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Impacto de los desintegrantes en la estructura y desintegración de comprimidos de dispersión sólida amorfa a base de

Natsuki Takahashi¹, Miho Inoue², Takayuki Terukina²

¹Department of Pharmaceutical Engineering and Drug Delivery Science, Graduate School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-Ku, Shizuoka-Shi, Shizuoka, 422-8526, Japan; Analytical Research Labs., Astellas Pharma Inc., 180 Ozumi, Yaizu-shi, Shizuoka, 425-0072, Japan.

Journal of pharmaceutical sciences

|February 7, 2026

Resumen

La elección del desintegrante impacta críticamente el rendimiento de los comprimidos de dispersión sólida amorfa (DSE). La crospovidona (CPV) mantiene la desintegración del comprimido, a diferencia del croscarmelosa sódica (CCS), que provoca retrasos debido a cambios estructurales en la HPMC.

Área de la Ciencia:

Tecnología Farmacéutica
Ciencia de Materiales

Sus antecedentes:

Las dispersiones sólidas amorfas (DSE) mejoran la solubilidad de fármacos poco solubles en agua.
El retraso de la desintegración en los comprimidos de DSE después del almacenamiento es un desafío importante en la formulación.

Objetivo del estudio:

Investigar cómo las propiedades del desintegrante afectan la desintegración de comprimidos de DSE a base de hidroxipropilmetilcelulosa (HPMC) que contienen griseofulvina (GRF).
Evaluar el impacto del croscarmelosa sódica (CCS) y la crospovidona (CPV) en la estructura y el rendimiento de los comprimidos de DSE en condiciones de almacenamiento acelerado (40 °C/75 % HR).

Principales métodos:

Mediciones viscoelásticas dinámicas
Pruebas de dureza
Pruebas de desintegración en condiciones de almacenamiento acelerado (40 °C/75 % HR).

Principales resultados:

El tipo de desintegrante influyó significativamente en la reorganización estructural de la HPMC después del almacenamiento.
El CCS provocó plastificación y retrasó la desintegración debido a la reorganización de las cadenas de HPMC facilitada por la retención de agua.
La CPV mantuvo la integridad del comprimido y el rendimiento de la desintegración a través de su capacidad de absorción, previniendo cambios estructurales.

Conclusiones:

La selección del desintegrante es crucial para optimizar la desintegración de los comprimidos de DSE y la absorción del fármaco.
Comprender los mecanismos de los desintegrantes es clave para desarrollar formulaciones de DSE estables y eficaces con una biodisponibilidad mejorada.

Palabras clave:

Dispersión sólida amorfa (DSE)Excipiente(s)Dureza Fármaco(s) poco soluble(s) en agua Estabilidad Comprimido(s)

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