Laura Hirshfield

Dropwise additive manufacturing of pharmaceutical products for solvent-based dosage forms.

In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, 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. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then 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. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms.

Real-Time Process Management Strategy for Dropwise Additive Manufacturing of Pharmaceutical Products

PurposeThis paper presents a real-time process management (RTPM) strategy for Dropwise Additive Manufacturing of Pharmaceutical Products (DAMPP), a mini-manufacturing method for pharmaceutical dosage forms. The semicontinuous, small-scale nature of DAMPP allows for more automation and control than traditional large-scale batch pharmaceutical manufacturing processes and can be used to manufacturing drug products with precise amounts of active pharmaceutical ingredients (API), suitable for production of high-potency drug products or individualized medicine.MethodsThe RTPM strategy for DAMPP consists of advanced process control to ensure that every dosage unit meets quality specifications. We use temperature control systems and an imaging system linked to a LabVIEW automation program.ResultsThe system is successful in controlling deposition of both solvent-based and melt-based dosage forms. It controls process and product temperature and monitors each drop visually. It records data pertinent to each deposited drop, determines the drop volume and thus API amount deposited, and automatically detects and diagnoses process faults.ConclusionsWith a proper automation, control, and monitoring strategy, DAMPP is a viable manufacturing method for pharmaceutical dosage forms.

Task choice, group dynamics and learning goals: Understanding student activities in teams

In this work-in-progress research paper, we explore the task choice of students in first-year, team-based engineering design project courses, with the goal of gaining insight on how to best structure and scaffold team projects so that all students have a positive, effective experience. What factors affect student task choice? Do students select tasks that they feel the most confident about completing, or do they challenge themselves to learn new skills? Do gender or team dynamics or self-imposed roles affect how students participate? If students are asked to develop individual learning goals for the project, does that influence the activities that they engage in, and does articulating learning goals lead to a more beneficial project experience? We are using a mixed-methods approach to investigate the experiences of a small cohort of students engaged in a first-year design project, in order to better understand how students choose to undertake different tasks in team projects.

Extended abstract: Assigning reflection essays in a chemical engineering product design course

Reflection has been shown to be an important aspect of the design process, as it forces designers to think about challenges, obstacles, decisions, or ideas. This presentation will address how reflection essays were assigned in a two-semester chemical engineering product design capstone course to assist students in their design thinking. In addition to providing sample writing prompts and student and instructor responses, the benefits, challenges, and limitations will be presented.

Teaching entrepreneurial communication in a chemical engineering product design capstone course

This work-in-progress paper describes the entrepreneurial approach used to structure a two-semester product design capstone course in chemical engineering. Historically, the course instructors defined the products that the student teams could create, and thus they were only tasked with developing the assigned product and were not involved in the problem identification and opportunity exploration processes. Some student commentary on course evaluations expressed desire for more freedom and creativity in this process. Therefore, this updated offering of the course did not assign specific projects and instead required the student teams to develop and pitch a unique product idea, using techniques within entrepreneurial communication. Class activities also further emphasized entrepreneurial skills such as creativity, innovation, and project and conflict management. Student commentary on the mid-semester course evaluations and anecdotally, the entrepreneurial approach has been positively received, and the students seem genuinely excited about their project topics. At the end of the course in April 2016, the instructors will review the student course evaluations and weekly student reflections. We anticipate the entrepreneurship component will affect how the students approach and value the projects.