FDA issues guidance on maximum 'sprinkle drug' bead size

Some drug capsules come with labels indicating it's OK to break them open and sprinkle the pharmaceutical beads onto soft food for easier swallowing. However, many of these beads are manufactured to release the medicine at different rates. So, it is important that these beads not be chewed, since that might produce unintended consequences and spoil the time-release aspect of delivery.

So, the FDA has produced a nonbinding draft guidance on bead size for products "labeled for sprinkle." The threshold, the FDA suggests, should be 2 mm. Any larger than that, and the chewing reflex kicks in. "It is important to have reasonable assurance that the patient will be able to swallow the beads with the food that the beads are mixed with without stimulating the urge to chew," the FDA says.

If beads are chewed, the agency adds, not only will it have an impact on "taste and performance," but might bring the medication out of compliance and decrease its therapeutic efficacy.

In-PharmaTechnologist.com points out the FDA's recommendations are roughly in line with research published last year in the AAPS PharmSciTech Journal, which recommended maximum bead sizes of 1.5 mm.

- read the FDA's guidance (.pdf)
- and a report from in-PharmaTechnologist.com