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Abstract
The thermal stability of polyethylene oxide (PEO) in sustained release tablets prepared
by hot-melt extrusion was investigated. The weight average molecular weight of the
polymer was studied using gel permeation chromatography. The chemical stability of
PEO was found to be dependent on both the storage and processing temperature, and
the molecular weight of the polymer. Storage of the polymer above its melting point
significantly increased polymer degradation, and the degradation process was accelerated
as the molecular weight was reduced. The thermal stability of PEO MW = 1,000,000 (PEO
1 M) in sustained release chlropheniramine maleate (CPM) tablets prepared by hot-melt
extrusion was found to depend on the processing temperature and screw speed. Lower
molecular weight PEO MW = 100,000 (PEO 100 K) was demonstrated to be a suitable processing
aid for PEO 1 M. Incorporation of PEO 100 K reduced degradation of PEO 1 M and did
not alter the release rate of CPM. Vitamin E, Vitamin E Succinate and Vitamin E TPGS
were found to be suitable stabilizers for PEO, however, ascorbic acid was shown to
degrade the polymer in solution. Thermal analysis demonstrated that Vitamin E Succinate
and Vitamin E TPGS were dispersed at the molecular level in hot-melt extruded tablets.
Solubilized Vitamin E Succinate and Vitamin E TPGS suppressed the melting point of
the polyethylene oxide. Drug release rates from hot-melt extruded tablets stabilized
with antioxidants were found to be dependent on the hydrophilic nature of the antioxidant.