Evaluation of pH Dependent Solubility and Examination of Variation in Pharmacokinetic Properties of Alectinib: A Quantitative Study by Implementing Integrated Quality by Design Approach for RP-HPLC Method Development and Optimization

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Alectinib is used in the therapeutic management of non-small cell lung cancer (NSCLC). Alectinib exhibits a weakly basic nature and its solubility is influenced by pH. Consequently, there is a possibility of interaction between alectinib and acid reducing agents that are co-prescribed. A micro-dissolution experiment was conducted using biorelevant media to replicate the pH changes occurring in the gastrointestinal (GI) tract. This experiment proved to be valuable in identifying interactions influenced by pH shift. The observed change in pH from 1.2 to 6.8 had no significant impact on the solubility of alectinib. However, these findings can be utilized to assess the pH susceptibility of high-risk anticancer therapies.

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