Ms. Mesiha et D. Rivera, FACTORIAL DESIGN OF PHENYLPROPANOLAMINE PROLONGED RELEASE TABLETS FORMULATIONS USING FLUID-BED DRYER GRANULATOR, Drug development and industrial pharmacy, 20(1), 1994, pp. 31-48
A two level factorial design approach was applied to the formulation o
f prolonged release phenylpropanolamine tablets using three factors: E
thylacrylate-methyl methacrylate co-polymer (Eudragit NE-40D) concentr
ation, Microcrystalline cellulose (Avicel PH102) addition to the table
ts formula, and the milling of the granulations before compression. Th
e release rate of the drug was the measured parameter. The rate of dru
g release was mainly affected by the level of the Eudragit. Avicel pro
motes the release of the drug, specially at low Eudragit level concent
rations, Tablets prepared from unmilled lots showed slower drug releas
e than the corresponding lots of milled granules.