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

Maria S Synaridou,Dimitrios G Fatouros,Constantinos K Zacharis,Catherine K Markopoulou,Eleftherios G Andriotis

doi:10.3390/pharmaceutics12040354

Maria S Synaridou, Dimitrios G Fatouros + Show 3 more

Open Access

https://doi.org/10.3390/pharmaceutics12040354

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Journal: Pharmaceutics	Publication Date: Apr 14, 2020
Citations: 2	License type: CC BY 4.0

Affiliation: Aristotle University of Thessaloniki

Abstract

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.

Highlights

Taste is considered to be the main sensory system which affects the acceptability of any medicine, especially in oral dosage form
Dexamethasone sodium phosphate (DSP) is a glucocorticosteroid utilized for the treatment of many inflammatory conditions, such as allergic disorders, ulcerative colitis, arthritis, psoriasis, etc
For the high-performance liquid chromatographic (HPLC) method: Methanol, acetonitrile and water were of HPLC grade and supplied by VWR chemicals (Vienna, Austria)

Summary

Introduction

Taste is considered to be the main sensory system which affects the acceptability of any medicine, especially in oral dosage form. Children, are reluctant to take certain types of medicines mainly due to their unpleasant organoleptic properties, such as smell, taste, aftertaste, texture, etc. Corticosteroids are naturally occurring compounds produced by the adrenal gland in the body and are involved in a wide range of physiological processes. Dexamethasone sodium phosphate (DSP) is a glucocorticosteroid utilized for the treatment of many inflammatory conditions, such as allergic disorders, ulcerative colitis, arthritis, psoriasis, etc. According to the World Health Organization (WHO), DSP is considered to be one of the most effective and safest medicines [4,5] for a lot of therapeutic schemes. DSP is hydrolyzed rapidly by phosphatases producing its free form [6]

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Results