Nebulizer – In vitro Bioequivalence testing requirements: A review
DOI:
https://doi.org/10.22270/ajprd.v8i1.647Keywords:
In-Vitro equivalence, APSD, Unit Dose Content, delivered dose, Morphologically-Directed Raman Spectroscopy (MDRS)Abstract
Generic Nebulized aerosol is often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. International regulatory agencies have developed recommendations and guidance for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the approaches can be used for to show bioequivalence requirement for Food and Drug Administration (FDA) in the United States of America (USA) with reference product. This review endorsed that inhalation solutions and suspensions undertaken to determine the drug substance delivery rate, total drug substance delivered and Aerodynamic assessment of nebulized aerosols [aerodynamic particle size distribution (APSD)/droplet size distribution (DSD)].These are the most important parameters in characterization, evaluation and bioequivalence studies of nebulizers. These devices operate continuously; once loaded and require little or no co-ordination on the part of user they proved that these devices suitable for weak, pediatric or geriatric patients. The regulatory agencies declared that; there is no specific requirements testing in case of nebulizers like Metered dose inhalers (MDI) and Dry powder inhalers (DPIs). In United States of America (USA) regulation falls under the auspices of centre for devices and radiological health (CDRH), and new devices require 510(k) premarket notification. This review outlines all the bioequivalence test parameter.
Downloads
References
2. Faarc Dr. Nebulizers: principles and performance. Respiratory care. 2000; 45(6):609.
3. Newman SP. Nebuliser therapy: scientific and technical aspects. Draco; 1989.
4. Dennis J, Berg E, Sandell D, Kreher C, Karlssin M, Lamb P. European Pharmaceutical Aerosol Group (EPAG) nebulizer sub-team: assessment of proposed European Pharmacopoeial (Ph. Eur.) monograph Preparations for Nebulization. J Aerosol Med. 2007; 20: 40.
5. Hess D. Aerosol Delivery Devices in the Treatment of Asthma; Respiratory Care, 2008; 53(6):699-725.
6. Hou S, Wu J, Li X, Shu H. Practical, regulatory and clinical considerations for development of inhalation drug products. Asian journal of pharmaceutical sciences. 2015; 10(6):490-500.
7. Lee, Sau L., Bhawana Saluja, Alfredo García-Arieta, Gustavo Mendes Lima Santos, Ying Li, Sarah Lu, Shuguang Hou et al. "Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India." 2015:1285-1304.
8. Egusa, Kenji, Fumiaki Okazaki, Joerg Schiewe, Ulrike Werthmann, and Markus Wolkenhauer. "Identification of Polymorphic Forms of Active Pharmaceutical Ingredient in Low-Concentration Dry Powder Formulations by Synchrotron X-Ray Powder Diffraction." Drugs in R&D 17, 2017; (3):413-418.
9. Patton, J. S., & Byron, P. R. Inhaling medicines: delivering drugs to the body through the lungs. Nature Reviews Drug Discovery, 2007; 6(1):67-74.
10. Selby, Matthew D., Pieter D. de Koning, and Dannielle F. Roberts. "A perspective on synthetic and solid-form enablement of inhalation candidates." Future medicinal chemistry. 201; (13):1679-1701.
11. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_2092
12. Berlinski A, Hayden JB. Optimization of a procedure used to measure aerosol characteristics of nebulized solutions using a cooled next generation impactor. Journal of aerosol medicine and pulmonary drug delivery. 2010; 23(6):397-404.
13. Dennis J, Berg E, Sandell D, Ali A, Lamb P, Tservistas M, Karlsson M, Mitchell J. Cooling the NGI-an approach to size a nebulised aerosol more accurately. Pharm Europa scientific notes. 2008; (1):27-30.
14. Hiller C, Mazumdar M, Wilson D, Bone R. Aerodynamic size distribution of metered-dose bronchodilator aerosols. American Review of Respiratory Disease. 1978; 118(2):311-7.
15. Peters TM, Chein H, Lundgren DA, Keady PB. Comparison and combination of aerosol size distributions measured with a low-pressure impactor, differential mobility particle sizer, electrical aerosol analyser, and aerodynamic particle sizer. Aerosol Science and Technology. 1993; 19(3):396-405.
16. Fromen CA, Shen TW, Larus AE, Mack P, Maynor BW, Luft JC, DeSimone JM. Synthesis and characterization of monodisperse uniformly shaped respirable aerosols. AIChE Journal. 2013; 59(9):3184-94.
17. Marple VA, Olson BA, Santhanakrishan K, Roberts DL, Mitchell JP, and Hudson-Curtis BL: Next generation pharmaceutical impactor: a new impactor for pharmaceutical inhaler testing. Part III. Extension of archival calibration to 15 L/min. J Aerosol Med. 2004; (17):335–343.
18. http://dissolutiontech.com/issues/201802/inews-copley02.php
19. Copley M. Improving inhaled product testing: methods for obtaining better in vitro-in vivo relationships. Pharmaceutical Technology. 2013; 2(2):37.
20. https://www.copleyscientific.com/files/ww/news/.
21. Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective, AAPS J. 2019; 7;21(2):14
22. https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009.
23. https://www.malvernpanalytical.com/en/products/product-range/morphologi-range/morphologi-g3-id
24. http://www.pharmtech.com/morphologically-directed-raman-spectroscopy-uncovering-good-bad-and-ugly-drug-formulations.Song X, Hu J, Zhan S, Zhang R, Tan W. Effects of temperature and humidity on laser diffraction measurements to jet nebulizer and comparison with NGI. AAPS Pharm SciTech. 2016; 17(2):380-8.
25. USP<1601>Page no. 7875, 2018, USP 41.
26. JayeshKumar, S.M., Yashvi, P., Bhimani, B., Patel, G., Patel, J. and Patel, U. Nebulization Therapy for Lung Cancer. Research Journal of Pharmacy and Technology, 2019; 12(2):920-934.
27. Mitchell JP, Nagel MW, Nichols S, Nerbrink O. Laser diffractometry as a technique for the rapid assessment of aerosol particle size from inhalers. Journal of aerosol medicine. 2006; 19(4):409-33.
28. https://www.mspcorp.com/pharmaceutical/ngi-cooler.
29. Vecellio None L, Grimbert D, Becquemin MH, Boissinot E, Le Pape A, Lemarié E, Diot P. Validation of laser diffraction method as a substitute for cascade impaction in the European Project for a Nebulizer Standard. Journal of aerosol medicine. 2001; 14(1):107-14.
30. Bouwman AM, Heijstra MP, Schaefer NC, Duiverman EJ, Lesouëf PN, Devadason SG. Improved efficiency of budesonide nebulization using surface-active agents. Drug delivery. 2006; 13(5):357-63.
31. Pham S, Ferguson GT, Kerwin E, Goodin T, Wheeler A, Bauer A. In vitro characterization of the eFlow closed system nebulizer with glycopyrrolate inhalation solution. Journal of aerosol medicine and pulmonary drug delivery. 2018 ;31(3):162-9.
32. https://www.malvernpanalytical.com/en/products/product-range/spraytec.
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.