President Rolara Medaka Consulting Fishers, Indiana
Despite much progress in recent years, there are still many hurdles to overcome before age-appropriate pediatric formulations are readily available across multiple indications and diseases, and accessible worldwide. For this symposium we will examine opportunities to address these challenges in the precompetitive space. The symposium will discuss recent advances, future trends and highlight areas where more research is needed. We will examine these issues from the industry and public biomedical research funder’s perspectives and will also showcase the development of bitter blockers for taste masking as an example of ongoing efforts to facilitate pediatric formulation development.
Topic 1: Industrial perspective on recent advances in pediatric formulation and delivery systems. The acceptability of pediatric formulations across all intended age-ranges is critical for adherence, compliance, and ultimately for the desired clinical outcomes of any therapeutic. Technologies that help promote these outcomes are therefore the focus for many pediatric developers. Age-appropriate dosing and formulations play key roles in acceptance, which can be improved with tools such as advanced PK/PB modeling, platform technologies, bitter blockers, etc. Some pediatric-centric formulation platforms such as orally dispersible tablets, minitablets, 3D printed dosage forms, long-acting formulations, etc. will facilitate faster development of acceptable dosage forms for new molecular entities, as well as generics. In addition, new applications of Artificial Intelligence/Machine Learning (AI/ML) are expected to facilitate and accelerate formulation development.
Topic 2: Recent advances in taste masking using bitter blockers. To maximize patient acceptance of such compounds and benefit pediatric patients, new approaches need to be developed beyond the traditional taste masking methods of adding sweeteners and flavors, or just applying a functional coating on granules or multiparticulate systems. Bitter blockers are among the most promising new approaches in this effort. Currently, 26 different bitter receptors have been identified on the human tongue. From this research it appears that a cocktail of bitter blockers could solve taste masking challenges for many of the most bitter drugs. In this session, we will present the current “state of the art” in bitter blocker research and discuss challenges and opportunities for pediatric applications.
Topic 3: New collaborations opportunities for pediatric formulation development. New dosage forms and formulation concepts need to be commercially viable and worldwide access needs to be maximized. Due to limited commercial incentives for pediatric products, resources need to be focused and therapeutic choices prioritized. This has been widely recognized by the NIH and various philanthropic organizations active in this field. In this session, the changing collaboration landscape will be assessed, and opportunities discussed from a formulation technology perspective – including a consideration of the efforts of groups such as the IQ Consortium, DPLG’s Pediatric Working Group, and the European Paediatric Formulation Initiative (EuPFI). The idea of a global “pediatric product innovation hub” will be discussed to advance and the possibility of coordinating efforts in bringing pediatric medicines to children who need them the most.
Learning Objectives:
Describe the recent advances and trends in pediatric formulation development, e.g., better insights into the different dosage forms suitable for pediatric formulations.
The participant will be able to describe the key drivers behind the development of pedatric formulations from the industry perspective.
Describe how companies could work together and share resources and list the services that NIH offers and how they may be applicable to their own development programs.
The participant will understand some emerging risks and opportunities associated with formulation strategies associated with both adult and pediatric formulations.