Mini-Tablet

https://www.crystalpharmatech.com/pediatric-formulation.html


Mini-Tablet
Dosage forms designed for pediatric use has long been an unmet medical need. The lack of pediatric formulation has led to unsafe behaviors such as breaking adult tablet arbitrarily and dosing randomly for children. Physiologically and pharmaceutically speaking, pediatric medicines are not "mini" versions of adult medicine. Instead, it is necessary to make changes or adjustments in dosage form, dose and administration method. Due to the lack of pediatric dosage forms, there is a pervasive off-label use of adult dosage for pediatric patients, leading to incorrect doses, altered bioavailability, and poor patient compliance, etc. In recent years, the importance of paediatric formulations has been recognized in China. NMPA has issued a set of policies and regulations encouraging the development and innovation in pediatric medicines. Meanwhile, CDE also published a series of technical guidance to better help drug companies in pediatric drug development. In the US, the FDA requires drug companies to submit initial pediatric study plan (iPSP) after Phase II clinical trials. In the EU, the EMA demands drug companies submit pediatric investigation plan (PIP) after Phase I clinical trials and complete the development work in the PIP within certain time limits. Therefore, the demand in pediatric formulation development will continue to increase with time.