Model Independent and Dependent Methods for Dissolution Profiles Comparison: Can we take the Road Less Travelled?

Adithya Karthik Bhattiprolu, Sivacharan Kollipara, Rajkumar Boddu, Arvind Rachapally and Tausif Ahmed*

Dissolution testing plays an important role in pharmaceutical development due to its ability to provide critical insight into in vivo performance. Dissolution testing during routine pharmaceutical development can ensure batch-to-batch consistency and helps to ensure that the commercial batches are of representative quality to that of studied in the pivotal clinical studies. For comparing the dissolution profiles, there are multitude of approaches suggested by various regulatory agencies that consist of model independent and dependent approaches. The present review aims to summarize the current understanding of dissolution profile similarity approaches. Dissolution profile comparison approaches suggested by various regulatory agencies were compared and contrasted. Further, detailed procedural aspects were provided for the determination of similarity using model independent and dependent approaches. Model independent approaches such as f2 bootstrap, and Multivariate Statistical Distance (MSD) were portrayed from a practical perspective. Advanced tools such as Bias-Corrected and accelerated (BCa) for f2 bootstrap were discussed in depth. Further, model dependent approaches such as zero order, and Weibull models were discussed from realistic scenarios. Finally, the utility of modeling and simulation approaches such as physiologically based pharmacokinetics model (PBPK) and physiologically based biopharmaceutics model (PBBM) were discussed in the context of their ability and potential to supersede traditional dissolution dissimilarity. Overall, this article acts as a ready-to-use guide for pharmaceutics and biopharmaceutics scientists for effective methodologies for dissolution profile comparison for internal decision-making and regulatory justifications.

Keywords:

Published on: Jul 5, 2024 Pages: 22-29

Full Text PDF Full Text HTML DOI: 10.17352/ijpsdr.000053
CrossMark Publons Harvard Library HOLLIS Search IT Semantic Scholar Get Citation Base Search Scilit OAI-PMH ResearchGate Academic Microsoft GrowKudos Universite de Paris UW Libraries SJSU King Library SJSU King Library NUS Library McGill DET KGL BIBLiOTEK JCU Discovery Universidad De Lima WorldCat VU on WorldCat