Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients

Area of Science:

• Pharmaceutical Sciences
• Paediatric Drug Development

Background:

• Paediatric drug development presents unique challenges due to diverse patient needs and differing physiological responses.
• Ensuring palatability of oral paediatric medicines is crucial for patient adherence, a growing focus for regulatory bodies.
• Many active pharmaceutical ingredients (APIs) possess undesirable tastes, necessitating effective taste masking strategies.

Purpose of the Study:

• To review various taste masking techniques for active pharmaceutical ingredients (APIs) in paediatric oral dosage forms.
• To emphasize the tolerability and safety of excipients used in these taste-masked formulations.
• To provide examples of commercially available paediatric oral medicines employing taste masking.

Main Methods:

• Literature review of scientific databases and regulatory guidelines.
• Analysis of taste masking technologies applied to paediatric oral formulations.
• Evaluation of excipient safety profiles in paediatric populations.
• Identification and assessment of marketed paediatric oral products with taste-masked APIs.

Main Results:

• Multiple taste masking approaches exist, including microencapsulation, complexation, and formulation strategies.
• Excipient selection is critical, requiring careful consideration of paediatric-specific tolerability and safety data.
• Successful taste masking can significantly improve the palatability and acceptance of paediatric medicines.
• Several marketed products demonstrate effective taste masking for paediatric use.

Conclusions:

• Taste masking is essential for palatable paediatric oral medicines, enhancing adherence.
• A thorough understanding of API characteristics and excipient safety is vital for successful paediatric formulation.
• Continued research and development in taste masking technologies are needed to meet the specific needs of paediatric patients.