Characterization of new functionalized calcium carbonate-polycaprolactone composite material for application in geometry-constrained drug release formulation development

Abstract

A new mineral–polymer composite (FCC-PCL) performance was assessed to produce complex geometries to aid in development of controlled release tablet formulations. The mechanical characteristics of a developed material such as compactibility, compressibility and elastoplastic deformation were measured. The results and comparative analysis versus other common excipients suggest efficient formation of a complex, stable and impermeable geometries for constrained drug release modifications under compression. The performance of the proposed composite material has been tested by compacting it into a geometrically altered tablet (Tablet-In-Cup, TIC) and the drug release was compared to commercially available product. The TIC device exhibited a uniform surface, showed high physical stability, and showed absence of friability. FCC-PCL composite had good binding properties and good compactibility. It was possible to reveal an enhanced plasticity characteristic of a new material which was not present in the individual components. The presented FCC-PCL composite mixture has the potential to become a successful tool to formulate controlled-release dosage solid forms.

Keywords:

• Mineral-polymer composite
• elastoplastic deformation
• geometrically modified release
• tablet formulation
• TIC device
• dry-coated tablet
• functionalized calcium carbonate
• polycaprolactone

Acknowledgements

Many thanks also go to Evi Bieler for her support with scanning electron microscopy. We also thank Darryl Borland and Silvia M. Rogers who provided editorial assistance.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The financial support for this PhD thesis was kindly provided by Omya International AG.