Application of Polyethylene Oxide in Mirabegron Extended-Release Tablets
OBJECTIVE To investigate the impact of polyethylene oxide(PEO,POLYOX™),penetration additives,and buty-lated hydroxytoluene(BHT)on tablet properties and drug release of mirabegron extended release(ER)tablets and provide some ideas of formulating polyethylene oxide based ER tablets for the formulators.METHODS Single-factor-experiment was applied to investi-gate the impact of formulation components on drug release of mirabegron ER tablets.Different molecular weight(MW),series of parti-cle size and use level of polyethylene oxide,three types of penetration additives(PEG 8000,PEG 4000 and lactose)and several use levels of butylated hydroxytoluene(BHT)were investigated.RESULTS Mirabegron ER tablets formulated with polyethylene oxide WSR N60K at 28％use level got statistically equivalent drug release with marketed mirabegron ER tablets.Higher MW and higher use level of polyethylene oxide led to slower drug release,while lower MW and lower use level led to faster drug release.Particle size of polyethylene oxide WSR N60K did not significantly affect mirabegron drug release.The tablets using either polyethylene glycol(PEG 8000 or 4000)or lactose as penetration additives could achieve equivalent drug release as marketed mirabegron ER tablets.The blend of polyethylene oxide WSR 301 and N12K at ratio of 35:65 has the same viscosity with polyethylene oxide WSR N60K and led to statistically similar drug release.CONCLUSION Formulation of polyethylene oxide based mirabegron ER tablets are robust.
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