Paediatric orodispersible lozenges produced by moulding process: quality and stability control

Abstract

Abstract Objectives Active pharmaceutical ingredients for paediatric patients are formulated at hospital pharmacy services and compounding pharmacies when they are not commercially available. This work evaluated the quality and stability of lozenges, an orodispersible dosage form, elaborated by a simple and low-cost moulding process. Methods The lozenges were formulated with 10 mg of hydrochlorothiazide as an active pharmaceutical ingredient and a commercial excipient suitable for paediatric use (Natatroche®). A High-Performance Liquid Chromatography system was used to quantify the active pharmaceutical ingredient from pure and extracted from dosage form samples. The quality of the lozenges was checked by the European Pharmacopeia tests indicated for oromucosal preparations, and additional quality tests specified for orodispersible and dispersible tablets. The stability of this dosage form was evaluated by the International Conference of Harmonization indications. Results The chromatographic method could quantify the active pharmaceutical ingredient extracted from excipient matrix. This formulation met uniformity of dosage units test for oromucosal dosage forms and, in addition, met the disintegration time test for orodispersible tablets and the fineness of dispersion test for dispersible tablets. Hydrochlorothiazide in lozenges was stable for 60 days when stored at 5 °C. Conclusions Moulded hydrochlorothiazide tablets are quick-to-prepare dosage forms that can be prepared in a simple, low-cost manufacturing process. They are safe and stable, disintegrate quickly in the mouth, and are therefore a recommended option for children, or other patients with swallowing problems.