In this piece with Pharmaceutical Outsourcing, Nazim Kanji, Executive Director of Pediatric Services, speaks on current trends in the pediatric dosage form market and offers insight on how these influence product development strategies.
Nazim discusses his experience working with sponsor companies, highlighting the growing interest in developing a wide and full range of liquid and solid dose formats, noting a common preference for a single formulation that can be flexibly dosed to a wide age range of children and in dosage forms such as solutions, suspensions, powder for reconstitution, minitablets, and sprinkles. He also addresses key factors in determining product development strategy.
Nazim discusses the major challenges faced by pharmaceutical companies in developing pediatric dosage forms, particularly concerning safety, efficacy, and palatability. He touches on important factors to consider in initial stages and after formulation development in order to develop an acceptable pediatric product that achieves clinical, regulatory, and commercial success.
He also speaks on the issue of dose accuracy and variability in pediatric formulations, considering the diverse age groups and physiological differences among children. Nazim says, "Dosing is generally done in bands that are based on age, weight, or body surface area, with oral liquid formulations and minitablets among the most popular choices for their acceptability and efficacy in younger patients. Modeling and simulation can also be used to aid dose extrapolation from adult data and predict the in-vivo performance of a dosage form in children."
To read more, check out the full article here on the Pharmaceutical Outsourcing website.