Therapeutic applications and pharmacoeconomics of microneedle technology

References

• Chiarello K. Breaking the barrier: advances in transdermal technology. Pharm Tech. 2004;28:46–56.
   Google Scholar
• Prausnitz MR. Microneedles for transdermal drug delivery. Adv Drug Delivery Rev. 2004;56:581–587.
   PubMed Web of Science ®Google Scholar
• BusinessWire. Global transdermal drug delivery market worth USD 95.57 billion by 2025 - analysis, technologies & forecasts report 2016–2025. [cited 2018 Apr]. Available from: https://www.businesswire.com/news/home/20161111005701/en/Global-Transdermal-Drug-Delivery-Market-Worth-USD
   Google Scholar
• Indermun S, Luttge R, Choonara YE, et al. Current advances in the fabrication of microneedles for transdermal delivery. J Control Release. 2014;185:130–138.
   PubMed Web of Science ®Google Scholar
• Henry S, McAllister DV, Allen MG, et al. Microfabricated microneedles: a novel approach to transdermal drug delivery. J Pharm Sci. 1998;87(8):922–925.
   PubMed Web of Science ®Google Scholar
• Wermeling D, Banks S, Hudson D, et al. Microneedles permit transdermal delivery of a skin-impermeant medication to humans. PNAS. 2008;105(6):2058–2063.
   PubMed Web of Science ®Google Scholar
• Bariya SH, Gohel MC, Mehta TA, et al. Microneedles: an emerging transdermal drug delivery system. J Pharm Pharmacol. 2012;64:11–29.
   PubMed Web of Science ®Google Scholar
• Sivaraman A, Banga AK. Novel in situ forming hydrogel microneedles for transdermal drug delivery. Drug Delivery Transl Res. 2017;7:16–26.
   PubMed Web of Science ®Google Scholar
• Kim YC, Park JH, Prausnitz M. Microneedles for drug and vaccine delivery. Adv Drug Delivery Rev. 2012;64:1547–1568.
   PubMed Web of Science ®Google Scholar
• Donnelly RF, Singh TRR, Woolfson AD. Microneedle-based drug delivery systems: microfabrication, drug delivery, and safety. Drug Delivery. 2010;17:187–207.
   PubMed Web of Science ®Google Scholar
• Vieira MG, da Silva MA, dos Santos LO, et al. Natural-based plasticizers and biopolymer films: a review. Eur Polym J. 2011;47(3):254–263.
   Web of Science ®Google Scholar
• Bhatnagar S, Dave K, Venugantia VVK. Microneedles in the clinic. J Controlled Release. 2017;260:164–182.
   PubMed Web of Science ®Google Scholar
• Cheung K, Das DB. Microneedles for drug delivery: trends and progress. Drug Delivery. 2016;23(7):2338–2354.
   PubMed Web of Science ®Google Scholar
• Ma G, Wu C. Microneedle, bio-microneedle and bio-inspired microneedle: a review. J Controlled Release. 2017;251:11–23.
   PubMed Web of Science ®Google Scholar
• Ling MH, Chen MC. Dissolving polymer microneedle patches for rapid and efficient transdermal delivery of insulin to diabetic rats. Acta Biomater. 2013;9:8952–8961.
   PubMed Web of Science ®Google Scholar
• Benson HAE, Namjoshi S. Proteins and peptides: strategies for delivery to and across the skin. J Pharm Sci. 2008;97:3591–3610.
   PubMed Web of Science ®Google Scholar
• Kochhar JS, Zou S, Chan SY, et al. Protein encapsulation in polymeric microneedles by photolithography. Int J Nanomed. 2012;7:3143–3154.
   PubMed Web of Science ®Google Scholar
• Edens C, Collins ML, Ayers J, et al. Measles vaccination using a microneedle patch. Vaccine. 2013;31:3403–3409.
   PubMed Web of Science ®Google Scholar
• Torrisi BM, Zarnitsyn V, Prausnitz MR, et al. Pocketed microneedles for rapid delivery of a liquid-state botulinum toxin A. J Control Release. 2013;165:146–152.
   PubMed Web of Science ®Google Scholar
• Morefield GL, Tammariello RF, Purcell BK, et al. An alternative approach to combination vaccines: intradermal administration of isolated components for control of anthrax, botulism, plague and staphylococcal toxic shock. J Immune Based Ther Vaccines. 2008;6:5–11.
   PubMedGoogle Scholar
• Hirschberg HJ, van de Wijdeven GG, Kraan H, et al. Bioneedles as alternative delivery system for hepatitis B vaccine. J Control Release. 2010;147:211–217.
   PubMed Web of Science ®Google Scholar
• Laurent PE, Bourhy H, Fantino M, et al. Safety and efficacy of novel dermal and epidermal microneedle delivery systems for rabies vaccination in healthy adults. Vaccine. 2010;28:5850–5856.
   PubMed Web of Science ®Google Scholar
• Zhang S, Qin G, Wu Y, et al. Enhanced bioavailability of L-carnitine after painless intradermal delivery vs. oral administration in rats. Pharm Res. 2011;28:117–123.
   PubMed Web of Science ®Google Scholar
• Fukushima K, Ise A, Morita H, et al. Two-layered dissolving microneedles for percutaneous delivery of peptide/protein drugs in rats. Pharm Res. 2011;28:7–21.
   PubMed Web of Science ®Google Scholar
• Ito Y, Yoshimitsu J, Shiroyama K, et al. Self-dissolving microneedles for the percutaneous absorption of EPO in mice. J Drug Target. 2006;14:255–261.
   PubMed Web of Science ®Google Scholar
• Gupta J, Park SS, Bondy B, et al. Infusion pressure and pain during microneedle injection into skin of human subjects. Biomaterials. 2011;32:6823–6831.
   PubMed Web of Science ®Google Scholar
• Norman JJ, Brown MR, Raviele NA, et al. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013;14(6):459–465.
   PubMed Web of Science ®Google Scholar
• Cormier M, Johnson B, Ameri M, et al. Transdermal delivery of desmopressin using a coated microneedle array system. J Controlled Release. 2004;97:503–511.
   PubMed Web of Science ®Google Scholar
• Daddona PE, Matriano JA, Mandema J, et al. Parathyroid hormone (1–34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis. Pharm Res. 2011;28:159–165.
   PubMed Web of Science ®Google Scholar
• Macedo CG, Jain AK, Franz-Montan M, et al. Microneedles enhance topical delivery of 15-deoxy-Δ12,14-prostaglandin J2 and reduce nociception in temporomandibular joint of rats. J Control Release. 2017;265:22–29.
   PubMed Web of Science ®Google Scholar
• Li X, Zhao R, Qin Z, et al. Microneedle pretreatment improves efficacy of cutaneous topical anesthesia. Am J Emerg Med. 2010;28(2):130–134.
   PubMed Web of Science ®Google Scholar
• Park JH, Allen MG, Prausnitz MR. Biodegradable polymer microneedles: fabrication, mechanics and transdermal drug delivery. J Control Release. 2005;104:51–66.
   PubMed Web of Science ®Google Scholar
• Qiu Y, Gao Y, Hu K, et al. Enhancement of skin permeation of docetaxel: a novel approach combining microneedle and elastic liposomes. J Control Release. 2008;129:144–150.
   PubMed Web of Science ®Google Scholar
• Jiang J, Gill HS, Ghate D, et al. Coated microneedles for drug delivery to the eye. Invest Oph-Thalmol Vis Sci. 2007;48:4038–4043.
   PubMed Web of Science ®Google Scholar
• Gill HS, Prausnitz MR. Coated formulations for microneedles. Pharm Res. 2007;24:1369–1380.
   PubMed Web of Science ®Google Scholar
• Sivamani RK, Liepmann D, Maibach HI. Microneedles and transdermal applications. Exp Op Drug Delivery. 2007;4:19–25.
   PubMed Web of Science ®Google Scholar
• Davis SP, Landis BJ, Adams ZH. Insertion of microneedles into skin: measurement and prediction of insertion force and needle fracture force. J Biomech. 2004;37:1155–1163.
   PubMed Web of Science ®Google Scholar
• Donnelly R, Douroumis D. Microneedles for drug and vaccine delivery and patient monitoring. Drug Delivery Transl Res. 2015;5(4):311–312.
   PubMed Web of Science ®Google Scholar
• Dogra S, Yadav S, Sarangal R. Microneedling for acne scars in Asian skin type: an effective low-cost treatment modality. J Cosmet Dermatol. 2014;13:180–187.
   PubMed Web of Science ®Google Scholar
• Lee YB, Eun YS, Lee JH, et al. Effects of topical application of growth factors followed by microneedle therapy in women with female pattern hair loss: a pilot study. J Dermatol. 2013;40:81–83.
   PubMed Web of Science ®Google Scholar
• Larrañeta E, Lutton R, Woolfson D, et al. Microneedle arrays as transdermal and intradermal drug delivery systems: materials science, manufacture and commercial development. Mater Sci Eng. 2016;104:1–32.
   Google Scholar
• Ogundele M, Okafor HK. Transdermal drug delivery: microneedles, their fabrication and current trends in delivery methods. J Pharm Res Int. 2017;18(5):1–14.
   Google Scholar
• LTS Lohman website. [cited 2018 May]. Available from: https://ltslohmann.de/en/technology/transdermal-therapeutic-systems/
   Google Scholar
• Corium website. Manufacturing: from concept to commercialization. [cited 2018 May]. Available from: http://www.coriumintl.com/
   Google Scholar
• Jina A, Tierney MJ, Tamada JA, et al. Development, and evaluation of a novel microneedle array-based continuous glucose monitor. J Diabetes Sci Technol. 2014;8(3):483–487.
   PubMedGoogle Scholar
• Bal SM, Caussin J, Pavel S, et al. In vivo assessment of safety of microneedle arrays in human skin. Eur J Pharm Sci. 2008;35(3):193–202.
   PubMed Web of Science ®Google Scholar
• Rouphael NG, Paine M, Mosley R, et al. The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial. Lancet. 2017;390(10095):649–658.
   PubMed Web of Science ®Google Scholar
• Vicente-Perez E, Larrañeta E, McCrudden MTC, et al. Repeat application of microneedles does not alter skin appearance or barrier function and causes no measurable disturbance of serum biomarkers of infection, inflammation or immunity in mice in vivo. Eur J Pharm Biopharm. 2017;117:400–407.
   PubMed Web of Science ®Google Scholar
• Al-Zahrani S, Zaric M, McCrudden C, et al. Microneedle mediated vaccine delivery: harnessing cutaneous immunobiology to improve efficacy. Expert Opin Drug Deliv. 2012;9:541–550.
   PubMed Web of Science ®Google Scholar
• Prausnitz MR, Mitragoti S, Langer R. Current status and future potential of transdermal drug delivery. Nat Rev Drug Discov. 2004;3:115–124.
   PubMed Web of Science ®Google Scholar
• You SK, Noh YW, Park HH, et al. Effect of applying modes of the polymer microneedle roller on the permeation of L-ascorbic acid in rats. J Drug Target. 2010;18:15–20.
   PubMed Web of Science ®Google Scholar
• Norman JJ, Arya JM, McClain MA, et al. Microneedle patches: usability and acceptability for self-vaccination against influenza. Vaccine. 2014;32(16):1856–1862.
   PubMed Web of Science ®Google Scholar
• Prausnitz MR. Engineering microneedle patches for vaccination and drug delivery to skin. Annu Rev Chem Biomol Eng. 2017;8:177–200.
   PubMed Web of Science ®Google Scholar
• Birchall JC, Clemo R, Anstey A, et al. Microneedles in clinical practice–an exploratory study into the opinions of healthcare professionals and the public. Pharm Res. 2011;28:95–106.
   PubMed Web of Science ®Google Scholar
• Vicente-Pérez EM, Quinn HL, McAlister E, et al. The use of a pressure-indicating sensor film to provide feedback upon hydrogel-forming microneedle array self-application in vivo. Pharm Res. 2016;33(12):3072–3080.
   PubMed Web of Science ®Google Scholar
• Donnelly RF, Moffatt K, Alkilani AZ, et al. Hydrogel-forming microneedle arrays can be effectively inserted in skin by self-application: a pilot study centred on pharmacist intervention and a patient information leaflet. Pharm Res. 2014;31(8):1989–1999.
   PubMed Web of Science ®Google Scholar
• Mooney K, McElnay JC, Donnelly RF. Children’s views on microneedle use as an alternative to blood sampling for patient monitoring. Int J Pharm Pract. 2014;22:335–344.
   PubMedGoogle Scholar
• Ripolin A, Quinn J, Larrañeta E, et al. Successful application of large microneedle patches by human volunteers. Int J Pharm. 2017;521:92–101.
   PubMed Web of Science ®Google Scholar
• Schmier J, Ogden K, Nickman N, et al. Costs of providing infusion therapy for rheumatoid arthritis in a hospital-based infusion center setting. Clin Ther. 2017;39(8):1600–1617.
   PubMed Web of Science ®Google Scholar
• Kim S, Lee J, Shayan FL, et al. KimPhysicochemical study of ascorbic acid 2-glucoside loaded hyaluronic acid dissolving microneedles irradiated by electron beam and gamma ray. Carbohydr Polym. 2018;180:297–303.
   PubMed Web of Science ®Google Scholar
• Barbé B, Gillet P, Beelaert G, et al. Assessment of desiccants and their instructions for use in rapid diagnostic tests. Malar J. 2012;11:326.
   PubMed Web of Science ®Google Scholar
• Lutton RE, Moore J, Larrañeta E, et al. Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation. Drug Deliv Transl Res. 2015;5(4):313–331.
   PubMed Web of Science ®Google Scholar
• Lee K, Jung H. Drawing lithography for microneedles: a review of fundamentals and biomedical applications. Biomaterials. 2012;33:7309–7326.
   PubMed Web of Science ®Google Scholar
• Larrañeta E, McCrudden M, Courtenay A, et al. Microneedles: a new frontier in nanomedicine delivery. Pharm Res. 2016;33:1055–1073.
   PubMed Web of Science ®Google Scholar
• Tuan-Mahmoud T, McCrudden M, Torrisi B, et al. Microneedles for intradermal and transdermal drug delivery. Eur J Pharm Sciences. 2013;50:623–637.
   PubMed Web of Science ®Google Scholar
• Badilescu S, Packirisamy M. BioMEMS: science and engineering perspectives. Boca Raton: CRC Press; 2012.
   Google Scholar
• O’Mahony C. Structural characterization and in-vivo reliability evaluation of silicon microneedles. Biomed Microdev. 2014;16:333–343.
   PubMed Web of Science ®Google Scholar
• Quinn HL, Bonham L, Hughes CM, et al. Design of a dissolving microneedle platform for transdermal delivery of a fixed-dose combination of cardiovascular drugs. J Pharm Sci. 2015;104:3490–3500.
   PubMed Web of Science ®Google Scholar
• Dean CH, Alarcon JB, Waterston AM, et al. Cutaneous delivery of a live, attenuated chimeric flavivirus vaccine against Japanese encephalitis (ChimeriVax)-JE) in non- human primates. Hum Vaccin. 2005;1:106–111.
   PubMed Web of Science ®Google Scholar
• So JW, Park HH, Lee SS, et al. Effect of microneedle on the pharmacokinetics of ketoprofen from its transdermal formulations. Drug Delivery. 2009;16(1):52–56.
   PubMed Web of Science ®Google Scholar
• Ita K. Transdermal delivery of drugs with microneedles—potential and challenges. Pharmaceutics. 2015;7:90–105.
   PubMed Web of Science ®Google Scholar
• Adhikari BB, Goodson JL, Chu SY, et al. Assessing the potential cost-effectiveness of microneedle patches in childhood measles vaccination programs: the case for further research and development. Drugs R D. 2016;16:327–338.
   PubMed Web of Science ®Google Scholar
• Lee BY, Bartsch SM, Mvundura M, et al. An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine. Vaccine. 2015;33:4727–4736.
   PubMed Web of Science ®Google Scholar
• Lim D-J, Vines JB, Park H, et al. Microneedles: a versatile strategy for transdermal delivery of biological molecules. Int J Biol Macromol. 2017; Accepted Manuscript. DOI:10.1016/j.ijbiomac.2017.12.027
   Web of Science ®Google Scholar
• Singh A, Yadav S. Microneedling: advances and widening horizons. Ind Derma. 2016;7(4): 244–254. Online J.
   PubMedGoogle Scholar
• Jeong HR, Lee HS, Choi IJ, et al. Considerations in the use of microneedles: pain, convenience, anxiety and safety. J Drug Target. 2017;25(1):29–40.
   PubMed Web of Science ®Google Scholar
• Zeng Q, Gammon JM, Tostanoski LH, et al. In vivo expansion of melanoma-specific T cells using microneedle arrays coated with immune-polyelectrolyte multilayers. ACS Biomater Sci Eng. 2017;3:195–205.
   PubMed Web of Science ®Google Scholar
• Wang M, Hu L, Xu C. Recent advances in the design of polymeric microneedles for transdermal drug delivery and biosensing. Lab Chip. 2017;17:1373–1387.
   PubMed Web of Science ®Google Scholar
• Yang S, Wu F, Liu J, et al. Phase-transition microneedle patches for efficient and accurate transdermal delivery of insulin. Adv Funct Mater. 2015;25:4633–4641.
   Web of Science ®Google Scholar