Dose Dumping Study for Pramipexole Hydrochloride Sustained Release Hydrophilic Matrix Tablets

OBJECTIVE To evaluate the effects of in vitro dissolution release conditions for pramipexole hydrochloride sustained release hydrophilic matrix tablets and conduct the risk assessment for the dose dumping. METHODS Different conditions such as different hydroalcohol concentration in the release media and rotation speed of paddle were evaluated. The cumulative drug release within the sepcified duration was determined by HPLC. The in vitro dissolution equivalence through profile comparison to the commercial product Sifrol^® was conducted using similarity factor method. RESULTS The cumulative release degree between the test and reference formulations under several conditions such as in pH 6.8 PBS media at 75, 100, 200 r·min^-1 and in the presence of 5%, 20% and 40% ethanol of 0.1 mol·L^-1 hydrochloric acid media at 100 r·min^-1 was similar. CONCLUSION There is little impact on the in vitro dissolution profile for pramipexole hydrochloride sustained release hydrophilic matrix tablets between various hydroalcohol concentrations and roation speed of paddle. The risk of dose dumping from the developed formulation is controllable.