QbD in paediatric formulations

Obtaining formulations for paediatric diseases is one of the major challenges to face in the coming years. EMA, in the Guideline on pharmaceutical development of medicines for paediatric use (1) said in the General considerations: Any medicine should be designed to meet patient needs and to consistently deliver the intended product performance. A systematic approach to the pharmaceutical development in accordance with ICH Q8 could be followed in order to meet these objectives. When applied, the quality target product profile (QTPP) should be established taking into consideration the specific needs of the paediatric population. Based on the QTPP the critical product quality attributes (CQAs) should then be identified as well as the formulation and process parameters that may affect them. This approach will help defining the pharmaceutical design of the paediatric medicinal products.

Download
QbD in paediatric formulations
Ricard Canadell1; Anna Nardi1, Isaac Nofrerías1, Marc Suñé1, Pilar Pérez1,2, Montse Miñarro1,2, Josep R Tico1,2, Josep M Suñé Negre1,2, García Montoya Encarna1,2
1 University of Barcelona. Department of Pharmacy and Pharmaceutical Technology.. Avd. Joan XXIII 27-32 08028 Barcelona. encarnagarcia@ub.edu.
2 Grupo de investigación “Farmacoterapia, Farmacogenética y Tecnología Farmacéutica” IDIBELL (UB). Avinguda Granvia, 199-203, 08908 L'Hospitalet de Llobregat, Barcelona, Barcelona
QbD-in-paediatric-formulations-EXCIPRESS
Adobe Acrobat Document 202.9 KB

Write a comment

Comments: 0