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COMPOSITION CONTAINING SILVER METAL NANOPARTICLES AND A HYALURONATE SALT AS INTERMEDIATE IN THE PREPARATION OF TOPICAL PHARMACEUTICAL FORMULATIONS
专利权人:
SAKURA ITALIA S.R.L.
发明人:
ADELIZZI, Giovanna,PALLAVICINI, Piersandro,RICCIARDI, Celestino
申请号:
EPEP2018/066475
公开号:
WO2018/234407A1
申请日:
2018.06.20
申请国别(地区):
WO
年份:
2018
代理人:
摘要:
A process for preparing a composition (A) is disclosed containing an aqueous dispersion of a pharmaceutically acceptable hyaluronic acid salt, having a weight average molecular weight ranging from 1,000,000 and 1,400,000 in an amount of from 0.4 to 2% by weight based on the total composition weight and metal silver particles, having an average size of from 4 to 10 nm in a concentration of from 0.004 to 0.02% comprising the following steps: a) Preparing an aqueous solution of said pharmaceutically acceptable hyaluronic acid salt having the above molecular weight with a concentration comprised in the aforementioned range, b) Adding an aqueous solution of a silver salt, to the aqueous solution and an alkaline metal hydroxide until reaching a pH ranging from 9.8 to 12.5, and an Ag ion concentration of from 0.004 to 0.02% c) Letting react the mixture of step b) at temperature ranging from 20 to 65°C d) Neutralizing the reacted mixture of step c) with an organic acid. This composition A) s used as intermediate for preparing pellets (B), wherein said metal silver nanoparticles are dispersed within said pharmaceutically acceptable hyaluronate salt or film (C) or gel (C) obtained by addition of a filming or gelling polymer to said composition (A) previously neutralized with an organic acid. Topical compositions are also disclosed containing: • The pellets (B) • The film (C) or the gel (C) in combination with suitable excipients and/or diluents, to be used in particular in the treatment of wound and lesions in particular of skin, and vaginal mucosa.Linvention concerne un procédé de préparation dune composition (A) contenant une dispersion aqueuse dun sel dacide hyaluronique pharmaceutiquement acceptable, ayant un poids moléculaire moyen en poids dans la plage de 1 000 000 à 1 400 000 en une quantité de 0,4 à 2 % en poids sur la base du poids total de la composition et des particules dargent métallique, ayant une taille moyenne de 4 à 10 nm à une concentration dans la plage de
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