WO2005046634A3 - Gastric juice-resistant form of administration - Google Patents

Gastric juice-resistant form of administration Download PDF

Info

Publication number
WO2005046634A3
WO2005046634A3 PCT/CH2004/000677 CH2004000677W WO2005046634A3 WO 2005046634 A3 WO2005046634 A3 WO 2005046634A3 CH 2004000677 W CH2004000677 W CH 2004000677W WO 2005046634 A3 WO2005046634 A3 WO 2005046634A3
Authority
WO
WIPO (PCT)
Prior art keywords
core
administration
optionally
pellets
constituted
Prior art date
Application number
PCT/CH2004/000677
Other languages
German (de)
French (fr)
Other versions
WO2005046634A2 (en
WO2005046634A8 (en
Inventor
Waltraud Bueb
Bilge Bilgin-Zetler
Original Assignee
Siegfried Generics Int Ag
Waltraud Bueb
Bilge Bilgin-Zetler
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
Application filed by Siegfried Generics Int Ag, Waltraud Bueb, Bilge Bilgin-Zetler filed Critical Siegfried Generics Int Ag
Publication of WO2005046634A2 publication Critical patent/WO2005046634A2/en
Publication of WO2005046634A3 publication Critical patent/WO2005046634A3/en
Publication of WO2005046634A8 publication Critical patent/WO2005046634A8/en

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
    • A61K9/20—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
    • 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
    • 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
    • A61K9/14—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
    • A61K9/1611—Inorganic compounds
    • 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
    • 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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
    • A61K9/5073—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

Abstract

The invention relates to an entericcoated form of administration in the form of granules, pellets or tablets, for oral administration. The inventive form of administration comprises at least one optionally substituted 2-[(2-pyridyl)methylsulfinyl]benzimidazole compound or a salt of said compound, wherein (A) the granules and the pellets are constituted of a core and a gastric juice-resistant film coating, the core has an inner and an outer phase and optionally an intermediate phase, and (i) the inner phase of the core comprises as the active substance at least one benzimidazole compound and/or a salt thereof, and optionally an organic, alkaline-reacting compound; and selected additives; (ii) the outer phase of the core is constituted of at least one additive selected from the group including fillers, flowing agents, lubricating agents and mold-release agents; (iii) the optionally present intermediate layer consists of at least one polymer polyol and/or a polyalkylene oxide; and (iv) the gastric juice-resistant film coating is constituted of selected enteric compounds. The invention also relates to tablets produced on the basis of the aforementioned granules, pellets, granule cores, pellet cores or the compounds used therefor.
PCT/CH2004/000677 2003-11-14 2004-11-08 Gastric juice-resistant form of administration WO2005046634A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH1956/03 2003-11-14
CH19562003 2003-11-14

Publications (3)

Publication Number Publication Date
WO2005046634A2 WO2005046634A2 (en) 2005-05-26
WO2005046634A3 true WO2005046634A3 (en) 2005-10-13
WO2005046634A8 WO2005046634A8 (en) 2005-12-22

Family

ID=34578648

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH2004/000677 WO2005046634A2 (en) 2003-11-14 2004-11-08 Gastric juice-resistant form of administration

Country Status (1)

Country Link
WO (1) WO2005046634A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200633731A (en) * 2004-12-06 2006-10-01 Freund Corp Film coating composition, and coating and tablet of the composition
WO2007078271A2 (en) * 2005-12-20 2007-07-12 Teva Pharmaceutical Industries Ltd. Lansoprazole orally disintegrating tablets
CN105307624B (en) * 2013-06-18 2019-12-31 株式会社Lg生活健康 Oral composition
CN103705483B (en) * 2013-12-30 2016-02-17 湖北华世通潜龙药业有限公司 A kind of stable, homogeneous, efficient Lansoprazole enteric-coated tablet and preparation method thereof
CA2910865C (en) 2014-07-15 2016-11-29 Isa Odidi Compositions and methods for reducing overdose

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4853230A (en) * 1986-04-30 1989-08-01 Aktiebolaget Hassle Pharmaceutical formulations of acid labile substances for oral use
WO1994002140A1 (en) * 1992-07-17 1994-02-03 Astra Aktiebolag Pharmaceutical composition containing antiulcer agent
WO1996001623A1 (en) * 1994-07-08 1996-01-25 Astra Aktiebolag Multiple unit tableted dosage form i
WO1996024338A1 (en) * 1995-02-09 1996-08-15 Astra Aktiebolag New pharmaceutical formulation and process
WO1999027917A1 (en) * 1997-11-28 1999-06-10 Byk Gulden Lomberg Chemische Fabrik Gmbh Medicament preparation in the form of a tablet or pellet for acid-labile active substances
US5997903A (en) * 1991-06-17 1999-12-07 Byk Gulden Lomberg Chemische Fabrik Gmbh Oral-administration forms of a medicament containing pantoprazol

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4853230A (en) * 1986-04-30 1989-08-01 Aktiebolaget Hassle Pharmaceutical formulations of acid labile substances for oral use
US5997903A (en) * 1991-06-17 1999-12-07 Byk Gulden Lomberg Chemische Fabrik Gmbh Oral-administration forms of a medicament containing pantoprazol
WO1994002140A1 (en) * 1992-07-17 1994-02-03 Astra Aktiebolag Pharmaceutical composition containing antiulcer agent
WO1996001623A1 (en) * 1994-07-08 1996-01-25 Astra Aktiebolag Multiple unit tableted dosage form i
WO1996024338A1 (en) * 1995-02-09 1996-08-15 Astra Aktiebolag New pharmaceutical formulation and process
WO1999027917A1 (en) * 1997-11-28 1999-06-10 Byk Gulden Lomberg Chemische Fabrik Gmbh Medicament preparation in the form of a tablet or pellet for acid-labile active substances

Also Published As

Publication number Publication date
WO2005046634A2 (en) 2005-05-26
WO2005046634A8 (en) 2005-12-22

Similar Documents

Publication Publication Date Title
WO2007149801A3 (en) Enteric coated particles containing an active ingredient
AU780678B2 (en) New use of compounds as antibacterial agents
UA97084C2 (en) Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same, use thereof and capsule containing the pellets
WO2007072495A3 (en) Coated tablets having prolonged gastric retention
DK1086694T3 (en) Solid release oral modified pharmaceutical formulation containing an acid labile benzimidazole compound
HU229153B1 (en) Oral pharmaceutical dosage forms comprising a proton pump inhibitor and an antacid agent or alginate
JP2007501251A5 (en)
DK0752851T3 (en) Process for the preparation of a pharmaceutical composition
GEP20094639B (en) Coated tablet formulation and method
WO2005117895A8 (en) Compositions comprising meloxicam
WO2008048867A3 (en) Bicyclic heteroaromatic compounds
YU46421B (en) PROCEDURE FOR PREPARATION OF PHARMACEUTICAL PREPARATION OF ACID LABEL SUBSTANCES FOR ORAL USE
WO2007082808A3 (en) Thiazoles as 11 beta-hsd1 inhibitors
DE60232189D1 (en) COMPOSITIONS WITH DELAYED RELEASE CONTAINING VENAL FAXINE HYDROCHLORIDE AS ACTIVE AGENT
NO20084915L (en) Nicotine acetylcholine receptor ligand 101
WO2007122478A3 (en) Multiple unit compositions
WO2007130438A3 (en) Solid dosage formulations
WO2007138022A3 (en) Lipoic acid pellets
WO2005046634A3 (en) Gastric juice-resistant form of administration
SG165162A1 (en) Modified release pharmaceutical formulation
WO2003042185A1 (en) Xanthine oxidase inhibitors
BR0207872A (en) Active agent release compound, composition, unit dosage form and method of administration
CA2290824A1 (en) Benzimidazole pharmaceutical composition and process of preparation
CN102225202A (en) Compound preparation containing aspirin and proton pump inhibitor
AR038951A1 (en) POROUS PARTICLES, MANUFACTURE AND USE FOR THE PREPARATION OF A MEDICINAL PRODUCT

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
CFP Corrected version of a pamphlet front page
CR1 Correction of entry in section i

Free format text: IN PCT GAZETTE 21/2005 UNDER (71) REPLACE "BRAUNPAT BRAUN EDER AG [CH/CH]; REUSSSTRASSE 22, CH-4054 BASEL (CH)" BY "SIEGFRIED GENERICS INTERNATIONAL AG/SA/LTD. [CH/CH]; UNTERE BRUEHLSTRASSE 4, CH-4800 ZOFINGEN (CH)"

WR Later publication of a revised version of an international search report
122 Ep: pct application non-entry in european phase