𝗪𝗲𝗲𝗸𝗹𝘆 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 #2 📢

Navigating Pediatric Medicines Development: EMA Guideline (2013)

🔍 The 2013 EMA guideline on pharmaceutical development of medicines for pediatric use has recognized the unique challenges associated with formulations targeting this special age group. Solid oral dosage forms, including minitablets (tablets with 2-4 mm diameter), were suggested to address these challenges. Their adaptability allows for precise dosing and improved palatability, providing a patient-centric approach to pediatric medicine delivery. 💊

🚀 Since the guideline's release, increasing scientific research focusing on the acceptability of minitablets in younger patient populations (0-18 years old) was conducted, which pointed towards the superiority of minitablets over liquid formulations. These findings have led pharmaceutical companies to start considering the applicability of solid oral dosage forms, such as minitablets and multiparticulates, as pediatric drug product alternatives in their internal pipelines.

🏆 Such advancements have significantly contributed to the development of tailored medications that meet the unique needs of pediatric populations. In upcoming posts, we will explore some of the studies that contributed to this paradigm shift.

📚 Reference:
Guideline on pharmaceutical development of medicines for pediatric use,  EMA/CHMP/QWP/805880/2012 Rev. 2.