Design and Characterization of a New Miniaturized Rotating Disk Equipment for In Vitro Dissolution Rate Studies

Multivariate Data Analysis of Factors Affecting the In Vitro Dissolution Rate and the Apparent Solubility for a Model Basic Drug Substance in Aqueous Media

“…The miniaturized equipment with the cell of Plexiglas integrated to a RP-HPLC system using a DAD for analysis, as well as an external HPLC pump connected to the cell, has been described previously (60)(61)(62). The disk of substance in the miniaturized apparatus had a diameter of 1.5 mm and was rotated by a magnetic stirrer with graded rotating speeds, obtained from Heidolph MR 3001 K (Steinheim, Germany).…”

“…The knowledge of the physicochemical composition of media united with the consideration of the motility in the GI tract during the design of a dissolution test can lead to a better IVIVC (15,59). A miniaturized apparatus that uses the flowthrough technique combined with the rotating disk performance has been developed and characterized (60)(61)(62). The miniaturized equipment is used for simple screening of the dissolution rate-around 10 min for one run-and consumes small amounts of substance (approximately 5 mg) and volumes of dissolution media (roughly 20 ml per disk) (61,62).…”

Miniaturized Rotating Disk Intrinsic Dissolution Rate Measurement: Effects of Buffer Capacity in Comparisons to Traditional Wood’s Apparatus

“…However, there appears to be a reluctance among some of the traditional dissolution practitioners-as noted in discussions at scientific meetings-to use very small dissolution media volumes, on concerns that the familiar (USP) "hydrodynamic and sink conditions" may not be maintained when media volumes are as low as 1-10 mL. If this concern can be alleviated, miniaturization of IDR methods (28,30) in early development can promote the increased, and much earlier, use of simulated gastrointestinal fluids to predict absorption properties of drug candidates (32).…”

“…The main objective of the study was to demonstrate that the miniaturized disk IDR apparatus and method can produce results of comparable reliability as those obtained by traditional Wood's apparatus methods, without the need for any scaling adjustments (30), and that the miniaturized apparatus can be potentially useful in BCS classification of solubility, applied at a much earlier time in the development cycle. We therefore investigated 14 compounds with the miniaturized disk IDR method, using as little as 5 mg to make compacted disks of 0.071 cm 2 exposed surface area, rotated in 10 mL of buffer media.…”

“…API-sparing methods are essential (26,28,30). Furthermore, these methods need to be media-sparing, especially when simulated intestinal fluid or human intestinal fluid are used.…”