Abstract
In the pharmaceutical technology, paediatric population still presents the greatest challenge in terms of developing flexible and appropriate drug dosage forms. As for many medicines, there is a lack of paediatric dosage forms adequate for a child’s age; it is a prevailing practice to use off label formulations. Children need balanced and personalized treatment, patient-friendly preparations, as well as therapy that facilitates dosing and thus eliminates frequent drug administration, which can be ensured by modified release (MR) forms. MR formulations are commonly used in adult therapy, while rarely available for children. The aim of this article is to elucidate how to modify drug release in paediatric oral dosage forms, discuss the already accessible technologies and to introduce novel approaches of manufacturing with regard to paediatric population.
Highlights
Creating an appropriate dosage form designed exactly for children still appears as an outgoing challenge for pharmaceutical technology and the distinction between adults and children pharmacokinetics should be considered
The main goal raised by regulations of European Medicines Agency (EMA) or paediatric scientific network groups is increasing the safety and efficiency of paediatric therapy by the enhancement the quality of clinical studies for children in various age groups with better availability of pharmacokinetic data [5,6]
The main directives implemented in the appropriate paediatric dosage forms development point basic difficulties connected with paediatric therapy
Summary
Creating an appropriate dosage form designed exactly for children still appears as an outgoing challenge for pharmaceutical technology and the distinction between adults and children pharmacokinetics should be considered. Attempts were made to obtain omeprazole as liquid form, due to its instability (rapid decomposition at wide range of pH), such a formulation could not be manufactured and launched in the market [101,102] Another example of MultiP with paediatric licence is MoxatagTM—prolonged release pulsatile delivery technology (PULSYSTM) with multiple pellets inside. The technology utilized in the tablet uses two different types of microparticles: Adzenys®—3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg, and Cotempla®—8.6 mg, 17.3 mg, and 25.9 mg allowing dosing in a wide age group These products are obtained by XR-ODT (extended-release orally disintegrating tablet) technology and they dissolve quickly in the mouth (according to the FDA guidelines—up to 30 s or less) so that it can be swallowed. The formulation is intended for children ≥ 2 years of age and body weight around 12 kg [117]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
