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

2024

50. Heba Abd-El-Azim, Haidy Abbas, Nesrine El Sayed, Mohamed R. Mousa, Hadil M. Elbardisy, Mariam Zewail, "Hypericin emulsomes combined with hollow microneedles as a non-invasive photodynamic platform for rheumatoid arthritis treatment," International Journal of Pharmaceutics, Volume 653, 2024.
Based on the results of the publication, the quantitative benefits of the AdminPen hollow microneedle array devices (Ho-MNs) used for the delivery of hypericin-loaded emulsomes (HYP EMLs) include:
• 100% Dermal Penetration: AdminPen™ Ho-MNs successfully and smoothly punctured the stratum corneum of excised human skin, demonstrating a dermal penetration percentage of 100%. This indicates the device's effectiveness in overcoming the skin's barrier for drug delivery (Page 7).
• Efficient Intradermal Distribution: The use of AdminPen™ Ho-MNs for injecting HYP EMLs into full-thickness excised human skin allowed the emulsomes to freely flow into deeper skin layers without needle blockage or drug leakage, ensuring efficient intradermal distribution of the drug (Page 7).
• Stability of HYP EMLs: The optimized HYP EMLs formulations maintained their physico-chemical characteristics, including homogenous particle size distribution and negative zeta potential, with encapsulation efficiency (EE%) values of 99% ± 0.05%, indicating superior stability without any drug leakage over 3 months at 4°C.
• Innovative Design to Prevent Clogging: AdminPen™ Ho-MNs are designed with an off-centered hollow pore on its side to avoid needle blockage during skin insertion, ensuring continuous and efficient drug delivery (Page 7).
• Rapid Skin Barrier Restoration: Upon removal of the AdminPen™ MNs, the microchannels created in the skin quickly collapse, allowing the skin barrier to be shortly restored, minimizing the risk of infection. This feature underscores the device's safety and efficacy for transdermal drug delivery.
These points highlight the AdminPen™ hollow microneedle array devices (Ho-MNs) effectiveness in enhancing the delivery of HYP EMLs for the treatment of Rheumatoid arthritis (RA), ensuring deep penetration, efficient distribution, and stability of the formulation, while also addressing potential challenges such as needle clogging and ensuring rapid skin barrier restoration post-application.
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2023

49. Shawn P. Grogan, Nicholas E. Glembotski, and Darryl D. D'Lima, "ALK-5 Inhibitors for Efficient Derivation of Mesenchymal Stem Cells from Human Embryonic Stem Cells," Tissue Engineering Part A, Mar 2023, 127-140.
Based on the publication, the qualitative benefits of using AdminPatch microneedle arrays for holding embryonic stem cell (ESC) hydrogel constructs include:
• Facilitation of Chondrogenic Tissue Formation: The AdminPatch microneedle arrays support the formation of chondrogenic tissue from ESC-derived mesenchymal stem cells (MSCs) encapsulated in extracellular matrix (ECM)-fibrin hydrogel, enabling effective differentiation and maturation into cartilage-like tissue.
• Maintenance of Construct Integrity: The microneedle arrays play a crucial role in maintaining the integrity and shape of the ECM-fibrin hydrogel constructs during the culture period. This structural support is essential for the development of mechanically stable constructs.
• Enhanced Cartilage Regeneration Capabilities: The combination of the AdminPatch microneedle arrays with ECM-fibrin hydrogel constructs loaded with ESC-derived MSCs demonstrates enhanced capabilities for cartilage regeneration, as evidenced by the formation of high-quality neocartilage tissues.
• Successful Integration with Host Tissue: The study shows that the constructs can integrate well with ex vivo osteoarthritic cartilage, suggesting that the microneedle arrays can facilitate the delivery and integration of regenerative constructs into diseased or damaged cartilage.
• Versatility in Stem Cell Therapy Applications: The use of AdminPatch microneedle arrays for holding ESC hydrogel constructs underscores the versatility and potential of microneedle-based platforms in enhancing the delivery and efficacy of stem cell therapies for cartilage regeneration and possibly other therapeutic applications.
These qualitative benefits highlight the potential of AdminPatch microneedle arrays in advancing regenerative medicine, particularly in the field of cartilage repair and regeneration.
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48. Heba Abd-El-Azim, Haidy Abbas, Nesrine S. El Sayed, Ahmed M. Fayez, Mariam Zewail, "Non-invasive management of rheumatoid arthritis using hollow microneedles as a tool for transdermal delivery of teriflunomide loaded solid lipid nanoparticles," International Journal of Pharmaceutics, Volume 644, 2023, 123334.
Based on the publication regarding the AdminPen hollow microneedle array devices (Ho-MNs) used for the delivery of teriflunomide encapsulated in solid lipid nanoparticles (TER-SLNs), the following quantitative benefits were identified:
• Minimally Invasive and Efficient Drug Delivery: The AdminPen hollow microneedles are designed to enable transdermal or intradermal delivery of liquid formulations, comprising 43 sharp-edged microneedle shafts for efficient drug delivery without needle blockage. Their structure facilitates direct drug administration to the inflammation sites, significantly enhancing the treatment's effectiveness.
• Reduced Risk of Skin Infection: Upon application, the AdminPen device creates tiny micropores in the skin that collapse and the skin barrier is quickly restored after the microneedles are removed, eliminating the risk of skin infection. This feature underscores the safety of using Ho-MNs for drug delivery.
• Superiority in Reducing Inflammation and Healing RA: The combination of TER-SLNs with AdminPen hollow microneedles demonstrated significant efficacy in reducing inflammation and healing Rheumatoid Arthritis (RA) in rats, compared to other methods. This combination could represent a promising non-invasive and self-administering alternative for RA treatment.
• Painless and Self-Administering Treatment Modality: The AdminPen hollow microneedles, combined with the nanoencapsulation of TER-SLNs, offer a painless and self-administering treatment modality. This approach not only improves patient compliance but also has the potential to replace invasive intra-articular injections.
• Potential Next Generation Anti-Arthritic Drug Delivery System: The innovative combination of MNs and nanotechnology platforms, exemplified by the AdminPen hollow MNs and TER-SLNs, is considered the next generation of anti-arthritic drug delivery systems, showcasing a significant advancement in RA treatment methodologies.
This study highlights the promising implications of combining hollow microneedle technology with nanotechnology for non-invasive, effective, and patient-friendly treatment options for RA.
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2022

47. 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.
Based on the results of the study, the quantitative benefits of using AdminPatch microneedle array devices are:
• Enhanced Immunogenicity: The AdminPatch microneedle array devices were used to deliver an HPV16 vaccine, which demonstrated enhanced immunogenicity in preclinical models. The microneedle delivery of the vaccine elicited robust immune responses, which were significantly higher than those observed with intramuscular injection.
• High Encapsulation Efficiency: For the microparticulate (MP) vaccine formulation, the encapsulation yield was notably high at 80.5 ± 0.85%, indicating efficient incorporation of the HPV16 antigen into the microparticles, essential for maintaining the vaccine's integrity and immunogenicity.
• Significant Immune Activation: The microparticulate vaccines, when administered intradermally using AdminPatch, showed a substantial expansion of crucial immune cell populations. Specifically, there was a significant increase in CD4+, CD45R, CD27, and CD62L cell populations in vaccinated mice, demonstrating the vaccine's effectiveness in activating both innate and adaptive immune responses.
• Robust Antibody Production: The study reported a marked elevation in HPV16-specific IgG antibodies in the group receiving the microparticulate vaccine compared to those administered antigen solutions, highlighting the enhanced immunogenicity offered by the microparticulate form and the AdminPatch delivery system.
• Effective Memory B-Cell Generation: In the lymph nodes, memory B-cell counts were significantly higher in the microparticulate vaccine groups, with 27.2% and 25.5% for different formulations, compared to only 7.7% in the positive control group, indicating a strong, sustained immunological memory response.
• Enhanced Seropositivity with Optimized Formulation: Adjustments in the vaccine formulation, including changes in polymer matrix concentrations and adjuvant types, led to increased seropositivity. Specifically, using a prime dose of 20 µg HPV16 VLPs/mouse, which is two times greater than the initial formulation, enhanced the immune response, indicating the system's adaptability for improved outcomes.
These points underscore the AdminPatch microneedle array devices' effectiveness in delivering microparticulate vaccines, enhancing immunogenic responses, and offering a promising strategy for improved HPV vaccination protocols.
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46. 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.
Here are the identified benefits of using AdminPen™ hollow microneedle array liquid injection devices (600, 900, 1200, and 1500 μm):
• Enhanced Delivery Efficiency: The AdminPen devices assisted in the efficient intradermal delivery of hypericin lipid nanocapsules (Hy-LNCs), overcoming the challenges of poor water solubility and limited skin penetration that typically hinder the effectiveness of hypericin (Hy). This efficient delivery system is crucial for ensuring that therapeutic agents reach their target site in optimal concentrations.
• Improved Physicochemical Properties of Hypericin: The study formulated Hy into lipid nanocapsules (Hy-LNCs), which were successfully created with a particle size of 47.76 ± 0.49 nm and a high encapsulation efficiency of 99.67% ± 0.35. These nanocapsules were then effectively delivered using AdminPen devices, indicating a synergistic benefit in the delivery of therapeutic compounds with enhanced stability and bioavailability.
• Significant Increase in Photoactivity: The use of AdminPen devices with Hy-LNCs resulted in a 396-fold higher photoactivity compared to free Hy. This substantial increase is pivotal in photodynamic therapy (PDT), particularly for the treatment of conditions like non-melanoma skin cancers, where the generation of reactive oxygen species from photosensitizers is used to destroy cancer cells.
• Enhanced Skin Drug Deposition: The study observed a 7-fold higher skin drug deposition with the use of AdminPen devices. This improvement is critical for topical therapies, especially in treating skin conditions, ensuring that drugs penetrate deeply and remain within the skin layers where they can exert their therapeutic effects.
• Remarkable Anti-Tumor Effects: In vivo assessments using a nude mouse model with transplanted tumors demonstrated that Hy-LNCs delivered by AdminPen devices showed significant anti-tumor activity, with a remarkable 85.84% tumor destruction post-irradiation. This finding underscores the potential of AdminPen devices in enhancing the therapeutic efficacy of anticancer agents.
In summary, the AdminPen™ hollow microneedles liquid injection devices (referred to as Ho-MNs) offer an efficient and effective method for intradermal delivery of hypericin lipid nanocapsules, enhancing their therapeutic potential in photodynamic therapy against skin cancer.
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45. 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.
Based on the results of the publication, the quantitative benefits of the AdminPatch microneedle array devices used for the delivery of RSV vaccine are as follows:
• Enhanced Immune Response: The study hypothesized and demonstrated that the transdermal delivery of RSV-F VLP microparticles via AdminPatch could result in enhanced uptake by immune cells and improved antigen presentation and recognition by the immune system, leading to more robust and long-lasting immune responses compared to conventional intramuscular (I.M.) vaccination (Page 3).
• High Encapsulation Efficiency: The encapsulation efficiency of RSV-F VLP in microparticles after spray drying was found to be approximately 85%, which is considerably high for encapsulation efficiency in polymeric nano/microparticles compared to other methods of preparation (Page 11).
• Effective Viral Clearance: The RSV-F VLP + MPL® delivered via the AdminPatch microneedle array was most effective in lowering lung viral titers compared to all other groups, indicating its potential to induce significant viral clearance and production of serum-neutralizing antibodies (Pages 8-9).
• Particle Size and Charge for Efficient Uptake: The average size of the microparticles was 2.53 ± 0.5 µm, with a positive charge of +25 ± 0.5 mV, facilitating phagocytosis and preferential uptake by dendritic cells, which are crucial for initiating immune responses (Page 6).
• Induction of IgG Antibodies: The transdermal vaccination with RSV-F VLP + MPL® microparticles induced IgG antibodies, which are known to confer protection against respiratory viruses (Page 6).
These points highlight the effectiveness of the AdminPatch microneedle array in delivering the RSV vaccine, emphasizing its potential to enhance vaccine efficacy and immune response.
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2021

44. 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.
AdminPatch 600, 777, and 1200 microneedle arrays were successfully used for the delivery of resveratrol for breast cancer therapy. The demonstrated benefits of the AdminPatch 600, 777, and 1200 microneedle arrays (denoted as 600 MN, 777 MN, and 1200 MN in the manuscript) are the following:
* Localized Delivery: The microneedle array system facilitates the localized delivery of resveratrol (RVT) to breast tissues. This targeted approach ensures that the drug is delivered directly to the affected area, increasing its therapeutic efficacy.
* Improved Permeation: The study found that RVT delivered using the microneedle array AdminPatch 1200 showed a higher permeation of RVT across the skin compared to pure RVT. This suggests that the microneedle system enhances the skin's permeability to the drug.
* Reduced Skin Retention: The RVT-NLCs (nanostructured lipid carriers) delivered using the microneedle array AdminPatch 1200 resulted in lower skin retention compared to pure RVT. This means that more of the drug is able to penetrate deeper tissues rather than remaining on the skin's surface.
* Enhanced Anticancer Activity: The RVT-NLCs showed higher anticancer activity on MDA-MB-231 breast cancer cell lines compared to pure RVT. This indicates that the combination of the microneedle system and the nanostructured lipid carriers enhances the drug's ability to combat cancer cells.
* Inhibition of Cancer Cell Migration: The RVT-NLCs were found to inhibit the migration of MDA-MB-231 breast cancer cell lines. This suggests that the treatment not only kills cancer cells but also prevents them from spreading.
* Increased Drug Concentration: Preclinical studies demonstrated that RVT-NLCs delivered via microneedles resulted in a remarkable increase in the Cmax (maximum serum concentration), Tmax (time to reach maximum concentration), and AUC0-inf (area under the curve, indicating overall drug exposure). Additionally, there was a higher localization of the drug in breast tissue compared to pure RVT administered orally.
* Effective Strategy for Breast Cancer Therapy: The results suggest that administering RVT-NLCs using the AdminPatch microneedle array system is an effective strategy for localized delivery of RVT for breast cancer therapy.
The AdminPatch microneedle arrays, specifically the AdminPatch 600, AdminPatch 777, and AdminPatch 1200, offer several benefits in the delivery of resveratrol for breast cancer therapy. These benefits include improved drug permeation, reduced skin retention, enhanced anticancer activity, and increased drug concentration in the target area.
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2020

43. Maria Mir, Andi Dian Permana, Ismaiel A. Tekko, Helen O. McCarthy, Naveed Ahmed, Asim. ur. Rehman, Ryan F. Donnelly,
"Microneedle liquid injection system assisted delivery of infection responsive nanoparticles: A promising approach for enhanced site-specific delivery of carvacrol against polymicrobial biofilms-infected wounds, " International Journal of Pharmaceutics, Volume 587, 2020, 119643.
Based on the results reported in this publication, some key benefits of the AdminPen microneedle array liquid injection devices are:
* Allowed delivery of larger volumes of nanoparticle suspension compared to solid microneedles. The hollow design enables connection to syringes for injection of formulations.
* Rapid and direct delivery of nanoparticles into skin layers. Ex vivo studies showed the devices delivered over 80% of the dose within 2 hours, compared to only 15% with topical hydrogel over 6 hours.
* Improved drug retention at the application site. In vivo studies showed up to 85% of nanoparticles remained in the skin 24 hrs after AdminPen injection, versus only 30% retained from a hydrogel.
* Delivered higher drug concentrations to skin. AdminPen 1500 gave 8.5 times higher skin concentrations compared to topical hydrogel in vivo.
* Different needle lengths (777, 1200, 1500 μm) provide control over injection depth. Longer needles like 1500 μm gave deeper delivery into dermis.
* Successfully inserted into skin and created microconduits for drug delivery, with 100% insertion efficiency seen.
* Rapid restoration of skin barrier after removal, with complete closure of pores within 10 minutes observed.
* Sterile, minimal skin trauma, avoids pain and infection risk compared to hypodermic needles.
In summary, the AdminPen devices seem beneficial for rapid, targeted, and painless delivery of larger volumes of drug nanoparticles into the skin at higher concentrations than topical formulations. The AdminPen 1500 μm device gave optimal delivery into deeper skin layers in this study.
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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.
AdminPen microneedle array devices have demonstrated more effective delivery of a Particulate Breast Cancer Vaccine. The publication discusses the development and evaluation of a breast cancer vaccine delivered through the skin using the AdminPen microneedle array device. Here are the key findings and benefits of using the AdminPen microneedle array device:
• Efficient Delivery and Skin Penetration: The AdminPen™ facilitated the delivery of the microparticulate vaccine into the skin effectively, creating microchannels that were about 50 ± 10 μm, ensuring the vaccine was adequately administered into the skin layers.
• Enhanced Immune Response: Animals vaccinated with the AdminPen™ showed a significantly higher concentration of serum IgG, IgG2a, and an increase in B and T cell (CD4+ and CD8+) populations compared to control animals. This indicates a robust immune response activated by the vaccine delivered through the AdminPen™.
• Significant Tumor Suppression: Upon challenge with live murine breast cancer cells, the vaccinated animals demonstrated a fivefold increase in tumor suppression compared to the control group. This outcome confirms the effectiveness of the immune response activated by the vaccine delivery through the AdminPen™.
• Increased Antibody Production: The study observed a substantial increase in specific antibody production (IgG) in the vaccinated group, indicating a heightened adaptive immune response due to the vaccine's administration via the AdminPen™.
• Potential for Improved Clinical Outcomes: The enhanced immunogenic response and the significant tumor suppression presented by the use of AdminPen™ suggest the potential for improved clinical outcomes in breast cancer therapy, contributing to prolonged episodes between relapses.
These points summarize the quantitative benefits observed in the study, highlighting the potential of the AdminPen™ microneedle system in enhancing the effectiveness of cancer vaccines.
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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
This study investigates the efficacy of a microparticulate ovarian cancer vaccine administered through transdermal and oral routes. The AdminPen™ 1200 microneedle liquid injection system, a metallic microneedle device comprised of an array of 43 metallic microneedles of 1100 nm length in a 1 cm sq area of a circular microneedle array made of SS316 stainless steel, was used for transdermal delivery. Based on the results of the study, the quantitative benefits of using the AdminPen™ 1200 microneedle liquid injection system for delivering a microparticulate ovarian cancer vaccine are as follows:
• Significant Tumor Volume Reduction: The use of the AdminPen™ 1200 system for intradermal vaccine delivery resulted in a notable decrease in tumor volume. Specifically, there was around 1.5 times tumor suppression with the intradermal route and combination of routes compared to controls. When interleukins were included, there was a 3 times tumor suppression with the intradermal vaccine and approximately 9 times tumor suppression for the combination route of delivery.
• Enhanced Immunogenicity: The vaccine delivery through the AdminPen™ 1200 system significantly increased specific antibody (IgG) titers, indicating a robust immune response. The inclusion of interleukins in the vaccine formulation further enhanced these titers.
• Effective Cellular Immune Responses: The approach led to an increase in CD8+ T-cell, CD4+ T-cell, and NK-cell populations, essential factors in the body's ability to fight cancer cells. These cellular responses were particularly potentiated by the addition of interleukins to the vaccine formulation.
• Improved Th1/Th2 Response: The inclusion of interleukins in the intradermally delivered vaccine influenced the Th1/Th2 response, contributing to the vaccine's overall efficacy. This was evidenced by increased IgG1 (Th2 response) and IgG2a (Th1 response) titers.
• Potentiation of Therapeutic Effects: The combination of intradermal and oral vaccine administration, especially when interleukins were included, resulted in even more significant tumor suppression, demonstrating the system's potential in comprehensive cancer therapy strategies.
These quantitative benefits highlight the AdminPen™ 1200 system's effectiveness in enhancing the delivery and immunogenicity of cancer vaccines, contributing to improved therapeutic outcomes in ovarian cancer treatment.
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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
The key qualitative benefits of using the AdminPatch microneedle arrays for microneedle-assisted transdermal delivery of levodopa through skin are:
• The microneedles successfully penetrated the skin and created microconduits/micropores, disrupting the stratum corneum barrier to enhance transdermal delivery of levodopa.
• Histological examination confirmed the formation of microconduits in the skin layers after application of the microneedle arrays.
• Compared to passive permeation, the 1.2 mm microneedle array resulted in a 9-fold increase in levodopa flux and a 16-fold decrease in lag time across pig ear skin.
• The microneedle treatment increased the cumulative amount of levodopa permeated across skin by up to 5.7-fold compared to passive permeation over 24 hours.
• The penetration depth of the microneedles into the skin was approximately 40-50% of the microneedle length, creating sufficiently deep channels for levodopa permeation enhancement.
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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
* The publication titled "Use of Drawing Lithography-Fabricated Polyglycolic Acid Microneedles for Transdermal Delivery of Itraconazole to a Human Basal Cell Carcinoma Model Regenerated on Mice" by Jennifer Zhang et al. explores the use of microneedles for transdermal delivery of itraconazole to a human Basal Cell Carcinoma (BCC) model regenerated on mice. The study utilized two types of microneedles: polyglycolic acid microneedles and 316L stainless steel microneedles, which were purchased from AdminMed, Sunnyvale, CA, USA.
* The AdminPen 900 316L stainless steel microneedle arrays used in the study contained 85 microneedles, each 800 microns tall, organized in a 1-cm² circular array. The study aimed to explore the effectiveness of using microneedles to facilitate the transdermal delivery of itraconazole, an antifungal agent that has also shown to inhibit the growth of BCC through suppression of the Sonic Hedgehog (SHH) signaling pathway.

Here are some key findings and benefits based on the summarized content of the publication:

Microneedle Facilitation for Transdermal Delivery:
* Microneedles were used to create channels in the skin, specifically the 15-µm-thick keratinized stratum corneum layer, which typically hinders the transport of pharmacologic agents through the skin.
* The use of microneedles minimizes tissue damage and bleeding due to their small dimensions and does not penetrate deeper skin layers, reducing pain.

Itraconazole Delivery:
* Itraconazole, which has antifungal properties and can inhibit the growth of BCC, was delivered to a human BCC model regenerated on mice using the microneedles.
* The study utilized a solution of itraconazole dissolved in 60% dimethylsulfoxane and 40% polyethylene glycol-400 for the treatment, which was facilitated by both polyglycolic acid microneedle arrays and stainless steel microneedle arrays.

Treatment Results:
* The epidermal tissues treated with both polyglycolic acid microneedles and stainless steel microneedles were markedly thinner than the control (untreated) graft tissue.
* The study indicates that microneedles may be used to facilitate transdermal delivery of itraconazole for localized treatment of BCC.

Microneedle Characteristics:
* The AdminPen 900 316L stainless steel microneedles were 800 µm tall and were organized in a 1-cm² circular array, containing 85 microneedles.
* The polyglycolic acid microneedles were fabricated using injection molding and drawing lithography, resulting in microneedles with sharp tips and heights of 641 µm ± 9.5 µm.

Potential Advantages:
* The use of microneedles for transdermal delivery of itraconazole may offer a localized treatment option for BCC, potentially minimizing systemic absorption and associated side effects.
* The microneedles, due to their small size and minimal penetration, are associated with low levels of pain and minimal tissue damage, offering a potentially patient-friendly method of drug delivery.

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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.
The key qualitative benefits of using AdminPatch microneedle arrays for controlled delivery of ropinirole hydrochloride through the skin are:
• Successful creation of microchannels in the skin, as confirmed by dye-binding studies and confocal microscopy, enabling enhanced transdermal delivery of ropinirole hydrochloride.
• Precise control over the depth of microchannels (160 ± 25 μm) created by the 600 μm-long microneedles, avoiding contact with the dermis and associated pain.
• Increased transdermal delivery of ropinirole hydrochloride (66.97 ± 10.39 μg/cm2) compared to passive delivery (8.25 ± 2.41 μg/cm2) when used alone.
• Synergistic enhancement in transdermal delivery when used in combination with modulated iontophoresis (84.91 ± 9.21 μg/cm2) compared to modulated iontophoresis alone (46.50 ± 6.46 μg/cm2).
• Ability to control the transdermal delivery rate by varying the microneedle pore density (higher delivery with increased pore density).
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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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