(344b) Drug-On-Demand: A Mini-Manufacturing Method Using Drop-On-Demand Technology

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.