abstract |
The invention relates to a solid controlled release oral dosage form containing an analgesically effective amount of oxycodone or a salt thereof in a single matrix, wherein the rate of dissolution of the dosage form in vitro is measured by a so-called. Using the USP Paddle Method at 100 min-1 in 900 ml of aqueous buffer solution (pH between 1.6 and 7.2) at 37 ° C, between 12.5 and 42.5% (wt) of oxycodone released after 1 hour , between 25 and 55% (wt) of oxycodone released after 2 hours, between 45 and 75% (wt) of oxycodone released after 4 hours, and between 55 and 85% (wt) of oxycodone released after 6 hours, with in vitro release rates is essentially pH independent when the pH is between 1.6 and 7.2. This dosage form is in the form of a tablet. The invention also relates to a method for preparing such an oral dosage form. |