Applying competitive technology intelligence to reveal advances in final end user applications, user acceptability, quality assurance, and digital technologies of 3D printing for oral drug delivery systems

Abstract

The demands for high-value innovative treatments, investment in Research and Development (R&D), and personalized medicines are shaping the pharmaceutical industry, for this, current manufacturing methods may not be able to satisfy these needs. Three-dimensional printing offers different solutions for specific needs that cannot be attended due to the high cost of production, limitations on the process, or individualized demands. 3D printing oral drug delivery systems enhance the delivery of a pharmaceutical substances in the body and the dynamics between pharmaceutical ingredients, while providing personalized formulation, geometry, size, controlled release rate and time on the gastrointestinal tract. On the other hand, for a company to stay relevant in the market, it should be able to develop and integrate a sustainable differentiation, also known as a long-term competitive advantage (Porter, M., 1996). This competitive advantage can be based on the introduction and acquisition of new technologies. The process of identifying market opportunities, trends and new technologies is not always direct, for this, Competitive Technology Intelligence methodology and Scientometric analysis are utilized to reveal technological knowledge and technologies, in order to identify trends that can be turned into actionable information. The aim of this thesis is to use Competitive Technology Intelligence (CTI) methodology to reveal advances in Final End User Applications, User Acceptability, Quality Assurance, and Digital Technologies of 3D Printing for Oral Drug Delivery Systems and facilitate decision-making to stakeholders, upper management, firms or people belonging to the pharmaceutical, medical, healthcare and 3D printing area. Using a query developed from the CTI methodology a total of 621 papers from 01-01-1900 to 05-01-2023, after the database cleaning process the number of results decreased to 512. The 512 publications were categorized into 9 classifications, where the 149 corresponding to the categories Final End User Applications, User Acceptability, Quality Assurance, and Digital Technologies were analyzed. The results demonstrated a tendency towards digitalization of the industry, that looks forward to migrating clinical trials to digital solutions. Machine Learning is being used to optimize and predict parameters of the process and the behavior of the formulations. Applications like DEFEND3D are being examined to avoid the cyber risks of remote digital transfer of electronic prescriptions to the 3D printer. Quality assurance is one of the main concerns while developing 3D printed oral drug delivery systems. Quality by Design (QbD) approach is being used to efficient the design of a product. At the same time, protocols to standardize compounding procedures (mixing, preparation, and printing) as well as decision maps to facilitate decision-making of the pharmacist are being developed. The integration of all these methods can lead to quality assurance in the different types of dosage forms. In the Final End User application trend, abuse-deterrent 3D printed oral dosage forms are being designed to limit the accessibility to non-prescribed opioids, as a solution to the opioid abuse world crisis. For disease treatment, 3D printed capsules that permit the intake of multiple drugs and avoid the negative interactions between active pharmaceutical ingredients are being developed. User preferences and palatability are also being taken into consideration while designing 3D printed dosage forms, as it can facilitate their entry to the market.