[b]The US FDA has suggested pharmaceutical firms use a maximum bead size of 2.0mm for modified-release drugs formulated for “sprinkle” delivery to avoid problems resulting from inadvertent chewing.
The recommendation, part of draft guidelines issued last week, is designed to ensure that capsule-formulated drug products that are approved for mixture with soft food to aid delivery perform correctly and can be properly absorbed.
The Food and Drug Administration (FDA) said it: “Recognized the specific importance of a maximum bead size limit for modified-release products, where unintentional chewing of beads may lead to pharmacokinetic differences.”
The agency suggested that considerable “taste and performance issues” may arise from accidental chewing and that these again could result in non-compliance and decreased therapeutic efficacy. [/b]
fda-draft Guidance.pdf (43.1 KB)