Potential Use of Magnesium Oxide as an Excipient to Maintain the Hardness of Orally Disintegrating Tablets during Unpackaged Storage.

ABSTRACT

This study aimed to clarify the effects of magnesium oxide (MgO) on the hardness of orally disintegrating tablets (ODTs) during storage. ODTs containing a range of MgO concentrations were prepared by direct powder compression and stored for up to 4 weeks in an unpackaged condition at 40°C, with 75% relative humidity. Tablets that did not contain MgO showed a significant decrease in hardness after one week in storage, while those containing MgO at a mass fraction of ≥4% maintained their hardness for up to 4 weeks. The tablet disintegration times after storage were equivalent to those observed before storage (approximately 30 s), regardless of the MgO level. Furthermore, the dissolution behavior of a model drug (acetaminophen) from the ODTs was not affected by the level of MgO. These findings revealed that the addition of MgO suppressed the reduction in ODT hardness during storage in the unpackaged state, without delaying tablet disintegration or inhibiting drug release.