Abstract
Personalized drug delivery systems (PDDS), implying the patient-tailored dose, dosage form, frequency of administration and drug release kinetics, and digital health platforms for diagnosis and treatment monitoring, patient adherence, and traceability of drug products, are emerging scientific areas. Both fields are advancing at a fast pace. However, despite the strong complementary nature of these disciplines, there are only a few successful examples of merging these areas. Therefore, it is important and timely to combine PDDS with an increasing number of high-end digital health solutions to create an interactive feedback loop between the actual needs of each patient and the drug products. This review provides an overview of advanced design solutions for new products such as interactive personalized treatment that would interconnect the pharmaceutical and digital worlds. Furthermore, we discuss the recent advancements in the pharmaceutical supply chain (PSC) management and related limitations of the current mass production model. We summarize the current state of the art and envision future directions and potential development areas.
Highlights
More than 100 years ago, a renowned Canadian physician, William Osler, quoted that, ‘‘If it were not for the great variability among individuals, medicine might as well be a science, not an art.” Over the past century, most therapeutic strategies were developed based on randomized clinical trials and applied for a ‘‘statistically average patient”
We provide an overview of advanced approaches for manufacturing personalized medicines and how to bridge pharmaceutical and digital worlds with the appearance of new products such as digital drug products and digital therapeutics
To overcome the challenges of the currently marketed drug products, innovative solutions with improved functionalities are needed. One such innovation is personalized drug delivery systems (PDDS) defined in this review as solid dosage forms, containing the patient-tailored precise dose of a single or multiple active pharmaceutical ingredients (APIs) and possessing customized appearance that can aid in drug identification, swallowability, release and monitoring of the treatment
Summary
More than 100 years ago, a renowned Canadian physician, William Osler, quoted that, ‘‘If it were not for the great variability among individuals, medicine might as well be a science, not an art.” Over the past century, most therapeutic strategies were developed based on randomized clinical trials and applied for a ‘‘statistically average patient”. The modern society is becoming increasingly digitized and dependent on the virtual world and enormous amount of data This is changing how we design products and deliver them to customers – an example of this is the recent revolution in value creation and customer demand due to the COVID-19 pandemic that has spiked the whole e-business industry. Distribution of pharmaceutical products has been one of the key challenges and, among others, the established ‘‘Pharmaceutical strategy for Europe” from 2020 is aiming to ‘‘make sure that patients across Europe have new medicines and therapies in their countries quickly and under all circumstances and that there are fewer shortages of medicines” [4] This should be ensured while at the same time (1) delivering solutions allowing for personalized medicine, (2) combating falsified and counterfeit products, and (3) reducing the environmental footprint of related manufacturing. We provide an overview of advanced approaches for manufacturing personalized medicines and how to bridge pharmaceutical and digital worlds with the appearance of new products such as digital drug products and digital therapeutics
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