For complex encapsulated controlled-release OSD therapeutics
Extrusion-spheronization as a drug delivery strategy has achieved tremendous success in improving safety, efficacy, and dose compliance across a diverse range of therapeutic areas.
Our formulation skills and experience with the mechanisms of continuous-flow extrusion-spheronization support a broad range of controlled release dose forms including fixed-dose combinations (FDCs), combined and modified-release single-capsule forms, and multi-unit particulate system (MUPS) tablet designs.
State-of-the-art capabilities and global regulatory compliance
Bora’s extrusion–spheronization capabilities can accommodate small-batch to commercial-scale manufacturing and includes a continuous processing line. All production activities related to extrusion–spheronization processing are conducted in temperature/relative humidity monitored and controlled areas. Process rooms have individual temperature and humidity recorders installed to tightly control optimal conditions.
Our facilities are inspected by leading international regulatory authorities and comply with Pharmaceutical Inspection Co-operation Scheme (PIC/S), Current Good Manufacturing Practice (CGMP), and Good Distribution Practice (GDP) guidance for all drug products.
