Orodispersible tablets as delivery platform for oral administration of drug-loaded nanoparticles to paediatric patients.

Patient-friendly solid oral dosage forms remain a rather understudied part of pharmaceutical development, particularly in paediatric patients. Thus, patients and caregivers around the world must resort to traditional approaches, such as liquid dosage forms or division of solid dosage forms, which can lead to inaccurate dosing and drug inactivation. To avoid these issues, as well as the swallowing problems and choking risk of conventional solid oral dosage forms, there is a need for modern, safe and effective oral dosage forms. Orodispersible tablets enhance the ease of administration for patients with deglutition difficulties, but their use is typically confined to immediate-release delivery systems. In this study, we addressed these shortcomings by developing orodispersible tablets as delivery platform for oral administration of loratadine-loaded zein-based nanostructures to paediatric patients. First, the nanostructures were freeze-dried with mannitol and maltodextrin as cryoprotectants. The resulting powders were compressed as such or mixed with different ratios of co-processed excipients for orodispersible tablets, in order to understand their compression behaviour. To ensure dose uniformity and powder homogeneity, a near infrared spectroscopic method was developed for non-destructive assessment of the API content. With the aid of the co-processed excipients and supplementary lubrication to reduce the tablet ejection stress, tablets with adequate mechanical properties and a disintegration time within the required range of 180 s were obtained from the nanostructures lyophilised with mannitol. Through this methodology, we have transformed loratadine-based nanosystems into an innovative and patient-friendly oral delivery system that meets the specific quality requirements of orodispersible pharmaceutical forms.