A REVIEW ON THE SOLID ORAL DOSAGE FORM FOR PEDIATRICS, REGULATORY ASPECTS, CHALLENGES INVOLVED DURING THE FORMULATION, AND TOXICITY OF THE EXCIPIENTS USED IN PEDIATRIC FORMULATION

Abstract

Designing an appropriate dosage form in medical treatment for the pediatric population is very challenging. The major challenges faced during designing the oral solid dosage form for pediatrics are also the prerequisites for the development of the dosage form, and they are, administering the drug according to the body weight and taste masking, which is followed by other factors like the safety of excipients, size of dosage form and so on. Oral solid dosage forms like mini-tablets, soluble films, and orally disintegrating tablets are a few promising dosage forms for use in the pediatric population. The obstacles, such as physiological differences between the various age groups, excipient safety, technology requirements, low profitability, clinical trial limitations, and regulatory ambiguity all have an impact on pediatric dosage form development. Recent advancement in the development of pediatrics formulations has been made due to new regulations, more financial opportunities, and novel collaborative research programs. A shift of pattern towards solid oral dosage form and an emphasis on innovative preparations, such as dispersible, flexible, as well as multi-particulate oral solid dose forms, are some of the advanceme nts. Such advancements have allowed for more flexibility of dose, easy administration, and improved medication formulation acceptance in pediatrics. In consideration of dosage forms for pediatrics, issues such as pediatric suitability, excipient selection, prospects for modified drug release formulations or fixed-dose combinations, palatability, and acceptability, as well as challenges were reviewed in the current manuscript.