Elsevier

Clinical Therapeutics

Volume 36, Issue 2, 1 February 2014, Pages 180-183
Clinical Therapeutics

Commentary
Necessity of Rethinking Oral Pediatric Formulations

https://doi.org/10.1016/j.clinthera.2014.01.010Get rights and content

Abstract

This commentary reviews the difficulties in formulating oral products for children. The significance of the fragmentation of the pediatric population in terms of development and ability to ingest different dosage formulations is examined. It is postulated that a flexible formulation, acceptable by all patient groups, is needed, and an automated compounding concept is proposed. The finishing of the formulation is done at the dispensing pharmacy using an automated process. The individual components (pudding-like carrier, microencapsulated drug, and the dispensing robot and its software) are reviewed. The involvement of different stakeholders is considered because new regulatory, clinical, and marketing thinking is required.

Section snippets

Background

Many of the comments included here are presented in a book to be published in February 2014.1 The bookʼs editors asked the chapter authors to avoid using the truism “children are not small adults,” but it still appears—with good reason—in many places throughout the book. Intuitively, we believe in the truth of this statement, and the book, particularly in the first chapters dealing with “the patient” (the child) from a physiologic, anatomical, and developmental point of view, presents numerous

oral Flexible-dose formULATIONs?

Here it is suggested to backtrack and start again from scratch. Define the parameters of the “ideal” formulation—acceptable to all age groups, palatable, stable, and able to smuggle the drugs into the digestive tract—and then try to accommodate the specifications.

One would probably ask for a dosage formulation that children (≥6 months of age) will ingest. This means something familiar, like a semisolid (pudding, cream, applesauce, or porridge-like) mass. It need not to be too well-accepted,

Conclusions

The purposes of this commentary are to provoke and stimulate the imaginations of stakeholders in the field of pediatric formulations. The proposal outlined here may have serious flaws and might never be taken up. The author’s goals are to indicate that there might be alternatives to what has been tried—with limited success—in the past and to point out that if we do not try new things, we will not succeed. We owe it to our children to try.

Conflicts of Interest

The author has indicated that he has no conflicts of interest with regard to the content of this article.

Acknowledgments

The author would like to thank Klaus Rose, the co-editor of the book on pediatric formulations and all the chapter authors for inspiration and enlightenment and his students for the enthusiasm and dedication.

References (9)

  • Bar-Shalom D, Slot L, Fischer G, Hemmingsen PH. Swellable dosage form comprising gellan gum. US patent application no....
  • A. Canan et al.

    Design of Vehicles for Oral Medication of Heterogeneous Groups, Based on Mass Medication Scenarios and Inspired by Food Science [thesis]

    (2011)
  • P. Bjørnsholt et al.

    Development and Characterization of a Fast Hydrating Semi-Solid Formulation for Oral Pediatric Use Based on Cellulosics [thesis]

    (2013)
There are more references available in the full text version of this article.
View full text
Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.