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

ABSTRACT

Introduction

The current availability of 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.

Areas covered

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

KEYWORDS:

• Age-appropriate dosage forms
• administration devices
• paediatric patient
• palatability
• patent, patient compliance
• taste masking

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 pediatrics market growth.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.