Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle |
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Authors: | Laxma R Nagavelli Robert A Lionberger Vilayat A Sayeed Lawrence Yu James Allgire Anjanette Smith Anna Wokovich Benjamin J Westenberger Lucinda Buhse |
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Institution: | Office of Generic Drugs, Office of Pharmaceutical Science, Food and Drug Administration, 7500 Standish Place, Rockville, Maryland 20855, USA. |
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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 microm (1.5 mm). Based on this information, a bead size of less than 1,500 microm should generally be considered acceptable for use in generic products labeled for sprinkling. |
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