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Compositions d'oxycodone à libération contrôlée
专利权人:
Napp Pharmaceutical Holdings Limited
发明人:
申请号:
EP10181156.0
公开号:
EP2340833A3
申请日:
1992.11.25
申请国别(地区):
EP
年份:
2012
代理人:
摘要:
A method for substantially reducing the range in daily dosages required to control pain in approximately 80% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg-of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated "q12h" (i.e., every 12 hours) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients. The figure is a graph showing the mean plasma oxycodone concentration for a 10 mg controlled release oxycodone formulation prepared in accordance with the present invention and a study reference standard.
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