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1. WO2013004462 - A COMPLEX OF AMORPHOUS TOMOXIPROLE AND CYCLODEXTRIN WITH FAST DISSOLUTION RATE AND PROCESS FOR THE PREPARATION THEREOF

Publication Number WO/2013/004462
Publication Date 10.01.2013
International Application No. PCT/EP2012/061261
International Filing Date 14.06.2012
IPC
A61K 47/48 2006.01
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
A61P 29/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
29Non-central analgesic, antipyretic or antiinflammatory agents, e.g antirheumatic agents; Non-steroidal antiinflammatory drugs (NSAIDs)
A61K 31/4184 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
41having five-membered rings with two or more ring hetero atoms, at least one of which is nitrogen, e.g. tetrazole
41641,3-Diazoles
4184condensed with carbocyclic rings, e.g. benzimidazoles
CPC
A61K 47/6951
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
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
69the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
6949inclusion complexes, e.g. clathrates, cavitates or fullerenes
6951using cyclodextrin
A61K 9/0053
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0053Mouth and digestive tract, i.e. intraoral and peroral administration
A61P 19/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
19Drugs for skeletal disorders
02for joint disorders, e.g. arthritis, arthrosis
B82Y 5/00
BPERFORMING OPERATIONS; TRANSPORTING
82NANOTECHNOLOGY
YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
5Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
C07D 215/18
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
DHETEROCYCLIC COMPOUNDS
215Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
02having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
16with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
18Halogen atoms or nitro radicals
C07D 235/02
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
DHETEROCYCLIC COMPOUNDS
235Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
02condensed with carbocyclic rings or ring systems
Applicants
  • FONDAZIONE ISTITUTO INSUBRICO DI RICERCA PER LA VITA [IT]/[IT] (AllExceptUS)
  • FONDAZIONE CARIPLO [IT]/[IT] (AllExceptUS)
  • MILANESE, Alberto [IT]/[IT] (UsOnly)
  • NEBULONI, Marino [IT]/[IT] (UsOnly)
  • CARRANO, Lucia [IT]/[IT] (UsOnly)
Inventors
  • MILANESE, Alberto
  • NEBULONI, Marino
  • CARRANO, Lucia
Agents
  • SGARBI, Renato
Priority Data
MI2011A00123501.07.2011IT
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) A COMPLEX OF AMORPHOUS TOMOXIPROLE AND CYCLODEXTRIN WITH FAST DISSOLUTION RATE AND PROCESS FOR THE PREPARATION THEREOF
(FR) COMPLEXE DE TOMOXIPROLE AMORPHE ET DE CYCLODEXTRINE PRÉSENTANT UNE VITESSE DE DISSOLUTION ÉLEVÉE ET SON PROCÉDÉ DE PRÉPARATION
Abstract
(EN)
A stable complex of tomoxiprole with 2-hydroxypropyl-beta-cyclodextrin with fast dissolution rate and rapid absorption wherein amorphous tomoxiprole forms a complex with 2-hydroxypropyl-beta-cyclodextrin in about equimolecular ratio. The complex shows a remarkably faster dissolution rate and absorption with respect to crystalline tomoxiprole and is particularly suitable for the production of pharmaceutical oral dosage forms, such as tablets and capsules, where rapid onset of therapeutical action is required. A method of manufacture of the complex is also described and claimed.
(FR)
L'invention porte sur un complexe stable de tomoxiprole avec de la 2-hydroxypropyl-bêta-cyclodextrine présentant une vitesse de dissolution élevée et une absorption rapide, le tomoxiprole amorphe formant un complexe avec la 2-hydroxypropyl-bêta-cyclodextrine en un rapport environ équimoléculaire. Le complexe présente une vitesse de dissolution et une absorption remarquablement plus élevées par rapport au tomoxiprole cristallin et il est particulièrement approprié pour la production de formes pharmaceutiques orales, telles que des comprimés et des capsules, quand un début rapide d'action thérapeutique est requis. L'invention porte également sur un procédé de fabrication du complexe.
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