Research Publication: Precellys Evolution Homogenizer – a versatile instrument for milling, mixing, and amorphization of drugs in preformulation

Eur J Pharm Biopharm

. 2023 Aug:189:1-14.

 Precellys® Evolution Homogenizer – a versatile instrument for milling, mixing, and amorphization of drugs in preformulation

Jochem Alsenz ¹, Elisabeth Haenel ²

Abstract

The aim of this work was the evaluation and introduction of the Bertin Precellys® Evolution homogenizer with Cryolys® as a valuable and versatile tool for the improvement of workflows in the preformulation phase of drug development. The presented pilot experiments indicate that the instrument can be applied for (1) screening of appropriate vehicles for the generation of micro- and nano suspensions, (2) small-scale manufacturing of suspension formulations for preclinical animal studies, (3) drug amorphization and identification of appropriate excipients for amorphous systems, and (4) preparation of homogenous powder blends. The instrument allows the rapid, parallel, and compound-sparing screening of formulation approaches and small-scale formulation manufacturing, in particular for low solubility compounds. For the characterization of generated formulations, miniaturized methods are introduced such as a screening tool for suspension sedimentation and redispersion and a non-sink dissolution model in biorelevant media in microtiter plates. This work summarizes exploratory, proof-of-concept studies and opens up new opportunities for more extended studies with this instrument in various application areas.

Keywords: Amorphization; Bertin Precellys Evolution homogenizer with Cryolys; Dissolution; Micro- and Nanoparticles; Milling; Miniaturization; Particle size; Preformulation; Suspension.