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Thermal Processing of PVP- and HPMC-Based Amorphous Solid Dispersions.

Justin S LaFountaine1, Leena Kumari Prasad2, Chris Brough2,3

  • 1Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas, 78712, USA. justin.lafountaine@utexas.edu.

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KinetiSol® Dispersing (KSD) enables amorphous solid dispersions (ASDs) with higher drug loads and polymer molecular weights than hot-melt extrusion (HME). KSD offers broader applicability for ASD manufacturing, overcoming limitations of traditional thermal processing.

Keywords:
KinetiSol® Dispersinggriseofulvinhot-melt extrusionhydroxypropyl methylcellulosepolyvinylpyrrolidone

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Area of Science:

  • Pharmaceutical Manufacturing
  • Materials Science
  • Polymer Chemistry

Background:

  • Thermal processing, including hot-melt extrusion (HME), is increasingly important in pharmaceutical manufacturing.
  • Polymer selection for HME is often restricted by thermal and rheological properties.
  • Amorphous solid dispersions (ASDs) enhance drug solubility and bioavailability.

Purpose of the Study:

  • To compare KinetiSol® Dispersing (KSD) and HME for producing ASDs.
  • To investigate the impact of polymer type, molecular weight, and drug loading on ASD formation.
  • To evaluate the processing capabilities of KSD versus HME.

Main Methods:

  • Preparation of griseofulvin (GRIS) ASDs using HME and KSD.
  • Utilized polymers: polyvinylpyrrolidone (PVP) and hydroxypropyl methylcellulose (HPMC) of varying grades.
  • Analysis via Powder X-ray Diffraction (PXRD), imaging, solid-state, thermal, and solution-state techniques.

Main Results:

  • KSD successfully produced amorphous dispersions at higher drug loads (up to 40%) compared to HME.
  • KSD processed higher molecular weight polymers (PVP, HPMC) not feasible with HME.
  • HME showed significant crystallinity at 40% drug load, while KSD maintained amorphous nature with only trace crystallinity.

Conclusions:

  • KSD demonstrates superior capability in producing amorphous solid dispersions over a wider range of drug loads and polymer types.
  • KSD overcomes the processing limitations of HME, particularly with high molecular weight polymers.
  • KSD offers a more versatile thermal processing technology for pharmaceutical ASD development.