Scientific papers
Orodispersible minitablets (ODMTs) offer several advantages such as ease of swallowability, dose flexibility, and straightforward manufacturing through direct compression. This study investigates the impact of lubrication on five different co-processed excipients (Ludiflash®, Parteck® ODT, Prosolv® ODT G2, galenIQ™ 721, and SuperTab® 50 ODT) for orodispersible tablets (ODTs) with diameters of 11.28 mm and 2 mm.
The study compares external lubrication with internal lubrication using 0.5%, 1%, or 2% magnesium stearate, or 1%, 2%, or 4% sodium stearyl fumarate. Lubrication efficiency is assessed alongside the mechanical strength and disintegration time of the ODTs. Particularly, mannitol-based co-processed excipients exhibit a strong dependence on lubricant concentration, while both ODTs and ODMTs, as well as minitablets with isomalt, demonstrate comparable properties for both lubricants and their concentrations.
Sodium stearyl fumarate is identified as the preferred lubricant for ODMTs due to its higher lubrication efficiency and less negative impact on disintegration time. External lubrication results in higher tensile strength for plastic materials but increases disintegration time, especially for ODMTs, owing to the high specific surface where the lubricant is applied. In summary, this study demonstrates that minitablets necessitate higher lubricant concentrations compared to conventionally sized tablets.
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