Development of Dropwise Additive Manufacturing of Pharmaceutical Products
In recent years, the FDA has encouraged pharmaceutical companies to place renewed emphasis the development of more innovative, efficient manufacturing methods with higher levels of on-line monitoring and control. Mini-manufacturing of medicine is one such method that can alleviate the need to mass-manufacture all drugs and create forms individually for patients. This work presents Dropwise Additive Manufacturing of Pharmaceutical Products (DAMPP), an automated, controlled mini-manufacturing method that deposits API directly onto edible substrates using drop-on-demand inkjet printing technology. The use of drop-on-demand technology allows for precise control over the material properties, drug morphology, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. This work describes the development of the DAMPP system as part of the Engineering Research Center for Structured Organic Particulate Systems, the implementation of a bench-scale prototype of the manufacturing process and the analysis of two types of products made using the prototype. The discussion of the manufacturing process includes a process narrative, which describes each step of the process in terms of the scientific and engineering considerations that apply; the real time process management strategy implemented on the process, including automation, monitoring and control; and a proposed Exceptional Events Management framework to detect, diagnose and mitigate process failures. DAMPP can create dosage form products by depositing either solvent-based formulations or polymer-melt-based formulations. These dosage forms were later analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time.
Reklaitis, Purdue University.
Biochemistry|Chemical engineering|Pharmacy sciences
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