HS-DESIGN, INC — Department of Health and Human Services SBIR Phase II: NCI

Description

Oncology drugs continue to advance at a rapid pace with many therapies delivered orally as tablets or capsulesSmaller childrenhowevercannot swallow tablets or capsulesFor these drugs to be used in the pediatric population they need to be reformulatedTraditionally this has meant creating a liquid suspensionchewableor rapid dissolve tabletCancer medicationshoweveroften have terrible taste profiles that require large amounts of sugar and flavorants to maskif the taste can be masked at allThe taste issue can lead to longer development times for pediatric formulations and dosing compliance issuesOne potential solution to the taste issue is to formulate the drugs as multiparticulatedrytaste masked microspheresMultiparticulate formulated drugsMPare ideal candidates for giving to children since they can be flavorless do not require liquid reconstitutionand do not require refrigerationThey should be better tolerated by childrenespecially those with sensitivity to flavors as can occur with some cancer therapiesMP drugs also pose a lower risk of toxicity effects from skin contact vsliquid formulationsto patients and caregiversTo dateMP drugs have been delivered in unit dose sprinkle capsules or sachetsWhile those methods might work for singleset dosesthey are not suitable for pediatric cancer drugs which require precision dosing based on weight or size of the childThis lack of delivery system is a major hurdle to the use of MP drugs for pediatric cancerHS DesignHSDis developing theml Sympfinysystem to accurately measure and dose MP drugs in volumes suitable for pediatric cancer treatmentsHSD is taking a platform approachso the system can be tailored for a variety of pediatric cancer drugs