Buccal/Sublingual Drug Delivery for the Paediatric Population

Abstract

Oral mucosal drug delivery has emerged as a potential route of drug administration which represents a strategy of maximising the availability of the oral route for easy administration without the need to swallow a dosage form whilst offering the possibility of local delivery and direct access to the systemic circulation thus avoiding first pass metabolism. However, changes in anatomical, physiological and biochemical functions that occur from birth to adolescence are required to be considered when designing such formulations. Currently marketed formulations include liquids, semi-solids and solid dosage forms; however, there is significant research in developing alternative dosage forms for oral mucosal delivery such as nanotablets, films, microparticles and mouth sprays which is partly due to problems (e.g., posology or excipients present in formulation) associated with using currently marketed products in children. Despite the development of novel technologies including NanoTabs and mucosal sprays, there still remains relatively few products approved for use in the paediatric population. This is likely explained by the fact that alongside the normal problems that need to be overcome during product development, additional issues including compliance, palatability, paediatric safety, the needs and capabilities of carers and the implications of global paediatric regulatory guidance need to be considered.