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Knowledge of operating variables for a dissolution apparatus is important to the pharmaceutical scientist interested in product development,quality assurance, and research applications. The dissolution performance of USP Apparatus 1 and 2 is dependent on both convection and diffusion as coupled dissolution mechanisms. The sensitivity and variability of the data may be compromised when either the convection or diffusion mechanism dominates. When convection dominates,there may be a loss of sensitivity. For example,Hamlin et al., (1) demonstrated a loss of sensitivity in distinguishing real differences in dissolution rates due to increasing agitation intensity. When diffusion is the predominant mechanism,the dissolution results are affected by density gradients and may vary considerably (2, 3). USP Apparatus 1 and 2 depend on a balance between these two mechanisms in order to produce sensitive and reproducible data. Experimental dissolution methods that employ configurations linked with convective-diffusion models,such as the rotating disk or the stationary disk,are useful to understand the relationship between the diffusion and convective mechanisms. The dissolution rates determined from either of these two experimental methods are often termed “intrinsic dissolution rates”. Intrinsic dissolution rates have been defined as “the rate of dissolution of a pure pharmaceutical active ingredient when conditions such as surface area, temperature,agitation or stirring speed,pH, and ionic strength of the dissolution medium are kept constant”(4). This research was motivated by previous studies (2,3) that suggested the possibility of using modified salicylic acid calibrator tablets supplemented by visualization studies (5) as a method to evaluate the intrinsic dissolution performance of USP Apparatus 2. Intrinsic dissolution performance in this context is the intrinsic dissolution rate due to the inherent convection and diffusion mechanisms that govern dissolution for a given apparatus. The premise for the current study is that these dissolution rates provide a framework for evaluating the dissolution performance of USP Apparatus 2. Therefore, the goals of this study were to:

dissolution technologies

Intrinsic Dissolution Performance Testing of the USP Dissolution Apparatus 2 (Rotating Paddle) Using Modified Salicylic Acid Calibrator Tablets: Proof of Principle