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Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use.
AAPS PharmSciTech. 2015 Apr; 16(2):234-41.AP

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.

Authors+Show Affiliations

Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Building 26.22, Universitaetsstrasse 1, 40225, Duesseldorf, Germany, maren.preis@hhu.de.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

25739913

Citation

Preis, Maren. "Orally Disintegrating Films and Mini-tablets-innovative Dosage Forms of Choice for Pediatric Use." AAPS PharmSciTech, vol. 16, no. 2, 2015, pp. 234-41.
Preis M. Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use. AAPS PharmSciTech. 2015;16(2):234-41.
Preis, M. (2015). Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use. AAPS PharmSciTech, 16(2), 234-41. https://doi.org/10.1208/s12249-015-0313-1
Preis M. Orally Disintegrating Films and Mini-tablets-innovative Dosage Forms of Choice for Pediatric Use. AAPS PharmSciTech. 2015;16(2):234-41. PubMed PMID: 25739913.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use. A1 - Preis,Maren, Y1 - 2015/03/05/ PY - 2014/11/18/received PY - 2015/02/20/accepted PY - 2015/3/6/entrez PY - 2015/3/6/pubmed PY - 2015/12/15/medline SP - 234 EP - 41 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 16 IS - 2 N2 - 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. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/25739913/Orally_disintegrating_films_and_mini_tablets_innovative_dosage_forms_of_choice_for_pediatric_use_ L2 - https://dx.doi.org/10.1208/s12249-015-0313-1 DB - PRIME DP - Unbound Medicine ER -
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