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

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      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.

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      Affiliations
      [1 ] a Department of Pharmaceutical Sciences , University of Basel , Basel , Switzerland.
      [2 ] b R&D Minerals and Surface Chemistry , Omya International AG , Oftringen , Switzerland.
      Journal
      Drug Dev Ind Pharm
      Drug development and industrial pharmacy
      Informa UK Limited
      1520-5762
      0363-9045
      May 23 2017
      28481735
      10.1080/03639045.2017.1328435

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