(745c) Practical Applications of Dry-Coating for Pharmaceutical Tablet Manufacturing

Dry-coating processes designed to coat API or excipients with glidant (nano-sized silicon dioxide), have been shown effective to improve the manufacturability of formulations containing APIs with poor flowability and tabletability. Despite the advantages of dry-coating at the lab-scale using a wide variety of equipment such as powder blenders/mixers and mills, manufacturing-scale processes have yet to gain significant acceptance. This may be due to the poor scalability of dry-coating processes or presumably due to the aversion of risk associated with adopting new technology in the pharmaceutical industry. To address this issue, this work details the industrial application of dry-coating for use in tablet manufacturing.

In this study, enhancement to powder flowability and tabletability are discussed. Effects and issues related to dissolution as well as sticking/picking during tabletting are also presented. As a major novelty, scale-up studies utilizing a conical screen mill (comill) are detailed. While the comill is frequently employed in the production of tablets as a screening/de-lumping or particle size reduction process, it has not gained acceptance as a dry-coating process. This work shows that the comill can be used as an effective and efficient process for the purpose of dry coating at both lab and manufacturing scale. While our previous work has shown the effectiveness of the comill at the lab scale [1], this work will focus on matters of scale up. The parameters affecting development of the comill as a dry-coating process are examined.

[1] M. Capece, C. Borchardt, A. Jayaraman, Improving the effectiveness of the Comil as a dry-coating process: Enabling direct compaction for high drug loading formulations. Powder Technology 379 (2021) 617-629.

AbbVie funded and participated in the study design, research, data collection, analysis and interpretation of data, as well as writing, reviewing, and approving the publication. Maxx Capece and Jeffery Larson are AbbVie employees and may own AbbVie stock/options.