“But, the effects of newer formulations, such as effervescent and chewable dosage forms, granules and sprinkles … are largely untested with regards to medication adherence.”
– Zuidgeest et al. Update on 2004 Background Paper, Priority Medications for Children. 2013
“Sprinkles,” to many, conjure up the image of flavorless colored dots to make ice cream look festive. In drug delivery, however, sprinkle medications are beads filled with API that patients can pour onto soft food and swallow if they have trouble swallowing full capsules. In order for sprinkle medications to be drug delivery option for patients with dysphagia, they must follow certain parameters, such as size, bioavailability and ease of use.
In May 2012, the U.S. FDA released revised nonbinding recommendations for drug products labeled for sprinkle. The first guideline in the recommendations is that of maximum sprinkle size. The beads must be smaller than 2.5 mm with less than 10% size variation, so patients don’t chew the beads. It is important that patients don’t chew sprinkle medication. Many sprinkle medications are extended-release or delayed-release drugs, and chewing the beads could cause early release or drug burst.
Another guideline the FDA lists is that of bioavailability. As with any new drug delivery method, bioavailability must be at acceptable levels, and for controlled-release forms, bioequivalence must be retained. Because sprinkle medications are designed to be taken with soft food, pharmaceutical companies must factor in the pharmacokinetics of food with the sprinkles.
A point the FDA doesn’t address that is still important for the success of sprinkle medications is ease of use. Developers of sprinkle medications target patients with dysphagia, often pediatric and geriatric populations. Many such patients have difficulty opening things. The capsule containing the beads must be easy to open to truly be effective.
In order for the sprinkle method of drug delivery to be most effective, the medication must be consistently small, retain bioavailability and be easy to use. Orbis BiosciencesTM uses Precision Particle FabricationTM technology to create uniform particles as small as two microns. Our technology allows us to develop flexible-format medication. The titratable, fillable powder is easy to use and appropriate for pediatric patients, geriatric patients and other patients with dysphagia or other restrictions. Unlike ice cream sprinkles, which are disappointingly flavorless, our drugs can be intentionally taste-masked, which can bring as much festivity as ice cream to a patient or caregiver who needs easy-to-swallow, good-tasting medication.