title: Formulation and stability of a beclomethasone dipropionate enema.
abstract: 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 degrees C) and of the BDP/mesalazine enema (44 days at 4 degrees C, 20 degrees C and 37 degrees C, respectively). Progressive darkening of colour occurred for the BDP/mesalazine enema during storage at 20 degrees C and at 37 degrees C, probably induced by mesalazine degradation products. Only very slight colouring was observed at 4 degrees C. Hardly any precipitation of BDP and mesalazine was seen during the storage period and the enemas could easily be resuspended.
authors.affiliation: Department of Pharmacy, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: L M
authors.initials: LM
authors.lastname: Stolk
authors.forename: M
authors.initials: M
authors.lastname: Gerrits
authors.forename: E H
authors.initials: EH
authors.lastname: Wiltink
authors.forename: C J
authors.initials: CJ
authors.lastname: Mulder
authors.forename: G N
authors.initials: GN
authors.lastname: Tytgat
mesh_terms: D001507:Beclomethasone / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D004733:Enema; D012995:Solubility
chemical_list: D001507:Beclomethasone