A consensus research agenda for optimising nasal drug delivery

References

• Ozsoy Y, Gungor S, Cevher E. Nasal delivery of high molecular weight drugs. Molecules. 2009;14(9):3754–3779.
   PubMed Web of Science ®Google Scholar
• Hellfritzsch M, Scherließ R. Mucosal vaccination via the respiratory tract. Pharmaceutics. 2019;11:375.
   PubMed Web of Science ®Google Scholar
• Sonvico F, Clementino A, Buttini F, et al. Surface-modified nanocarriers for nose-to-brain delivery: from bioadhesion to targeting. Pharmaceutics. 2018;10:34.
   PubMed Web of Science ®Google Scholar
• Quintana DS, Westlye LT, Rustan ØG, et al. Low-dose oxytocin delivered intranasally with breath powered device affects social-cognitive behavior: a randomized fourway crossover trial with nasal cavity dimension assessment. Transl Psychiatry. 2015;5:e6.
   Web of Science ®Google Scholar
• Craft S, Claxtond A, Bakera LD. Effects of regular and long-acting insulin on cognition and Alzheimer’s disease biomarkers: a pilot clinical trial. J Alzheimers Dis. 2017;57:1325–1334.
   PubMed Web of Science ®Google Scholar
• Forbes B, Asgharian B, Dailey LA, et al. Challenges in inhaled product development and opportunities for open innovation. Adv Drug Deliv Rev. 2011;63:69–78.
   PubMed Web of Science ®Google Scholar
• FDA. Guidance for industry: nasal spray and inhalation solution, suspension, and spray drug products - chemistry, manufacturing, and controls documentation. 2002. https://www.fda.gov/media/70857/download
   Google Scholar
• Djupesland PG. Nasal drug delivery devices. Characteristics and performance in a clinical perspective-a review. Drug Deliv Transl Res. 2013;3:42–62.
   PubMed Web of Science ®Google Scholar
• Kublik K, Vidgren MT. Nasal delivery systems and their effect on deposition and absorption. Adv Drug Deliv Rev. 1998;29:157–177.
   PubMed Web of Science ®Google Scholar
• Costantino HR, Illum L, Brandt G, et al. Intranasal delivery: physicochemical and therapeutic aspects. Int J Pharm. 2007;337:1–24.
   PubMed Web of Science ®Google Scholar
• Grmaš J, Stare K, Bozič D, et al. Elucidation of formulation and delivery device-related effects on in vitro performance of nasal spray with implication to rational product specification identification. J Aerosol Med Pulm Drug Del. 2017;30:230–246.
   PubMed Web of Science ®Google Scholar
• Fasiolo LT, Manniello MD, Tratta E, et al. Opportunity and challenges of nasal powders: drug formulation and delivery. Eur J Pharm Sci. 2018;113:2–17.
   PubMed Web of Science ®Google Scholar
• Salade L, Wauthoz N, Goole J, et al. How to characterize a nasal product. The state of the art of in vitro and ex vivo specific methods. Int J Pharm. 2019;561:47–65.
   PubMedGoogle Scholar
• Salade L, Wauthoz N, Deleu M, et al. Development of coated liposomes loaded with ghrelin for nose-to-brain delivery for the treatment of cachexia. Int J Nanomedicine. 2017;12:S8531–8543.
   PubMed Web of Science ®Google Scholar
• Fransén N, Bredenberg S, Björk E. Clinical study shows improved absorption of desmopressin with novel formulation. Pharm Res. 2009;26:1618–1625.
   PubMed Web of Science ®Google Scholar
• Rygg A, Hindle M, Longest PW. Linking suspension nasal spray drug deposition patterns to pharmacokinetic profiles: a proof-of-concept study using computational fluid dynamics. J Pharm Sci. 2016;105:1995–2004.
   PubMed Web of Science ®Google Scholar
• EMA - Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, 2006
   Google Scholar
• Trows S, Wuchner K, Spycher R, et al. Analytical challenges and regulatory requirements for nasal drug products in Europe and the U.S. Pharmaceutics. 2014;6:195–219.
   PubMedGoogle Scholar
• FDA. Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. 2016
   Google Scholar
• Suman JD, Laube BL, Dalby R. Validity of in vitro tests on aqueous spray pumps as surrogates for nasal deposition, absorption, and biologic response. J Aerosol Med. 2006;19:510–521.
   PubMedGoogle Scholar
• Liu Q, Absar M, Saluja B, et al. Scientific considerations for the review and approval of first generic mometasone furoate nasal suspension spray in the United States from the bioequivalence perspective. AAPSJ. 2019;21:14.
   PubMed Web of Science ®Google Scholar
• Riley T, Christopher D, Arp J, et al. Challenges with developing in vitro dissolution tests for Orally Inhaled Products (OIPs). AAPS PharmSciTech. 2012;13:978–989.
   PubMed Web of Science ®Google Scholar
• Le Guellec S, Le Pennec D, Gatier S, et al. Validation of anatomical models to study aerosol deposition in human nasal cavities. Pharm Res. 2014;31:228–237.
   PubMed Web of Science ®Google Scholar
• Lim ST, Forbes B, Brown MB, et al. Physiological factors affecting nasal drug delivery. Chapter 19. In: Touitou E, Barry BW, editors. Enhancement in drug delivery. Boca Raton: CRC Press; 2007. p. 355–372.
   Google Scholar
• Grainger C, Greenwell LL, Lockley DJ, et al. Culture of Calu-3 cells at the air-liquid interface provides a representative model of the airway epithelial barrier. Pharm Res. 2006;23:1482–1490.
   PubMed Web of Science ®Google Scholar
• Pozzoli M, Ong HX, Morgan L, et al. Application of RPMI 2650 nasal cell model to a 3D printed apparatus for the testing of drug deposition and permeation of nasal products. Eur J Pharm Biopharm. 2016;107:223–233.
   PubMed Web of Science ®Google Scholar
• Ong HX, Jackson CL, Cole JL, et al. Primary air-liquid interface culture of nasal epithelium for nasal drug delivery. Mol Pharm. 2016;13:2242–2252.
   PubMed Web of Science ®Google Scholar
• Mercier C, Jacqueroux E, He Z, et al. Pharmacological characterization of the 3D MucilAir™ nasal model. Eur J Pharm Biopharm. 2019;139:186–196.
   PubMed Web of Science ®Google Scholar
• Borgmann-Winter K, Willard SL, Sinclair D, et al. Translational potential of olfactory mucosa for the study of neuropsychiatric illness. Transl Psychiatry. 2015;5(3):e527–e527.
   PubMedGoogle Scholar
• Sveinbjörn G. The effect of cilia and the mucociliary clearance on successful drug delivery. Biol Pharm Bull. 2015;38:497–506.
   PubMed Web of Science ®Google Scholar
• Quadir M, Zia H, Needham TE. Toxicological implications of nasal formulations. Drug Deliv. 1999;6:227–242.
   Web of Science ®Google Scholar
• Boger Elin FM. Physiologically based pharmacokinetic/pharmacodynamic modeling accurately predicts the better bronchodilatory effect of inhaled versus oral salbutamol dosage forms. J Aerosol Med Pulm Drug Del. 2019;32:1–12.
   PubMed Web of Science ®Google Scholar
• Möller W, Schuschnig U, Khadem Saba G, et al. Pulsating aerosols for drug delivery to the sinuses in healthy volunteers. Otolaryngol Head Neck Surg. 2010;142:382–388.
   PubMed Web of Science ®Google Scholar
• Durand M, Le Guellec S, Pourchez J, et al. Sonic aerosol therapy to target maxillary sinuses. Eur Ann Otorhinolaryngol Head Neck Dis. 2012;129:244–250.
   PubMed Web of Science ®Google Scholar
• Casettari L, Illum L. Chitosan in nasal delivery systems for therapeutic drugs. J Control Release. 2014;190:189–200.
   PubMed Web of Science ®Google Scholar
• Wingrove J, Swedrowska M, Scherließ R, et al. Characterisation of nasal devices for delivery of insulin to the brain and evaluation in humans using functional magnetic resonance imaging. J Control Release. 2019;302:140–147.
   PubMed Web of Science ®Google Scholar
• Grand View Research. Report ID: GVR-2-68038-740-7, Jan 2019. Cited 2019 Sep 06. Available from: https://www.grandviewresearch.com/industry-analysis/nasal-drug-delivery-technology-system-market
   Google Scholar
• Morgan P, Brown DG, Lennard S, et al. Impact of a five-dimensional framework on R&D productivity at AstraZeneca. Nat Rev Drug Discov. 2018;17:167–181.
   PubMed Web of Science ®Google Scholar