nach oben

Erschienen in:

2021 | OriginalPaper | Buchkapitel

11. CFD Applications for Drug Delivery

verfasst von : Kendra Shrestha, Ross Walenga, Jinxiang Xi, Yidan Shang, Hana Salati, Jim Bartley, David White

Erschienen in: Clinical and Biomedical Engineering in the Human Nose

Verlag: Springer Singapore

Einloggen

Aktivieren Sie unsere intelligente Suche, um passende Fachinhalte oder Patente zu finden.

search-config

KI-gestützte Suche

Aus

Abstract

This chapter provides the latest research trends in applications of CFD for investigating nasal drug delivery. Contributions include research and outcomes from the regulatory body, US Food Drug Administration on recent projects. Additionally, the chapter showcases the application of multiphase flow for capturing nasal spray drug delivery for improving olfactory targeting for nose-to-brain drug delivery, and nasal irrigation targeting the sinuses.

Sie haben noch keine Lizenz? Dann Informieren Sie sich jetzt über unsere Produkte:

Springer Professional "Wirtschaft+Technik"

Online-Abonnement

Mit Springer Professional "Wirtschaft+Technik" erhalten Sie Zugriff auf:

über 102.000 Bücher
über 537 Zeitschriften

aus folgenden Fachgebieten:

Automobil + Motoren
Bauwesen + Immobilien
Business IT + Informatik
Elektrotechnik + Elektronik
Energie + Nachhaltigkeit
Finance + Banking
Management + Führung
Marketing + Vertrieb
Maschinenbau + Werkstoffe
Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Jetzt informieren

Springer Professional "Technik"

Online-Abonnement

Mit Springer Professional "Technik" erhalten Sie Zugriff auf:

über 67.000 Bücher
über 390 Zeitschriften

aus folgenden Fachgebieten:

Automobil + Motoren
Bauwesen + Immobilien
Business IT + Informatik
Elektrotechnik + Elektronik
Energie + Nachhaltigkeit
Maschinenbau + Werkstoffe

Jetzt Wissensvorsprung sichern!

Jetzt informieren

Springer Professional "Wirtschaft"

Online-Abonnement

Mit Springer Professional "Wirtschaft" erhalten Sie Zugriff auf:

über 67.000 Bücher
über 340 Zeitschriften

aus folgenden Fachgebieten:

Bauwesen + Immobilien
Business IT + Informatik
Finance + Banking
Management + Führung
Marketing + Vertrieb
Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Jetzt informieren

Vorheriges Kapitel Clinical CFD Applications 2

Nächstes Kapitel Future Topics, Challenges

Center for Drug Evaluation and Research, FDA. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (2003). https://www.fda.gov/media/70867/download. Accessed 12 Aug. 2009

U.S. Food and Drug Administration, Product-Specific Guidances for Generic Drug Development (2019). https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development. Accessed 10 Sep. 2019

Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112–144, Title iii

U.S. Food and Drug Administration. GDUFA II Commitment Letter

U.S. Food and Drug Administration. Science & Research

M. Andersen, R. Sarangapani, R. Gentry, H. Clewell, T. Covington, C. Frederick, Application of a hybrid CFD-PBPK nasal dosimetry model in an inhalation risk assessment: an example with acrylic acid. Toxicol. Sci. 57(2), 312–325 (2000)CrossRef

B.S. Bleier, I. Debnath, R.J. Harvey, R.J. Schlosser, Temporospatial quantification of fluorescein-labeled sinonasal irrigation delivery. Int. Forum Allergy Rhinol. 1(5), 361–5 (2011)CrossRef

M. Bush, C. Frederick, J. Kimbell, J. Ultman, A CFD-PBPK hybrid model for simulating gas and vapor uptake in the rat nose. Toxicol. Appl. Pharmacol. 150(1), 133–145 (1998)CrossRef

J. Campbell, M. Andersen, H. Clewell, A hybrid CFD-PBPK model for naphthalene in rat and human with ivive for nasal tissue metabolism and cross-species dosimetry. Inhal. Toxicol. 26(6), 333–344 (2014)CrossRef

10.

X. Chen, S. Feng, L. Chang, X. Lai, X. Chen, X. Li, G. Zhang, The effects of nasal irrigation with various solutions after endoscopic sinus surgery: Systematic review and meta-analysis. J. Laryngol. Otol. 132(8), 673–679 (2018)CrossRef

11.

Y. Cheng, T. Holmes, J. Gao, R. Guilmette, S. Li, Y. Surakitbanharn, C. Rowlings, Characterization of nasal spray pumps and deposition pattern in a replica of the human nasal airway. J. Aerosol Med. 14(2), 267–280 (2001)CrossRef

12.

L.Y. Chong, K. Head, C. Hopkins, C. Philpott, S. Glew, G. Scadding, M.J. Burton, A.G. Schilder, Saline irrigation for chronic rhinosinusitis. Cochrane Database Syst. Rev. 4, CD011995 (2016)

13.

R. Corley, K. Minard, S. Kabilan, D. Epstein, A. Kuprat, J. Harkema, J. Kimbell, M. Gargas, J. Kinzell, Magnetic resonance imaging and computational fluid dynamics (CFD) simulations of rabbit nasal airflows for the development of hybrid CFD/PBPK models. Inhal. Toxicol. 21(6), 512–518 (2009)CrossRef

14.

R.A. Corley, S. Kabilan, A.P. Kuprat, J.P. Carson, K.R. Minard, R.E. Jacob, C. Timchalk, R. Glenny, S. Pipavath, T. Cox, C.D. Wallis, R.F. Larson, M.V. Fanucchi, E.M. Postlethwait, D.R. Einstein, Comparative computational modeling of airflows and vapor dosimetry in the respiratory tracts of rat, monkey, and human. Toxicol. Sci. 128(2), 500–516 (2012)CrossRef

15.

J.R. Craig, J.N. Palmer, K. Zhao, Computational fluid dynamic modeling of nose-to-ceiling head positioning for sphenoid sinus irrigation. Int. Forum Allergy Rhinol. 7(5), 474–479 (2017)CrossRef

16.

J.R. Craig, K. Zhao, N. Doan, S. Khalili, J.Y. Lee, N.D. Adappa, J.N. Palmer, Cadaveric validation study of computational fluid dynamics model of sinus irrigations before and after sinus surgery. Int. Forum Allergy Rhinol. 6(4), 423–8 (2016)CrossRef

17.

P. Dayal, M. Shaik, M. Singh, Evaluation of different parameters that affect droplet-size distribution from nasal sprays using the malvern spraytec. J. Pharm. Sci. 93(7), 1725–1742 (2004)CrossRef

18.

S.H. De Paiva Leite, R.G. Douglas, How does sinus surgery affect topical irrigation distribution? Curr. Opin. Otolaryngol. Head Neck Surg. 26(1), 21–26 (2018)CrossRef

19.

R. Eccles, Nasal airflow in health and disease. Acta Otolaryngol. 120(5), 580–95 (2000)CrossRef

20.

FDA, Predictive lung deposition models for safety and efficacy of orally inhaled drug products (Worth Longest, P), in Generic Drug User Fee Amendments Grant 1U01FD004570 (2012)

21.

FDA, Development of hybrid CFD-PBPK models for absorption of intranasal corticosteroids (Schroeter, J), in Generic Drug User Fee Amendments Grant 1U01FD005201 (2014)

22.

FDA, Evaluating relationships between in vitro nasal spray characterization test metrics for bioequivalence and nasal deposition in silico and in vitro (Golshahi, L). HHSF223201810144C (2018)

23.

FDA, Nasal mucociliary clearance affecting local drug-absorption in subject-specific geometries (Kleinstreuer, C), in Generic Drug User Fee Amendments Grant 1U01FD006537 (2018)

24.

M. Foo, Y. Cheng, W. Su, M. Donovan, The influence of spray properties on intranasal deposition. J. Aerosol Med. 20)(4), 495–508 (2007)

25.

C. Frederick, P. Gentry, M. Bush, L. Lomax, K. Black, L. Finch, J. Kimbell, K. Morgan, R. Subramaniam, J. Morris, J. Ultman, A hybrid computational fluid dynamics and physiologically based pharmacokinetic model for comparison of predicted tissue concentrations of acrylic acid and other vapors in the rat and human nasal cavities following inhalation exposure. Inhal. Toxicol. 13(5), 359–376 (2001)CrossRef

26.

M.C. Fung, K. Inthavong, W. Yang, J. Tu, CFD modeling of spray atomization for a nasal spray device. Aerosol Sci. Technol. 46(11), 1219–1226 (2012)CrossRef

27.

A. Grobler, E.K. Weitzel, A. Buele, C. Jardeleza, Y.C. Cheong, J. Field, P.J. Wormald, Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope 118(11), 2078–81 (2008)CrossRef

28.

L. Hanson, W. Frey, Strategies for intranasal delivery of therapeutics for the prevention and treatment of neuroaids. J. Neuroimmune Pharmacol. 2(1), 81–86 (2007)CrossRef

29.

K. Head, K. Snidvongs, S. Glew, G. Scadding, A.G. Schilder, C. Philpott, C. Hopkins, Saline irrigation for allergic rhinitis. Cochrane Database Syst. Rev. 6, CD012597 (2018)

30.

J.D. Hoekman, R.J.Y. Ho, Effects of localized hydrophilic mannitol and hydrophobic nelfinavir administration targeted to olfactory epithelium on brain distribution. AAPS Pharmscitech. 12(2), 534–543 (2011)CrossRef

31.

32.

K. Inthavong, M.C. Fung, W. Yang, J. Tu, Measurements of droplet size distribution and analysis of nasal spray atomization from different actuation pressure. J. Aerosol Med. Pulm Drug Delivery 28(1), 59–67(2014)

33.

J.D. Schroeter, D. Stricklin, J.S. Kimbell, R.R. Delvadia, X. Zhang, A physiologically-based pharmacokinetic model framework to estimate systemic bioavailability of fluticasone propionate nasal spray, in Respiratory Drug Delivery, April 17–21, Scottsdale, AZ, USA (2016)

34.

J.D. Schroeter, J.S. Kimbell, B. Saluja, R.R. Delvadia, E.L. Vallorz, P. Sheth, The impact of actuation force on droplet size distribution and spray duration of three commercially available nasal sprays, in Respiratory Drug Delivery, April 17–21, Scottsdale, AZ, USA (2016)

35.

G. Jo, S. Chung, Y. Na, Numerical study of the effect of the nasal cycle on unilateral nasal resistance. Respir. Physiol. Neurobiol. 219, 58–68 (2015)CrossRef

36.

J.T. Kelly, B. Asgharian, J.S. Kimbell, B.A. Wong, Particle deposition in human nasal airway replicas manufactured by different methods. Part I: Inertial regime particles. Aerosol Sci. Technol. 38, 1063–1071 (2004)

37.

J.S. Kimbell, J.D. Schroeter, P. Sheth, G. Tian, R.R. Delvadia, B. Saluja, R. Walenga, Effect of actuation force on simulated regional nasal spray deposition in a healthy nasal cavity. Respiratory Drug Delivery, April 17–21, Scottsdale, AZ, USA (2016)

38.

J. Kimbell, J. Schroeter, G. Tian, R. Walenga, A. Babiskin, R. Delvadia, Estimating size-specific numbers of active pharmaceutical ingredient particles in the regional deposition of a nasal spray. J. Aerosol Med. Pulm. Drug Deliv. 30(3), 18–19 (2017)

39.

J.S. Kimbell, R.A. Segal, B. Asgharian, B.A. Wong, J.D. Schroeter, J.P. Southall, C.J. Dickens, G. Brace, F.J. Miller, Characterization of deposition from nasal spray devices using a computational fluid dynamics model of the human nasal passages. J. Aerosol Med. 20(1), 59–74 (2007)

40.

J. Kimbell, R. Subramaniam, Use of computational fluid dynamics models for dosimetry of inhaled gases in the nasal passages. Inhal. Toxicol. 13(5), 325–334 (2001)CrossRef

41.

D. King, B. Mitchell, C.P. Williams, G.K. Spurling, Saline nasal irrigation for acute upper respiratory tract infections. Cochrane Database Syst. Rev. 4, CD006821 (2015)

42.

B. Li, F. Jin, S. Lee, T. Bai, B. Chowdhury, H. Caramenico, D. Conner, Bioequivalence for locally acting nasal spray and nasal aerosol products: standard development and generic approval. AAPS J. 15(3), 875–883 (2013)CrossRef

43.

X. Liu, W.H. Doub, C. Guo, Evaluation of droplet velocity and size from nasal spray devices using phase doppler anemometry (pda). Int. J. Pharm. 388, 82–87 (2010)CrossRef

44.

A. Mistry, S. Stolnik, L. Illum, Nanoparticles for direct nose-to-brain delivery of drugs. Int. J. Pharm. 379(1), 146–157 (2009)CrossRef

45.

S.P. Newman, F. Moren, S.W. Clarke, Deposition pattern of nasal sprays in man. Rhinology 26, 111–120 (1988)

46.

R. Patel, G. Garcia, D. Frank-Ito, J. Kimbell, J. Rhee, Simulating the nasal cycle with computational fluid dynamics. Otolaryngol. Head Neck Surg. 152(2), 353–60 (2015)CrossRef

47.

N. Principi, S. Esposito, Nasal irrigation: an imprecisely defined medical procedure. Int. J. Environ. Res. Public Health 14, 5 (2017)

48.

A. Rygg, M. Hindle, P. Longest, Absorption and clearance of pharmaceutical aerosols in the human nose: effects of nasal spray suspension particle size and properties. Pharm. Res. 33(4), 909–921 (2016)CrossRef

49.

A. Rygg, M. Hindle, P. Longest, Linking suspension nasal spray drug deposition patterns to pharmacokinetic profiles: a proof-of-concept study using computational fluid dynamics. J. Pharm. Sci. 105(6), 1995–2004 (2016)CrossRef

50.

A. Rygg, P. Longest, Absorption and clearance of pharmaceutical aerosols in the human nose: development of a CFD model. J. Aerosol Med. Pulm. Drug Deliv. 29(5), 416–431 (2016)CrossRef

51.

S. Gizurarson, Method for administration of active substances to the olfactory region. in.: Patents ca 2298596

52.

Salati, H., Investigation Into Nasal Saline Irrigation Within a Healthy Human Nose. Thesis (2019)

53.

B. Saluja, B. Li, S. Lee, Bioequivalence for Orally Inhaled and Nasal Drug Products (Springer, New York, 2014), pp. 369–394

54.

J. Schroeter, J. Kimbell, R. Walenga, A. Babiskin, R. Delvadia, A CFD-PBPK model to simulate nasal absorption and systemic bioavailability of intranasal fluticasone propionate. J. Aerosol Med. Pulm. Drug Deliv. 30(3), 13–14 (2017)

55.

P.K. Senecal, D.P. Schmidt, I. Nouar, C.J. Rutland, R.D. Reitz, M.L. Corradini, Modeling high-speed viscous liquid sheet atomization. Int. J. Multiph. Flow 25(6–7), 1073–1097 (1999)MATHCrossRef

56.

X. Si, J. Xi, J. Kim, Y. Zhou, H. Zhong, Modeling of release position and ventilation effects on olfactory aerosol drug delivery. Respir. Physiol. Neurobiol. 186(1), 22–32 (2013)CrossRef

57.

K. Snidvongs, P. Chaowanapanja, S. Aeumjaturapat, S. Chusakul, P. Praweswararat, Does nasal irrigation enter paranasal sinuses in chronic rhinosinusitis? Am. J. Rhinol. 22, 483–86 (2008)CrossRef

58.

J.D. Suman, B.L. Laube, T. Lin, G. Brouet, R. Dalby, Validity of in vitro tests on aqueous spray pumps as surrogates for nasal deposition. Pharm. Res. 19(1), 1–6, Springer (2002)

59.

W.W. Thomas, R.J. Harvey, L. Rudmik, P.H. Hwang, R.J. Schlosser, Distribution of topical agents to the paranasal sinuses: an evidence-based review with recommendations. Int. Forum Allergy Rhinol. 3(9), 691–703 (2013)

60.

J. Tu, K. Inthavong, G. Ahmad, Computational Fluid and Particle Dynamics in the Human Respiratory System (Springer, Berlin, 2013)

61.

J. Wang, J. Bentz, R. Anderson, Nasal device for delivery to the olfactory region

62.

D. White, A. Al-Jumaily, J. Bartley, J. Lu, Correlation of nasal morphology to air-conditioning and clearance function. Respir. Physiol. Neurobiol. 179(2–3), 137–41 (2011)CrossRef

63.

P. Wormald, T. Cain, L. Oates, L. Hawke, I. Wong, A comparative study of three methods of nasal irrigation. Laryngoscope 114(2), 2224–7 (2004)CrossRef

64.

J. Xi, A. Berlinski, Y. Zhou, B. Greenberg, X. Ou, Breathing resistance and ultrafine particle deposition in nasal-laryngeal airways of a newborn, an infant, a child, and an adult. Ann. Biomed. Eng. 40(12), 2579–2595 (2012)CrossRef

65.

J. Xi, J. Kim, X.A. Si, R.A. Corley, Y. Zhou, Modeling of inertial depositions in scaled models of rat and human nasal airways: towards in vitro regional dosimetry in small animals. J. Aerosol Sci. 99, 78–93 (2015)CrossRef

66.

J. Xi, P.W. Longest, Characterization of submicrometer aerosol deposition in extrathoracic airways during nasal exhalation. Aerosol Sci. Technol. 43(8), 808–827 (2009)CrossRef

67.

J. Xi, X. Si, W. Longest, Electrostatic charge effects on pharmaceutical aerosol deposition in human Nasal–Laryngeal airways. Pharmaceutics 6(1), 26–35 (2014)

68.

J. Xi, X.A. Si, J. Kim, Y. Zhang, R.E. Jacob, S. Kabilan, R.A. Corley, Anatomical details of the rabbit nasal passages and their implications in breathing, air conditioning, and olfaction. Anat. Rec. 299(7), 853–868 (2016)CrossRef

69.

J. Xi, J. Yuan, M. Alshaiba, D. Cheng, Z. Firlit, A. Johnson, A. Nolan, W. Su, Design and testing of electric-guided delivery of charged particles to the olfactory region: experimental and numerical studies. Curr. Drug Deliv. 10 (2015)

70.

J. Xi, J.E. Yuan, Y. Zhang, D. Nevorski, Z. Wang, Y. Zhou, Visualization and quantification of nasal and olfactory deposition in a sectional adult nasal airway cast. Pharm. Res. 33(6), 1527–41 (2016)CrossRef

71.

J. Xi, Z. Zhang, X. Si, Improving intranasal delivery of neurological nanomedicine to the olfactory region using magnetophoretic guidance of microsphere carriers. Int. J. Nanomed. 10, 1211–1222 (2015)CrossRef

72.

J. Xi, Z. Zhang, X.A. Si, J. Yang, W. Deng, Optimization of magnetophoretic-guided drug delivery to the olfactory region in a human nose model. Biomech. Model. Mechanobiol. 15(4), 877–891 (2016)CrossRef

73.

Y. Zhang, Y. Shang, K. Inthavong, Z. Tong, B. Sun, K. Zhu, A. Yu, G. Zheng, Computational investigation of dust mite allergens in a realistic human nasal cavity. Inhal. Toxicol. 31(6), 224–235 (2019). PMID: 31431101CrossRef

74.

K. Zhao, J. Craig, N. Cohen, N. Adappa, S. Khalili, J. Palmer, Sinus irrigations before and after surgery - visualization through computational fluid dynamics simulations. Laryngoscope 126(3), E90–E96 (2016)CrossRef

75.

K. Zhao, P. Dalton, The way the wind blows: implications of modeling nasal airflow. Curr. Allergy Asthma Rep. 7(2), 117–25

76.

Y. Zhou, M. Guo, J. Xi, H. Irshad, Y.-S. Cheng, Nasal deposition in infants and children. J. Aerosol Med. Pulm. Drug Deliv. 27(2), 110–116 (2014)CrossRef

77.

Y. Zhou, J. Xi, J. Simpson, H. Irshad, Y.-S. Cheng, Aerosol deposition in a nasopharyngolaryngeal replica of a 5-year-old child. Aerosol Sci. Technol. 47(3), 275–282 (2013)CrossRef

Titel: CFD Applications for Drug Delivery
verfasst von: Kendra Shrestha
Ross Walenga
Jinxiang Xi
Yidan Shang
Hana Salati
Jim Bartley
David White
Verlag: Springer Singapore
Buch: Clinical and Biomedical Engineering in the Human Nose
Print ISBN: 978-981-15-6715-5

Electronic ISBN: 978-981-15-6716-2

Copyright-Jahr: 2021
DOI: https://doi.org/10.1007/978-981-15-6716-2_11

Premium Partner

Marktübersichten

Die im Laufe eines Jahres in der „adhäsion“ veröffentlichten Marktübersichten helfen Anwendern verschiedenster Branchen, sich einen gezielten Überblick über Lieferantenangebote zu verschaffen.

Zur Marktübersicht

Springer Professional

Abstract

Bitte loggen Sie sich ein, um Zugang zu Ihrer Lizenz zu erhalten.

Sie haben noch keine Lizenz? Dann Informieren Sie sich jetzt über unsere Produkte:

Springer Professional "Wirtschaft+Technik"

Springer Professional "Technik"

Springer Professional "Wirtschaft"

Premium Partner

Marktübersichten