In recent years , the FDA has encouraged pharmaceutical companies to place renewed emphasis on model-based process design and the development of more innovative , efficient manufacturing methods. “Mini-manufacturing” of medicine can alleviate the need to mass-manufacture all drugs and can be beneficial in the creation of high-potency drug forms or products tailored to a specific patient. We describe one such mini-manufacturing process , "drug-on-demand ," which uses drop-on-demand printhead technology to deposit API onto edible substrates. We use a high precision positive displacement pump to deposit solvent-based drug systems or polymer-drug melts. This method allows for the creation of individualized dosage forms , multi-layered films with all of the API needed for one patient , or the creation of personalized medicine , in which the amount of API can be varied depending on the patient. In this work , we present the details of the drug-on-demand pilot facility created as part of the Engineering Research Center for Structured Organic Particulate Systems. We present a process narrative of the setup and discuss the automation implemented on the drug-on-demand system. The system , consisting of a positive-displacement pump , xy staging , imaging system , and various temperature controllers , allows for precise control over the material properties , drug morphology , drop size , and drop dynamics. With careful consideration of process parameters and an effective control strategy , we can execute an automated , optimized , and controlled print cycle while closely monitoring drop size , drug morphology , and drop deposition pattern. In this paper , we summarize our achievements and current research in this area , including a description of the engineering principles behind our process and analysis of drug forms created using solvent-polymer systems.
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