JCNRJournal of Clinical and Nursing Research2208-36852208-3693Bio-Byword Scientific Publishing Pty. Ltd.10.26689/jcnr.v6i3.3909ArticleMethods in Determining the Bioequivalence of Inhaled Productshttps://artdesignp.com/journal/JCNR/6/3/10.26689/jcnr.v6i3.3909TonySara M,AbdelrahimMohamed EA2022632022-05-12Aerosol delivery to the lungs can be achieved with several devices that differ in their operating mechanisms and efficacies of aerosol delivery. There are several methods to measure aerosol delivery and deposition in a subject’s lung, in order to assess the efficacy of aerosol generators and the impact of certain drugs. Instruments such as cascade impactors, imaging techniques, and laser diffraction are available for measuring the particle size of aerosols, which is the main factor in the deposition and distribution of the produced aerosol. From impactors to laser diffractors, they have different operating mechanisms, analysis times, and characteristics, in which each has its own advantages and limitations. Several models are available to investigate aerosol delivery and deposition, such as in vitro, in vivo, and ex vivo models.

Barry PW, O’Callaghan C, 2003, The Influence of Inhaler Selection on Efficacy of Asthma Therapies. Adv Drug Deliv Rev, 55(7): 879-923.

Abdelrahim ME, Saeed H, Harb HS, et al., 2021, Essentials of Aerosol Therapy in Critically Ill Patients, Springer.

Chrystyn H, 2001, Methods to Identify Drug Deposition in the Lungs Following Inhalation. Br J Clin Pharmacol, 51(4): 289-299.

Borgstrom L, Nilsson M, 1990, A Method for Determination of the Absolute Pulmonary Bioavailability of Inhaled Drugs: Terbutaline. Pharm Res, 7(10): 1068-1070.

Chrystyn H, 2000, Methods to Determine Lung Distribution of Inhaled Drugs – Could Gamma Scintigraphy Be the Gold Standard?. Br J Clin Pharmacol, 49(6): 525-528.

Hindle M, Chrystyn H, 1992, Determination of the Relative Bioavailability of Salbutamol to the Lung Following Inhalation. Br J Clin Pharmacol, 34(4): 311-315.

Chrystyn H, 1994, Standards for Bioequivalence of Inhaled Products. Clin Pharmacokinet, 26(1): 1-6.

Aswania OA, Corlett SA, Chrystyn H, 1998, Validation of a High-Performance Liquid Chromatography Assay for Urinary Nedocromil Sodium Following Oral and Inhaled Administration. J Chromatogr B Biomed Sci Appl, 718(2): 290-295.

Al-Amoud AI, Clark BJ, Chrystyn H, 2002, Determination of Gentamicin in Urine Samples After Inhalation by Reversed-Phase High-Performance Liquid Chromatography Using Pre-Column Derivatisation with O-Phthalaldehyde. J Chromatogr B Analyt Technol Biomed Life Sci, 769(1): 89-95.

Barber SJ, 2002, The Relative Bioavailability to the Lungs of Inhaled Tobramycin Using a Urinary Pharmacokinetic Method: Development and Validation of a High Performance Liquid Chromatographic Method. Identification of a Urinary Pharmacokinetic Method to Evaluate the Relative Bioavailability to the Lungs of Tobramycin Following Inhalation, Bradford, 253.

Nadarassan DK, Chrystyn H, Clark BJ, et al., 2007, Dose Emission of Formoterol Fumarate from a Turbuhaler Using In-Vitro and In-Vivo Methods, Postgraduate Studies in Pharmaceutical Technology, School of Pharmacy, University of Bradford, UK.

Newman SP, Wilding IR, 1999, Imaging Techniques for Assessing Drug Delivery in Man. Pharm Sci Technolo Today, 2(5): 181-189.

Heald D, Berridge MS, Lee Z, et al., 1997, In Vivo Lung Deposition of Triamcinolone Acetonide (Azmacort) With and Without the Integrated Spacer, in Respiratory Drug Delivery, Interpharm Press Inc, 345-347.

Berridge M, Lee Z, Leisure G, et al., 1998, Nasal Delivery and Kinetics of Fluticasone Propionate Using Positron Tomography (PET). Pharm Sci, 1(Suppl 4): S208-S209.

Borgstrom L, Newman S, Weisz A, et al., 1992, Pulmonary Deposition of Inhaled Terbutaline: Comparison of Scanning Gamma Camera and Urinary Excretion Methods. J Pharm Sci, 81(8): 753-755.

Snell J, Ganderton D, 1999, Assessing Lung Deposition of Inhaled Medications: Consensus Statement from a Workshop of the British Association of Lung Research. Respir Med, 93: 123-133.

Mobley C, Hochhaus G, 2001, Methods Used to Assess Pulmonary Deposition and Absorption of Drugs. Drug Discov Today, 6(7): 367-375.

Eiser NM, Phillips C, Wooler PA, 2001, Does the Mode of Inhalation Affect the Bronchodilator Response in Patients with Severe COPD?. Respir Med, 95(6): 476-483.

Rodriguez-Carballeira M, Heredia JL, Rue M, et al., 2001, The Bronchodilator Test with Increasing Doses of Terbutaline in Chronic Obstructive Pulmonary Disease Patients. Pulmonary Pharmacology & Therapeutics, 14(1): 61-65.

Tattersfield AE, 1987, Effect of Beta-Agonists and Anticholinergic Drugs on Bronchial Reactivity. Am Rev Respir Dis, 136(4 Pt 2): S64-8.

Britton J, Hanley SP, Garrett HV, et al., 1988, Dose Related Effects of Salbutamol and Ipratropium Bromide on Airway Calibre and Reactivity in Subjects with Asthma. Thorax, 43(4): 300-305.

Casterline CL, Evans 3rd R, Ward Jr GW, 1976, The Effect of Atropine and Albuterol Aerosols on the Human Bronchial Response to Histamine. J Allergy Clin Immunol, 58(5): 607-613.

Cockcroft DW, Killian DN, Mellon JJ, et al., 1977, Protective Effect of Drugs on Histamine-Induced Asthma. Thorax, 32(4): 429-437.

Dahl R, Lundback B, Malo JL, et al., 1993, A Dose-Ranging Study of Fluticasone Propionate in Adult Patients with Moderate Asthma. International Study Group. Chest, 104(5): 1352-1358.

Raphael GD, Lanier RQ, Baker J, et al., 1999, A Comparison of Multiple Doses of Fluticasone Propionate and Beclomethasone Dipropionate in Subjects with Persistent Asthma. J Allergy Clin Immunol, 103(5 Pt 1): 796-803.

Barnes PJ, Pride NB, 1983, Dose-Response Curves to Inhaled Beta-Adrenoceptor Agonists in Normal and Asthmatic Subjects. Br J Clin Pharmacol, 15(6): 677-682.

Newman SP, Talaee N, Clarke SW, 1991, Salbutamol Aerosol Delivery in Man with the Rondo Spacer. Acta Ther, 17: 49-50.

Tomlinson HS, Corlett SA, Allen MB, et al., 2005, Assessment of Different Methods of Inhalation from Salbutamol Metered Dose Inhalers by Urinary Drug Excretion and Methacholine Challenge. Br J Clin Pharmacol, 60(6): 605-610.

Newman SP, Moren F, Trofast E, et al., 1991, Terbutaline Sulphate Turbuhaler: Effect of Inhaled Flow Rate on Drug Deposition and Efficacy. Int J Pharm, 74(2-3): 209-213.

Ross DL, Schultz RK, 1996, Effect of Inhalation Flow Rate on the Dosing Characteristics of Dry Powder Inhaler (DPI) and Metered Dose Inhaler (MDI) Products. J Aerosol Med, 9(2): 215-226.

United States Pharmacopeia, 2005, Aerosols, Nasal Sprays, Metered Dose Inhalers and Dry Powder Inhalers, in The United States Pharmacopeia 28 [and] The National Formulary 23, The Board of Trustees, 2359-2377.

Newman SP, Kenyon CJ, 1994, Asthma Products Bioequivalence. Pharm J, 253: 42.

O’Callaghan C, Barry PW, 1997, The Science of Nebulised Drug Delivery. Thorax, 52(2): S31-S44.

Allen T, 1990, Sampling and Sizing from the Atmosphere, in Particle Size Measurement, Chapman and Hall, New York, 78-80.

Boe J, Dennis JH, O’Driscoll BR, et al., 2001, European Respiratory Society Guidelines on the Use of Nebulizers. Eur Respir J, 18(1): 228-242.

Comite-Europeen-Normalisation, 2001, Respiratory Therapy Equipment – Part 1: Nebulizing System and Their Components, prEN 13544-1, CEN Brussels, Belgium, 33-38.

Jauernig J, Hug M, Knoch M, 2002, Contribution to the Aerodynamic Particle Size Assessment of Nebulized Drugs Using the Next Generation Impactor (NGI), in Drug Delivery to the Lungs XIII, Aerosol Society, London, UK, 44-47.

Jauernig J, Ohl S, Knoch M, et al., 2004, Effects of the Test Set-Up Formulation, and Nebulizer Type on Aerodynamic Droplet Characteristics. Resp Drug Deliv, IX: 609-612.

Sears MR, Lotvall J, 2005, Past, Present and Future – [Beta]2-Adrenoceptor Agonists in Asthma Management. Respir Med, 99(2): 152-170.

Waldeck B, 2002, [Beta]-Adrenoceptor Agonists and Asthma – 100 Years of Development. Eur J Pharmacol, 445(1-2): 1-12.

Anderson GP, 1993, Formoterol: Pharmacology, Molecular Basis of Agonism, and Mechanism of Long Duration of a Highly Potent and Selective Beta 2-Adrenoceptor Agonist Bronchodilator. Life Sci, 52(26): 2145-2160.

Vilsvik J, Ankerst J, Palmqvist M, et al., 2001, Protection Against Cold Air and Exercise-Induced Bronchoconstriction While on Regular Treatment with Oxis(R). Respir Med, 95(6): 484-490.

Pearce N, Crane J, Burgess C, et al., 1991, Beta Agonists and Asthma Mortality: Deja Vu. Clin Exp Allergy, 21(4): 401-410.

Pearce N, Beasley R, Crane J, et al., 1995, End of the New Zealand Asthma Mortality Epidemic. Lancet, 345(8941): 41-44.

Mullen M, Mullen B, Carey M, 1993, The Association Between Beta-Agonist Use and Death from Asthma. A Meta-Analytic Integration of Case-Control Studies. Jama, 270(15): 1842-1845.

Florey K, 1990, Analytical Profiles, Terbutaline, in Analytical Profiles of Drug Substances, Academic Press, London, 601-625.

Sweetman CS, (ed) 2002, Martindale, Bronchodilators and Anti-Asthmata Drugs., In Martindale: The Complete Drug Reference, Pharmaceutical Press, London, 757-786.

Comis A, Valletta EA, Sette L, et al., 1993, Comparison of Nedocromil Sodium and Sodium Cromoglycate Administered by Pressurized Aerosol, With and Without a Spacer Device in Exercise-Induced Asthma in Children. Eur Respir J, 6(4): 523-526.

Nyberg L, 1984, Pharmacokinetic Parameters of Terbutaline in Healthy Man. An Overview. Eur J Respir Dis Suppl, 134: 149-160.

Smith SR, Kendall MJ, 1986, Potentiation of the Adverse Effects of Intravenous Terbutaline by Oral Theophylline. Br J Clin Pharmacol, 21(4): 451-453.

O’Sullivan EA, Curzon MEJ, 1998, Drug Treatments for Asthma May Cause Erosive Tooth Damage. BMJ, 317(7161): 820.

Lipworth B, Tan S, Devlin M, et al., 1998, Effects of Treatment with Formoterol on Bronchoprotection Against Methacholine. Am J Med, 104(5): 431-438.

Hancox RJ, Cowan JO, Flannery EM, et al., 2000, Bronchodilator Tolerance and Rebound Bronchoconstriction During Regular Inhaled [Beta]-Agonist Treatment. Respir Med, 94(8): 767-771.

Korn SH, Wouters EF, Wesseling G, et al., 1998, Interaction Between Glucocorticoids and [Beta]2-Agonists: [Alpha] and [Beta] Glucocorticoid-Receptor mRNA Expression in Human Bronchial Epithelial Cells. Biochem Pharmacol, 56(12): 1561-1569.

Zeng XM, Martin GP, Marriott C, 1995, The Controlled Delivery of Drugs to the Lung. Int J Pharm, 124(2): 149-164.

Andersson P, 1976, Bronchospasmolytic and Cardiovascular Effects in Anaesthetized Cats of Ibuterol and Terbutaline Given Intravenously and After Inhalation: Drug and Prodrug Compared. Acta Pharmacol Toxicol (Copenh), 39(2): 225-231.