References and Papers

Ellenberger, et al. “Expanding the Application and Formulation Space of Amorphous Solid Dispersions with KinetiSol – a Review.” AAPS PharmSciTech, 2018.

    1. General review summarizing KinetiSol technology and product development work up to 2018.
    2. Written for a pharmaceutical scientist audience with extensive discussion of KinetiSol formulation projects and benefits over other technologies.

Gala, et al. “Harnessing the Therapeutic Potential of Anticancer Drugs through Amorphous Solid Dispersions.” BBA Reviews on Cancer, 2020.

    1. Review of the solubility challenges in developing oral cancer drugs and the state of the art in applying ASD technology to them
    2. Illuminates the reasons that 65% of approved cancer drugs are poorly soluble vs. 40% across all therapeutic areas
    3. Extensive examples of approved and in development cancer drugs with solubility challenges and results of ASD formulation

Gala, et al. “Improved Dissolution and Pharmacokinetics of Abiraterone through KinetiSol Enabled Amorphous Solid Dispersions.” Pharmaceutics, 2020.

    1. Explains the bioavailability challenges of abiraterone acetate (active ingredient in Zytiga) which no other technology has succeeded in addressing.
    2. Highlights that KinetiSol bioavailability enhanced abiraterone up to 6x more than an abiraterone acetate prodrug with no exposure plateau.
    3. Shows that neither abiraterone nor the optimal formulation solution for it can be processed in other technologies.

Tan, et al. “Innovations in thermal processing: Hot-Melt Extrusion and KinetiSol Dispersing.” AAPS PharmSciTech, 2020.

    1. Highlights new developments in both HME and KinetiSol.
    2. Provides updates on KinetiSol technology improvements/discoveries since the 2018 Ellenberger review paper.

Jermain, et al. “In Vitro and In Vivo Behavior of KinetiSol® and Spray Dried Amorphous Solid Dispersions of a Weakly Basic Drug and Ionic Polymer.” Mol. Pharmaceutics, 2020.

    1. Compares KinetiSol and spray drying, co-written with Merck Research Labs.
    2. Delves into the particle property differences between spray-dried and KinetiSol formulations that led to a 4x greater bioavailability of a KinetiSol formulation than of a spray-dried Boehringer Ingelheim drug (BI639667) using the same formulation ingredients.