A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/00 (2006.01) A61K 9/10 (2006.01) A61K 9/16 (2006.01) A61K 9/19 (2006.01) A61K 38/21 (2006.01) A61K 38/27 (2006.01) A61K 38/28 (2006.01)
Patent
CA 2653537
The present invention concerns new pharmaceutical formulations based on aqueous colloidal suspensions for sustained release of active ingredient(s) -AI - in particular, protein(s) and peptide(s), as well as the applications, especially therapeutic, of these formulations. This formulation comprises an aqueous colloidal suspension with low viscosity based on micrometric particles of amphiphilic polymer PO that is biodegradable, hydrosoluble and carrying hydrophobic groups (HG) - alpha-tocopherol- and ionizable hydrophilic groups (IG) -Glu -, ionized at least in part, said particles being suitable for spontaneously combining non-covalently with an AI at pH = 7.0 under isotonic conditions; and with a size between 0.5 and 100 µm. This suspension contains multivalent ions (Mg++) with a polarity opposite that of IH groups of the PO, the ratio r fulfilling the formula (A) where n is the valence of said multivalent ions, [MI] is the molar of multivalent ions, [IG] is the molar concentration of ionizable groups IG, is between 0.3 and 10.
La présente invention concerne de nouvelles formulations pharmaceutiques à base de suspensions colloïdales aqueuses pour la libération prolongée de principe(s) actif(s) -PA-, en particulier protéique(s) et peptidique(s), ainsi que les applications, notamment thérapeutiques, de ces formulations. Cette formulation comprend une suspension colloïdale aqueuse, de basse viscosité, à base de particules micrométriques de polymère PO amphiphile, biodégradable, hydrosoluble et porteur de groupements hydrophobes (GH) -alpha-tocophérol- et de groupements hydrophiles ionisables (GI) -Glu-, au moins en partie ionisés, lesdites particules étant aptes à s'associer spontanément de façon non covalente avec un PA, à pH = 7,0, en condition isotonique; et ayant une taille comprise entre 0,5 et 100 µm. Cette suspension contient des ions multivalents (Mg++) de polarité opposée à celle des groupements GI de PO, le rapport r, répondant à la formule (A) où - n est la valence desdits ions multivalents, [IM] est la concentration molaire en ions multivalents, [GI] est la concentration molaire en groupements ionisables GI, étant compris entre 0,3 et 10.
Bonnet-Gonnet Cecile
Chognot David
Constancis Alain
Soula Olivier
Flamel Technologies
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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