AAPS PharmSciTech publishes five papers in a theme highlighting the use of KinetiSol technology.
KinetiSol first appeared in the pharmaceutical literature a decade ago as a novel thermal processing technology, adapted from the plastics recycling industry, to produce amorphous solid dispersion (ASD) systems. As a thermal process with a similar narrative of entry into the pharmaceutical space, initial publications focused on differentiating KinetiSol from hot-melt extrusion (HME). These studies identified various KinetiSol advantages over HME, such as: the ability to process thermally labile drugs, high melting point drugs, and highly viscous polymers without the need for plasticizers, all stemming from KinetiSol’s unique mixing dynamics and brief processing durations.
While initial publications focused on drawing comparisons to and establishing advantages over HME, the commercial position of the process evolved toward that of a complementary technology to HME; an alternative non-solvent ASD technology to consider when melt extrusion was either not applicable, or failed to produce the desired product. The commercial interest, therefore, put more emphasis on KinetiSol as a competing technology to solvent based manufacturing approaches. KinetiSol also began to be differentiated as a preferred, or ASD enabling, process when drug properties were not amenable to both spray drying and HME. Finally, with the applicable excipients not being limited to those that are thermally processible, or that share a common solvent with the drug, KinetiSol was found to be highly valuable as a reformulation option to maximize ASD-based drug product performance and value.
In this theme issue, a compilation of five research articles are presented focusing on the development and characterization of advanced ASD systems with specific emphasis on applications of the KinetiSol technology. The aim is to provide a comprehensive perspective on KinetiSol with particular focus on commercially relevant applications that illustrate the technology’s value to Industry.
Excerpt from AAPS PharmSciTech theme editorial, Theme: Applications of KinetiSol for Advanced Amorphous Solid Dispersions, by Dave A. Miller, Ph.D., guest editor.
Learn more about using KinetiSol technology for ASDs through five articles in this AAPS PharmSciTech theme:
Articles in AAPS PharmSciTech, The AAPS Journal, and Pharmaceutical Research are available with AAPS membership. Log in to the AAPS website and click through once on any cover to gain access to all articles within that browsing session. AAPS Open articles are freely available to read anytime.