Orodispersible tablets for pediatric drug delivery: current challenges and recent advances

ABSTRACT

Introduction

Child appropriate dosage forms are indispensable in modern medicine and are a prerequisite for successful pediatric drug therapy. For years, experts have called for a paradigm shift, from liquid dosage forms to novel oral solid dosage forms. This review aims to shed light on recent developments in Orodispersible tablets (ODTs) and mini-tablets (ODMTs).

Areas covered

This review focuses on the presentation and critical discussion of current challenges as well as recent advances in ODTs for pediatric drug delivery. Highlighted aspects are the evidence for acceptability by children, e.g. in comparison to other dosage forms, and limitations given by tablet size at different ages, as well as advances in special ODT formulations (taste masking, modified release, enabling formulations).

Expert opinion

It is the authors’ belief that OD(M)Ts have significant potential as dosage forms in pediatric therapy that has not yet been fully exploited. The reasons for this are, first, that the number of direct acceptance studies is extremely low and the resulting knowledge is therefore rather anecdotal. Despite the high relevance, there seems to be reluctance both in the therapeutic use and conduction of respective studies in children. However, if one combines the knowledge from the few existing studies, surveys, and from approved products, it becomes apparent that so far there is no evidence on limitations of the use of ODTs in pediatric patients.

KEYWORDS:

• Acceptability
• child-appropriate dosage forms
• drug administration
• orally disintegrating tablets
• orodispersible mini-tablets
• pediatric drug delivery
• taste masking

Funding

This paper was not funded.

Article highlights

• In absence of large acceptance studies, all available sources on acceptance of orodispersible tablets by children were evaluated and the information combined.

• The acceptance of ODTs was concluded to be high in all pediatric age groups. Superiority/inferiority to other dosage forms proved to be age-dependent, with increasing status of ODTs with age ranging from neonates to adolescents.

• Data from clinical studies, surveys, and registered products were combined to assess the question of how tablet size affects the acceptability of ODTs in children of different ages: the largest acceptable ODT size increases with age from 4 mm for 1–2 year olds to 10 mm for 12–16 year olds.

• Orodispersible mini-tablets prove to be the ideal pediatric dosage form, since they combine the inherent advantages of oral solid dosage form, are well accepted even by neonates, and offer the possibility for personalized dosing.

• Immense efforts have been made to solve the issues of taste masking, modified release, and solubility enhancement in ODTs. Challenges remain, especially where these approaches are combined with high drug loads.

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.