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Orally Disintegrating Films and Mini-Tablets—Innovative Dosage Forms of Choice for Pediatric Use

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Abstract

Oral drug delivery is a non-invasive and therefore a very convenient route of administration. Orally disintegrating dosage forms, like soluble films and (mini-)tablets, appear promising for use in the pediatric population. New guidance for the development of pediatric medicines has been published, which provides considerations on how pediatric products should be designed. However, most of the considerations leave a lot of room for interpretations. Bearing in mind the different aspects discussed in the latest guideline, the use of orally disintegrating films and tablets, in particular, small-sized tablets, is discussed and reflected upon by providing evidence from the scientific literature. The available dosage forms for children are various and examples of currently licensed products for use in the pediatric population were compiled. Aspects such as the appropriateness for pediatrics, the choice of excipients, the opportunities for modified drug release preparations or fixed-dose combinations, the acceptability and palatability, and also limitations were discussed with respect to the new dosage forms of orally disintegrating films and mini-tablets. This paper points out that innovation in pediatric medicines are planned and should be encouraged; however, supported by the regulatory guidance, only general considerations are provided. Nevertheless, the guideline summarizes multiple points to consider during the development of medicines for pediatric use. Considering the scientific evidence and the regulatory guidance, orally disintegrating dosage forms, like soluble films and (mini-)tablets, offer an innovative solution for pediatric drug delivery.

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Authors and Affiliations

  1. Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Building 26.22, Universitaetsstrasse 1, 40225, Duesseldorf, Germany

    Maren Preis

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  1. Maren Preis
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Correspondence to Maren Preis.

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Excerpts from this review were published as part of the Catalent Institute’s ‘Thoughts from Science Leaders of Tomorrow’. The previously published excerpt (‘Pediatric drugs - regulatory challenges and available dosage forms’) was one of the five winning entries of the 3rd Annual Global Academic Competition by the Catalent Applied Drug Delivery Institute in cooperation with the American Association of Pharmaceutical Scientists (AAPS).

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Preis, M. Orally Disintegrating Films and Mini-Tablets—Innovative Dosage Forms of Choice for Pediatric Use. AAPS PharmSciTech 16, 234–241 (2015). https://doi.org/10.1208/s12249-015-0313-1

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