T. Govender et Cm. Dangor, FORMULATION AND PREPARATION OF CONTROLLED-RELEASE PELLETS OF SALBUTAMOL BY THE AIR SUSPENSION TECHNIQUE, Journal of microencapsulation, 14(4), 1997, pp. 445-455
Citations number
19
Categorie Soggetti
Pharmacology & Pharmacy","Chemistry Applied","Engineering, Chemical
A controlled release preparation of salbutamol may improve patient com
pliance, minimise side effects and be valuable in the treatment of noc
turnal asthma by extending drug action throughout the night. The aim o
f the study was therefore to formulate a controlled release pellet pre
paration of salbutamol via the air suspension technique. The study est
ablished that curing for 24 h at 38 +/- 0.5 degrees C was necessary fo
r homogeneous film coats of Eudragit(R) RS30D and hence stable drug re
lease characteristics. Pellets coated with 6% Eudragit(R) RS30D (polym
er), 12.5% triethyl citrate (plasticiser) and 0.5% magnesium stearate
(antitackiness agent) displayed desirable controlled drug release char
acteristics over the 8 h testing period. The manufacturing conditions
employed in the study were shown to be reproducible thus ensuring repr
oducibility of drug release characteristics between batches of salbuta
mol controlled release pellets. Short term stability testing on the ne
wly formulated pellets indicated no significant change in drug release
characteristics relative to the initial drug release data when stored
for 8 weeks at room temperature 20 +/- 2 degrees C or 37 degrees C wi
th 80% Relative Humidity or at low temperature (5 +/- 1 degrees C). Ho
wever, pellets stored at 40 degrees C, showed a slower in-vitro drug r
elease after 8 weeks of storage and therefore failed to maintain their
initial drug release profile.