 3086782 T3 DK3086782 T3 DK 3086782T3 DK 14814872 T DK14814872 T DK 14814872T DK 3086782 T3 DK3086782 T3 DK 3086782T3
- Authority
- DK
- Denmark
- Prior art keywords
- orodispersible
- tablet
- budesonide
- effervescent
- shower
- Prior art date
Links
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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (12)
1. Orodispersibel brusetablet indeholdende 0,25 mg til 5 mg budesonid, og saltet af mindst en farmakologisk acceptabel syre, som i vandige omgivelser med en yderligere syre kan frigive en gas, og saltet af en yderligere svag syre eller en yderligere svag syre, som sænker pH-værdien i en vandig opløsning, hvor brusetabletten har en masse på 100 mg til 200 mg, kendetegnet ved, at den har sucralose i en mængde på 0,1 til 1,0 vægt-% baseret på den færdige tablet, og at saltet af den farmaceutisk acceptable syre, som i vandige omgivelser med en syre kan frigøre en gas, er NaHCC>3, Na2CC>3, KHCO3, K2CO2, CaCC>3 eller en blanding deraf, og saltet af den yderligere farmaceutisk acceptable svage syre, som sænker pH-værdien i en vandig opløsning, er dinatri-umcitrat, mononatriumcitrat eller en blanding deraf.
2. Orodispersibel brusetablet ifølge krav 1, kendetegnet ved, at den har en diameter på 5 til 10 mm.
3. Orodispersibel brusetablet ifølge krav 1 eller 2, kendetegnet ved, at den har en højde på 1,5 til 3,0 mm.
4. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har en brudstyrke på 10 N til 100 N.
5. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har en sprødhed på maksimalt 5 %.
6. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har povidon K25 i en mængde på 0,5 til 10 vægt-% baseret på den færdige tablet.
7. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har docusat-Na i en mængde på 0,01 til 0,2 vægt-% baseret på den færdige tablet.
8. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har mannitol i en mængde på 2,0 til 10,0 vægt-% baseret på den færdige tablet.
9. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har macrogol 6000 i en mængde på 1,0 til 10,0 vægt-% baseret på den færdige tablet.
10. Orodispersibel brusetablet ifølge et af de foregående krav, kendetegnet ved, at den har magnesiumstearat i en mængde på 0,05 til 0,5 vægt-% baseret på den færdige tablet.
11. Orodispersibel brusetablet ifølge et af de foregående krav til anvendelse ved behandling af inflammatoriske ændringer af spiserøret.
12. Orodispersibel brusetablet ifølge krav 11 til anvendelse ved behandling af inflammatoriske ændringer af spiserøret, hvor den inflammatoriske ændring er en eosinofil øsofagit.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13199278.6A EP2886108B2 (de) | 2013-12-23 | 2013-12-23 | Optimierte pharmazeutische Formulierung zur Behandlung von entzündlichen Veränderungen des Ösophagus |
| PCT/EP2014/078391 WO2015097053A1 (de) | 2013-12-23 | 2014-12-18 | Optimierte pharmazeutische formulierung zur behandlung von entzündlichen veränderungen des ösophagus |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3086782T3 true DK3086782T3 (da) | 2018-11-26 |
Family
ID=49911300
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13199278.6T DK2886108T4 (da) | 2013-12-23 | 2013-12-23 | Optimeret farmaceutisk formulering til behandling af inflammatoriske ændringer af øsofagus |
| DK14814872.9T DK3086782T3 (da) | 2013-12-23 | 2014-12-18 | Optimeret farmaceutisk formulering til behandling af inflammatoriske ændringer af øsofagus |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13199278.6T DK2886108T4 (da) | 2013-12-23 | 2013-12-23 | Optimeret farmaceutisk formulering til behandling af inflammatoriske ændringer af øsofagus |
Country Status (24)
| Country | Link |
|---|---|
| US (4) | US9867780B2 (da) |
| EP (2) | EP2886108B2 (da) |
| JP (3) | JP6522626B2 (da) |
| CN (1) | CN105848648B (da) |
| AU (1) | AU2014372739B2 (da) |
| CA (1) | CA2934009C (da) |
| CY (2) | CY1121168T1 (da) |
| DK (2) | DK2886108T4 (da) |
| EA (1) | EA029166B1 (da) |
| ES (2) | ES2716990T5 (da) |
| FI (1) | FI2886108T4 (da) |
| HK (1) | HK1209362A1 (da) |
| HR (2) | HRP20190677T4 (da) |
| HU (2) | HUE042009T2 (da) |
| IL (1) | IL246172B (da) |
| LT (2) | LT2886108T (da) |
| PL (2) | PL2886108T5 (da) |
| PT (2) | PT2886108T (da) |
| RS (2) | RS58543B2 (da) |
| SI (2) | SI2886108T2 (da) |
| TR (1) | TR201815823T4 (da) |
| UA (1) | UA117162C2 (da) |
| WO (1) | WO2015097053A1 (da) |
| ZA (1) | ZA201604225B (da) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2742525T3 (es) | 2009-10-01 | 2020-02-14 | Adare Pharmaceuticals Us L P | Composiciones de corticosteroides administradas oralmente |
| WO2015034678A2 (en) | 2013-09-06 | 2015-03-12 | Aptalis Pharmatech, Inc. | Corticosteroid containing orally disintegrating tablet compositions for eosinophilic esophagitis |
| SI2886108T2 (sl) * | 2013-12-23 | 2023-02-28 | Dr. Falk Pharma Gmbh | Optimizirana farmacevtska formulacija za zdravljenje vnetnih sprememb požiralnika |
| TWI728172B (zh) | 2016-08-18 | 2021-05-21 | 美商愛戴爾製藥股份有限公司 | 治療嗜伊紅性食道炎之方法 |
| EP4091615A1 (en) | 2021-05-20 | 2022-11-23 | Dr. Falk Pharma Gmbh | Orodispersible effervescent tablet comprising budesonide for use in the treatment of eosinophilic esophagitis |
| CN116869927B (zh) * | 2023-09-06 | 2023-11-10 | 中国医学科学院北京协和医院 | 一种用于治疗嗜酸性食管炎的食道温敏凝胶 |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3937455A1 (de) * | 1989-11-10 | 1991-05-16 | Nordmark Arzneimittel Gmbh | Antacidatabletten |
| DK0481294T4 (da) * | 1990-10-19 | 2001-06-18 | Spirig Ag | Fast, hurtigt-opløseligt lægemiddelpræparat indeholdende N-acetylcystein |
| DE4332394A1 (de) | 1993-09-23 | 1995-03-30 | Falk Pharma Gmbh | Budesonid-Pellets mit kontrolliertem Freigabeprofil und Verfahren zu ihrer Herstellung |
| US5639475A (en) | 1995-02-03 | 1997-06-17 | Eurand America, Incorporated | Effervescent microcapsules |
| US5607697A (en) | 1995-06-07 | 1997-03-04 | Cima Labs, Incorporated | Taste masking microparticles for oral dosage forms |
| US5807577A (en) | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
| US5807578A (en) | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
| US6350470B1 (en) | 1998-04-29 | 2002-02-26 | Cima Labs Inc. | Effervescent drug delivery system for oral administration |
| FR2834893B1 (fr) * | 2002-01-23 | 2004-02-27 | Servier Lab | Composition pharmaceutique orodispersible de perindopril |
| WO2003080023A2 (en) | 2002-03-20 | 2003-10-02 | Elan Pharma International Limited | Fast dissolving dosage forms having reduced friability |
| EP1595533B1 (en) | 2003-01-21 | 2010-01-06 | Nippon Shinyaku Co., Ltd. | Tablet quickly melting in oral cavity |
| SE0401031D0 (sv) | 2004-04-22 | 2004-04-22 | Duocort Ab | A new glucocorticoid replacement therapy |
| US20060013873A1 (en) | 2004-07-16 | 2006-01-19 | Chih-Chiang Yang | Bioadhesive dosage form of steroids |
| US20070020330A1 (en) | 2004-11-24 | 2007-01-25 | Medpointe Healthcare Inc. | Compositions comprising azelastine and methods of use thereof |
| US20070071817A1 (en) | 2005-09-26 | 2007-03-29 | Phyzz, Inc. | Effervescent oral care compositions and method of use |
| US8679545B2 (en) * | 2005-11-12 | 2014-03-25 | The Regents Of The University Of California | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract |
| US8324192B2 (en) | 2005-11-12 | 2012-12-04 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
| CA2642577A1 (en) | 2006-02-15 | 2007-08-23 | Tika Lakemedel Ab | Methods of manufacturing corticosteroid solutions |
| BRPI0817927A2 (pt) | 2007-10-01 | 2015-04-07 | Lesvi Laboratorios Sl | Comprimidos orodispersiveis |
| MX349677B (es) | 2007-11-13 | 2017-08-08 | Meritage Pharma Inc | Composiciones corticosteroides. |
| US20090264392A1 (en) | 2008-04-21 | 2009-10-22 | Meritage Pharma, Inc. | Treating eosinophilic esophagitis |
| PL2151235T3 (pl) * | 2008-07-21 | 2011-05-31 | Dr Falk Pharma Gmbh | Preparat farmaceutyczny do leczenia górnego przewodu pokarmowego |
| US20100034894A1 (en) | 2008-08-08 | 2010-02-11 | Szymczak Christopher E | Use of Sucralose as a Granulating Agent |
| US20110097401A1 (en) * | 2009-06-12 | 2011-04-28 | Meritage Pharma, Inc. | Methods for treating gastrointestinal disorders |
| SI2886108T2 (sl) | 2013-12-23 | 2023-02-28 | Dr. Falk Pharma Gmbh | Optimizirana farmacevtska formulacija za zdravljenje vnetnih sprememb požiralnika |
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2013
- 2013-12-23 SI SI201331391T patent/SI2886108T2/sl unknown
- 2013-12-23 ES ES13199278T patent/ES2716990T5/es active Active
- 2013-12-23 HR HRP20190677TT patent/HRP20190677T4/hr unknown
- 2013-12-23 PT PT13199278T patent/PT2886108T/pt unknown
- 2013-12-23 HU HUE13199278A patent/HUE042009T2/hu unknown
- 2013-12-23 EP EP13199278.6A patent/EP2886108B2/de active Active
- 2013-12-23 RS RS20190347A patent/RS58543B2/sr unknown
- 2013-12-23 DK DK13199278.6T patent/DK2886108T4/da active
- 2013-12-23 PL PL13199278.6T patent/PL2886108T5/pl unknown
- 2013-12-23 FI FIEP13199278.6T patent/FI2886108T4/fi active
- 2013-12-23 LT LTEP13199278.6T patent/LT2886108T/lt unknown
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2014
- 2014-12-18 SI SI201430930T patent/SI3086782T1/sl unknown
- 2014-12-18 RS RS20181398A patent/RS58112B1/sr unknown
- 2014-12-18 CA CA2934009A patent/CA2934009C/en active Active
- 2014-12-18 ES ES14814872.9T patent/ES2694331T3/es active Active
- 2014-12-18 EP EP14814872.9A patent/EP3086782B1/de active Active
- 2014-12-18 US US15/107,735 patent/US9867780B2/en active Active
- 2014-12-18 HU HUE14814872A patent/HUE041911T2/hu unknown
- 2014-12-18 UA UAA201608055A patent/UA117162C2/uk unknown
- 2014-12-18 JP JP2016542264A patent/JP6522626B2/ja active Active
- 2014-12-18 EA EA201600497A patent/EA029166B1/ru not_active IP Right Cessation
- 2014-12-18 PL PL14814872T patent/PL3086782T3/pl unknown
- 2014-12-18 TR TR2018/15823T patent/TR201815823T4/tr unknown
- 2014-12-18 WO PCT/EP2014/078391 patent/WO2015097053A1/de active Application Filing
- 2014-12-18 CN CN201480070548.1A patent/CN105848648B/zh active Active
- 2014-12-18 PT PT14814872T patent/PT3086782T/pt unknown
- 2014-12-18 LT LTEP14814872.9T patent/LT3086782T/lt unknown
- 2014-12-18 AU AU2014372739A patent/AU2014372739B2/en active Active
- 2014-12-18 DK DK14814872.9T patent/DK3086782T3/da active
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2015
- 2015-10-16 HK HK15110188.4A patent/HK1209362A1/xx active IP Right Maintenance
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2016
- 2016-06-13 IL IL246172A patent/IL246172B/en active IP Right Grant
- 2016-06-22 ZA ZA2016/04225A patent/ZA201604225B/en unknown
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2017
- 2017-12-06 US US15/833,428 patent/US10369100B2/en active Active
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2018
- 2018-10-30 HR HRP20181799TT patent/HRP20181799T1/hr unknown
- 2018-11-21 CY CY20181101233T patent/CY1121168T1/el unknown
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2019
- 2019-04-08 CY CY20191100386T patent/CY1121523T1/el unknown
- 2019-04-24 JP JP2019082802A patent/JP6757444B2/ja active Active
- 2019-06-17 US US16/442,756 patent/US10695291B2/en active Active
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2020
- 2020-05-15 US US16/875,573 patent/US11382860B2/en active Active
- 2020-08-28 JP JP2020144070A patent/JP7009575B2/ja active Active
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