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Solid Dosage Forms of Dexamethasone Sodium Phosphate Intended for Pediatric Use: Formulation and Stability Studies

Undesirable taste has always been a key issue for oral dosage forms. The aim of the present study was to co-formulate dexamethasone sodium phosphate (DSP), in common pediatric oral forms, using sweet preserves and/or different types of chocolate as excipients. An array of different kinds of chocolat...

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Detalles Bibliográficos
Autores principales: Synaridou, Maria S., Andriotis, Eleftherios G., Zacharis, Constantinos K., Fatouros, Dimitrios G., Markopoulou, Catherine K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238162/
https://www.ncbi.nlm.nih.gov/pubmed/32295189
http://dx.doi.org/10.3390/pharmaceutics12040354
Descripción
Sumario:Undesirable taste has always been a key issue for oral dosage forms. The aim of the present study was to co-formulate dexamethasone sodium phosphate (DSP), in common pediatric oral forms, using sweet preserves and/or different types of chocolate as excipients. An array of different kinds of chocolate were co-formulated with DSP and were further characterized by means of dynamic light scattering (DLS), x-ray diffraction (XRD), differential scanning calorimetry (DSC) and Fourier-transform infrared (FT-IR) spectroscopy. For the assay of active pharmaceutical ingredient (API), the chocolate samples were pre-treated by means of liquid extraction and analyzed using an high-performance liquid chromatographic (HPLC) method with a strong anion exchange column and a phosphate buffer (17 mM, pH = 3)/acetonitrile, 50:50 v/v as mobile phase. The developed chromatographic method was validated based on the International Conference on Harmonization (ICH) guidelines (%Mean Recovery = 99.4% and %Relative Standard Deviation, RSD = 0.43%). Furthermore, dissolution and in vitro digestion tests of chocolate formulations were evaluated. The DSP was found to be stable for at least 1 year in prepared preparations.