Insight into the Development of Desirable Dosage Forms and Bioenabling Strategies to Improve the Food Effect of Anticancer Drugs for the Pediatric Population.

The design and development of suitable dosage forms for pediatric patients face myriad challenges. Compared to other dosage forms, oral dosage forms are widely used and accepted in pediatric patients. However, oral dosage forms have their own challenges, which include the requirement for dose flexibility, limited bioavailability due to the poor solubility of the drug, safety concerns regarding excipients, and drug administration challenges for pediatric patients. The importance of research in drug delivery of anticancer drugs has increased due to poor drug solubility and the limited availability of pharmacokinetic data in pediatric patients. The poor solubility of anticancer drugs necessitates higher doses, leading to increased episodes of adverse effects. Furthermore, administering these drugs in the fed state results in bioavailability variations compared to the fasting state, which becomes more critical for pediatric patients. Therefore, it is essential to screen formulation strategies for these drugs to improve their bioavailability in the early stages of development. This review outlines key concerns of pediatric patients receiving long-term cancer drug therapy, including physiological and pharmacological challenges in the pediatric population, the impact of food on drug efficacy, and potential adverse effects associated with it. It also highlights various formulation strategies aimed at mitigating food-related variability through bioavailability enhancement. Furthermore, the review addresses the safety levels of excipients and development of age-appropriate dosage forms for the pediatric population.