Zm. Mathir et al., IN-VITRO CHARACTERIZATION OF A CONTROLLED-RELEASE CHLORPHENIRAMINE MALEATE DELIVERY SYSTEM PREPARED BY THE AIR-SUSPENSION TECHNIQUE, Journal of microencapsulation, 14(6), 1997, pp. 743-751
Citations number
21
Categorie Soggetti
Pharmacology & Pharmacy","Chemistry Applied","Engineering, Chemical
Non-pareil cores were spray-coated with a chlorpheniramine maleate (an
alkylamine antihistamine) layer and a Eudragit(R) NE30D overcoat in a
Wurster air-suspension apparatus. In vitro dissolution studies demons
trated that drug release was a function of polymer membrane thickness.
Polyethylene glycol 6000, as a hydrophillic additive, increased the i
n vitro release of chlorpheniramine maleate from the pellets. Pellets
coated with 8.30% Eudragit(R) NE30D, 0.50% talc and 1.00% polyethylene
glycol 6000 were found to display desirable controlled release charac
teristics for chlorpheniramine maleate over the 8-h testing period, wh
ich were also comparable with that of Dykatuss(R) capsules. The contro
lled release pellets exhibited first-order release characteristics for
chlorpheniramine maleate. Reproducibility of the manufacturing condit
ions employed in the study were confirmed thus ensuring reproducibilit
y of drug release characteristics between batches of chlorpheniramine
maleate pellets. Drug release from the pellets was shown to be indepen
dent of the dissolution method and medium used. Pellets displayed no s
ignificant change in drug release characteristics relative to the init
ial drug release data when stored for 12 weeks at room temperature (20
+/- 2 degrees C) and for 8 weeks at a low temperature (5 +/- 1 degree
s C). However, pellets stored at 37 degrees C with 80% relative humidi
ty and at 40 +/- 2 degrees C showed a slower in vitro drug release aft
er 8-week storage and therefore failed to maintain their initial drug
release profile.