Modular spiral jet mill: an innovative tool for targeted micronization of pharmaceutical products

TLDR: In this paper, a modular spiral jet mill was developed and tested to generate, theoretically, 215 different jet-mill configurations, which could be used for the micronization and classification performances investigation and optimization.

Abstract: Approximately 70% of new chemical entities fall into the BCS Class II category [1], hence requiring application of appropriate pharmaceutical technologies during dosage-form development to achieve an improved biopharmaceutical profile. For this class of drugs, the dissolution rate is the key parameter for the in-vitro evaluation of delivery systems. In fact, increasing the dissolution rate could lead to an enhancement in bioavailability and therapeutic effect [2]. Micronization is one of the most popular, robust and reliable process in the pharmaceutical field for improving the bioavailability of poorly soluble APIs by increasing particle surface area through particle size reduction. The effect of the spiral jet mill on the powder to be milled is related to many geometric and process parameters; in fact, each powder is characterized by a particular physico-mechanical profile and therefore requires a specific mill configuration. According to literature [3-6] and based on practical experience in using jet-milling equipment, 18 parameters (i.e., 15 geometrical and 3 process parameters) have been identified as critical for their impact on the micronization performance and on the subsequent powder classification capabilities. This work deals with the development and the testing of a modular spiral jet mill that could be used to generate, theoretically, 215 different jet-mill configurations. This modular mill will represent a tool to be used for the micronization and classification performances investigation and optimization.