Scientific publications written by our academic customers summarizing studies successfully performed using our microneedle array products.

2022

46. Vo, Trinh Phuong, Gitika Panicker, Kimberly Braz-Gomes, Ashwin C. Parenky, Ira Rajbhandari, Mangalathu S. Rajeevan, Elizabeth R. Unger, Martin J. D’Souza, and Mohammad N. Uddin. 2022. "Enhanced Immunogenicity of Adjuvanted Microparticulate HPV16 Vaccines Administered via the Transdermal Route" Pharmaceuticals 15, no. 9: 1128.

Abstract: Human papillomavirus (HPV) causes cervical cancer among women and is associated with other anogenital cancers in men and women. Prophylactic particulate vaccines that are affordable, self-administered and efficacious could improve uptake of HPV vaccines world-wide. The goal of this research is to develop a microparticulate HPV16 vaccine for transdermal administration using AdminPatch® and assess its immunogenicity in a pre-clinical mouse model. HPV16 microparticles were prepared using a biocompatible polymer and characterized in terms of size, zeta potential, encapsulation efficiency and microparticle yield. Scanning and transmission electron microscopy were conducted to confirm particle image and to visualize the conformation of HPV16 vaccine particles released from microparticle formulation. In vivo studies performed to evaluate the potential of the microparticulate vaccine initiated a robust and sustained immune response. HPV16 IgG antibodies were significantly elevated in the microparticle group compared to antigen solutions administered by the transdermal route. Results show significant expansion of CD4+, CD45R, CD27 and CD62L cell populations in the vaccinated mice group, indicating the high efficacy of the microparticulate vaccine when administered via transdermal route. The findings of this study call attention to the use of minimally invasive, pain-free routes to deliver vaccine.
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45. Heba Abd-El-Azim, Ismaiel A. Tekko, Ahlam Ali, Alyaa Ramadan, Noha Nafee, Nawal Khalafallah, Taifur Rahman, William Mcdaid, Rania G. Aly, Lalitkumar K. Vora, Steven J. Bell, Fiona Furlong, Helen O. McCarthy, Ryan F. Donnelly, "Hollow microneedle assisted intradermal delivery of hypericin lipid nanocapsules with light enabled photodynamic therapy against skin cancer," Journal of Controlled Release, Volume 348, 2022, Pages 849-869.

Abstract: Photodynamic therapy (PDT) to manage non-melanoma skin cancers has garnered great attention over the past few years. Hypericin (Hy) is a potent lipid-soluble photosensitiser with promising anticancer therapeutic activities. Nevertheless, its poor water-solubility, aggregation in biological systems and insufficient skin penetration restricted its effective exploitation. Herein, we report for the first-time encapsulation of Hy into lipid nanocapsules (Hy-LNCs), and then application of an AdminPen™ hollow microneedles (Ho-MNs) array and an in-house fabricated Ho-MN to enable efficient intradermal delivery. The physicochemical properties, photoactivity, ex vivo drug distribution and cellular uptake were evaluated. Results showed that Hy-LNCs were successfully formed with a particle size of 47.76 ± 0.49 nm, PDI of 0.12 ± 0.02, high encapsulation efficiency (99.67% ± 0.35), 396 fold higher photoactivity, 7 fold higher skin drug deposition, significantly greater cellular uptake and higher photocytotoxicity compared to free Hy. The therapeutic effect of Hy-LNCs was finally assessed in vivo using a nude mouse model with transplanted tumours. Interestingly, Hy-LNCs delivered by Ho-MN exhibited remarkable anti-tumour destruction (85.84%) after irradiation with 595 nm. This study showed that Ho-MNs-driven delivery of Hy-LNCs followed by irradiation could form a promising minimally invasive, effective and site-specific approach for managing non-melanoma skin cancers.
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44. D’Sa, Sucheta, Kimberly Braz Gomes, Grace Lovia Allotey-Babington, Cemil Boyoglu, Sang-Moo Kang, and Martin J. D’Souza. 2022. "Transdermal Immunization with Microparticulate RSV-F Virus-like Particles Elicits Robust Immunity" Vaccines 10, no. 4: 584.

Abstract: No approved vaccines against respiratory syncytial virus (RSV) infections exist to date, due to challenges arising during vaccine development. There is an unmet need to explore novel approaches and a universal strategy to prevent RSV infections. Previous studies have proven the immune efficacy of virus-like particles (VLPs) consisting of RSV fusion (F) protein, yielding a highly immunogenic RSV-F VLP subunit vaccine. In this study, RSV-F VLP (with or without MPL®) was added to a polymer mix and spray-dried, forming microparticles. The formulations were transdermally administered in C57BL/6 mice to evaluate vaccine efficacy. The transdermal delivery of RSV-F VLP + MPL® was more effective in clearing lung viral loads and preventing weight loss after RSV challenge. At the cellular level, MPL® augmented the vaccine response in microparticulate form, which was evidenced by higher serum and lung antibody titers, and lower lung viral titers in the vaccinated groups. These preliminary results validate the effectiveness of the RSV-F VLP microparticulate vaccine via the transdermal route due to its potential to trigger robust immune responses.
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2021

43. Shivaprasad Gadag, Reema Narayan, Archana S. Nayak, Diana Catalina Ardila, Shilpa Sant, Yogendra Nayak, Sanjay Garg, Usha Y. Nayak,
"Development and preclinical evaluation of microneedle-assisted resveratrol loaded nanostructured lipid carriers for localized delivery to breast cancer therapy," International Journal of Pharmaceutics, Volume 606, 2021, 120877.

Abstract: Resveratrol (RVT) is one of the potent anticancer phytochemicals which has shown promising potential for breast cancer therapy. However, its short half-life and low bioavailability is a major hurdle in its effective use. In this study, we have developed nanostructured lipid carriers (NLCs) of RVT to enable localized delivery of the drug to the breast tissues using microneedle arrays to improve effectiveness. The NLCs were optimized using the Design of Experiments approach and characterized for their particle size, polydispersity index, zeta potential and entrapment efficiency. The RVT-NLCs delivered using microneedle array 1200 showed a higher permeation of RVT across the skin with lower skin retention compared to pure RVT. Further, RVT-NLCs showed higher anticancer activity on MDA-MB-231 breast cancer cell lines and enhanced internalization compared to pure RVT. Moreover, the RVT-NLCs were found to inhibit the migration of MDA-MB-231 breast cancer cell lines. Preclinical studies in rats showed that RVT-NLCs delivered via microneedles demonstrated a remarkable increase in the Cmax, Tmax and AUC0-inf, and a higher localization in breast tissue compared to pure RVT administered orally. These results suggests that the RVT-NLCs administered by microneedle array system is an effective strategy for the local delivery of RVT for breast cancer therapy.
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2019

42. Lipika Chablani, Suprita A. Tawde, Archana Akalkotkar, Martin J. D’Souza, "Evaluation of a Particulate Breast Cancer Vaccine Delivered via Skin," AAPS J (2019) 21: 12.

Abstract: Breast cancer impacts female population globally and is the second most common cancer for females. With various limitations and adverse effects of current therapies, several immunotherapies are being explored. Development of an effective breast cancer vaccine can be a groundbreaking immunotherapeutic approach. Such approaches are being evaluated by several clinical trials currently. On similar lines, our research study aims to evaluate a particulate breast cancer vaccine delivered via skin. This particulate breast cancer vaccine was prepared by spray drying technique and utilized murine breast cancer whole cell lysate as a source of tumor-associated antigens. The average size of the particulate vaccine was 1.5 μm, which resembled the pathogenic species, thereby assisting in phagocytosis and antigen presentation leading to further activation of the immune response. The particulate vaccine was delivered via skin using commercially available metal microneedles. Methylene blue staining and confocal microscopy were used to visualize the microchannels. The results showed that microneedles created aqueous conduits of 50 ± 10 μm to deliver the microparticulate vaccine to the skin layers. Further, an in vivo comparison of immune response depicted significantly higher concentration of serum IgG, IgG2a, and B and T cell (CD4+ and CD8+) populations in the vaccinated animals than the control animals (p < 0.001). Upon challenge with live murine breast cancer cells, the vaccinated animals showed five times more tumor suppression than the control animals confirming the immune response activation and protection (p < 0.001). This research paves a way for individualized immunotherapy following surgical tumor removal to prolong relapse episodes.
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2018

41. Tanja Ilić, Sanela Savić, Bojan Batinić, Bojan Marković, Markus Schmidberger, Dominique Lunter, Miroslav Savić, Snežana Savić, Combined use of biocompatible nanoemulsions and solid microneedles to improve transport of a model NSAID across the skin: In vitro and in vivo studies, European Journal of Pharmaceutical Sciences, Volume 125, 2018, Pages 110-119.
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40. Olatunji, O., Olubowale, M. & Okereke C., Microneedle-assisted transdermal delivery of acetylsalicylic acid (aspirin) from biopolymer films extracted from fish scales, C. Polym. Bull. (2018) 75: 4103.
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2017

39. C. Uppuluri, J. Devineni, T. Han, A. Nayak, K. J. Nair, B. R. Whiteside, D. B. Das, B. N. Nalluri, Microneedle-assisted transdermal delivery of Zolmitriptan: effect of microneedle geometry, in vitro permeation experiments, scaling analyses and numerical simulations, Drug Development and Industrial Pharmacy (2017), Volume 43, Number 8, pp. 1292-1303.
AdminMed's Note: There are several following issues in this publication:
* AdminPatch microneedle arrays have 1 cm2 active area in contrast to this publication incorrectly referencing 1.77 cm2 active area;
* AdminPatch 1200 has 43 (forty-three) microneedles located within 1 cm2 circular area while the publication incorrectly says that AdminPatch 1200 has 41 microneedles per 1.77 cm2;
* AdminPatch microneedle arrays have 3D hollow microneedle shape and not “Flat (2D)” as reported in this publication. AdminPatch microneedle and base thicknesses are incorrectly measured in this publication as well.
* The correct Reference 21 should be: Vadim V. Yuzhakov, Microneedle array, patch, and applicator for transdermal drug delivery, US Patent No. 7,658,728. Washington DC: U.S.Patent and Trademark Office; 2010.
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38. B. N. Nalluri, C. Uppuluri, J. Devineni, A. Nayak, K. J. Nair, B. R. Whiteside, D. B. Das, Effect of microneedles on transdermal permeation enhancement of amlodipine, Drug Deliv. and Transl. Res. (2017) 7:383–394.
AdminMed's Note: There are several following issues in this publication:
* AdminPatch microneedle arrays have 1 cm2 active area in contrast to this publication incorrectly referencing 1.77 cm2 active area;
* AdminPatch 1200 has 43 (forty-three) microneedles located within 1 cm2 circular area while the publication incorrectly says that AdminPatch 1200 has 41 microneedles per 1.77 cm2;
* AdminPatch microneedle arrays have 3D hollow microneedle shape and not “Flat (2D)” as reported in this publication. AdminPatch microneedle and base thicknesses are incorrectly measured in this publication as well.
* The correct Reference 23 should be: Vadim V. Yuzhakov, Microneedle array, patch, and applicator for transdermal drug delivery, US Patent No. 7,658,728. Washington DC: U.S.Patent and Trademark Office; 2010.
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37. P.-C. Hsu, C. Liu, A. Y. Song, Z. Zhang, Y. Peng, J. Xie, K. Liu, C.-L. Wu, P. B. Catrysse, L. Cai, S. Zhai, A. Majumdar, S. Fan, Y. Cui, A dual-mode textile for human body radiative heating and cooling. Sci. Adv. 3, e1700895 (2017).
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36. M. Gkikas, R. K. Avery, C. E. Mills, R. Nagarajan, E. Wilusz, B. D. Olsen, Hydrogels That Actuate Selectively in Response to Organophosphates, Adv. Funct. Mater. 2017, 27, 1602784.
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35. Uppuluri, C., Shaik, A., Han, T. et al., Effect of Microneedle Type on Transdermal Permeation of Rizatriptan, AAPS PharmSciTech (2017) 18: 1495.
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2016

34. Brendan Koch, Ilaria Rubino, Fu-Shi Quan, Bongyoung Yoo, and Hyo-Jick Choi, Microfabrication for Drug Delivery, Materials. 2016; 9(8):646
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33. Suprita A. Tawde, Lipika Chablani, Archana Akalkotkar, Martin J. D'Souza, Evaluation of microparticulate ovarian cancer vaccine via transdermal route of delivery, Journal of Controlled Release, Volume 235, August 2016, Pages 147-154
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32. Buchi Naidu Nalluri, Sirivalli Kosuri, Sai Sri Anusha Valluru, Chandra Teja Uppuluri, Ashraf Sultana Shaik, Microneedle Assisted Transdermal Delivery of Levodopa, Indian Journal of Pharmaceutical Education and Research., 2016; 50(2):287-294
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31. Jennifer Zhang, Yan Wang, Jane Y. Jin, Simone Degan, Russell P. Hall, Ryan D. Boehm, Panupong Jaipan, Roger J. Narayan, Use of Drawing Lithography-Fabricated Polyglycolic Acid Microneedles for Transdermal Delivery of Itraconazole to a Human Basal Cell Carcinoma Model Regenerated on Mice, JOM, April 2016, Volume 68, Issue 4, pp 1128-1133
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2015

30. Leeladurga, V, Teja, UC, Sultana, SKA, Sudeep, K, Anusha, VSS, Han, T, Nalluri, BN, Das, DB, Application of Microneedle Arrays for Enhancement of Transdermal Permeation of Insulin: In Vitro Experiments, Scaling Analyses and Numerical Simulations, AAPS PharmSciTech, 2015.
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29. Naresh Modepalli, HN Shivakumar, KL Paranjothy Kanni, and S Narasimha Murthy, Transdermal iron replenishment therapy, Therapeutic Delivery, 2015, Vol. 6, No. 6, Pages 661-668.
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28. Ololade Olatunji, Richard T. Olsson, Microneedles from Fishscale-Nanocellulose Blends Using Low Temperature Mechanical Press Method, Pharmaceutics, 2015, 7(4), 363-378;
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27. Hiep X. Nguyen, Ajay K. Banga, Enhanced skin delivery of vismodegib by microneedle treatment, Drug Delivery and Translational Research, August 2015, Volume 5, Issue 4, pp 407-423.
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26. Karmen Cheung, Geoff West, Diganta Bhusan Das, Delivery of large molecular protein using flat and short microneedles prepared using focused ion beam (FIB) as a skin ablation tool. Drug Delivery and Translational Research, August 2015, Volume 5, Issue 4, pp 462-467. DOI10.1007/s13346-015-0252-0
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25. Nayak, A, Short, L, Das, DB (2015) Lidocaine permeation from a lidocaine NaCMC:gel microgel formulation in microneedle pierced skin: vertical (depth averaged) and horizontal permeation profiles, Drug Delivery and Translational Research, August 2015, Volume 5, Issue 4, pp 372-386.
DOI: 10.1007/s13346-015-0229-z
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24. Ita, K. Transdermal Delivery of Drugs with Microneedles—Potential and Challenges. Pharmaceutics 2015, 7, 90-105. doi:10.3390/pharmaceutics7030090
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23. Nayak, A., Das, D. B., Chao, T. C. and Starov, V. M. (2015), Spreading of a Lidocaine Formulation on Microneedle-Treated Skin. J. Pharm. Sci.. doi: 10.1002/jps.24625
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22. Tao Han and Diganta Bhusan Das, "A New Paradigm for Numerical Simulation of Microneedle-Based Drug Delivery Aided by Histology of Microneedle-Pierced Skin," Journal of Pharmaceutical Sciences (2015)
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21. Atul Nayak, Hiten Babla, Tao Han, and Diganta Bhusan Das, "Lidocaine carboxymethylcellulose with gelatine co-polymer hydrogel delivery by combined microneedle and ultrasound," Drug Delivery (2015)
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20. Buchi N. Nalluri, Sai Sri Anusha, Sri R. Bramhini, J. Amulya, Ashraf S. Sultana, Chandra U. Teja and Digantha B. Das, "In Vitro Skin Permeation Enhancement of Sumatriptan by Microneedle Application" (2015), http://dx.doi.org/10.2174/1567201812666150304123150
http://www.eurekaselect.com/129118/article
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2014

19. Hiep Nguyen, Ajay K. Banga, Conference Paper: "Enhanced Delivery of Vismodegib by Microneedle Treatment: Effect of Needle Length, Equilibration Time and Treatment Duration." 2014 AAPS Annual Meeting and Exposition, San Diego, California, November 2014
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18. Hiep Nguyen, Ajay K. Banga, Conference Paper: "Effect of Microneedle Treatment on the In-vitro Skin Permeation of Vismodegib." The Third International Conference on Microneedles 2014, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA, May 2014
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17. Dongwei Zhang, Diganta B. Das, "Microneedle assisted microparticle delivery: experiments using a skin mimicking agarose gel." The Third International Conference on Microneedles 2014, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA, May 2014, pp. 67-68.
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16. Dongwei Zhang, Diganta B. Das, Chris D. Rielly. "Microneedle assisted micro-particle delivery by gene guns: Mathematical model formulation and experimental verification," Chemical Engineering Science (2014), ISSN 0009-2509, http://dx.doi.org/10.1016/j.ces.2014.06.031.
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15. Dongwei Zhang, Chris D. Rielly, and Diganta B. Das. "Microneedle-assisted microparticle delivery by gene guns: experiments and modeling on the effects of particle characteristics," Drug Delivery (2014).
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14. Cheung, K, Han, T, Das, DB. "Effect of Force of Microneedle Insertion on the Permeability of Insulin in Skin," Journal of Diabetes Science and Technology (2014).
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13. Monika Kaur, Kevin B. Ita, Inna E. Popova, Sanjai J. Parikh, Daniel A. Bair, Microneedle-assisted delivery of verapamil hydrochloride and amlodipine besylate, European Journal of Pharmaceutics and Biopharmaceutics.
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12. Zhang, Dongwei, Diganta B. Das, and Chris D. Rielly. "Microneedle Assisted Micro‐Particle Delivery from Gene Guns: Experiments Using Skin‐Mimicking Agarose Gel." Journal of pharmaceutical sciences (2014).
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2013

11. Yuen, Clement, and Quan Liu. "Ag coated microneedle based surface enhanced Raman scattering probe for intradermal measurements." European Conferences on Biomedical Optics. International Society for Optics and Photonics, 2013.
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10. Yuen, Clement, and Quan Liu. "Towards in vivo intradermal surface enhanced Raman scattering (SERS) measurements: silver coated microneedle based SERS probe." Journal of biophotonics (2013).
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9. Zhang, Dongwei, Diganta B. Das, and Chris D. Rielly. "An Experimental Study of Microneedle‐Assisted Microparticle Delivery." Journal of pharmaceutical sciences 102.10 (2013): 3632-3644.
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8. Tao Han, Diganta B. Das, "Permeability Enhancement for Transdermal Delivery of Large Molecule Using Low-Frequency Sonophoresis Combined with Microneedles." Journal of Pharmaceutical Sciences, Vol. 102, 3614–3622 (2013)
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7. Juluri, Abhishek, et al. "Minimally invasive transdermal delivery of iron–dextran." Journal of pharmaceutical sciences 102.3 (2013): 987-993.
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6. Ita, Kevin, Nanik Hatsakorzian, and Vladimir Tolstikov. "Microneedle-Mediated Delivery of Atenolol and Bisoprolol Hemifumarate." Journal of Nanopharmaceutics and Drug Delivery 1.1 (2013): 38-44.
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5. Atul Nayak, Diganta B. Das, Goran T. Vladisavljević, "Microneedle-Assisted Permeation of Lidocaine Carboxymethylcellulose with Gelatine Co-polymer Hydrogel." Pharmaceutical Research, November 2013.
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4. Singh, Neha D., and Ajay K. Banga. "Controlled delivery of ropinirole hydrochloride through skin using modulated iontophoresis and microneedles." Journal of drug targeting 21.4 (2013): 354-366.
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2012

3. Modepalli, Naresh, et al. "Microporation and ‘Iron’tophoresis for Treating Iron Deficiency Anemia." Pharmaceutical research (2013): 1-10.
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2011

2. Lipika Chablani, Suprita Tawde, Archana Akalkotkar and Martin J. D’Souza, Formulation of Novel Particulate Breast Cancer Vaccines using Spray Drying and In Vivo Evaluation of Vaccine Efficacy.
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2010

A well-known journal Drug Delivery Technology published our paper describing AdminPen devices. Please click on the following link to read the publication reviewing AdminPen devices and the enabling AdminPatch microneedle technology:

1. Yuzhakov, Vadim V. "The AdminPen™ Microneedle Device for Painless & Convenient Drug Delivery." Drug Deliv. Technol 10.4 (2010): 32-36.
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