The Renaissance Of Sprinkle Formulations

By Sven Stegemann, PhD, Capsugel

About 25 years ago, multi-particulates were applied in pharmaceutical product development as so-called sprinkle formulations to overcome swallowing issues with larger oral dosage forms. Sprinkle formulations use small multi-particulates in a capsule that can either be swallowed or opened to disperse the multi-particulates or “sprinkles” in liquid or soft food for administration. Sprinkles have applications for special patient populations, such as infants and young children as well as older adults.

In emerging markets, sprinkle formulations are considered "essential medicines," satisfying the priority health care needs of the population. There are a number of reasons. Due to their solid state, they are suitable for transport and storage in hot and humid environments. They also offer dosing flexibility and can be converted into easy-to-swallow suspensions in liquid or food. Moreover, sprinkle formulations are multi-particulates that can provide many different release kinetics and a combination of different drugs or “fixed-dose combinations” that may improve patient adherence. In addition, they provide more effective treatments by combining different drug classes and disease targets simultaneously within one dosage form. From a manufacturing standpoint, multi-particulates are considered to be a technologically efficient dosage form, as they are based on established granulation or pellet-coating technologies without the need for further processing aside from the standard encapsulation.