FDA Releases Guidance on Proper Size, Testing of Sprinkled Drug Products
The US Food and Drug Administration (FDA) released guidance 29 February that provides the agency's current thinking about the proper size ranges and testing methods for drug products that are sprinkled in bead form.
Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle advises sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics licensing applications (BLAs) that:
- It is important to have reasonable assurance that the patient will be able to swallow the beads (uncrushed) with the food with which the beads are mixed without stimulating the urge to chew
- The Agency recommends a target bead size up to 2.5 mm with no more than 10 percent variation over this size, to a maximum size of 2.8 mm
- Applicant should provide justification for the proposed bead size, including studies demonstrating that the bead can be swallowed without chewing using sprinkle administration in the intended population, if the bead size is larger than 2.8mm
- Target and maximum bead size, including bead size distribution, can be determined through analytical sieving in accordance with USP <786> or other appropriately validated methods
- Additional assurances may be needed when the label also includes specific language concerning alternate administration via an enteral feeding tube
- Products being tested for bioavailability and bioequivalence should be tested under fasting conditions
- If the product is an ANDA, it must be tested on the reference-listed product's recommended food products to ensure bioequivalence
Read more:
FDA - Guidance for Industry Size of Beads in Drug Products Labeled for Sprinkle