Abstract
The bead sizes used in approved modified release capsules labeled for sprinkling on food was investigated to generate bead size guidelines for generic products labeled for sprinkling. The conclusions from a survey of FDA databases were corroborated with experimental data obtained by measuring the bead sizes of several reference-listed drugs on the market labeled for administration by sprinkling on food. The experimental data show that majority of the marketed products were found to have bead sizes of less than 1,500 μm (1.5 mm). Based on this information, a bead size of less than 1,500 μm should generally be considered acceptable for use in generic products labeled for sprinkling.
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Acknowledgment
Authors thank Devinder Gill and Robert Iser of Office of Generic Drugs for helpful discussions during the execution of this project.
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Nagavelli, L.R., Lionberger, R.A., Sayeed, V.A. et al. Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle. AAPS PharmSciTech 11, 1508–1510 (2010). https://doi.org/10.1208/s12249-010-9529-2
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DOI: https://doi.org/10.1208/s12249-010-9529-2