REDUCTION OF THE DEALLYLATION OF NALOXONE DURING THE STORAGE OF A NALOXONE-CONTAINING RETARD FORMULATION

摘要

#$%^&*AU2016101552A420161013.pdf#####Abstract The present invention relates to a packaged drug comprising a pharmaceutical retard 5 formulation of naloxone or a pharmaceutically acceptable salt thereof and a package; a method for the preparation of a storage-stable drug comprising the packaging of a retard formulation of naloxone or a pharmaceutically acceptable salt thereof; the use of a package for the storage-stabilization of a drug comprising a pharmaceutical retard formulation of naloxone or a pharmaceutically acceptable salt thereof; as well 10 as the use of a package for the reduction of the deallylation of naloxone or the pharmaceutically acceptable salt thereof during the storage of a pharmaceutical retard formulation of naloxone or a pharmaceutically acceptable salt thereof. 15Figures 120.00------100.00 80.0 0 - - - - - - - - - - -u60.00 40.00----------------------------------------- 20.00 0.00 i - r ---- ,-- ---- 1 0.0 2.0 4,0 6.0 8.0 10.0 12.0 14.0 Time [Ih -+- reference product -- test product Fig. 1: Release profiles of OxyHCI from 40/20mg OxyHCl/Na!HCI formulations (pH 68) 100.00 90.00 60.00 60.00 --.-....---...-.-----..-- - -------- - ----------------6 0.00 -------------------------------------- --------------- --_-_--_-_ 2 40.00 30.00------- ----- --- ------ 20.00 --------------------- - - - - - - - - - - - -10.00----________________ 0.00 ... . 0.0 2.0 4.0 6.0 8.0 10,0 12.0 14.0 Time [h) -- reference product -M- test product Fig. 2: Release profiles of NalHCI from 5/2.5mg OxyHCI/NaIHCI formulations (pH 6.8).