Date Available

12-17-2022

Year of Publication

2021

Degree Name

Master of Science in Mechanical Engineering (MSME)

Document Type

Master's Thesis

College

Engineering

Department/School/Program

Mechanical Engineering

First Advisor

Dr. Kozo Saito

Second Advisor

Dr. Andrew Bernard

Abstract

Personalized Medicine - from a one-size fits all to a tailored approach is the future in pharmaceutical therapeutics and medical applications. The aim of this study is demonstrate additive manufacturing in two personalized medicine applications: 1. Patient- customized solid dose medicines, and 2. Patient-customized wound care device. The aim of the first application is to develop an inexpensive and accurate method to design and fabricate patient-customized tablets. Particularly this paper focuses on fabricating and dose controlling of patient-customized extended release prednisolone-poly(vinyle alcohole) PVA. Dry-Blending, Wet Granulation, Extrusion, Spherionization, Hot melt extrusion (HME) was adopted to produce drug loaded prednisolone-PVA filaments suitable for 3D-printing on a commercially available fused deposition modeling (FDM) 3D-printer. Filaments with 3% and 5% drug loading were successfully fabricated, followed by FDM 3D-printing of disk shape tablets. X-ray diffraction (XRD) and modulated deferential scanning calorimetry (DSC) were adopted to study the physical form of drug within the polymer matrix. The results showed that the majority of prednisolone existed in the amorphous form within the 3D-printed tablets, confirming the ability of coupled HME-FDM for amorphous drug dispersion. Thermogravimetric analyses (TGA) revealed that 3D-printed tablets also exhibited a good thermal sta- bility. In vitro drug release patterns showed that all 3D-printed tablets with different doses exhibited nearly the same extended release profiles, indicating the ability of cou- pled HME-FDM to successfully control dosing. The results confirm that the developed process-train has the potential to provide a fast, inexpensive and controllable tool to fabricate patient-customized extended release tablets. The aim of the second application is to present the need for personalized medical therapeutics follow surgical interventions. Open abdominal surgery often results in large wounds which experience complications such as Enteratmospheric Fistulas (orEAFs). These EAFs are deeply difficult to manage, and often lead to severe infection and/or inflammation. This results in the need for constant medical attention and long periods of hospitalization, often in the range of 6-12 months. The current standard of treatment involves the use of what is called a Negative Pressure Wound Therapy device (or NPWT), which restricts the patient to a medical bed during use. Furthermore, frequent dressing changes per day are both necessary and difficult - taking up to 1-2 hours for each exchange. Most often, these dressings cannot be handled by the patient or their family and instead must be supported by dedicated medical personnel. In comparison to existing treatment, our solution expects to provide significant reductions in cost and medical resources while improving patient recovery time and quality of life. These benefits can be achieved by leveraging 3D printing to produce a personalized wound-specific device that protects the exposed wound, controls effluent flow, provides greater patient mobility, and reduces hospitalization time and support requirements. First, the dimensions of the wounds are captured using imaging software to establish the required shape and size of the device to fit the patient comfortably. A mold is then printed to match these dimensions and to create the biocompatible device. As the wound heals, the process is repeated until such dressings are no longer necessary. For patients with EAFs, a pressure-controlled and multi-compartment device is created to provide a reliable seal of the exposed stoma while providing control of effluent. In my collaboration with the UKY College of Medicine, multiple prototypes were trialed in a patient suffering from an EAF. The devices demonstrated substantial improvements in patient mobility, an approximate 90% reduction of medical support required for dressing changes and an early discharge from the hospital after 4 months, instead of the typical 6-12 months. The clinical trial is on-going and is still actively recruiting patients. As this approach is expected to be suitable for a range of conditions, we are also exploring alternative patient populations, such as those recovering from bariatric surgery, ulcers, and similar situations.

Digital Object Identifier (DOI)

https://doi.org/10.13023/etd.2024.30

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