Abstract

During the last decades, the term “drug delivery systems” (DDSs) has almost fully replaced previously used terms, such as “dosage forms”, in an attempt to emphasize the importance of the drug carrier in ensuring the claimed safety and effectiveness of the product. However, particularly in the case of delivery devices, the term “system”, which by definition implies a profound knowledge of each single part and their interactions, is not always fully justified when using the DDS term. Within this context, dry powder inhalers (DPIs), as systems to deliver drugs via inhalation to the lungs, require a deep understanding of the complex formulation–device–patient interplay. As of now and despite the progress made in particle engineering and devices design, DPIs’ clinical performance is limited by variable patients’ breathing patterns. To circumvent this pitfall, next-generation DPIs should ideally adapt to the different respiratory capacity of individuals across age, health conditions, and other related factors. In this context, the recent wave of digitalization in the health care and industrial sectors may drive DPI technology towards addressing a personalized device–formulation–patient liaison. In this review, evolving technologies are explored and analyzed to outline the progress made as well as the gaps to fill to align novel DPIs technologies with the systems theory approach.

Highlights

  • A thorough literature search in Science Direct and PubMed databases evidenced a significant rate increase over the last decade of publications on dry powder inhalers (DPIs), confirming a constant growth of the interest in inhaled medicines

  • Several market reports predict a similar growth in the pulmonary administration route, due to an increase in respiratory disease incidence and the need for more effective combination therapies [1,2,3]

  • A real breakthrough in next-generation inhalers may result from the application of smart technologies, allowing device performance to be tailored based on a patient’s variable breathing patterns, while providing user-friendly features and preventing, compensating for, and/or recording potential handling and actuation errors

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Summary

Introduction

A thorough literature search in Science Direct and PubMed databases evidenced a significant rate increase over the last decade of publications on dry powder inhalers (DPIs), confirming a constant growth of the interest in inhaled medicines. Smart technologies are emerging to satisfy specific market requirements for cost-effective innovation. In this regard, digital systems have already vehemently penetrated the inhaler market, carrying notorious advantages in the prevention of device use errors. In spite of the winds of change in the inhalation device market, the global inhalers scenario is still lacking innovative technologies for a number of reasons that this review attempts to examine and discuss, with a specific view on DPIs. we provide the reader with an updated prospect on the DPI digitalization market as well as shedding light on the application of novel smart technologies and the required steps ahead

State of the Art
Limitations of Currently Available DPIs
Bioequivalence and Bioavailability Issues of DPI Products
Digitalization
Marketed and under Development Digitalized DPIs
Regulatory Standards in DPI Digitalization
Gaps to Be Filled to Reach Digitalization
Summary of the digitaldigital functions of the current
Perspectives after Digitalization
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