pMDIs

1 Contents Introduction ...................................................................................................................................... 3 Significance for Public Health ............................................................................................................. 3 Literature Review: ........................................................................................................................... 4 Overview of pMDIs in Respiratory Disease Management .............................................................. 4 Impact of Poor Inhaler Technique ....................................................................................................... 4 Introduction of Spacer Devices ........................................................................................................... 4 Efficacy of Spacer Devices .................................................................................................................. 5 Research Gaps ....................................................................................................................................... 5 Research Aims and Objectives: ....................................................................................................... 5 Aim: ........................................................................................................................................................ 5 Objectives: ............................................................................................................................................. 5 Methods ........................................................................................................................................... 6 Rationale for Methods .......................................................................................................................... 6 Data Analysis Methods ......................................................................................................................... 7 Anticipated Outcomes: ......................................................................................................................... 7 Enhanced Drug Deposition .................................................................................................................. 7 Verification of Bioequivalence ............................................................................................................ 8 Identification of Optimal Spacer Designs .......................................................................................... 8 Practical Implications for Patient Education and Training ............................................................... 8 Impact on Different Inhalation Profiles .............................................................................................. 8 Potential for Broader Respiratory Therapy Guidelines .................................................................... 9 Scope and Limitation: ...................................................................................................................... 9 Study Plan / Gantt Chart: ................................................................................................................. 9 Annotated Bibliography ................................................................................................................. 10 References ...................................................................................................................................... 12 Appendix ........................................................................................................................................ 15

2 Relative Bioequivalence of Salbutamol Pressurized Metered Dose Inhalers (pMDIs) With and Without Spacer Devices. Student’s Name Professor’s Name Institutional Affiliation Course Date

4 with them. This study will significantly increase what we know about using medicine inhalers and spacer gadgets for better lung health care. Literature Review: Overview of pMDIs in Respiratory Disease Management Inhalers with pMDIs are really important for treating illness like asthma and COPD using pressure. They give a simple and good way to send medicine right into the lungs (Shakshuki and Agu, 2017). The main way pMDIs work is to give a measured medicine dose in spray form. Patients then take this in and breathe it into their lungs. How well this breathing system works depends on factors like size of the tiny particles and how it's made. But what matters most is how the patient uses it. Challenges in pMDI Usage Although pMDIs are very common, using them properly to get the best results can be hard because people often get it wrong. Studies always show that many mistakes are made by people using pMDIs ( Lavorini, et al., 2019 ). Some common errors are not working together well between using the inhaler and breathing in, not breathing in fast enough, and not holding breath for long enough. These mistakes can greatly lower the amount of medicine that gets to the lungs, making treatment less effective. Impact of Poor Inhaler Technique Using an inhaler, the wrong way can lead to bad control of the disease and a higher use of healthcare services. A study by Usmani et al., (2018) showed that wrong use of pMDI was connected to more hospital stays for asthma patients. This shows how important it is to use an inhaler the right way when dealing with breathing problems. Introduction of Spacer Devices To solve these problems related to methods, spacer tools have been added. Spacers are made to stop the mist cloud from the pMDI. This allows patients to take in the medicine

5 properly. They can reduce the amount of drug in the mouth and make more of it go to lower airways. Efficacy of Spacer Devices Some studies have explored if spacer devices improve drug delivery. Chandel and team (2019) discovered that spacers can fix common breathing problems, especially for kids and elderly people. But, how much a person can improve can be different depending on the type of spacer and the patient. For instance, holes work differently with different sets of kids. Kids who are young get more help because their breath flow is less and they don't have much control while breathing in. Research Gaps While existing literature provides valuable insights into the benefits of spacer use, comprehensive research comparing the bioequivalence of salbutamol delivery through pMDIs with and without spacers is limited. We need more research on how salbutamol gets into the lungs of different patient types, like kids. This should be done using modern testing ways. We also need more study to learn how different spacer shapes affect drug delivery success. Research Aims and Objectives: Aim: To evaluate the impact of inhalation profile parameters on the performance of salbutamol pMDIs and pulmonary drug deposition with and without spacer devices. Objectives: 1. Assess the in vitro lung deposition of salbutamol from pMDIs with different inhalation profiles. 2. Compare the efficacy of pMDIs with and without spacer devices in achieving optimal lung deposition. 3. Evaluate the user-friendliness and practicality of using spacer devices with pMDIs.

7 if pMDIs work and how they get affected by spacer gear. In addition to this, a thorough review of the books helps make sure that the pretend testing created in the lab mirrors real situations. This makes the study's results more useful for doctors. Data Analysis Methods The data from the lab testing will be examined using a computer program for math. We will do two types of numbers study. First, we'll show the main points of data using descriptive stats. Then, we'll see if there is any big difference in drug going into lungs when using pMDI with or without spacer gadgets. For the study, we will use methods like ANOVA (Analysis of Variance) to see if the scene changes are important statistically ( do Nascimento Silva and Padeiro 2020 ). The study will look at how different kinds of breathing patterns used with pMDIs affect how they work. This will give us important information on the best ways to use these devices. The findings will be showed in an easy-to-get way. Graphs will be used to help understand and compare data simply. Anticipated Outcomes: The primary hypothesis of this study is that the use of spacer devices in conjunction with pressurized metered dose inhalers (pMDIs) significantly enhances the lung deposition of salbutamol. This idea is based on the idea that extra devices can help with mistakes that are often made when using a small aerosol can for medicine. It is especially helpful when people have a problem with how they breathe in the medicine. The study anticipates several key outcomes that will contribute to our understanding of pMDI efficacy and the role of spacer devices in respiratory therapy: Enhanced Drug Deposition One of the main anticipated outcomes is a demonstrable increase in the lung deposition of salbutamol when using pMDIs with spacer devices compared to pMDIs used alone ( Ramadon, et al., 2021 ). People think this result will happen because spacer gadgets can keep medicine in the

8 air. This allows patients to breathe it slowly, slowly over time. This is very helpful for patients who have trouble with using something while they breathe or for those who can't keep on asking for air over a proper time. Verification of Bioequivalence A big result will be checking how similar the bio-equivalence is when getting salbutamol from pMDIs with spacers compared to without spacers. This means showing that the spacing doesn't change how well the medicine works, but helps to send it rightly into the lungs ( Patil, et al., 2019 ). Identification of Optimal Spacer Designs The study might show, through testing spacer designs without them being mixed with living things, which kind of gaps work best to make the drug reach further. This could show important results for helping people with health issues. It might help doctors choose the best spacer tools for their patients. Practical Implications for Patient Education and Training This research is expected to help in training patients how to use pMDIs. Respiratory therapists and health workers can teach their patients better ways to breath ( Abdelrahman, et al., 2021 ). They understand how certain tools help patients when they don't use correct breathing methods. This results in improved patient care strategies that make treatments more successful. Impact on Different Inhalation Profiles The study is trying to show how when breathing in differently can affect how well pMDIs work with and without special devices called spacers ( Anderson, et al., 2018 ). The study will pretend different patient cases, like those with poor breathing methods. It will show which patient types may gain most from using spacer items. This might involve kids, old people, or those with small lungs or problems moving and working together well.

10 Annotated Bibliography Al-Showair, R.A., Pearson, S.B. and Chrystyn, H., 2007. The potential of a 2Tone Trainer to help patients use their metered-dose inhalers.  Chest ,  131 (6), pp.1776-1782 The scientists looked at if 2Tone Trainer could help asthma patients get better at using their metered-dose inhaler (MDI). Many patients have a hard time using MDIs the right way.  Minai, B.A., Martin, J.E. and Cohn, R.C., 2004. Results of a physician and respiratory therapist collaborative effort to improve long-term metered-dose inhaler technique in a pediatric asthma clinic.  Respiratory care ,  49 (6), pp.600-605. The goal was to make breathing through an MDI better and improve asthma results in kids with asthma at a PACT clinic in a big city. Doctors and breathing therapists worked together to give standard tests and help patients use the MDI properly during their visits.  Virchow, J.C., Crompton, G.K., Dal Negro, R., Pedersen, S., Magnan, A., Seidenberg, J. and Barnes, P.J., 2008. Importance of inhaler devices in the management of airway disease.  Respiratory medicine ,  102 (1), pp.10-19. A detailed study was done to check if dry powder inhalers (DPIs) work better than pressurized canned inhalers (pMDIs) when managing asthma. Our study, which looked at many types of tests and studies up to January 2022, showed that DPIs have special benefits compared to pMDIs.  Abdelrahman, M. A., Saeed, H., Osama, H., Harb, H. S., Madney, Y. M., and Abdelrahim, M. E. 2021. Effect of verbal counselling on metred‐dose inhaler proper use and lung function test amongst asthmatic patients: a meta‐analysis. International Journal of Clinical Practice, 75(6), e14077. A meta-analysis, which is meant to address the problem of bad asthma control because of wrong use of pMDI in people suffering from asthma. A careful look at 10 studies with 1937 asthma patients who got at least two verbal talks on how to use pMDI correctly showed big improvements.  Anderson, G., Johnson, N., Mulgirigama, A., and Aggarwal, B. 2018. Use of spacers for patients treated with pressurized metered dose inhalers: focus on the VENTOLIN™ Mini Spacer. Expert Opinion on Drug Delivery, 15(4), 419-430. They paid attention to using spacers, especially the VENTOLIN™ Mini Spacer. They used it with pressurized metered-dose inhalers (pMDIs). The study method was about looking at the past, features and good things of spacers. It showed their important role in making better use of inhalers and delivering medicine.  Chandel, A., Goyal, A. K., Ghosh, G., and Rath, G. 2019. Recent advances in aerosolised drug delivery.   Biomedicine and Pharmacotherapy ,   112 , 108601.

11 The article talks about using the lungs to find out and treat sicknesses such as asthma, tuberculosis, and bronchitis. It shows how important making the right formula, using inhaling tools, and checking the size of particles is for how well aerosols work. 

13 Minai, B.A., Martin, J.E. and Cohn, R.C., 2004. Results of a physician and respiratory therapist collaborative effort to improve long-term metered-dose inhaler technique in a pediatric asthma clinic.   Respiratory care ,   49 (6), pp.600-605. Mitchell, J. P., Carter, I., Christopher, J. D., Copley, M., Doub, W. H., Goodey, A., ... and Suman, J. D. 2023. Good Practices for the Laboratory Performance Testing of Aqueous Oral Inhaled Products (OIPs): an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).   AAPS PharmSciTech ,   24 (3), 73. Patil, T. S., Deshpande, A., Shende, P. K., Deshpande, S., and Gaud, R. 2019. Evaluation of nanocarrier-based dry powder formulations for inhalation with special reference to anti- tuberculosis drugs.   Critical Reviews™ in Therapeutic Drug Carrier Systems ,   36 (3). Ramadon, D., McCrudden, M. T., Courtenay, A. J., and Donnelly, R. F. 2021. Enhancement strategies for transdermal drug delivery systems: Current trends and applications.   Drug delivery and translational research , 1-34. Rezaei, H., Khoubnasabjafari, M., Jouyban-Gharamaleki, V., Hamishehkar, H., Afshar Mogaddam, M. R., Rahimpour, E., ... and Jouyban, A. 2023. A new method for investigating bioequivalence of inhaled formulations: A pilot study on salbutamol.   Journal of Pharmacy and Pharmaceutical Sciences ,   26 , 11466. Roche, N., and Dekhuijzen, P. R. 2016. The evolution of pressurized metered-dose inhalers from early to modern devices.   Journal of aerosol medicine and pulmonary drug delivery ,   29 (4), 311-327. Shakshuki, A., and Agu, R. U. 2017. Improving the efficiency of respiratory drug delivery: a review of current treatment trends and future strategies for asthma and chronic obstructive pulmonary disease.   Pulmonary Therapy ,   3 (2), 267-281.

14 Usmani, O. S., Lavorini, F., Marshall, J., Dunlop, W. C. N., Heron, L., Farrington, E., and Dekhuijzen, R. 2018. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes.   Respiratory research ,   19 , 1-20. Virchow, J.C., Crompton, G.K., Dal Negro, R., Pedersen, S., Magnan, A., Seidenberg, J. and Barnes, P.J., 2008. Importance of inhaler devices in the management of airway disease.   Respiratory medicine ,   102 (1), pp.10-19.

16 Laboratory Consumables 100 Instrumentation Maintenance and Calibration 50 Contingency Fund 100 Total Budget 600