Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics

Abstract

Trihexyphenidyl (THP) has been widely used for over three decadesas pediatric pharmacotherapy in patients affected by segmental and generalized dystonia.In order to achieve effective and safe pharmacotherapy for this population, new formulationsare needed. Objective: The aim of this work is the development of trihexyphenidylorodispersible minitablets (ODMTs) for pediatric use. Methods: Six different excipientswere tested as diluents. The properties of powder mixtures were evaluated before directcompression and pharmacotechnical tests were performed on the final formulation. Thedetermination of the API content, uniformity of dosage, and physicochemical stabilitystudies were analyzed by an HPLC-UV method. Results: The developed ODMTs metpharmacopeia specifications for content, hardness, friability, disintegration, and dissolutiontests. The physicochemical stability study performed over 18 months shows that APIcontent remains within 90.0–110.0% at least for this period. Conclusions: These ODMTswill allow efficient, safe, and high-quality pharmacotherapy.