EP2331084A4 - Pharmaceutical compositions comprising amorphous esomeprazole, dosage forms and process thereof - Google Patents

Pharmaceutical compositions comprising amorphous esomeprazole, dosage forms and process thereof

Info

Publication number
EP2331084A4
EP2331084A4 EP09818889.9A EP09818889A EP2331084A4 EP 2331084 A4 EP2331084 A4 EP 2331084A4 EP 09818889 A EP09818889 A EP 09818889A EP 2331084 A4 EP2331084 A4 EP 2331084A4
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical compositions
dosage forms
amorphous esomeprazole
esomeprazole
amorphous
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Withdrawn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
EP09818889.9A
Other languages
German (de)
French (fr)
Other versions
EP2331084A1 (en
Inventor
Gopal Rajan
Pratik Kumar
Gour Mukherji
Pulak Kumar Metia
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.)
Jubilant Pharmova Ltd
Original Assignee
Jubilant Life Sciences 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
Application filed by Jubilant Life Sciences Ltd filed Critical Jubilant Life Sciences Ltd
Publication of EP2331084A1 publication Critical patent/EP2331084A1/en
Publication of EP2331084A4 publication Critical patent/EP2331084A4/en
Withdrawn legal-status Critical Current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
    • A61K9/2077—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
    • A61K9/48—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
    • A61K9/501—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
    • A61K9/48—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
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/5005—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
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
EP09818889.9A 2008-10-06 2009-10-06 Pharmaceutical compositions comprising amorphous esomeprazole, dosage forms and process thereof Withdrawn EP2331084A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2315DE2008 2008-10-06
PCT/IN2009/000553 WO2010041276A1 (en) 2008-10-06 2009-10-06 Pharmaceutical compositions comprising amorphous esomeprazole, dosage forms and process thereof

Publications (2)

Publication Number Publication Date
EP2331084A1 EP2331084A1 (en) 2011-06-15
EP2331084A4 true EP2331084A4 (en) 2014-01-22

Family

ID=42100256

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09818889.9A Withdrawn EP2331084A4 (en) 2008-10-06 2009-10-06 Pharmaceutical compositions comprising amorphous esomeprazole, dosage forms and process thereof

Country Status (2)

Country Link
EP (1) EP2331084A4 (en)
WO (1) WO2010041276A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011140446A2 (en) * 2010-05-06 2011-11-10 Dr. Reddy's Laboratories Ltd. Pharmaceutical formulations
WO2011154009A1 (en) * 2010-06-10 2011-12-15 Lifecycle Pharma A/S Composition comprising an active principle in an amorphous form and a porous adsorbent material
IT1401284B1 (en) * 2010-08-06 2013-07-18 Valpharma S P A NEW PHARMACEUTICAL FORMULATIONS SUITABLE FOR ORAL ADMINISTRATION OF DIHYDRATE ESOMEPRAZOLE MAGNESIUM, IN THE FORM OF MUPS TABLETS (MULTI UNIT PELLETS SYSTEM).
EP2604256B1 (en) * 2011-12-14 2016-04-13 Hexal AG Multi layer coatings
CN103462924A (en) * 2012-06-06 2013-12-25 南京亿华药业有限公司 Prescription and preparation method of esomeprazole sustained release tablet
CN103520226B (en) * 2013-10-11 2015-09-02 惠州市九惠制药股份有限公司 A kind of pH dependent form conlon targeting hard capsule
EP3292862A1 (en) * 2016-09-07 2018-03-14 Sandoz Ag Omeprazole formulations

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1801110A1 (en) * 2005-12-22 2007-06-27 KRKA, tovarna zdravil, d.d., Novo mesto Esomeprazole arginine salt

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050214371A1 (en) * 2004-03-03 2005-09-29 Simona Di Capua Stable pharmaceutical composition comprising an acid labile drug
AR057181A1 (en) * 2005-11-30 2007-11-21 Astra Ab NEW COMBINATION DOSAGE FORM
EP1813275A1 (en) * 2005-12-20 2007-08-01 Teva Pharmaceutical Industries Ltd Lansoprazole orally disintegrating tablets
TR201816133T4 (en) * 2006-04-04 2018-11-21 Kg Acquisition Llc ORAL DOSAGE FORMS WITH AN ANTIPLATELET AGENT AND AN ACID INHIBITOR.
WO2008018825A1 (en) * 2006-08-10 2008-02-14 Astrazeneca Ab Oral polyvinyl alcohol capsules comprising proton pump inhibitors

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1801110A1 (en) * 2005-12-22 2007-06-27 KRKA, tovarna zdravil, d.d., Novo mesto Esomeprazole arginine salt

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2010041276A1 *

Also Published As

Publication number Publication date
EP2331084A1 (en) 2011-06-15
WO2010041276A1 (en) 2010-04-15

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