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1. WO2012063005 - PHARMACEUTICAL COMPOSITION AND DOSAGE FORM COMPRISING DRONEDARONE, AND PREPARATION METHOD THEREOF

Publication Number WO/2012/063005
Publication Date 18.05.2012
International Application No. PCT/FR2011/052622
International Filing Date 10.11.2011
IPC
A61K 9/48 2006.01
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 9/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61K 31/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
A61K 31/343 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
335having oxygen as the only ring hetero atom, e.g. fungichromin
34having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
343condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
CPC
A61K 31/343
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
335having oxygen as the only ring hetero atom, e.g. fungichromin
34having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
343condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
A61K 47/10
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
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
A61K 9/4858
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
4841Filling excipients; Inactive ingredients
4858Organic compounds
A61K 9/4866
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
4841Filling excipients; Inactive ingredients
4866Organic macromolecular compounds
A61P 9/06
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
9Drugs for disorders of the cardiovascular system
06Antiarrhythmics
Y10S 514/96
YSECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
10TECHNICAL SUBJECTS COVERED BY FORMER USPC
STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
514Drug, bio-affecting and body treating compositions
96Significant, tablet formulation, e.g. designated excipient, disintegrant, glydent or lubricant
Applicants
  • Sanofi [FR]/[FR] (AllExceptUS)
  • ABRAMOVICI, Bernard [FR]/[FR] (UsOnly)
  • BEILLES, Stéphane [FR]/[FR] (UsOnly)
  • GAUTIER, Jean-Claude [FR]/[FR] (UsOnly)
  • CHAMBONNET, Sandra [FR]/[FR] (UsOnly)
Inventors
  • ABRAMOVICI, Bernard
  • BEILLES, Stéphane
  • GAUTIER, Jean-Claude
  • CHAMBONNET, Sandra
Agents
  • BOURON, Estelle
Priority Data
105930610.11.2010FR
Publication Language French (FR)
Filing Language French (FR)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITION AND DOSAGE FORM COMPRISING DRONEDARONE, AND PREPARATION METHOD THEREOF
(FR) COMPOSITION PHARMACEUTIQUE ET FORME GALENIQUE A BASE DE DRONEDARONE ET SON PROCEDE DE PREPARATION
Abstract
(EN)
The invention generally relates to a pharmaceutical composition for oral administration, containing, as active principle, a benzofuran derivative having antiarrhythmic activity, in particular dronedarone and the pharmaceutically acceptable salts thereof, and at least one lipid carrier, said pharmaceutical composition being intended to be used in a dosage form of the capsule type, in particular with a hard shell. This pharmaceutical composition and the dosage form comprising such a composition aim to limit the meal effect following oral administration in humans. The lipid carrier allows: the solubilisation of the active principle of the invention; and the shielding thereof from the negative effects of pH in the intestinal tract, thereby allowing same to be spared from the meal effect to a significant extent.
(FR)
La présente invention se rapporte, d'une manière générale, à une composition pharmaceutique pour administration orale contenant comme principe actif un dérivé de benzofurane à activité antiarythmique, en particulier la dronédarone et ses sels pharmaceutiquement acceptables et au moins un excipient lipidique, ladite composition pharmaceutique étant destinée à être utilisée sous forme galénique de type capsule, en particulier à enveloppe dure. Cette composition pharmaceutique et ladite forme galénique comprenant une telle composition visent à limiter l'effet repas après administration orale chez l'homme. L'excipient lipidique permet d'une part de solubiliser le principe actif conforme à l'invention et d'autre part de le préserver des effets négatifs du pH au niveau du tractus intestinal, permettant ainsi de s'exonérer de l'effet repas de façon significative.
Latest bibliographic data on file with the International Bureau