Formulation and stability of a beclomethasone dipropionate enema.
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.
Stolk
L M
LM
Department of Pharmacy, Academic Medical Centre, Amsterdam, The Netherlands.
Gerrits
M
M
Wiltink
E H
EH
Mulder
C J
CJ
Tytgat
G N
GN
D001507:Beclomethasone / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D004733:Enema; D012995:Solubility
D001507:Beclomethasone