Formulation and stability of a beclomethasone dipropionate enema
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A beclomethasone dipropionate (BDP) enema and a BDP/mesalazine combination enema (containing 2 mg BDP and 1 g mesalazine and 2 mg BDP, respectively per 40 ml) were formulated. BDP and mesalazine were suspended in a carbomer-water gel. No degradation of BDP was measured during the storage period of the BDP enema (4 weeks at 20°C) and of the BDP/mesalazine enema (44 days at 4°C, 20°C and 37°C, respectively). Progressive darkening of colour occurred for the BDP/mesalazine enema during storage at 20°C and at 37°C, probably induced by mesalazine degradation products. Only very slight colouring was observed at 4°C. Hardly any precipitation of BDP and mesalazine was seen during the storage period and the enemas could easily be resuspended.
KeywordsBeclomethasone Chromatography, high pressure liquid Chromatography, thin layer Drug compounding Drug stability Enema Mesalazine
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