Biopharmaceutical considerations in the pediatric and geriatric formulation development

Abstract For both patients (i.e., pediatric and geriatric) the products should be age appropriate, an essential criterion for achieving efficient drug therapy. Some frequently reported problems associated with these formulations may include the inappropriateness of the product with different age-groups, imperfect labeling, incompatibility, and unacceptability of drugs, which are the primary concern for causing errors in pediatric populations. During formulation, some factors such as formulation components (active pharmaceutical ingredient and excipients), substances used in primary packaging, and employed devices should be considered for their suitability and safety. However, for both populations, the oral route is widely preferred for delivering drugs for efficient results. Further, recent clinical investigations advocate the suitability of minitablets if we consider swallow-ability and acceptability of formulation as compared to other traditional liquid products. This chapter provides deep insight into different oral products for pediatric and geriatric patients. It discusses various alternative novel formulations (e.g., minitablets and flexible oral formulations) over conventional solid and liquid products.