nanoBioSciences, LLC is developing an innovative line of novel transdermal drug delivery systems.

Scientific Publications and Presentations

Scientific publications written by our academic customers summarizing studies successfully performed using our microneedle 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. Here are the key findings and benefits of using the AdminPen microneedle array device based on the summarized content:

Background and Motivation:
* Breast cancer is the second most common cancer in females globally.
* Current therapies have various limitations and adverse effects, leading to the exploration of immunotherapies.
* The study aims to evaluate a particulate breast cancer vaccine delivered via skin using a spray drying technique with murine breast cancer whole cell lysate as the antigen source.

Microneedle Delivery:
* The skin is a unique site for vaccination as it houses various immune cells for an efficient immune response.
* Microneedles are micron-sized needles that create aqueous conduits in the skin, allowing for the delivery of the vaccine to immune-competent skin layers.
* Microneedles are minimally invasive, causing limited local injection site discomfort.
* The AdminPatch® 1200 microneedle array was used to deliver the particulate vaccine in this study.

Results:
* The average size of the particulate vaccine was 1.5 µm, which resembled pathogenic species, aiding in phagocytosis and antigen presentation, leading to immune response activation.
* AdminPatch® 1200 microneedle array created aqueous conduits of 50 ± 10 µm to deliver the microparticulate vaccine to the skin layers.
* In vivo results showed a significantly higher concentration of serum IgG, IgG2a, and B and T cell (CD4+ and CD8+) populations in vaccinated animals compared to control animals (p < 0.001).
* Vaccinated animals demonstrated five times more tumor suppression than control animals, confirming the immune response activation and protection (p < 0.001).

Conclusion:
* The research suggests a potential pathway 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

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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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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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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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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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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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

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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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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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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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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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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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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Ita, K. Transdermal Delivery of Drugs with Microneedles—Potential and Challenges. Pharmaceutics 2015, 7, 90-105. doi:10.3390/pharmaceutics7030090
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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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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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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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Buchi N. Nalluri, V Sai Sri Anusha, R Sri Bramhini, J Amulya, S K Ashraf Sultana, U Chandra 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

2014

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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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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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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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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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).
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Dongwei Zhang, Diganta B. Das, "Microneedle assisted microparticle delivery: experiments using a skin mimicking agarose gel. The Third International Conference on Microneedles 2014, University of Maryland School of Pharmacy in Baltimore, Maryland, 19th-21st May 2014, pp. 67-68.
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2013

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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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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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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Juluri, Abhishek, et al. "Minimally invasive transdermal delivery of iron–dextran." Journal of pharmaceutical sciences 102.3 (2013): 987-993.
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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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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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Wenchao Sun, Zeynep Araci, Mohammed Inayathullah, Sathish Manickam, Xuexiang Zhang, Marc A. Bruce, M. Peter Marinkovich, Alfred T. Lane, Carlos Milla, Jayakumar Rajadas, Manish J. Butte, Polyvinylpyrrolidone microneedles enable delivery of intact proteins for diagnostic and therapeutic applications, Acta Biomaterialia, Volume 9, Issue 8, August 2013, Pages 7767-7774.
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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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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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2012

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

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 paper about AdminPen devices was published in Drug Delivery Technology.
A well-known journal Drug Delivery Technology recently published our paper describing AdminPen devices. Please click on the following link to read the published paper about AdminPen devices and the enabling AdminPatch microneedle technology:
Yuzhakov, Vadim V. "The AdminPenTM Microneedle Device for Painless & Convenient Drug Delivery." Drug Deliv. Technol 10.4 (2010): 32-36.
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2007

V. V. Yuzhakov, “Advanced micro-needle Patch (AdminPatch™) for Minimally Invasive Transdermal Drug Delivery,” Invited Presentation at 1st Annual Skin Summit: Transdermal Drug Delivery & Development & Beyond, Philadelphia, PA, February 22-23, 2007.

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Your browser does not support inline frames or is currently configured not to display inline frames.		Scientific Publications and Presentations Scientific publications written by our academic customers summarizing studies successfully performed using our microneedle 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Here are the key findings and benefits of using the AdminPen microneedle array device based on the summarized content: Background and Motivation: * Breast cancer is the second most common cancer in females globally. * Current therapies have various limitations and adverse effects, leading to the exploration of immunotherapies. * The study aims to evaluate a particulate breast cancer vaccine delivered via skin using a spray drying technique with murine breast cancer whole cell lysate as the antigen source. Microneedle Delivery: * The skin is a unique site for vaccination as it houses various immune cells for an efficient immune response. * Microneedles are micron-sized needles that create aqueous conduits in the skin, allowing for the delivery of the vaccine to immune-competent skin layers. * Microneedles are minimally invasive, causing limited local injection site discomfort. * The AdminPatch® 1200 microneedle array was used to deliver the particulate vaccine in this study. Results: * The average size of the particulate vaccine was 1.5 µm, which resembled pathogenic species, aiding in phagocytosis and antigen presentation, leading to immune response activation. * AdminPatch® 1200 microneedle array created aqueous conduits of 50 ± 10 µm to deliver the microparticulate vaccine to the skin layers. * In vivo results showed a significantly higher concentration of serum IgG, IgG2a, and B and T cell (CD4+ and CD8+) populations in vaccinated animals compared to control animals (p < 0.001). * Vaccinated animals demonstrated five times more tumor suppression than control animals, confirming the immune response activation and protection (p < 0.001). Conclusion: * The research suggests a potential pathway for individualized immunotherapy following surgical tumor removal to prolong relapse episodes. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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). Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 35. Uppuluri, C., Shaik, A., Han, T. et al., Effect of Microneedle Type on Transdermal Permeation of Rizatriptan, AAPS PharmSciTech (2017) 18: 1495. Click here for Full Text (PDF) 2016 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. Click here for Full Text (PDF) Uppuluri, C., Shaik, A., Han, T. et al., Effect of Microneedle Type on Transdermal Permeation of Rizatriptan, AAPS PharmSciTech (2017) 18: 1495. Click here for Full Text (PDF) Brendan Koch, Ilaria Rubino, Fu-Shi Quan, Bongyoung Yoo, and Hyo-Jick Choi, Microfabrication for Drug Delivery, Materials. 2016; 9(8):646 Click here for Full Text (PDF) 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 Click here for Full Text (PDF) 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 Click here for Full Text (PDF) 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 Click here for Full Text (PDF) 2015 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. Click here for Full Text (PDF) 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. Click here for Full Text (PDF) Ololade Olatunji, Richard T. Olsson, Microneedles from Fishscale-Nanocellulose Blends Using Low Temperature Mechanical Press Method, Pharmaceutics, 2015, 7(4), 363-378; Click here for Full Text (PDF) 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. Click here for Full Text (PDF) 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 Click here for Full Text (PDF) 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 Click here for Full Text (PDF) Ita, K. Transdermal Delivery of Drugs with Microneedles—Potential and Challenges. Pharmaceutics 2015, 7, 90-105. doi:10.3390/pharmaceutics7030090 Click here for Full Text (PDF) 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 Click here for Full Text (PDF) 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) Click here for Full Text (PDF) 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) Click here for Full Text (PDF) Buchi N. Nalluri, V Sai Sri Anusha, R Sri Bramhini, J Amulya, S K Ashraf Sultana, U Chandra 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 2014 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). Full Text (PDF) 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. Full Text (PDF) 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). Full Text (PDF) 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). Full Text (PDF) 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). Full Text (PDF) Dongwei Zhang, Diganta B. Das, "Microneedle assisted microparticle delivery: experiments using a skin mimicking agarose gel. The Third International Conference on Microneedles 2014, University of Maryland School of Pharmacy in Baltimore, Maryland, 19th-21st May 2014, pp. 67-68. Full Text (PDF) 2013 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. Full Text (PDF) Atul Nayak, Diganta B. Das, Goran T. Vladisavljević, "Microneedle-Assisted Permeation of Lidocaine Carboxymethylcellulose with Gelatine Co-polymer Hydrogel." Pharmaceutical Research, November 2013. Full Text (PDF) 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. Full Text (PDF) Juluri, Abhishek, et al. "Minimally invasive transdermal delivery of iron–dextran." Journal of pharmaceutical sciences 102.3 (2013): 987-993. Full Text (PDF) 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). Full Text (PDF) 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. Full Text (PDF) Wenchao Sun, Zeynep Araci, Mohammed Inayathullah, Sathish Manickam, Xuexiang Zhang, Marc A. Bruce, M. Peter Marinkovich, Alfred T. Lane, Carlos Milla, Jayakumar Rajadas, Manish J. Butte, Polyvinylpyrrolidone microneedles enable delivery of intact proteins for diagnostic and therapeutic applications, Acta Biomaterialia, Volume 9, Issue 8, August 2013, Pages 7767-7774. Full Text (PDF) 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). Full Text (PDF) 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. Full Text (PDF) 2012 Modepalli, Naresh, et al. "Microporation and ‘Iron’tophoresis for Treating Iron Deficiency Anemia." Pharmaceutical research (2013): 1-10. Full Text (PDF) 2011 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. Full Text (PDF) 2010 A paper about AdminPen devices was published in Drug Delivery Technology. A well-known journal Drug Delivery Technology recently published our paper describing AdminPen devices. Please click on the following link to read the published paper about AdminPen devices and the enabling AdminPatch microneedle technology: Yuzhakov, Vadim V. "The AdminPenTM Microneedle Device for Painless & Convenient Drug Delivery." Drug Deliv. Technol 10.4 (2010): 32-36. Full Text (PDF) 2007 V. V. Yuzhakov, “Advanced micro-needle Patch (AdminPatch™) for Minimally Invasive Transdermal Drug Delivery,” Invited Presentation at 1st Annual Skin Summit: Transdermal Drug Delivery & Development & Beyond, Philadelphia, PA, February 22-23, 2007.
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