Background Budesonide is a frequently used glucocorticoid in the treatment of eosinophilic esophagitis and other inflammatory gastrointestinal diseases.
In the Czech Republic the treatment of oesophageal inflammation by topical corticosteroids has only been possible via commercially available metered dose inhalers. The treatment by inhalers was insufficient in terms of achieving a desired concentration of the drug at the site of inflammation.
Purpose To develop a viscous oral dosage form of budesonide with a minimum level of excipients to avoid allergen exposure. To determine the stability and shelf life of the oral suspension by a standardised method – High-performance liquid chromatography (HPLC).
Materials and methods A viscous budesonide 0.2 mg/ml suspension was prepared. Budesonide was dispersed in glycerol 85%. Viscosity was achieved by using aqueous methyl cellulose gel. Glycerol 85% and oil of orange (Oleum Aurantii) were used to cover the bitter taste of budesonide. Optimum stability was achieved by the preservative excipient glycerol. The stability of the suspension was assessed at room (15–25°C) and reduced (2–8°C) temperature by the HPLC method.
Results A suspended formulation of the drug was optimised with respect to stability and taste. A HPLC method was developed to test the stability. Viscous budesonide suspension improved the course of eosinophilic esophagitis (treatment success was verified endoscopically)
Conclusions A stable viscous oral budesonide suspension which effectively delivers budesonide into the oesophagus was developed. Adult and paediatric patients are being treated successfully with the viscous suspension in the Czech Republic.
No conflict of interest.
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