RESEARCH AND DEVELOPMENT OF DRUG DELIVERY SYSTEMS FOR PAEDIATRIC THERAPEUTIC NEEDS

Manipulation of medicinal products is a common practice in paediatric patients due to the lack of formulations in this heterogeneous group. Paediatric patients are frequently treated with unlicensed medicinal products like galenic preparations, and off-label use is widespread. Medication administration to the paediatric population often involves the manipulation of adult dosage forms. However, using extemporaneous preparation may result in treatment failure, toxicity in children dosing, or unknown and variable bioavailability. Consequently, the Paediatric Committee at the European Medicines Agency has identified the needs in the different therapeutic areas where research and development of medications for paediatric population should be conducted. On the basis of a literature review, polymeric and lipid nanoparticles were identified to approach paediatric disease problems and needs. Therefore, two drug delivery systems were developed and characterised for medium-long term opportunities for paediatric therapeutic needs. Firstly, nanoparticles based only on chitosan and cellulose acetate phthalate containing captopril were developed for preparing solid/liquid dosage forms for treating cardiovascular diseases in paediatric patients. Secondly, a thermosensitive chitosan/glycerophosphate nasal hydrogel containing dimethyl fumarate complexed with hydroxypropyl-β-cyclodextrin was studied as a new approach to treating paediatric multiple sclerosis. Finally, an overview of the oral medicinal product considerations for administration via different enteral feeding tubes in paediatric patients was reported. A systematic review was performed according to the PRISMA checklist. Additionally, it was registered on PROSPERO. Moreover, a feasibility study (in vitro study) was conducted to assess and streamline the key factors impacting medication administration via nasogastric tubes.

Manipulation of medicinal products is a common practice in paediatric patients due to the lack of formulations in this heterogeneous group. Paediatric patients are frequently treated with unlicensed medicinal products like galenic preparations, and off-label use is widespread. Medication administration to the paediatric population often involves the manipulation of adult dosage forms. However, using extemporaneous preparation may result in treatment failure, toxicity in children dosing, or unknown and variable bioavailability. Consequently, the Paediatric Committee at the European Medicines Agency has identified the needs in the different therapeutic areas where research and development of medications for paediatric population should be conducted. On the basis of a literature review, polymeric and lipid nanoparticles were identified to approach paediatric disease problems and needs. Therefore, two drug delivery systems were developed and characterised for medium-long term opportunities for paediatric therapeutic needs. Firstly, nanoparticles based only on chitosan and cellulose acetate phthalate containing captopril were developed for preparing solid/liquid dosage forms for treating cardiovascular diseases in paediatric patients. Furthermore, a thermosensitive chitosan/glycerophosphate nasal hydrogel containing dimethyl fumarate complexed with hydroxypropyl-β-cyclodextrin was studied as a new approach to treating paediatric multiple sclerosis. Finally, an overview of the oral medicinal product considerations for administration via different enteral feeding tubes in paediatric patients was reported. A systematic review was performed according to the PRISMA checklist. Additionally, it was registered on PROSPERO. Moreover, a feasibility study (in vitro study) was conducted to assess and streamline the key factors impacting medication administration via nasogastric tubes.