Associate Director FAS LAB Evonik Corporation/ St. Johns University hillsborough, New Jersey
Formulating live biotherapeutics is challenging as they are sensitive to acidic conditions and cannot withstand pharmaceutical unit operations. In current study functional coated HPMC capsules with EUDRAGIT® polymers are tested in vitro and In-vivo. In-Vitro testing is performed by standard and biorelevant dissolution. For In-vivo analysis Phase 1b clinical study, was performed with MaaT’s full ecosystem fecal microbiota for safety and tolerability in acute myeloid leukemia (AML) patients exposed to intensive rounds of chemotherapy and antibiotics.
In-vitro evaluation by both dissolutions showed enteric protection in acid till pH-7.2, showing no release, deformation or signs of leakage until Ileocecal passage. Results of clinical trial showed strong and sustained engraftment. Persistent engraftment as relatively stable operational taxonomic unit (OUT) levels at V4, after chemotherapy 4 weeks post treatment. Microbiome filled capsules are effective in restoring gut microbiota (increase in microbiota richness and an effective and persistent engraftment).
Learning Objectives:
Demonstrate and corelate In-vitro and In-vivo delivery of microbiome to distal region in the gut utilizing functional ready to use HPMC enteric capsules that can resist different buffers, agitation, pressures.
Evaluate simpler option of using eneteric capsules for microbiomed delivery.
utilize Eudracap for delivering sensitive active to distal region in gut.
