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Stability of Dexamethasone Oral Liquid Formulations
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| Author:
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MALATHE A ALSHAWI, NAWAR ADDAI, MOHAMMED SATTAR, MAZIN N MOUSA, BADER S ALABDULLAH
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| Abstract:
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Introduction: Dexamethasone is a glucocorticoid exhibiting potent anti-inflammatory effects. Oral liquid dosage forms are considered as the main age-adapted formulations of dexamethasone as they offer better dose adjustment, easy to swallow and possibility to mix with food for taste improvement. The aim of the current work is to formulate a stable dexamethasone oral solution that can resist degradation upon storage in the harsh environmental storage conditions of Iraq climate. Materials and Methods: Oral liquid preparations of dexamethasone was prepared using different excipients and stored under accelerated (40 ºC ± 2 ºC and relative humidity of 75% ± 5%) for 6 months and long term stability conditions (30 ºC ± 2 ºC and relative humidity of 65% ± 5%) for 18 months. The physicochemical properties of the prepared formulas in terms of appearance, specific gravity, color intensity, pH and drug content were determined. HPLC method according to USP was used to determine dexamethasone in the prepared formulas. Results: Under both sets of storage conditions, the physical parameters of all prepared formulas were within the specified range for the entire study period. F2 showed very high recovery of dexamethasone (more than 98%) at the end of accelerated and long term stability tests. Conclusion: F2 was prepared as stable oral liquid solution of dexamethasone in the presence of sodium metabisulfite as an antioxidant.
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| Keyword:
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Dexamethasone, oral liquid formulation, accelerated and long term stability.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.722
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| Download:
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