Smart Inhaler "Time to Get Smarter"

‘Smart’ inhalers are inhalers with extra digital features – they link to an app on your phone or tablet to help you and your doctor manage your asthma better.
Some smart inhalers have sensors which can work out if you’re in a high pollution or high pollen area, some can send you handy reminders, and some can tell if you need to check your inhaler technique.
They’re all designed to automatically track how often you’re using your inhaler, so you don’t need to keep your own records.
Some trials have suggested that if you use a smart inhaler it can make it easier to stick to taking your medicine. That means you get fewer symptoms.

1. Smart Inhalers “ Time to get Smarter” Presented by- Shrawan .M. Gehlot F.Y Mpharm (Pharmaceutics ) Under Guidance of- Dr.(Mrs.) Ganga Srinivasan Professor and H.O.D Pharmaceutics VES College of Pharmacy 1

2. CONTENTS 1 Introduction 2 Evolution of Inhaler Device 3 Inhalation Devices 4 Smart Inhaler 2 8 Reference 7 Conclusion 5 ProAir ®   Digihaler TM 6 Global Smart Inhaler Market – Key Finding 9 Acknowledgment

3. 1 PART 01 Introduction 3

4. Introduction The concept of inhaling medications known since more than 2000 years. Since second half of the 20th century, development of inhaler technology has advanced to nebulizer, pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI). T reatment and prophylaxis in bronchial asthma, cystic fibrosis, chronic obstructive pulmonary disease (COPD) and other chronic pulmonary conditions. This route has been found to be rapid, safe, effective and cheap requiring lower dosage amount. 4

5. Introduction E specially for medicines that are either not absorbed orally or get destroyed in stomach or during first pass metabolism in the liver . This noninvasive and patient-friendly route is being increasingly tried for therapy of systemic diseases. The large surface area, rich capillary network and high permeability with minimal metabolism of respiratory alveolar system allow for better bioavailability and targeted action. Hence, this route is an attractive option for management of pulmonary and systemic diseases. The feasibility of utilization of pulmonary surface for therapy and prophylaxis of systemic diseases has led to an impetus for more research into inhalational devices to make it into a more controlled, accurate and reproducible delivery. 5

6. Some 235 million people currently suffer from asthma. It is a common disease among children. Most asthma-related deaths occur in low- and lower-middle income countries. According to the latest WHO estimates, released in December 2016, there were 3,83,000 deaths due to asthma in 2015. Global Asthma Factsheet - WHO Source:-https://www.who.int/en/news-room/fact-sheets/detail/asthma 6

7. The Global Burden of Disease Study reports a prevalence of 251 million cases of COPD globally in 2016. More than 90% of COPD deaths occur in low­ and middle-income countries Globally, it is estimated that 3.17 million deaths were caused by the disease in 2015 (that is, 5% of all deaths globally in that year) Global COPD Factsheet - WHO Source:-https://www.who.int/en/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) 7

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9. Source:- The Indian Chest Society and National College of Chest Physicians. In 2015 Among India’s 1.31 billion people, about 6% of children and 2% of adults have asthma. 9 In 2015 Among India’s 1.31 billion people, about 6% of children and 2% of adults have asthma.

10. 1 PART 02 Evolution of Inhaler Device 10

11. History of Inhalation Therapy and Early Devices Back to basics: The early history of inhalation therapy Practice of inhalation therapy can be traced back thousands of years. 19th century saw the first advances in the development of inhalers, primarily for the treatment of tuberculosis. Initially , inhalers relied on either heat to volatilize the medication, or vapour to aerosolize it . 11

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13. The early 20th century saw many advances in inhaler design. Nebulizer devices were developed, powered by electrical compression (such as the Pneumostat manufactured by Weil, Frankfurt, Germany in the early 1930s) or by hand (for example, the Glaseptic made by Parke , Davis & Company, London, UK). In the 1930s, adrenalin chloride solution was supplied as a bronchodilator in both glass-bulb and plasticbulb , hand-powered nebulizers. Pneumostat manufactured by Weil, Frankfurt Glaseptic made by Parke , Davis & Company 13

14. 1 PART 03 Inhalation Devices 14

15. Inhalation Devices MDI Metered Dose Inhaler Dry Powder Inhaler DPI Nebulizer 15

16. Metered Dose Inhaler (MDI) The history of the MDI dates back to 1955. The first MDI included a 50μL metering device, a 10mL amber vial, and a plastic mouthpiece with molded nozzle to administer salts of isoproterenol and epinephrine. Today the modern MDI comprises of a pressurized metal canister containing a mixture of propellants, surfactants, preservatives, and the drug. pMDIs are the most popular inhalers to treat asthma and COPD. Particle size generated 1-10 micron 16

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18. Spacers and Holding Chambers A spacer is a simple tube or extension with no valves to contain the aerosol. whereas a VHC is an extension device with a 1-way valve that, when the attached pMDI is actuated, holds the aerosol until inhalation. VHS Spacer 18

19. Pressurized metered-dose Advantages Portable Compact Multi-dose device Dose delivered and particle size relatively independent of inhalation maneuver Quick and easy to use for many patients Suitable for emergencies 19

20. Marketed product 20

21. Dry powder Inhaler (DPI) 21

22. Classification of DPI E.g.- Aerolizer E.g.- Diskhaler E.g.- Turbuhaler E.g.- Rotahaler E.g.- Spiros 22

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24. Aerolizer Diskhaler Turbuhaler Rotahaler 24 Marketed product

25. Dry Powder Inhaler (DPI) Advantages Portable Compact Breath-actuated Less coordination needed Short treatment time Dose indicator Limitations Moderate to high inspiratory flow required for most devices Not suitable for young children Some devices are single-dose May not be suitable for emergencies Some devices are susceptible to environmental humidity Inability to use with a valved holding chamber Not all medications are available 25

26. Jet Nebulizer(pressurized gas source) Ultrasonic Nebulizer (Electric source) 26

27. Nebulizer Advantages Less coordination needed Cost Effective with tidal breathing High doses can be easily administered Dose modification possible Combination therapy if drugs compatible Some are breath-actuated Limitations Not portable Pressurized gas or electric source required Lengthy treatment time Contamination possible Device preparation Not all medications available 27

28. Adherence with inhaled therapy– the scale of the problem A dherence rates above 80% are acceptable. A dherence < 80% mortality rates were higher in COPD and asthmatics were more likely to be ventilated. ‘ Difficult to treat’ asthma has been linked to non-adherence but identifying this problem is not easy and many patients do not admit their adherence is poor. Asthma and COPD patients have been reported to prefer once daily therapy and this regimen was found to provide better adherence. limited number of once daily inhaled treatments and these are all DPIs. Adherence is assessed by either subjective (self report, questionnaire) methods or objectivity (prescription refill, dose counter , drug levels) and providing feedback has been shown to be the most effective method to improve adherence. More than 50% of patients suffering chronic illness do not take their medication as prescribed. This leads to poor patient outcomes, disease progression, and an estimated burden of $100B - $ 300B  annually in avoidable direct healthcare costs in the US alone  , and a $564B burden globally. Source:- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3934668/ 28

29. Inhaler technique– the scale of the problem In March 1956, pMDIs containing epinephrine ( Medihaler Epi ) and isoproterenol ( Medihaler Iso ) were made available and by the end of year inhaler technique problems were reported. More than 60 years later patients are still having problems using their inhalers. M aking critical errors is unacceptable resulting in poor disease control , hospitalisations. In 2017, the CRIT ical I nhaler mista K es and A sthma Contro L (CRITIKAL) identified which inhaler errors were clinically important. The inhalers studied were the Diskus , Turbuhaler and the pMDI . The percentage of patients making clinically significant inhaler technique errors in the CRITIKAL study When using the pMDI the CRITIKAL study revealed that starting an inhalation after actuating a dose was clinically important. Source:- http://rc.rcjournal.com/content/63/6/708/tab-pdf 29

30. 1 PART 04 Smart Inhaler 30

31. GINA and GOLD highlight the importance of ensuring patients are adherent to their prescribed dosing regimen and that they apply the correct technique . Randomized controlled trials (RCTs) patients adherent with trained inhaler technique shows more than 80% adherence and non-trained shows lower. In real-life studies rates varying from 8 to 73% have been reported and inhaler technique errors are high. Standard and traditional approach is to counsel patient . short term improvements occur long-term maintenance is limited. The recent advancement in Micro- Electro-Mechanical Systems (MEMS) and micro technology together with Bluetooth® connectivity, offers the potential to develop e-modules that contain batteries, connectors and sensors. Available as either add-ons to or integrated inside inhalers and provide real-life monitoring of a patient's inhaler usage. Smart Inhalers Potential to record the date and time of an inhalation, send reminders and measure the inhalation technique. 31

32. Smart Inhaler Instant Feedback about Inha lation technique Objective reports could be use in counselling session Connectivity using Bluetooth technology, to mobile phones Identify patient inhales a dose and the type of inhalation they use 32 It’s time to try a different approach!

33. What is a smart inhaler and how does it work ? ‘Smart’ inhalers are inhalers with extra digital features – they link to an app on your phone or tablet to help you and your doctor manage your asthma better . Some smart inhalers have sensors which can work out if you’re in a high pollution or high pollen area, some can send you handy reminders, and some can tell if you need to check your inhaler technique. They’re all designed to automatically track how often you’re using your inhaler, so you don’t need to keep your own records. Some trials have suggested that if you use a smart inhaler it can make it easier to stick to taking your medicine. That means you get fewer symptoms. How could using a smart inhaler help me ? Here are just some of the ways using a smart inhaler could make life a bit easier: Getting an alert on your smartphone when you hit a high pollen or high pollution area – helping you decide whether to avoid it Helping you prove to your doctor or asthma nurse that you’ve been taking your inhaler regularly, so they can better understand if your care needs changing Letting you know if you’ve used your inhaler correctly, helping to make sure you get more of the medicine into your lungs, and reducing possible side effects. 33

34. Smart Inhalation Devices SmartMist Identify correct co-ordination measure the inhalation flow and volume Monitors patient's breathing pattern to release a dose at the beginning of the inspiration. i-Neb T racks each time you use your inhaler. R eminds you if you miss a dose. D isplays your inhaler usage over time. Hailie 34

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38. Add-on Smart Inhaler:- Propeller Health 38

39. Smart eHaler – Crux (Prototype) What does Future holds ? 39

40. Global Smart Inhaler Market – Key Finding Globally, Asia-Pacific the fastest growing region and expected to grow at the rate of 55.3% during the forecast period. North America holds the largest market share of 54.3% of smart inhalers market and is anticipated to reach $888.4 million by the end of forecast period. The Smart Inhalers global market and is expected to reach $1636.1 million by 2022. Source:- https://www.reportlinker.com/p05804504/?utm_source=PRN https://www.mobihealthnews.com/content/smart-inhaler-market-predicted-be-worth-356b-2024 40

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42. Conclusion Studies have shown that smart inhalers, containing e-modules with connectivity to Smartphones, can measure real-life adherence and inhaler technique. This information can be used to give patients, instant feedback as well as reports about their inhaler usage that can be used during counselling sessions. They can also send dose reminders if a dose has been missed and instant reports of increased usage with or without changes in inhaler technique could be alerts of an impending acute exacerbation. The majority of smart inhalers are add-on devices that are externally attached to an inhaler. These only identify that a dose has been actuated and so do not confirm that the dose was inhaled or that the inhaler technique was satisfactory. There is a growing trend to introduce smart inhalers with the e-module integrated inside the device. These measure an inhalation profile and so confirm the dose was inhaled and can give feedback about the inhalation technique. The cost of smart inhalers and the associated increased work load of analysing the reports they provide need to be studied to show that the use of these is cost effective as well as providing better disease control, improved quality of life for patients and a reduction in exacerbations. 42

43. “ I f people cannot be SMART than the inhaler itself has to be SMART” 43

44. References:- 44 Kaur SS. Pulmonary drug delivery system: newer patents. Pharmaceutical patent analyst. 2017 Sep;6(5):225-44. Stein SW, Thiel CG. The history of therapeutic aerosols: a chronological review. Journal of aerosol medicine and pulmonary drug delivery. 2017 Feb 1;30(1):20-41. Sanchis J, Gich I, Pedersen S, Team AD. Systematic review of errors in inhaler use: has patient technique improved over time?. Chest. 2016 Aug 1;150(2):394-406. National Institutes of Health. Global Initiative for Asthma. Global strategy for asthma management and prevention. NHLBI/WHO work shop report. 1995. Rabe KF. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD executive summary. Am J Respir Crit Care Med. 2007;176:532-55. Roche N, Dekhuijzen PR. The evolution of pressurized metered-dose inhalers from early to modern devices. Journal of aerosol medicine and pulmonary drug delivery. 2016 Aug 1;29(4):311-27. Leach CL. The CFC to HFA transition and its impact on pulmonary drug development. Respiratory care. 2005 Sep 1;50(9):1201-8. Ibrahim M, Verma R, Garcia-Contreras L. Inhalation drug delivery devices: technology update. Medical Devices (Auckland, NZ). 2015;8:131. Khilnani GC, Banga A. Aerosol therapy. Indian journal of chest diseases and allied sciences. 2008;50(2):209. Chrystyn H, Audibert R, Keller M, Quaglia B, Vecellio L, Roche N. Real-life inhaler adherence and technique: Time to get smarter!. Respiratory Medicine. 2019 Sep 12. Kikidis D, Konstantinos V, Tzovaras D, Usmani OS. The digital asthma patient: the history and future of inhaler based health monitoring devices. Journal of aerosol medicine and pulmonary drug delivery. 2016 Jun 1;29(3):219-32.

45. I would like to thank our principal madam Dr.(Mrs.) Supriya Shidhaye for her constant support and my guide Dr.(Mrs.) Ganga Srinivasan mam for giving me an opportunity to explore the upgrading technological field of Smart Inhaler , thereby inculcating a research based approach in me. I would also like to thank our evaluators and the audience for their time and patience. And lastly I would like to thank my family members and my friends and my seniors for supporting me. Acknowledgment 45

46. THANK YOU 46