Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics
Camila Olivera,
Oriana Boscolo,
Cecilia Dobrecky,
Claudia A. Ortega,
Laura S. Favier,
Valeria A. Cianchino,
Sabrina Flor,
Silvia Lucangioli
Affiliations
Camila Olivera
Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina
Oriana Boscolo
Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina
Cecilia Dobrecky
Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina
Claudia A. Ortega
Área de Farmacotecnia, Ética y Legislación Farmacéutica, Departamento de Farmacia, Facultad de Química, Bioquímica y Farmacia, Universidad Nacional de San Luis, San Luis D5700HHW, Argentina
Laura S. Favier
Área de Farmacotecnia, Ética y Legislación Farmacéutica, Departamento de Farmacia, Facultad de Química, Bioquímica y Farmacia, Universidad Nacional de San Luis, San Luis D5700HHW, Argentina
Valeria A. Cianchino
Área de Farmacotecnia, Ética y Legislación Farmacéutica, Departamento de Farmacia, Facultad de Química, Bioquímica y Farmacia, Universidad Nacional de San Luis, San Luis D5700HHW, Argentina
Sabrina Flor
Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina
Silvia Lucangioli
Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina
Background: Trihexyphenidyl (THP) has been widely used for over three decades as pediatric pharmacotherapy in patients affected by segmental and generalized dystonia. In order to achieve effective and safe pharmacotherapy for this population, new formulations are needed. Objective: The aim of this work is the development of trihexyphenidyl orodispersible minitablets (ODMTs) for pediatric use. Methods: Six different excipients were tested as diluents. The properties of powder mixtures were evaluated before direct compression and pharmacotechnical tests were performed on the final formulation. The determination of the API content, uniformity of dosage, and physicochemical stability studies were analyzed by an HPLC-UV method. Results: The developed ODMTs met pharmacopeia specifications for content, hardness, friability, disintegration, and dissolution tests. The physicochemical stability study performed over 18 months shows that API content remains within 90.0–110.0% at least for this period. Conclusions: These ODMTs will allow efficient, safe, and high-quality pharmacotherapy.