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Importance of the Effect of MPEG on Wetted PEO in Extrusion-Spheronization of Beads
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UPLOADED BY-ADMIN, MATTHEW A. HOWARD, STEVEN H. NEAU
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| Abstract:
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An alternative approach to produce extruded-spheronized beads, devoid of microcrystalline cellulose and with a high
drug load (greater than 80% w/w), was offered in an earlier publication. Herein, the formulation components, namely
pseudoephedrine hydrochloride, polyethylene oxide and methoxypolyethylene glycol, were studied to investigate the function
of the excipients and, in particular, to propose a mechanism for the anti-tack effect of methoxypolyethylene glycol on
wetted polyethylene oxide. Extrusion-spheronization experiments were completed to directly evaluate the effect of the polyethylene
oxide:methoxypolyethylene glycol mass ratio on selected characteristics of the beads. The effect of increasing polyethylene
oxide, methoxypolyethylene glycol, and pseudoephedrine hydrochloride relative concentrations was evaluated in a
force of detachment study using well hydrated samples. The results confirmed that wetted polyethylene oxide functions as a
binder, increasing the force of detachment; changes in pseudoephedrine hydrochloride concentration produced a statistical
effect that could not be discriminated from no effect at all; and the antitack effect of methoxypolyethylene glycol could not
be enhanced above a certain level. Temperature modulated differential scanning calorimetry results helped establish that, up
to a 2:1 polyethylene oxide:methoxypolyethylene glycol mass ratio, methoxypolyethylene glycol occupies water binding
sites on the polyethylene oxide, which weakens the polyethylene oxide hydrogel. Above that 2:1 mass ratio, methoxypolyethylene
glycol self-associates to form multiple layers on polyethylene oxide.
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| Keyword:
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extrusion, spheronization, polyethylene oxide, methoxypolyethylene glycol, force of detachment, differential scanning calorimetry
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