A cost-effective robotic platform for on-demand production of flexibly dosed medications in a chewable gummy dosage form

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43HD095812-01
Agency Tracking Number: R43HD095812
Amount: $149,163.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PAR17-199
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-04-01
Award End Date (Contract End Date): 2018-09-30
Small Business Information
184 CYPRESS ST, UNIT 3, Providence, RI, 02906-2502
DUNS: 079665879
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (401) 200-8569
Business Contact
Phone: (407) 619-8694
Email: daniel@vitaeindustries.com
Research Institution
PROJECT SUMMARYThis project s goal is to develop an innovative cost effective robotic platform for fast on demand pharmacy production of pediatric drugs as individually tailored palatable gummy dosage formsMedication adherence is notoriously low among children due to difficulty swallowing pills and rejection of bad tasting medicationsAlthough some common pediatric drugs have flavored liquid formspediatric adherence is still low due to unacceptable taste and volumeCompound liquid formulations also contribute to the most common pediatric medical errorincorrect dosingCurrent mass manufacturing processes cannot economically provide the variety of flavors and doses needed in the comparatively smaller pediatric marketWhile existing gummy compounding practices are extremely slowerror proneand labor intensive which limits their practiceThis novel gummy production platform for pharmacies combinesD printing with gummy based pharmaceutical production for the first timeVitae s automated compounding platform for on demand custom dose tablet production provides a strong foundation for this projectIts capabilities will be expanded to support gummy productionThe first target is a clonidine gummy to replace current oral compound suspensionsAimis to develop a flavored clonidine gummy formulation compatible with the robotic platform s extrusion processThe proposed chemical gummy base formula is starch basedan ingredient widely used in food and drug productionWe will optimize this base for use with two additional model drugs to ensure platform versatilityThena predefined set of flavors compatible with clonidine will be incorporatedA final formula will be selected based on the active pharmaceutical ingredient sAPI sstabilityviscosityand viscoelastic propertiesAimis to develop algorithms for printing accurately dosed gummiesExistingD printingDPsoftware controls output by computing paths based on size and shapeHoweverproducing correct drug doses depends on volume and mass of APIs and excipientsThereforemathematical algorithms will be developed to translate the specified dose and characteristics of the starting materiale gconcentrationinto a precise gummy sizeshapevolume and path for robotic production viaDPSuccessful completion of this Phase I project will result in a clonidine gummy formulation that pharmacies can compound with Vitae s automated platform and dispense to patientsMedication acceptance relating to taste can then be evaluated by pediatric patientsThis project will also establish feasibility of formulating other drugs in the printable gummy base allowing Vitae to immediately testverify and deploy additional gummy drugs after completionDesigned for use in compounding and hospital pharmaciesthe proposed robotic platform will fully automate the currently slowmanual extemporaneous preparation processsignificantly increasing efficiency and reducing costsImproving accessibility and affordability of tailored gummies would facilitate large scale studies to evaluate custom doses and improve critically lacking pediatric dosing guidelines PROJECT NARRATIVE Adherence to properly dosed medications is essential for successful treatment outcomesbut pediatric adherence is notoriously low and incorrect dosing is the most commonly reported error in pediatricsThere is a clear need for more palatable medications that accurately provide the range of doses needed by childrenespecially since taste is the most commonly reported reason for rejecting medicationThis project will develop a novel robotic platform based onD printing technology to enable faston demand pharmacy production of custom flavored palatable gummy medications with precise tailored doses required by children of all ages and sizes

* Information listed above is at the time of submission. *

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