VRBINC MIHA,VRBINC MIHA,PUNCUH KOLAR ALESA,PUN&CcaronUH KOLAR ALE&ScaronA,VRECER FRANC,VRE&CcaronER FRANC,KOTAR JORDAN BERTA,KOTAR JORDAN BERTA,STANGELJ VERONIKA,&ScaronTANGELJ VERONIKA
申请号：
PL37211603
公开号：
PL212584B1
申请日:
2003.06.18
申请国别(地区):
PL
年份:
2012
代理人:
摘要：
The present invention relates to stabilised pharmaceutical composition amorphous form of 1-benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methyl-piperidine (donepezil) hydrochloride and a process for its stabilization. Pharmaceutical composition is prepared by in situ formation of donepezil chloride and loading of the obtained solution onto a mixture of pharmaceutically acceptable excipients. Amorphous form is stabilized by addition of crystallization inhibitor to the solution or to the mixture of pharmaceutically acceptable excipients.Predstavljeni izum se nanaša na stabilne farmacevtske fomulacije z amorfnim 1-benzil-4-((5,6-dimetoksi-1-indanon)-2-il)metil-piperidinijevim (donepezilijevim) kloridom in na postopek stabilizacije te spojine. Farmacevtsko formulacijo pripravimo s tvorbo donepezilijevega klorida "in situ" in z nanašanjem dobljene raztopine na zmes farmacevtsko sprejemljivih pomožnih snovi. Amorfni donepezilijev klorid stabiliziramo z dodatkom inhibitorja kristalizacije k raztopini ali k zmesi farmacevtsko sprejemljivih pomožnih snovi.ŕ
