EP1962844A2 - Comprime oral desintegrable de lansoprazole - Google Patents

Comprime oral desintegrable de lansoprazole

Info

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Withdrawn
Application number
EP06848925A
Other languages
German (de)
English (en)
Inventor
David Isaac Silver
Limor Ari-Pardo
Sivan Antler
Nava Shterman
Simona Di Capua
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US11/314,656 external-priority patent/US20070141151A1/en
Priority claimed from EP05257891A external-priority patent/EP1813275A1/fr
Priority claimed from PCT/US2005/046296 external-priority patent/WO2007078271A2/fr
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Priority to EP06848925A priority Critical patent/EP1962844A2/fr
Publication of EP1962844A2 publication Critical patent/EP1962844A2/fr
Withdrawn legal-status Critical Current

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)

Abstract

La présente invention concerne des comprimés qui se dissolvent facilement dans la bouche pour libérer le médicament contenu dans les comprimés entériques intérieurs enrobés.
EP06848925A 2005-12-20 2006-12-20 Comprime oral desintegrable de lansoprazole Withdrawn EP1962844A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06848925A EP1962844A2 (fr) 2005-12-20 2006-12-20 Comprime oral desintegrable de lansoprazole

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US11/314,656 US20070141151A1 (en) 2005-12-20 2005-12-20 Lansoprazole orally disintegrating tablets
EP05257891A EP1813275A1 (fr) 2005-12-20 2005-12-20 Comprime oral desintegrable de lansoprazole
PCT/US2005/046296 WO2007078271A2 (fr) 2005-12-20 2005-12-20 Comprimes a desintegration orale de lansoprazole
PCT/US2006/048961 WO2007075980A2 (fr) 2005-12-20 2006-12-20 Comprimes de lansoprazole se desintegrant oralement
EP06848925A EP1962844A2 (fr) 2005-12-20 2006-12-20 Comprime oral desintegrable de lansoprazole

Publications (1)

Publication Number Publication Date
EP1962844A2 true EP1962844A2 (fr) 2008-09-03

Family

ID=38218650

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06848925A Withdrawn EP1962844A2 (fr) 2005-12-20 2006-12-20 Comprime oral desintegrable de lansoprazole

Country Status (5)

Country Link
EP (1) EP1962844A2 (fr)
JP (1) JP2009524592A (fr)
CA (1) CA2633825A1 (fr)
IL (1) IL191923A0 (fr)
WO (1) WO2007075980A2 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2044929A1 (fr) * 2007-10-04 2009-04-08 Laboratorios del Dr. Esteve S.A. Comprimés oraux à désintégration rapide
WO2009113090A2 (fr) * 2008-01-17 2009-09-17 Alkem Laboratories Ltd. Procédé de préparation d’une formule orale d’un médicament à base de benzimidazole sensible à l’acide
UY31698A (es) 2008-03-11 2009-11-10 Takeda Pharmaceutical Preparacion solida de desintegracion oral
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 (fr) * 2010-03-11 2011-09-15 Dexcel Pharma Technologies Ltd. Formulation de comprimé oral dispersible à libération retardée
WO2012111024A1 (fr) * 2011-02-18 2012-08-23 Suven Nishtaa Pharma Pvt Ltd Compositions pharmaceutiques de 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)

* Cited by examiner, † Cited by third party
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.
PL186605B1 (pl) * 1995-09-21 2004-01-30 Pharma Pass Llc Tabletka lub mikrotabletka zawierająca rdzeń posiadający jako kwasolabilny składnik aktywny omeprazol oraz sposób wytwarzania tabletek lub mikrotabletek zawierających rdzeń posiadający jako kwasolabilny składnik aktywny omeprazol
SE9600070D0 (sv) * 1996-01-08 1996-01-08 Astra Ab New oral pharmaceutical dosage forms
ES2559766T3 (es) * 1998-05-18 2016-02-15 Takeda Pharmaceutical Company Limited Comprimidos disgregables en la boca
WO2005092297A2 (fr) * 2004-03-03 2005-10-06 Teva Pharmaceutical Industries Ltd. Composition pharmaceutique stable comprenant un medicament labile en milieu acide

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2007075980A3 *

Also Published As

Publication number Publication date
JP2009524592A (ja) 2009-07-02
WO2007075980A2 (fr) 2007-07-05
IL191923A0 (en) 2009-08-03
WO2007075980A3 (fr) 2008-02-21
CA2633825A1 (fr) 2007-07-05
WO2007075980A8 (fr) 2008-07-17

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