Patent landscape of paediatric-friendly oral dosage forms and administration devices

The current availability in dosage forms designed specifically for children is limited, constituting common practice the use of unlicensed or off-labeled medicines and extemporaneous preparations. Swallowing difficulties and taste aversion are the primary reasons for medicine rejection, therefore enhancing palatability and ease of administration are the most common approaches adopted to overcome these issues.

Article highlights

• Children still have therapeutic needs that remain unmet, even for essential medicines.

• Age-appropriate dosage forms and devices are critical for effective pharmacotherapy.

• Palatability enhancement and ease of swallowing and administration have been the main focus of patent activity.

• Research efforts have refocused attention on broadening the spectrum of age-appropriate pharmaceutical products.

• Collaboration between policy-makers, academia and pharmaceutical industry is critical for accelerating the paediatrics market growth.

Areas covered
A search of patents was performed for paediatric dosage forms and devices. The review aims to provide an overview on new formulation approaches and technologies adopted to develop paediatric-friendly dosage forms and devices, as well as on the regulatory efforts aiming to support the paediatrics market.

Expert opinion
Children deserve medicines of the same efficacy, quality and safety as adults. The present review highlights the momentum developed by pharmaceutical industries in the field of paediatrics, since more than 60 patents have been published in the last 5 years. An increasing interest especially in mini-tablets, orodispersible and chewable dosage forms, as well as on excipients and methods to achieve sufficient taste-masking was identified, recognizing also the need for coordinated research networks and sustainable collaborations across the public and private sectors to provide better medicines for children. Continue on Patent landscape of paediatric-friendly oral dosage forms and administration devices

Christina Karavasili, Angelos Gkaragkounis & Dimitrios G. Fatouros (2021) Patent landscape of paediatric-friendly oral dosage forms and administration devices, Expert Opinion on Therapeutic Patents, DOI: 10.1080/13543776.2021.1893691