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

Vitae Industries, Inc., Providence RI

Investigators

Abstract

PROJECT SUMMARY This 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 forms. Medi- cation adherence is notoriously low among children due to difficulty swallowing pills and rejection of bad-tasting medications. Although some common pediatric drugs have flavored liquid forms, pediatric adherence is still low due to unacceptable taste and volume. Compound liquid formulations also contribute to the most common pe- diatric medical error ? incorrect dosing. Current mass manufacturing processes cannot economically provide the variety of flavors and doses needed in the comparatively smaller pediatric market. While existing gummy compounding practices are extremely slow, error-prone, and labor-intensive which limits their practice. This novel gummy production platform for pharmacies combines 3D printing with gummy-based phar- maceutical production for the first time. Vitae?s automated compounding platform for on-demand custom dose tablet production provides a strong foundation for this project. Its capabilities will be expanded to support gummy production. The first target is a clonidine gummy to replace current oral compound suspensions. Aim 1 is to develop a flavored clonidine gummy formulation compatible with the robotic plat- form?s extrusion process. The proposed chemical gummy base formula is starch-based, an ingredient widely used in food and drug production. We will optimize this base for use with two additional model drugs to ensure platform versatility. Then, a predefined set of flavors compatible with clonidine will be incorporated. A final for- mula will be selected based on the active pharmaceutical ingredient?s (API?s) stability, viscosity, and viscoelas- tic properties. Aim 2 is to develop algorithms for printing accurately dosed gummies. Existing 3D printing (3DP) software controls output by computing paths based on size and shape. However, producing correct drug doses depends on volume and mass of APIs and excipients. Therefore, mathematical algorithms will be devel- oped to translate the specified dose and characteristics of the starting material (e.g. concentration) into a pre- cise gummy size, shape, volume and path for robotic production via 3DP. Successful completion of this Phase I project will result in a clonidine gummy formulation that pharma- cies can compound with Vitae?s automated platform and dispense to patients. Medication acceptance relating to taste can then be evaluated by pediatric patients. This project will also establish feasibility of formulating other drugs in the printable gummy base allowing Vitae to immediately test, verify and deploy additional gum- my drugs after completion. Designed for use in compounding and hospital pharmacies, the proposed robotic platform will fully automate the currently slow, manual extemporaneous preparation process, significantly in- creasing efficiency and reducing costs. Improving accessibility and affordability of tailored gummies would facil- itate large-scale studies to evaluate custom doses and improve critically lacking pediatric dosing guidelines.