Consistent aerodynamic performance and content uniformity of mometasone-magnesium stearate co-processed aerosols for asthma therapy

Schiffers C, Wouters EFM, Breyer-Kohansal R, Buhl R, Pohl W, Irvin CG, et al. Asthma Prevalence and Phenotyping in the General Population: The LEAD (Lung, hEart, sociAl, boDy) Study. J Asthma Allergy. 2023;16:367–82. https://doi.org/10.2147/JAA.S402326.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Ojo RO, Okobi OE, Ezeamii PC, Ezeamii VC, Nwachukwu EU, Gebeyehu YH, et al. Epidemiology of Current Asthma in Children Under 18: A Two-Decade Overview Using National Center for Health Statistics (NCHS) Data. Cureus. 2023;15:1–9. https://doi.org/10.7759/cureus.49229.

Article  Google Scholar 

Balaji M, Shaji S, Nair AK. Clinical profile and triggers of childhood asthma among patients diagnosed at paediatric asthma clinic. KERALA Med J. 2020;XIII:131–4.

Google Scholar 

Bahrami A, Jafarnejad S, Ebrahimi H, khoshnezhad, Mahmoudinezhad Dezfouli SM, Pahlevani R. Evaluation the Effect of Pulmicort Inhalation on Children with Acute Asthma Attack. Syst Reviews Pharm. 2020;11:905–12. https://doi.org/10.31838/srp.2020.9.132.

Article  CAS  Google Scholar 

Hisinger-Mölkänen H, Honkamäki J, Kankaanranta H, Tuomisto L, Backman H, Andersen H, et al. Age at asthma diagnosis is related to prevalence and characteristics of asthma symptoms. World Allergy Organ J. 2022;15:100675. https://doi.org/10.1016/j.waojou.2022.100675.

Article  PubMed  PubMed Central  Google Scholar 

Roche N, Aggarwal B, Boucot I, Mittal L, Martin A, Chrystyn H. The impact of inhaler technique on clinical outcomes in adolescents and adults with asthma: A systematic review. Respir Med. 2022;202:106949. https://doi.org/10.1016/j.rmed.2022.106949.

Article  PubMed  CAS  Google Scholar 

Hui RWH. Inhaled corticosteroid-phobia and childhood asthma: Current understanding and management implications. Paediatr Respir Rev. 2020;33:62–6. https://doi.org/10.1016/j.prrv.2019.03.009.

Article  PubMed  Google Scholar 

Raissy HH, Kelly HW. Benefits and Risks of Long-Term Asthma Management in Children: Where Are We Heading? Drug Saf. 2017;40:201–10. https://doi.org/10.1007/s40264-016-0483-0.

Article  PubMed  Google Scholar 

Heraghty F, Jameson H. The End of the Road for pMDIs? ONdrugDelivery. 2023:22–6.

Xi Q, Miao JY, Cao Z, Wang H. The Study of Spray-Freeze-Drying Technique for Development of Novel Combination pMDIs, Part I: Study on the Preparation Method. Pharm Fronts. 2022;4:E179–87. https://doi.org/10.1055/s-0042-1755455.

Article  Google Scholar 

Lingzhe Rao, Anesu J, Kusangaya N, Marasini HX, Ong B, Myatt P, Cocks et al. In-Vitro Evaluation of pMDI Spray Development of HFA134a, HFA152a and HFO1234ze(E). Drug Delivery to the Lungs 2022;33.

D’Angelo D, Chierici V, Quarta E, Varacca G, Cavalieri L, Piraino A, et al. No-shaking and shake-fire delays affect respirable dose for suspension but not solution pMDIs. Int J Pharm. 2023;631. https://doi.org/10.1016/j.ijpharm.2022.122478.

Wang H, Nobes DS, Vehring R. Particle Surface Roughness Improves Colloidal Stability of Pressurized Pharmaceutical Suspensions. Pharm Res. 2019;36. https://doi.org/10.1007/s11095-019-2572-0.

Xi Q, Miao J, Cao Z, Wang H. Inhalable aerosol microparticles with low carrier dosage and high fine particle fraction prepared by spray-freeze-drying. Int J Pharm X. 2023;5. https://doi.org/10.1016/j.ijpx.2023.100158.

Myrdal PB, Sheth P, Stein SW. Advances in metered dose inhaler technology: formulation development. AAPS PharmSciTech. 2014;15:434–55. https://doi.org/10.1208/s12249-013-0063-x.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Vishali DA, Monisha J, Sivakamasundari SK, Moses JA, Anandharamakrishnan C. Spray freeze drying: Emerging applications in drug delivery. J Controlled Release. 2019;300:93–101. https://doi.org/10.1016/j.jconrel.2019.02.044.

Article  CAS  Google Scholar 

Li J, Ma S, He X, Sun Y, Zhang X, Guan J, et al. Exploring the influence of magnesium stearate content and mixing modality on the rheological properties and in vitro aerosolization of dry powder inhaler. Int J Pharm. 2023;642. https://doi.org/10.1016/j.ijpharm.2023.123179.

Li J, He X, Sun Y, Song R, Ren X, Zhang X, et al. Effect of lubricants type and particle size on the rheological properties and aerosolization behavior of dry powder inhalers. Int J Pharm. 2024;667. https://doi.org/10.1016/j.ijpharm.2024.124911.

Sharif S, Muneer S, Izake EL, Islam N. Impact of Leucine and Magnesium Stearate on the Physicochemical Properties and Aerosolization Behavior of Wet Milled Inhalable Ibuprofen Microparticles for Developing Dry Powder Inhaler Formulation. Pharmaceutics 2023;15. https://doi.org/10.3390/pharmaceutics15020674

He X, Li J, Wen X, Ma S, An Y, Zhang X, et al. Synergistic effect of magnesium stearate and fine lactose in improving aerosolization performance of fluticasone propionate in dry powder formulation. Int J Pharm. 2024;664. https://doi.org/10.1016/j.ijpharm.2024.124609.

Stank K, Steckel H. Physico-chemical characterisation of surface modified particles for inhalation. Int J Pharm. 2013;448:9–18. https://doi.org/10.1016/j.ijpharm.2013.03.009.

Article  PubMed  CAS  Google Scholar 

D’Sa D, Chan H-K. A Review of Methods for Evaluating Particle Stability in Suspension Based Pressurized Metered Dose Inhalers. Curr Pharm Des. 2015;21:3955–65.

Article  PubMed  Google Scholar 

Alhajj N, O’Reilly NJ, Cathcart H. Designing enhanced spray dried particles for inhalation: A review of the impact of excipients and processing parameters on particle properties. Powder Technol. 2021;384:313–31. https://doi.org/10.1016/j.powtec.2021.02.031.

Article  CAS  Google Scholar 

Minootan Z, Wang H, Connaughton P, Lachacz K, Carrigy N, Ordoubadi M, et al. On the Feasibility of Rugose Lipid Microparticles in Pressurized Metered Dose Inhalers with Established and New Propellants. AAPS PharmSciTech. 2024;25. https://doi.org/10.1208/s12249-024-02776-z.

ChemicalBook. Magnesium stearate—Physical and Chemical Properties. https://WwwChemicalbookCom/Article/Magnesium-Stearate-Physical-and-Chemical-PropertiesHtm 2025.

BOC Sciences. Magnesium stearate. https://WwwBosschemicalCom/Magnesium-Stearate-557-04-0Html?Gad_source = 1&gad_ campaignid =22312301506&gbraid=0AAAAAoU1-VByPGgsc B6LXVZu1IYaEgenb&gclid=Cj0KCQjw2YDQBhD_ARIsAE1qeSdCCkQ0o1fEwYsrc AxjIkebQTCboQ0270_pWY_LzxnuB118YHlKFi4aAs8ZEALw_wcB 2025.

Ceschan NE, Bucalá V, Ramírez-Rigo MV. New alginic acid-atenolol microparticles for inhalatory drug targeting. Mater Sci Eng C. 2014;41:255–66. https://doi.org/10.1016/j.msec.2014.04.040.

Article  CAS  Google Scholar 

Nazareth E, Ceschan MaríaP, Caldarola Verónica, Bucalá JM, Figueroa AV, Dugour M. Verónica Ramírez-Rigo. Spray-dried indomethacin microparticles designed for asthma inhalatory treatments. 7ma Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2023), Rosario: 2023.

Ceschan NE, Bucalá V, Ramírez-Rigo MV, Smyth HDC. Impact of feed counterion addition and cyclone type on aerodynamic behavior of alginic-atenolol microparticles produced by spray drying. Eur J Pharm Biopharm. 2016;109:72–80. https://doi.org/10.1016/j.ejpb.2016.09.020.

Article  PubMed  Google Scholar 

Ceschan NE, Rosas MD, Olivera ME, Dugour AV, Figueroa JM, Bucalá V, et al. Development of a Carrier-Free Dry Powder Ofloxacin Formulation With Enhanced Aerosolization Properties. J Pharm Sci. 2020;109:2787–97. https://doi.org/10.1016/j.xphs.2020.05.027.

Article  PubMed  CAS  Google Scholar 

Büchi-Switzerland. Mini Spray Dryer B-290. Technical data sheet. n.d.Büchi Labortechnik AG. Mini Spray Dryer B-290: Technical data sheet (Doc. B-290 Data Sheet G en 1807). Flawil: Büchi Labortechnik AG; 2018.

< 1174 > POWDER. FLOW. USP44-NF39, 2021. United States Pharmacopeial Convention. <1174> Powder flow. In: United States Pharmacopeia and National Formulary (USP 44–NF 39). Rockville, MD: United States Pharmacopeial Convention; 2021.

de Charras YL, Bertin DE, Ramírez-Rigo MV. Influence of the valve on the performance of two cylindrical valved holding chambers. Powder Technol. 2023;414. https://doi.org/10.1016/j.powtec.2022.118094.

Ceschan N, Bucalá V, Ramírez-Rigo MV. Levofloxacin dry powder inhaler for high dose delivery. Powder Technol. 2024;432. https://doi.org/10.1016/j.powtec.2023.119168.

Ceschan N, Dugour AV, Behrend B, Figueroa JM, Smyth HDC, Bucalá V et al. Flowrate-Independent indomethacin dry powder inhaler for potential treatment of pediatric asthma: In vitro aerodynamic and anti-inflammatory evaluation. Eur J Pharm Biopharm 2025;216. https://doi.org/10.1016/j.ejpb.2025.114870

United States Pharmacopeial Convention. <601> Inhalation and nasal drug products: aerosols, sprays, and powders—performance quality tests. In: United States Pharmacopeia and National Formulary (USP 44–NF 39). Rockville, MD: United States Pharmacopeial Convention; 2021.

Karner S, Anne Urbanetz N. The impact of electrostatic charge in pharmaceutical powders with specific focus on inhalation-powders. J Aerosol Sci. 2011;42:428–45. https://doi.org/10.1016/j.jaerosci.2011.02.010.

Article  CAS  Google Scholar 

Tontul I, Topuz A. Spray-drying of fruit and vegetable juices: Effect of drying conditions on the product yield and physical properties. Trends Food Sci Technol. 2017;63:91–102. https://doi.org/10.1016/j.tifs.2017.03.009.

Article  CAS  Google Scholar 

Chen X, Carillo M, Haltiwanger RC, Bradley P. Solid state characterization of mometasone furoate anhydrous and monohydrate forms. J Pharm Sci. 2005;94:2496–509. https://doi.org/10.1002/jps.20470.

Article  PubMed  CAS  Google Scholar 

Rivelli GG, Perez AC, Silva PHR, Gomes EC, de Moreira L, de Tamashiro CP. E, Biodegradable Electrospun Nanofibers: A New Approach For Rhinosinusitis Treatment. Eur J Pharm Sci 2021;163. https://doi.org/10.1016/j.ejps.2021.105852

Mohammed GA, Puri V, Bansal AK. Coprocessing of nevirapine and stavudine by spray drying. Pharm Dev Technol. 2008;13:299–310. https://doi.org/10.1080/10837450802089164.

Article  PubMed  CAS  Google Scholar 

Jain M, Lohare GB, Bari MM, Chavan RB, Barhate SD, Shah CB. Spray Drying in Pharmaceutical Industry: A Review. Res J Pharma Dosage Forms Tech. 2011;4:74–9.

Google Scholar 

Zhou Q, Qu L, Gengenbach T, Larson I, Stewart PJ, Morton DAV. Effect of surface coating with magnesium stearate via mechanical dry powder coating approach on the aerosol performance of micronized drug powders from dry powder inhalers. AAPS PharmSciTech. 2013;14:38–44. https://doi.org/10.1208/s12249-012-9895-z.

Article  PubMed  CAS  Google Scholar 

Kumar V, Sethi B, Yanez E, Leung DH, Ghanwatkar YY, Cheong J, et al. Effect of magnesium stearate surface coating method on the aerosol performance and permeability of micronized fluticasone propionate. Int J Pharm. 2022;615:121470. https://doi.org/10.1016/J.IJPHARM.2022.121470.

Article  PubMed  CAS  Google Scholar 

Ph. Eur. 10.0. Dosage forms. Preparations for inhalation. Pressurised metered-dose preparations for inhalation. vol. 04. 10.0, 2018, p. 0671.

Xi Q, Cao Z, Miao JY, Wang H. The Study of Spray-Freeze-Drying Technique for Development of Novel Combination pMDIs, Part II: In Vitro and In Vivo Evaluations. Pharm Fronts. 2022;4:E275–83. https://doi.org/10.1055/s-0042-1758388.

Article  Google Scholar 

Chierici V, Cavalieri L, Piraino A, Paleari D, Quarta E, Sonvico F, et al. Consequences of not-shaking and shake-fire delays on the emitted dose of some commercial solution and suspension pressurized metered dose inhalers. Expert Opin Drug Deliv. 2020;17:1025–39. https://doi.org/10.1080/17425247.2020.1767066.

Article  PubMed  CAS 

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