Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics
<b>Background:</b> 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. <b>...
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2024-12-01
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| author | Camila Olivera Oriana Boscolo Cecilia Dobrecky Claudia A. Ortega Laura S. Favier Valeria A. Cianchino Sabrina Flor Silvia Lucangioli |
| author_facet | Camila Olivera Oriana Boscolo Cecilia Dobrecky Claudia A. Ortega Laura S. Favier Valeria A. Cianchino Sabrina Flor Silvia Lucangioli |
| author_sort | Camila Olivera |
| collection | DOAJ |
| description | <b>Background:</b> 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. <b>Objective:</b> The aim of this work is the development of trihexyphenidyl orodispersible minitablets (ODMTs) for pediatric use. <b>Methods:</b> 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. <b>Results</b>: 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. <b>Conclusions:</b> These ODMTs will allow efficient, safe, and high-quality pharmacotherapy. |
| format | Article |
| id | doaj-art-dbbf33074ff34853a72d8e169223a72f |
| institution | Kabale University |
| issn | 1999-4923 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-dbbf33074ff34853a72d8e169223a72f2025-01-24T13:45:33ZengMDPI AGPharmaceutics1999-49232024-12-01171510.3390/pharmaceutics17010005Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in NeuropediatricsCamila Olivera0Oriana Boscolo1Cecilia Dobrecky2Claudia A. Ortega3Laura S. Favier4Valeria A. Cianchino5Sabrina Flor6Silvia Lucangioli7Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, ArgentinaDepartamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, ArgentinaDepartamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, ArgentinaÁrea de Farmacotecnia, Ética y Legislación Farmacéutica, Departamento de Farmacia, Facultad de Química, Bioquímica y Farmacia, Universidad Nacional de San Luis, San Luis D5700HHW, ArgentinaÁrea de Farmacotecnia, Ética y Legislación Farmacéutica, Departamento de Farmacia, Facultad de Química, Bioquímica y Farmacia, Universidad Nacional de San Luis, San Luis D5700HHW, ArgentinaÁrea de Farmacotecnia, Ética y Legislación Farmacéutica, Departamento de Farmacia, Facultad de Química, Bioquímica y Farmacia, Universidad Nacional de San Luis, San Luis D5700HHW, ArgentinaDepartamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, ArgentinaDepartamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina<b>Background:</b> 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. <b>Objective:</b> The aim of this work is the development of trihexyphenidyl orodispersible minitablets (ODMTs) for pediatric use. <b>Methods:</b> 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. <b>Results</b>: 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. <b>Conclusions:</b> These ODMTs will allow efficient, safe, and high-quality pharmacotherapy.https://www.mdpi.com/1999-4923/17/1/5trihexyphenidylorodispersible minitabletspediatric pharmacotherapyorphan formulation |
| spellingShingle | Camila Olivera Oriana Boscolo Cecilia Dobrecky Claudia A. Ortega Laura S. Favier Valeria A. Cianchino Sabrina Flor Silvia Lucangioli Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics Pharmaceutics trihexyphenidyl orodispersible minitablets pediatric pharmacotherapy orphan formulation |
| title | Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics |
| title_full | Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics |
| title_fullStr | Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics |
| title_full_unstemmed | Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics |
| title_short | Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics |
| title_sort | development and characterization of trihexyphenidyl orodispersible minitablets a challenge to fill the therapeutic gap in neuropediatrics |
| topic | trihexyphenidyl orodispersible minitablets pediatric pharmacotherapy orphan formulation |
| url | https://www.mdpi.com/1999-4923/17/1/5 |
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