EP1962844A2 - Im mund zerfallende lansoprazol-tabletten - Google Patents
Im mund zerfallende lansoprazol-tablettenInfo
- Publication number
- EP1962844A2 EP1962844A2 EP06848925A EP06848925A EP1962844A2 EP 1962844 A2 EP1962844 A2 EP 1962844A2 EP 06848925 A EP06848925 A EP 06848925A EP 06848925 A EP06848925 A EP 06848925A EP 1962844 A2 EP1962844 A2 EP 1962844A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- sub
- tablet
- orally disintegrating
- tablets
- drug
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
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
- A61K9/48—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
- 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
- A61K9/2072—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
- A61K9/20—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
- A61K9/48—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
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
Definitions
- the invention is further directed to a method of preparing orally disintegrating tablets.
- the method comprises obtaining a plurality of inner cores, comprising an excipient and an acid sensitive drug, which is preferably a Benzimidazole derivative, such as Lansoprazole, Pantoprazole, Rabeprazole, Omeprazole, and Esomeprazole, in the core or in a layer over the core, applying an inert first coating layer, substantially free of the acid sensitive drug and alkaline stabilizing agent, over the acid sensitive drug and the inner cores, applying an alkaline stabilizing layer, comprising an alkaline stabilizing agent, over the inert first coating layer, applying an enteric coating layer, which is preferably polymeric, over the alkaline stabilizing layer, thereby forming enteric coated sub-tablets, and then mixing the enteric coated sub-tablets with one or more excipients, forming a tablet mixture, and compressing a portion of the resulting tablet mixture into an orally disintegrating tablet.
- the tablet comprises, by weight of the tablet, about 5% to about
- the inner core and the drug are combined into a single unit, produced, e.g., by extruding a formulated particle, comprising the drug, preferably, an acid sensitive drug, such as Lansoprazole, and excipients, without departing from the teachings of the invention.
- the sub-tablet of the orally disintegrating tablet comprises: an inner core, comprising the acid sensitive drug and excipients, an inert first coating layer, substantially free of both the drug and any alkaline stabilizing agent, an alkaline stabilizing layer, comprising an alkaline stabilizing agent, and an outer coating agent, comprising an enteric coating.
- the tablets exemplified in Table 1 were prepared as follows: An active compound dispersion consisting of Lansoprazole, hypromellose, extra fine talc and purified water was prepared by stirring. First and second sub-coat dispersions were prepared for forming the inert first coating layer and the alkaline stabilizing layer, the first sub-coat dispersion comprising hypromellose, extra fine talc, and purified water, and the second subcoat dispersion comprising hypromellose, magnesium carbonate, and purified water.
- the polymers used for the enteric coating were also tested. As discussed above, Lansoprazole is unstable in an acidic environment.
- the drug is provided with an enteric coating.
- the dosage form is a tablet that comprises coated particles or granules, preferably in the form of spheres, mixed together with excipients.
- the final tablets are preferably formed on a conventional tablet press without damage to the enteric coating layer of the coated particles during compression.
- a flexible and/or malleable enteric coating layer was provided.
- the tablet formulation preferably contains one or more types of polymer, alone or in a combination.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP06848925A EP1962844A2 (de) | 2005-12-20 | 2006-12-20 | Im mund zerfallende lansoprazol-tabletten |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2005/046296 WO2007078271A2 (en) | 2005-12-20 | 2005-12-20 | Lansoprazole orally disintegrating tablets |
EP05257891A EP1813275A1 (de) | 2005-12-20 | 2005-12-20 | In der Mundhöle zerfallende Lansoprazol-Tabletten |
US11/314,656 US20070141151A1 (en) | 2005-12-20 | 2005-12-20 | Lansoprazole orally disintegrating tablets |
EP06848925A EP1962844A2 (de) | 2005-12-20 | 2006-12-20 | Im mund zerfallende lansoprazol-tabletten |
PCT/US2006/048961 WO2007075980A2 (en) | 2005-12-20 | 2006-12-20 | Lansoprazole orally disintegrating tablets |
Publications (1)
Publication Number | Publication Date |
---|---|
EP1962844A2 true EP1962844A2 (de) | 2008-09-03 |
Family
ID=38218650
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP06848925A Withdrawn EP1962844A2 (de) | 2005-12-20 | 2006-12-20 | Im mund zerfallende lansoprazol-tabletten |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP1962844A2 (de) |
JP (1) | JP2009524592A (de) |
CA (1) | CA2633825A1 (de) |
IL (1) | IL191923A0 (de) |
WO (1) | WO2007075980A2 (de) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2044929A1 (de) * | 2007-10-04 | 2009-04-08 | Laboratorios del Dr. Esteve S.A. | Schnell lösliche Tabletten für orale Anwendung |
WO2009113090A2 (en) * | 2008-01-17 | 2009-09-17 | Alkem Laboratories Ltd. | Process for preparing an oral formulation of an acid-sensitive benzimidazole drug |
NZ588407A (en) | 2008-03-11 | 2012-07-27 | Takeda Pharmaceutical | Orally-disintegrating solid preparation |
CN101507718B (zh) * | 2009-03-03 | 2011-05-04 | 张登科 | 雷贝拉唑钠肠溶口崩片及其制备方法 |
FR2949061B1 (fr) * | 2009-08-12 | 2013-04-19 | Debregeas Et Associes Pharma | Microgranules flottants |
WO2011111027A2 (en) * | 2010-03-11 | 2011-09-15 | Dexcel Pharma Technologies Ltd. | Oral dispersible delayed release tablet formulation |
WO2012111024A1 (en) * | 2011-02-18 | 2012-08-23 | Suven Nishtaa Pharma Pvt Ltd | Pharmaceutical compositions of dexlansoprazole |
JP2020055755A (ja) * | 2018-09-28 | 2020-04-09 | 日本ケミファ株式会社 | 腸溶性製剤 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SE9402431D0 (sv) * | 1994-07-08 | 1994-07-08 | Astra Ab | New tablet formulation |
ES2094694B1 (es) * | 1995-02-01 | 1997-12-16 | Esteve Quimica Sa | Nueva formulacion farmaceuticamente estable de un compuesto de bencimidazol y su proceso de obtencion. |
ES2201200T3 (es) * | 1995-09-21 | 2004-03-16 | Pharma Pass Ii Llc | Composicion farmaceutica que contiene un omeprazol labil al acido, y procedimiento para su preparacion. |
SE9600070D0 (sv) * | 1996-01-08 | 1996-01-08 | Astra Ab | New oral pharmaceutical dosage forms |
CA2587022A1 (en) * | 1998-05-18 | 1999-11-25 | Takeda Pharmaceutical Company Limited | Orally disintegrable tablets |
US20050214371A1 (en) * | 2004-03-03 | 2005-09-29 | Simona Di Capua | Stable pharmaceutical composition comprising an acid labile drug |
-
2006
- 2006-12-20 EP EP06848925A patent/EP1962844A2/de not_active Withdrawn
- 2006-12-20 CA CA002633825A patent/CA2633825A1/en not_active Abandoned
- 2006-12-20 WO PCT/US2006/048961 patent/WO2007075980A2/en active Application Filing
- 2006-12-20 JP JP2008547591A patent/JP2009524592A/ja active Pending
-
2008
- 2008-06-03 IL IL191923A patent/IL191923A0/en unknown
Non-Patent Citations (1)
Title |
---|
See references of WO2007075980A3 * |
Also Published As
Publication number | Publication date |
---|---|
JP2009524592A (ja) | 2009-07-02 |
WO2007075980A8 (en) | 2008-07-17 |
IL191923A0 (en) | 2009-08-03 |
WO2007075980A2 (en) | 2007-07-05 |
CA2633825A1 (en) | 2007-07-05 |
WO2007075980A3 (en) | 2008-02-21 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
17P | Request for examination filed |
Effective date: 20080521 |
|
AK | Designated contracting states |
Kind code of ref document: A2 Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR |
|
AX | Request for extension of the european patent |
Extension state: AL BA HR MK RS |
|
17Q | First examination report despatched |
Effective date: 20100906 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
|
18D | Application deemed to be withdrawn |
Effective date: 20110118 |