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1. WO2011119477 - PHARMACEUTICAL COMPOSITIONS OF CARVEDILOL SALTS AND PROCESS FOR PREPARATION THEREOF

Publication Number WO/2011/119477
Publication Date 29.09.2011
International Application No. PCT/US2011/029178
International Filing Date 21.03.2011
IPC
A61K 9/48 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
A61K 47/48 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
48the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
A61K 47/30 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
A61K 31/403 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403condensed with carbocyclic rings, e.g. carbazole
CPC
A61K 31/403
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403condensed with carbocyclic rings, e.g. carbazole
A61K 9/2081
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2072characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
2081with microcapsules or coated microparticles according to A61K9/50
A61K 9/4808
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
4808characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
A61K 9/5047
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules ; 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
5005Wall or coating material
5021Organic macromolecular compounds
5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
A61K 9/5078
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules ; 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
5073having two or more different coatings optionally including drug-containing subcoatings
5078with drug-free core
A61K 9/5084
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules ; 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
5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
Applicants
  • AMNEAL PHARMACEUTICALS, LLC [US]/[US] (AllExceptUS)
  • DESAI, Jatin [US]/[US] (UsOnly)
  • GAJJAR, Vipul Rasikbhai [IN]/[IN] (UsOnly)
  • MISTRY, Gaurav Navinbhai [IN]/[IN] (UsOnly)
  • PUROHIT, Parva Yogeshchandra [IN]/[IN] (UsOnly)
Inventors
  • DESAI, Jatin
  • GAJJAR, Vipul Rasikbhai
  • MISTRY, Gaurav Navinbhai
  • PUROHIT, Parva Yogeshchandra
Agents
  • WHITNEY, Karen M.
Priority Data
0293/KOL/2010 22.03.2010IN
13/051,21218.03.2011US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITIONS OF CARVEDILOL SALTS AND PROCESS FOR PREPARATION THEREOF
(FR) COMPOSITIONS PHARMACEUTIQUES À BASE DE SELS DE CARVÉDILOL ET LEUR PROCÉDÉ DE PRÉPARATION
Abstract
(EN) The present invention relates provides pharmaceutical compositions comprising an amorphous carvedilol salt and one or more pharmaceutically acceptable excipients, wherein the amorphous carvedilol salt is formed in situ during the preparation of the pharmaceutical composition. The amorphous carvedilol salt is preferably an amorphous carvedilol phosphate salt. The pharmaceutical compositions can be prepared by providing one or more inert cores; contacting the core or cores with a solution or a dispersion comprising carvedilol, an acid component and optionally a binder, in a solvent; removing the solvent; and optionally coating the core or cores with an extended release composition. Preferred pharmaceutical compositions contain both immediate-release pellets and at least one population of extended-release pellet.
(FR) Cette invention concerne des compositions pharmaceutiques comprenant un sel de carvédilol amorphe et un ou plusieurs excipients pharmaceutiquement acceptables, le sel de carvédilol amorphe étant formé in situ lors de la préparation de la composition pharmaceutique. Le sel de carvédilol amorphe est, de préférence, un sel de phosphate de carvédilol amorphe. Les compositions pharmaceutiques peuvent être obtenues par préparation d'un ou de plusieurs cœurs inertes ; mise en contact du ou des cœurs avec une solution ou une dispersion comprenant le carvédilol, un composant acide et éventuellement, un liant, dans un solvant ; élimination du solvant ; et éventuellement, enrobage du ou des cœurs avec une composition à libération prolongée. Les compositions préférées contiennent à la fois des pastilles à libération immédiate et au moins une population de pastilles à libération prolongée.
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