NOVEL DOSING AND DISPENSING SYSTEM FOR MULTIPARTICULATE CANCER DRUGS Oncology drugs continue to advance at a rapid pace with many therapies delivered orally as tablets or capsules. Smaller children, however, cannot swallow tablets or capsules. For these drugs to be used in the pediatric population they need to be reformulated. Traditionally this has meant creating a liquid suspension, chewable, or rapid dissolve tablet. Cancer medications, however, often have terrible taste profiles that require large amounts of sugar and flavorants to mask, if the taste can be masked at all. The taste issue can lead to longer development times for pediatric formulations and dosing compliance issues. One potential solution to the taste issue is to formulate the drugs as multiparticulate; dry, taste-masked microspheres. Multiparticulate formulated drugs (MP) are ideal candidates for giving to children since they can be flavorless do not require liquid reconstitution, and do not require refrigeration. They should be better tolerated by children, especially those with sensitivity to flavors as can occur with some cancer therapies. MP drugs also pose a lower risk of toxicity effects from skin contact vs. liquid formulations, to patients and caregivers. To date, MP drugs have been delivered in unit-dose sprinkle capsules or sachets. While those methods might work for single, set doses, they are not suitable for pediatric cancer drugs which require precision dosing based on weight or size of the child. This lack of delivery system is a major hurdle to the use of MP drugs for pediatric cancer. HS Design (HSD) is developing the 1ml Sympfiny system to accurately measure and dose MP drugs in volumes suitable for pediatric cancer treatments. HSD is taking a platform approach, so the system can be tailored for a variety of pediatric cancer drugs. .
