New softgel used as a device to ensure safe oral administration in the pediatric population

The search for a suitable pediatric form is still ongoing. Most of the molecules used as active ingredients are poorly soluble and permeable. An openable capsule could provide a solution to these formulation issues and to the lack of commercial products suitable for pediatrics. However, the ability of this form to deliver the right dose of active ingredient remains to be demonstrated. A stability-indicating HPLC-UV analytical assay method has been fully validated in line with the relevant international recommendations (ICH), and used to assay vitamin K, the first active ingredient in this initial proof of concept. A study of the dose accuracy of the capsule and other commercial forms (two- and 10-mg ampoules) was also carried out, as was a second short stability study. This capsule showed better accuracy than the other two modalities (p value = 0.72 one-tailed comparison test below the theoretical Wilcoxon value), demonstrating its ability to deliver a safe dose to the patient. Other issues still to be resolved include transportability of the technology to hospital pharmacies, exploration of other active ingredients with other formulations, and biopharmaceutical characterization of the forms produced.