Pediatric Orally DisintegratingTablets: Advances in Formulation Design,Technology, and Regulatory Perspectives

Abstract

The non-invasive character and wide range of usage in both medical and home environments make the oral route the main choice for drug delivery in children. Nevertheless, the discrepancies in physiology and behavior
of kids and adults, particularly the underdeveloped coordination in swallowing, the very sensitive taste organ, and the partly developed gastrointestinal system, make it very hard to take conventional drug formulations and adapt them to the younger age group. A child under 6 years of age is most likely and often unable to take solid tablets and capsules, which results in poor compliance, choking risk, and inaccurate doses. Liquid formulations, though they are the common route, carry the risk of inaccurate dosing, microbial contamination, dental caries, and harmful excipients, among other drawbacks. These and other pitfalls have led to a growing interest in orally disintegrating tablets (ODTs) as they almost instantaneously dissolve in saliva, swallow with
very little effort, and still provide accurate dosing and improved portability. Innovations in ODT technology, to name a few lyophilization, direct compression, spray drying, sublimation, melt granulation, and 3-dimensional printing have made it possible to perfect disintegration time, mechanical strength, and taste. Modern tastemasking strategies, such as ion-exchange resins, microencapsulation, and multilayer coatings not only improve the taste but also make it the most important factor determining the children’s adherence. The application of superdisintegrants, such as crospovidone, croscarmellose sodium, and sodium starch glycolate, guarantees a very fast tablet disintegration, even for use in the case of children with low saliva output. US Food and Drug Administration, European Medicines Agency, and the World Health Organization all give prominence to the necessity of formulations that are age-appropriate and excipient safe, acknowledging ODTs as one of the most promising solutions, especially in low-resource settings where water-independent dosing increases the feasibility.