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1. WO2009008005 - PHARMACEUTICAL COMPOSITIONS OF RIFAXIMIN

Publication Number WO/2009/008005
Publication Date 15.01.2009
International Application No. PCT/IN2008/000397
International Filing Date 23.06.2008
IPC
A61K 9/20 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 31/44 2006.01
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
435having six-membered rings with one nitrogen as the only ring hetero atom
44Non-condensed pyridines; Hydrogenated derivatives thereof
CPC
A61K 31/44
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
435having six-membered rings with one nitrogen as the only ring hetero atom
44Non condensed pyridines; Hydrogenated derivatives thereof
A61K 9/1623
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1617Organic compounds, e.g. phospholipids, fats
1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
A61K 9/1652
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1629Organic macromolecular compounds
1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
A61K 9/2086
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
2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
A61K 9/2846
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
28Dragees; Coated pills or tablets ; , e.g. with film or compression coating
2806Coating materials
2833Organic macromolecular compounds
284obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
2846Poly(meth)acrylates
A61K 9/2866
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
28Dragees; Coated pills or tablets ; , e.g. with film or compression coating
2806Coating materials
2833Organic macromolecular compounds
286Polysaccharides, e.g. gums; Cyclodextrin
2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Applicants
  • LUPIN LIMITED [IN]/[IN] (AllExceptUS)
  • JAHAGIRDAR, Harshal, Anil [IN]/[IN] (UsOnly)
  • KULKARNI, Rajesh [IN]/[IN] (UsOnly)
  • KULKARNI, Shirishkumar [IN]/[IN] (UsOnly)
Inventors
  • JAHAGIRDAR, Harshal, Anil
  • KULKARNI, Rajesh
  • KULKARNI, Shirishkumar
Agents
  • MAJUMDAR, Subhatosh
Priority Data
968/KOL/200706.07.2007IN
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITIONS OF RIFAXIMIN
(FR) COMPOSITIONS PHARMACEUTIQUES DE RIFAXIMINE
Abstract
(EN)
A pharmaceutical composition comprising therapeutically effective amount of rifaximin or pharmaceutically acceptable salt or enantiomer or polymorph thereof, pharmaceutically acceptable excipient(s) and release controlling agent(s). Pharmaceutical composition of rifaximin comprising: at least two entities wherein one entity is an immediate release or fast release and the other is controlled release. The pharmaceutical composition in the form of multilayer tablet comprising, at least one layer comprising, therapeutically effective amount of rifaximin or pharmaceutically acceptable salt or enantiomer or polymorph thereof, pharmaceutically acceptable excipient(s); said layer providing controlled release rifaximin; and at least one layer which provides increased residence time of the dosage form in the gastrointestinal tract. The pharmaceutical formulation comprising rifaximin having an in vitro dissolution profile, wherein about 70% of rifaximin is released in about 24 hours. The composition comprising therapeutically effective amount of rifaximin or pharmaceutically acceptable salt(s) or enantiomer(s) or polymorph(s) thereof, one or more release controlling agent(s) and pharmaceutically acceptable excipient(s) causing pathogenic eradication.
(FR)
L'invention concerne une composition pharmaceutique contenant une quantité thérapeutiquement efficace de rifaximine ou un sel ou un énantiomère ou une forme polymorphe pharmaceutiquement acceptable de celle-ci, un ou plusieurs excipients pharmaceutiquement acceptables et un ou plusieurs agents de commande de libération. La composition pharmaceutique de rifaximine contient au moins deux entités, l'une de libération immédiate ou rapide, l'autre de libération contrôlée. La composition pharmaceutique, qui se présente sous forme de comprimé multicouche, comprend au moins une couche contenant une quantité thérapeutiquement efficace de rifaximine, ou un sel ou un énantiomère ou une forme polymorphe pharmaceutiquement acceptable de celle-ci, et un ou plusieurs excipients, ladite couche libérant la rifaximine de manière contrôlée, et au moins une couche facilitant une durée de résidence plus longue de la dose thérapeutique dans le tractus gastro-intestinal. La formulation pharmaceutique comprend de la rifaximine présentant un profil de dissolution in vitro, 70% de la rifaximine environ étant libéré en 24 heures environ. La composition contient une quantité thérapeutiquement efficace de rifaximine ou un ou plusieurs sels, ou un ou plusieurs énantiomères ou une ou plusieurs formes polymorphes pharmaceutiquement acceptables de celle-ci, un ou plusieurs agents de commande de libération et un ou plusieurs excipients pharmaceutiquement acceptables destinés à eradiquer l'agent pathogène.
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