ABSTRACT
Due to the lack of age-appropriate formulations for children, healthcare professionals and caregivers frequently manipulate dosage forms to facilitate oral administration and obtain the required dose. In this study, we investigated drug manipulation and age-appropriateness of oral medications for pediatric oncology patients with the aim of identifying the therapeutic needs for personalized dosage forms. An observational study at a pediatric oncology ward, combined with analysis of the age-appropriateness of the oral medications, was performed. Nurses frequently manipulated solid dosage forms to administer them via enteral feeding tubes. Of the active pharmaceutical ingredients (APIs) assessed for age-appropriateness, 74% (29 of 39) were identified to need personalization, either because of lack of child-friendly dosage form, suitable dosage strength, or both. Most APIs, due to limited solubility, were sensitive to formulation changes, such as drug manipulation. This study demonstrates problems and therapeutic needs regarding oral dosage forms in treatment of children with cancer. Expertise in formulation design, new manufacturing technologies, and patient-centered information are needed to address age-appropriate formulations for children.
