An Empirical Approach To Mitigate The Risk Of Content Uniformity Variability During The Tablet Compression Of Drug Coated Extended Release Beads

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Deva H Puranam , Srinivasa Rao Yarguntla , Shyamala Pulipaka

Abstract

Multiunit bead products are effective extended drug release systems, and the tablet manufacturing of multiunit beads is associated with risks such as content uniformity variabilitydue to beads segregation. The objective of current study is to introduce a new method of blend material transfer to mitigate the beads segregation during compression. The drug coated beads were blended with tablet excipients and compressed to tablets by transferring the homogenous blend to press hopper both by inversionand manual methods. The content uniformity was evaluated using Variance Component Analysis (VCA).The data demonstrated content uniformity variability in the samples obtained with inversion method and acceptable data with manual transfer method. The variability in the content uniformity was presumed due to beads segregation during the material transfer by inversion method. The drug release data of the compressed tablets was consistent to the uncompressed beads concluding no rupture of the film during the tablet compression. Although, the manual material transfer method is primitive and limited to smaller batch size, the method is of a great potential to alleviate the risk of beads segregation and improve the content uniformity. The VCA data analysis provides assurance that future samples from the batch will comply with USP<905>.

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