Cc. Wang et al., INFLUENCE OF PLASTICIZERS ON THE MECHANICAL-PROPERTIES OF PELLETS CONTAINING EUDRAGIT(R)-RS-30-D, International journal of pharmaceutics, 152(2), 1997, pp. 153-163
The influence of plasticizers on the mechanical properties of single p
ellets containing the acrylic polymeric dispersion, Eudragit(R) RS 30
D, as a granulating binder was investigated. Microcrystalline cellulos
e and anhydrous lactose were used as the substrate powders for pellets
prepared by the wet massing and extrusion/spheronization technique. T
he effects of hydrophilic and hydrophobic plasticizers on the mechanic
al properties of the pellets and thermal properties of free films were
investigated. The mechanical properties, including tensile strength a
nd Young's modulus, of individual pellets were determined by a diametr
al compression method with a Chatillon(R) tension/compression apparatu
s. The results demonstrated that both the tensile strength and Young's
modulus of the pellets decreased as the plasticizer content increased
in the pellet formulation, with the exception at low plasticizer leve
ls. The influence of plasticization on the granulating polymer was ref
lected in the mechanical properties of pellets, indicating that the pe
llets underwent a cohesive fracture. The unexpected increase in the te
nsile strength and Young's modulus of the pellets containing low level
s of plasticizers was ascribed to the antiplasticization of the polyme
r due to the immobilization of the polymer molecules by hydrogen bondi
ng, van der Waal's forces and steric hindrance from the plasticizer mo
lecules. Pellets containing low levels of plasticizers exhibited a bri
ttle fracture behavior under compression while a ductile property was
observed at higher plasticizer concentrations. The transition of the f
racture behavior from a brittle to a ductile pattern was found to take
place when plasticizer levels in the acrylic polymer were between 10
and 20% based on the weight of dry polymer. The transition was due to
the shift of the polymeric binder from a glassy to a rubbery state, wh
ich was verified by the glass transition temperature values of the fre
e films. (C) 1997 Elsevier Science B.V.