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Improved Vemurafenib Dissolution and Pharmacokinetics as an Amorphous Solid Dispersion Produced by KinetiSol®

Daniel J Ellenberger1,2, Dave A Miller3, Sandra U Kucera3

  • 1DisperSol Technologies, LLC, 111 W. Cooperative Way, Building 2, Suite 200, Georgetown, Texas, 78626, USA. daniel.ellenberger@dispersoltech.com.

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Summary

The KinetiSol process effectively creates amorphous solid dispersions of vemurafenib, improving its dissolution and pharmacokinetic performance compared to microprecipitated bulk powder (MBP). This novel formulation offers potential for reduced patient pill burden.

Keywords:
amorphous solid dispersionkinetiSolmicroprecipitated bulk powdersolubility enhancementvemurafenib

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Area of Science:

  • Pharmaceutical Science
  • Materials Science

Background:

  • Vemurafenib requires enhanced solubility formulations due to its poor solubility and permeability.
  • Conventional amorphous solid dispersion methods face challenges with vemurafenib's physicochemical properties.

Purpose of the Study:

  • To evaluate the KinetiSol process for producing amorphous solid dispersions of vemurafenib.
  • To compare the KinetiSol-produced formulation with microprecipitated bulk powder (MBP).

Main Methods:

  • Utilized KinetiSol high-shear processing to create amorphous solid dispersions of vemurafenib.
  • Analyzed material properties including phase, purity, stability, and particle morphology.
  • Assessed in-vitro dissolution and in-vivo pharmacokinetic performance in rats.

Main Results:

  • KinetiSol yielded amorphous, single-phase vemurafenib with good purity and stability, comparable to MBP.
  • KinetiSol particles exhibited dense morphology, contrasting with MBP's porous structure.
  • KinetiSol formulations showed significantly improved in-vitro dissolution and in-vivo pharmacokinetic profiles (at least 2-fold AUC increase).

Conclusions:

  • The KinetiSol process successfully produced superior amorphous solid dispersions of vemurafenib.
  • Improved drug nucleation and recrystallization in KinetiSol formulations enhance supersaturation maintenance.
  • KinetiSol offers a promising approach for developing vemurafenib dosage forms with reduced pill burden.