Development of a Glass-Bead Device for Dissolution Testing

作者：Bogataj Marija^*; Cof Greta; Mrhar Ales

来源：Dissolution Technologies, 2015, 22(3): 18-24.

DOI：10.14227/dt220315p18

• Dissolution
• release
• glass-bead dissolution device
• solid dosage forms
• nondisintegrating tablets

A device for dissolution testing with a special type of stirring element and typical movement of a dosage form was developed and constructed in our laboratory. It consists of a working vessel in which a suitable amount of small glass beads is pushed by a stirring bar in an appropriate medium. A heap of beads forms in front of the stirring bar and moves around the vessel. A solid dosage form, most frequently a tablet, is placed in the medium on the surface of the bead layer and is moved due to the movement of this bead layer. The newly developed device could be used in experimental work as a part of a dissolution system based on the flow-through principle. Two different series of tablets containing different drugs were tested to show the applicability of this device. Dissolution from one series of tablets was strongly dependent on increasing mechanical influences on the tablet during dissolution testing, while dissolution from the tablets of another series was not susceptible to the change in the same mechanical parameters. Comparison with dissolution results in USP Apparatus 2 also showed differences between different stirring rates in the case of mechanically susceptible tablets, while tablets that were not susceptible to these influences gave very similar dissolution profiles in both systems. Mechanical influences on the dosage form in the newly developed system could be varied by changing the amount of glass beads and the stirring rate; however, the biorelevance of parameters of this system remains to be determined.

• 出版日期2015-8