The development of an electronic add-on device for pressurized metered dose

inhalers to increase efficiency of inhaled drug administration

A. Kerekes, P. Safrany, T. Kerekes-Hever

Abstract
Inhalation drugs play an important role in modern medicine. Pulmonary diseases (mostly asthma or
COPD) affect more than 500 million people worldwide. Their daily treatment is based on inhaled drugs
that target lung receptors and provide fast and effective improvement of their condition. The main
challenge with inhaled drug delivery is precise dosing. Unlike pills and injections, where the amount
introduced into the body is known, the condition, physiology, the inhalation maneuver and breathing
characteristics of the patient have a significant impact on the efficiency of inhalation. Having information
on the exact dosage would be a major step forward in the field of inhaled drug treatments. The aim of this
study is to develop a system for the precise delivery of inhaled drugs, which is contains 1.) an add-on
device as user interface and data acquisition unit and 2.) a software platform which can determine the
delivered dose based on the patient's physiological parameters and the characteristics of the breathing
manoeuvre during inhalation. The smart device measures the air flow profile through the inhaler during
the patient's inhalation and uses this data to automatically activate the device. The software platform
determines the amount of medication delivered based on the recorded data and other patient parameters.
This information on deposition and drug efficacy can be used for personalised treatment planning.

Introduction

According to the WHO, approximately 300 million people worldwide suffer from asthma (40 million in
the EU, 23 million in the US) and 210 million people suffer from COPD (40 million in the EU, 25 million
in the US). Patients most commonly use inhalers for their medical treatment, as they allow targeted
delivery of medication to the appropriate areas of the lungs. Despite the widespread availability of inhaled
therapies, around half of asthma patients remain poorly controlled. Patients with COPD have very high
mortality rates, poor quality of life and regular exacerbations, which place a significant burden on both
patients and healthcare systems. The increased frequency of exacerbations, often due to inappropriate or
inadequate use of medication, is closely associated with higher mortality rates. The survival rate of COPD
patients with frequent exacerbations (based on probabilities) does not exceed that of cancer patients.
The above outcomes have shown little improvement despite the increasing availability of new drug
therapies. This is mainly due to poor patient adherence and inappropriate use of medicines. According to
the Global Initiative for Asthma (GINA), more than half of patients do not use their prescribed medication
as instructed by their doctor. Improving patient attitudes and making medication use transparent will
improve adherence and significantly improve the condition of these patients without the need for
additional therapies.
Considering the technological advancements that facilitate precise monitoring of medication
administration, it is both a realistic and imperative objective to devise a device that can facilitate the
monitoring of inhalation device utilization. Such a tool would enable both the patient and the physician to
assess the patient's condition based on accurately recorded medication usage. Once the use of medication
has been monitored, the subsequent objective is to educate patients on the correct and timely
administration of the medication, with the device providing continuous support and guidance on the
appropriate use. This would consequently result in an enhanced therapeutic effect. The achievement of
these objectives would facilitate more effective and consistent use of the devices by patients and enabling
continuous monitoring of their progress by their physicians at the same time.
In recent years, there have been numerous studies on the use of so-called smart inhalers that track patient
adherence in the therapeutic process, which have all proven their positive effect on adherence. Despite
this, there is still no truly successful device on the market that is used by a wide range of patients. When
defining the cornerstones of our development concept, we examined the reasons behind the market delay.
By analyzing and better understanding these reasons, we hope to create a more market-ready device that
can have a real impact on the lives of respiratory patients.
In addition to the physical interface, an important part of our development is the software infrastructure,
which is essential for collecting and analyzing information from the user network and providing data-
based services. The device will transmit data to a paired mobile device (e.g., a smartphone or tablet
computer), where it will be displayed in both time-series and graphical formats. Furthermore, the data
will be stored on a server located on the mobile device. The server-stored data will be accessible via a
web interface to physicians, patients, and other relevant stakeholders, thus facilitating the generation of
reports.

Materials and methods

Ahhoz, hogy sikeresen fejlesszünk egy olyan eszközt, mely a valódi életben is megállja a helyét, fontos
felmérnünk az eddig piacra vitt okos inhalátorok jellemzőit, piaci potenciálját.
Systematic literature search in the field of inhaled drug administration across several databases like
PubMed, sciencedirect ets. An other important search the annual reports of pharma industries (which have
significant interests in the field of inhaled medicines or in connected drug delivery technology)
Hány darab tanulmányt elemeztünk, milyen időintervallumban.

Selection of studies, corporate annual reports

Milyen szempontokat gyűjtöttünk össze, melyek szerintünk a kiindulási alapjai lehetnek a fejlesztésnek és
miért. Hogyan priorizáltuk a szempontokat, hogyan pontutunk és miért úgy
(terápiára gyakorolt hatása, környezetre gyakorolt hatás, használhatóság, ár, QALY-ra gyakorolt hatás
(becsült), szinergiák egyéb terápiás területtel

Results
Terápiára gyakorolt hatás – szinkronizáció, inhalációs manőver támogatása [doi: 10.21037/jtd-20-2360];
[doi: 10.1136/ bmjresp-2022-001400]; [doi: 10.1038/s41533-023-00343-w]
Környezeti hatás minimalizálása: add-on kivitel
Qaly – ra gyakorolt hatás: a lehető legszélesebb felhasználói réteg hosszú távú előnnyel
[https://doi.org/10.1186/1465-9921-15-66]

Ár:

Smart inhalers emerge as innovative tools to improve medication adherence and health outcomes for
patients with chronic respiratory diseases like asthma and Chronic Obstructive Pulmonary Disease
(COPD). The uploaded publications collectively highlight the technological, usability, and economic
aspects of these devices, providing evidence of their efficacy and potential implementation challenges.
Technological Capabilities and Data Monitoring
Smart inhalers incorporate advanced sensor technologies to monitor patient adherence, inhalation
techniques, and environmental triggers. Ma et al. (2024) emphasize that these devices collect
comprehensive data, including physiological, task-related, and environmental information, which are
analyzed using statistical methods and machine learning algorithms to provide actionable insights [8].
Usability and User Experience
Studies indicate that usability plays a crucial role in the adoption of smart inhalers. Features such as
intuitive applications, customizable reminders, and seamless data synchronization improve user
engagement. However, challenges such as data privacy concerns, technical issues, and patient motivation
need to be addressed to enhance implementation success [9].
Economic Viability and Healthcare Impact
Economic analyses, including the PHARMACOP-intervention study, demonstrate that smart inhalers can
lead to significant cost savings by reducing hospitalizations and exacerbations. The devices improve
adherence and inhalation techniques, resulting in better disease management and lower healthcare costs
[10].
Implementation Barriers and Recommendations
Barriers to adoption include reimbursement issues, regulatory challenges, and integration into existing
healthcare workflows. Future directions should focus on improving data integration protocols, enhancing
AI-driven personalized feedback, and addressing policy frameworks to support widespread
implementation [9].
fig. Structural drawing and visual design of the electronically controlled breath activated add-on device for pMDI.
A: firing mechanism, the 50N force required for firing is stored by spring; B: Schematic drawing of the pMDI
inhaler and the connected flow measurement electronics and firing mechanism; C: Visual design of the finished
device
Discussion

Fig. The range of connected sensors to measure the adherence of inhalation therapies.

Conclusions