Theory and Method
Dissolution testing quantifies the rate and extent to which an active pharmaceutical ingredient (API) is released from its dosage form into a defined dissolution medium under controlled hydrodynamic conditions. For solid oral dosage forms — tablets and capsules — dissolution testing is a critical quality attribute (CQA) that correlates with in vivo drug release and bioavailability, and is required by regulatory authorities (FDA, EMA, PMDA) as part of both drug approval submissions and routine batch release testing.
The QualiPharma™ DIS SA 2008 performs dissolution testing using the two most widely specified apparatus types: the basket method (USP Apparatus 1 / EP Type A), in which the dosage form is enclosed in a wire mesh basket rotating in dissolution medium, and the paddle method (USP Apparatus 2 / EP Type B), in which the dosage form sits on the vessel floor below a rotating paddle. The instrument additionally supports small cup method, paddle butterfly method, and rotating drum method for specialized dosage forms.
At precisely programmed time intervals, the 8-channel imported syringe pump simultaneously withdraws sample aliquots from all active dissolution vessels at the pharmacopeially specified sampling position. The withdrawn volume is automatically replaced with pre-warmed fresh dissolution medium (media replenishment) to maintain constant volume conditions. Samples are delivered to collection vials or test tubes in the autosampler rack, where they are available for direct analysis by HPLC, UV-Vis spectrophotometer, or fiber-optic in-line detection systems.
The water bath maintains dissolution medium temperature at 37.0°C ± 0.2°C (or other set point) using a ceramic heating element with PID-controlled thermal management, monitored continuously by independent temperature sensors. The square integrated water bath with arc corners and bottom-drain design eliminates dead zones where contamination could accumulate, ensuring hygienic bath operation across multi-day dissolution testing campaigns.
