EVALUATION OF AERODYNAMIC PARTICLE SIZE DISTRIBUTION OF DRUGS USED IN INHALATION THERAPY: A CONCISE REVIEW

  • Dr. Smita Nayak Department of Quality Assurance, Gahlot Institute of Pharmacy, University of Mumbai, Sector 14, Koparkhairane, Navi Mumbai-400709, Maharashtra, India https://orcid.org/0000-0002-8942-2001
  • Priyanka Ghugare Department of Quality Assurance, Gahlot Institute of Pharmacy, University of Mumbai, Sector 14, Koparkhairane, Navi Mumbai-400709, Maharashtra, India https://orcid.org/0000-0003-3458-0464
  • Bhaskar Vaidhun Department of Quality Assurance, Gahlot Institute of Pharmacy, University of Mumbai, Sector 14, Koparkhairane, Navi Mumbai-400709, Maharashtra, India
Keywords: Metered Dose Inhaler, Dry Powder Inhaler, Inertial Impaction, Anderson Cascade Impactor, Next Generation Impactor, Laser Diffraction, HELOS

Abstract

Most of the inhalation products in the market use metered dose inhaler (MDI) technology or dry powder inhaler (DPI) technology. MDIs use propellant to deliver desired dose of liquid formulation in aerosol form. DPI contains active in fine particulate form embedded onto an inert carrier. In both cases, amount of drug dispensed from the device reaching the lungs is dependent upon drug product characteristics as well as formulation-device relationship. Hence, in addition to particle size, aerodynamic distribution of the drug upon delivery by the device plays an important role in determining amount of drug reaching the lungs. Therefore particle size characterization is an important tool in determining the extent of drug delivery from the metered dose inhaler. Aerodynamic particle size distribution is frequently determined by use of cascade impactors and data so generated is accepted by regulatory agencies as a tool for predicting efficacy of MDIs and DPIs. This review discusses principle and working of cascade impactors. Additionally, the review also examines the role of laser diffraction technique in estimating size of dispersed particles.

References

Ibrahim, M., Verma, R. and Garcia-Contreras L. Inhalation Drug Delivery Devices: Technology Update. Medical Devices (Auckl). 8, 2015, 131–139. DOI: https://doi.org/10.2147/MDER.S48888

Simkovich, SM., Goodman, D. and Roa, C. The Health and Social Implications of Household Air Pollution and Respiratory Diseases. NPJ Primary Care Respiratory Medicine. 29, 2019, 12 -24. DOI: https://doi.org/10.1038/s41533-019-0126-x

Rau, JL., The Inhalation of Drugs: Advantages and Problems. Respiratory Care. 50, 2005, 367-382.

Garmise, R. and Hickey, J. Calibration of the Andersen Cascade Impactor for the Characterization of Nasal Products. Journal of Pharmaceutical Sciences. 97(8), 2008, 3462-3466. DOI: https://doi.org/10.1002/jps.21267

Roberts, D. and Romay, FJ. Relationship of Stage Mensuration Data to the Performance of New and Used Cascade Impactors. Journal of Aerosol Medicine. 18(4), 2005, 396 – 413. DOI: https://doi.org/10.1089/jam.2005.18.396

Copley, M. Cascade Impactors Enter a New Decade. Manuf. Chem 2007.

Lawrence, S. and Sonkin, L. Application of the Cascade Impactor to Studies of Bacterial Aerosols. American Journal of Epidemiology. 51(3), 1950, 319–342. DOI: https://doi.org/10.1093/oxfordjournals.aje.a119398

Mitchell, JP., Nagel, MW., Avvakoumova, V., MacKay, H. and Ali, R. The Abbreviated Impactor Measurement (AIM) Concept: Part 1--Influence of Particle Bounce and Re-Entrainment-Evaluation with a "Dry" Pressurized Metered Dose Inhaler (Pmdi)-Based Formulation. AAPS PharmSciTech. 10(1), 2009, 243–251. DOI: https://doi.org/10.1208/s12249-009-9202-9

Stein, H. and Olso, BA. Variability in size distribution measurements obtained using multiple Andersen Mark II cascade impactors. Pharmaceutical Research. 14(12), 1997, 1718-1725.

Hata, M., Linfa B, Otani, Y. and Furuuchi, M. Performance Evaluation of an Andersen Cascade Impactor with an Additional Stage for Nanoparticle Sampling. Aerosol and Air Quality Research. 12, 2012, 1041-1048. DOI: https://doi.org/10.4209/aaqr.2012.08.0204

Sethuraman, VV. and Hickey, AJ. Evaluation of preseparator performance for the 8-stage nonviable Andersen impactor. AAPS PharmSciTech, 2, 2001,34–52. DOI: https://doi.org/10.1208/pt020104

Bonam, M., Christopher, D., Cipolla, D., Donovan, B, Goodwin, D. and Holmes, S. Minimizing variability of cascade impaction measurements in inhalers and nebulizers. AAPS PharmSciTech. 9(2), 2008, 404–413. DOI: https://doi.org/10.1208/s12249-008-9045-9

Marple, VA., Olson, BA., Santhanakrishnan, 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. Journal of Aerosol Medicine. 17(4), 2004, 335-343. DOI: https://doi.org/10.1089/jam.2004.17.335

Byron, PR., Cummings, H., , SC., Poochikian, G., Smurthwaite, MJ., Stein, SW. and Truman, KG. Selection and Validation of Cascade Impactor Test Methods. Respiratory Drug Delivery IX. 1, 2004, 169-178.

Mitchell, J. and Nagel, M. Cascade Impactors for Size Characterization of Aerosols from Medical Inhalers: Their Uses and Limitations. Journal of Aerosol Medicine. 16(4), 2003, 341-377. DOI: https://doi.org/10.1089/089426803772455622

Malcolmso, RJ. and Embleton, JK. Dry Powder Formulations for Pulmonary Delivery. Pharmaceutical Science & Technology Today. 1, 1998, 394–398. DOI: https://doi.org/10.1016/S1461-5347(98)00099-6

HORIBA Scientific. "Principles and Applications of Laser Diffraction Technology". Available from https://www.azom.com/article.aspx?ArticleID=16153. (Accessed on May 16, 2020).

Xu, R. Laser Diffraction. In: Scarlet B, editor. Particle Characterization: Light Scattering Methods. Dordrecht: Springer Netherlands, Kluwer Academic Publishers; 2002. 111-181.

Merkus, H, editor. Particle Size Measurements. Dordrecht: Springer Netherlands;2009.

ISO 13320:2009, Particle size analysis - Laser diffraction methods.

Bohren, C., Huffman, D. editors. Absorption and Scattering of Light by Small Particles. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA, 2007.

Helos/BR. Available on https://www.sympatec.com/en/particle-measurement/ sensors/laser-diffraction/helos/ (Accessed on May 16, 2020).

Published
2020-08-01
How to Cite
Nayak, S., Ghugare, P., & Vaidhun, B. (2020). EVALUATION OF AERODYNAMIC PARTICLE SIZE DISTRIBUTION OF DRUGS USED IN INHALATION THERAPY: A CONCISE REVIEW. International Journal of Research -GRANTHAALAYAH, 8(7), 264-271. https://doi.org/10.29121/granthaalayah.v8.i7.2020.579