Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics

Pharmaceuticals

Silvana Alfei¹  Guendalina Zuccari¹  Leonardo Marchitto²  Paola Barabino³  Valentina Iurilli³  Danilo Marimpietri⁴ 

[1] Department of Pharmacy, University of Genoa, Viale Cembrano, 16148 Genoa, Italy;Department of Sciences for the Quality of Life, University of Bologna, Corso D’Augusto 237, 47921 Rimini, Italy;Pharmacy, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147 Genoa, Italy;Stem Cell Laboratory and Cell Therapy Center, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147 Genoa, Italy;

关键词: pediatric formulations;    mini-tablets;    European Paediatric Regulation;    excipients;    medicines for children;    solid dosage forms;   

DOI  :  10.3390/ph15010108

来源: DOAJ

【 摘 要 】

In the treatment of pediatric diseases, mass-produced dosage forms are often not suitable for children. Commercially available medicines are commonly manipulated and mixed with food by caregivers at home, or extemporaneous medications are routinely compounded in the hospital pharmacies to treat hospitalized children. Despite considerable efforts by regulatory agencies, the pediatric population is still exposed to questionable and potentially harmful practices. When designing medicines for children, the ability to fine-tune the dosage while ensuring the safety of the ingredients is of paramount importance. For these purposes solid formulations may represent a valid alternative to liquid formulations for their simpler formula and more stability, and, to overcome the problem of swelling ability, mini-tablets could be a practicable option. This review deals with the different approaches that may be applied to develop mini-tablets intended for pediatrics with a focus on the safety of excipients. Alongside the conventional method of compression, 3D printing appeared particularly appealing, as it allows to reduce the number of ingredients and to avoid both the mixing of powders and intermediate steps such as granulation. Therefore, this technique could be well adaptable to the daily galenic preparations of a hospital pharmacy, thus leading to a reduction of the common practice of off-label preparations.

【 授权许可】

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