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Ajay K. Banga - One of the best experts on this subject based on the ideXlab platform.

  • Enhancement of Transdermal Delivery of Heparin by Various Physical and Chemical Enhancement Techniques
    Critical Reviews in Therapeutic Drug Carrier Systems, 2020
    Co-Authors: Shankar Lanke, J. G. Strom, Ajay K. Banga
    Abstract:

    Conventional anticoagulants such as unfractionated heparin and warfarin have numerous limitations compared with low-molecular-weight heparin (LMWH). However, the need for repetitive parenteral administration is still a major disadvantage of LMWH, and the absorption of macromolecules such as LMWH across the gastrointestinal tract is very poor. Due to these problems with oral Delivery of LMWH, Transdermal Delivery can be considered as an alternate route of administration. However, overcoming the skin barrier is necessary for the transport of larger molecules across the stratum corneum. This review focuses on the Transdermal Delivery of LMWH, providing a brief overview of heparin Delivery via invasive and oral routes and discusses the advantages of using LMWH rather than heparin for Transdermal Delivery, and the primary reasons for poor permeability of LMWH. Various strategies employed for Transdermal Delivery of heparin are summarized, and chemical and physical enhancement techniques or suitable formulations that can be used to improve transcutaneous penetration and various chemical enhancers that act on the skin by different modes of action are discussed. We also consider physical approaches such as iontophoresis, electroporation, and ultrasound, as well as combination strategies to deliver heparin. The developments in physical and chemical enhancement strategies over the past decade are summarized. In addition, recent novel approaches such as microneedles employed for the Transdermal Delivery of LMWH are also discussed.

  • Transdermal Delivery of methotrexate for pediatrics using silicon microneedles
    Therapeutic Delivery, 2013
    Co-Authors: Mehtab J. Abla, Ayyappa Chaturvedula, Conor O'mahony, Ajay K. Banga
    Abstract:

    Background: The objective of this work was to study Transdermal Delivery of methotrexate using silicon microneedles and simulate plasma concentrations using a population pharmacokinetic model. Results: Characterization of silicon microneedles was carried out by scanning electron microscopy, transepidermal water loss, methylene blue staining, calcein imaging, pore permeability index and confocal microscopy, which confirmed the formation of microchannels. In vitro permeation studies were performed to study the enhancement in Transdermal Delivery following microporation. Conclusion: Simulation data demonstrated that with 16, 64, 128 and 192 microneedles, mean plasma concentrations of 0.3, 1.4, 2.8 and 4.2 ng/ml, respectively, can be achieved. Thus, therapeutically relevant doses could be delivered in pediatrics by increasing the number of microneedles and patch area.

  • Transdermal Delivery of proteins
    Aaps Pharmscitech, 2011
    Co-Authors: Haripriya Kalluri, Ajay K. Banga
    Abstract:

    Transdermal Delivery of peptides and proteins avoids the disadvantages associated with the invasive parenteral route of administration and other alternative routes such as the pulmonary and nasal routes. Since proteins have a large size and are hydrophilic in nature, they cannot permeate passively across the skin due to the stratum corneum which allows the transport of only small lipophilic drug molecules. Enhancement techniques such as chemical enhancers, iontophoresis, microneedles, electroporation, sonophoresis, thermal ablation, laser ablation, radiofrequency ablation and noninvasive jet injectors aid in the Delivery of proteins by overcoming the skin barrier in different ways. In this review, these enhancement techniques that can enable the Transdermal Delivery of proteins are discussed, including a discussion of mechanisms, sterility requirements, and commercial development of products. Combination of enhancement techniques may result in a synergistic effect allowing increased protein Delivery and these are also discussed.

  • in vitro Transdermal Delivery of therapeutic antibodies using maltose microneedles
    International Journal of Pharmaceutics, 2009
    Co-Authors: Guohua Li, Chandra Sekhar Kolli, Advait Badkar, Sandeep Nema, Ajay K. Banga
    Abstract:

    This paper investigates the microneedle-mediated in vitro Transdermal Delivery of human IgG as a model protein and demonstrates its applicability to deliver a monoclonal antibody. Microchannels created by the treatment of maltose microneedles in full thickness hairless rat skin were visualized using methylene blue staining. Cryostat sections were prepared and stained using hematoxylin and eosin to locate the depth of penetration. In vitro penetration studies were conducted using freshly excised full thickness hairless rat skin and various parameters like needle length, number of needles and effect of donor concentration were examined. Pathway of IgG transport across skin was confirmed by immunohistochemical (IHC) studies. A monoclonal antibody was delivered under optimized conditions. Methylene blue was taken up by microchannels indicating disruption of the stratum corneum and cryosections showed that microneedles just reached the dermis. Human IgG Delivery increased with increase in arrays of microneedles, concentration and length of microneedles. IHC studies demonstrated that IgG follows microchannels for transport across the skin. Transdermal Delivery was also demonstrated for the monoclonal antibody. In conclusion, maltose microneedles provide a means for the Transdermal Delivery of macromolecules.

  • In vitro Transdermal Delivery of therapeutic antibodies using maltose microneedles
    International Journal of Pharmaceutics, 2009
    Co-Authors: Guohua Li, Chandra Sekhar Kolli, Advait Badkar, Sandeep Nema, Ajay K. Banga
    Abstract:

    This paper investigates the microneedle-mediated in vitro Transdermal Delivery of human IgG as a model protein and demonstrates its applicability to deliver a monoclonal antibody. Microchannels created by the treatment of maltose microneedles in full thickness hairless rat skin were visualized using methylene blue staining. Cryostat sections were prepared and stained using hematoxylin and eosin to locate the depth of penetration. In vitro penetration studies were conducted using freshly excised full thickness hairless rat skin and various parameters like needle length, number of needles and effect of donor concentration were examined. Pathway of IgG transport across skin was confirmed by immunohistochemical (IHC) studies. A monoclonal antibody was delivered under optimized conditions. Methylene blue was taken up by microchannels indicating disruption of the stratum corneum and cryosections showed that microneedles just reached the dermis. Human IgG Delivery increased with increase in arrays of microneedles, concentration and length of microneedles. IHC studies demonstrated that IgG follows microchannels for transport across the skin. Transdermal Delivery was also demonstrated for the monoclonal antibody. In conclusion, maltose microneedles provide a means for the Transdermal Delivery of macromolecules. © 2008 Elsevier B.V. All rights reserved.

Ryan F Donnelly - One of the best experts on this subject based on the ideXlab platform.

  • Microneedle-Mediated Transdermal Delivery of Bevacizumab
    Molecular Pharmaceutics, 2018
    Co-Authors: Aaron J. Courtenay, Kathryn J. Mcavoy, Maelíosa T. C. Mccrudden, Helen O Mccarthy, Ryan F Donnelly
    Abstract:

    Bevacizumab is a recombinant humanized monoclonal antibody used clinically as a combination chemotherapeutic. Antibody therapeutics are usually formulated as parenteral injections, owing to their low oral bioavailability. Microneedle technology provides a Transdermal alternative for drug-Delivery using micron-scale needle structures to penetrate directly through the stratum corneum into the dermal interstitium. This study describes the design, formulation, and in vitro characterization of both dissolving and hydrogel-forming microneedle array platforms for Transdermal Delivery of bevacizumab. Bevacizumab recovery and Transdermal permeation studies were conducted and analyzed using bevacizumab specific ELISA. Prototype microneedle-patches were tested in vivo in Sprague–Dawley rats with serum, exterior lumbar and axial lymph nodes, spleen, and skin tissue concentrations of bevacizumab reported. This work represents the first example of high dose Transdermal Delivery of an antibody therapeutic in vivo using ...

  • Microneedle-Mediated Transdermal Delivery of Bevacizumab
    Molecular Pharmaceutics, 2018
    Co-Authors: Aaron J. Courtenay, Kathryn J. Mcavoy, Maelíosa T. C. Mccrudden, Helen O Mccarthy, Ryan F Donnelly
    Abstract:

    Bevacizumab is a recombinant humanized monoclonal antibody used clinically as a combination chemotherapeutic. Antibody therapeutics are usually formulated as parenteral injections, owing to their low oral bioavailability. Microneedle technology provides a Transdermal alternative for drug-Delivery using micron-scale needle structures to penetrate directly through the stratum corneum into the dermal interstitium. This study describes the design, formulation, and in vitro characterization of both dissolving and hydrogel-forming microneedle array platforms for Transdermal Delivery of bevacizumab. Bevacizumab recovery and Transdermal permeation studies were conducted and analyzed using bevacizumab specific ELISA. Prototype microneedle-patches were tested in vivo in Sprague-Dawley rats with serum, exterior lumbar and axial lymph nodes, spleen, and skin tissue concentrations of bevacizumab reported. This work represents the first example of high dose Transdermal Delivery of an antibody therapeutic in vivo using dissolving and hydrogel-forming microneedle platforms. Basic pharmacokinetic parameters are described including hydrogel-forming microneedles: C-max 358.2 +/- 100.4 ng/mL, T-max 48 h, AUC 44357 +/- 4540, and C-ss 942 +/- 95 ng/mL, highlighting the potential for these devices to provide sustained Delivery of antibody therapeutics to the lymph and systemic circulation. Targeted Delivery of chemotherapeutic agents to the lymphatic system by MN technology may provide new treatment options for cancer metastases.

  • Transdermal Delivery with microneedle patches using in silico modelling
    2017
    Co-Authors: Rkr Rajoli, Ryan F Donnelly, Charles Williams Flexner, Andrew Owen, Marco Siccardi
    Abstract:

    Design and qualification of a microneedle array patch PBPK model for Transdermal Delivery and prediction of ARV pharmacokinetics using this route

Audra L. Stinchcomb - One of the best experts on this subject based on the ideXlab platform.

  • Development of Opioid Transdermal Delivery Systems
    Opiate Receptors and Antagonists, 2020
    Co-Authors: Kalpana S Paudel, Stan Lee Banks, Paul Kiptoo, Dana C. Hammell, R. Reddy Pinninti, Caroline L. Strasinger, Audra L. Stinchcomb
    Abstract:

    Opioid therapies have been and will continue to be a vital part of opioid addiction and alcoholism treatments, as well as a vital part of chronic and acute pain management regimens. Transdermal Delivery of opioid antagonists and ago nists can be advantageous in order to help improve the quality of life of many patients. This mode of drug administration offers many advantages when compared to the traditional oral route of drug Delivery, including avoidance of hepatic first-pass metabolism, the potential for long-term controlled release with smoothing of the typical peak-trough plasma drug concentration profiles associated with multi ple dosing regimens, the ease of administration, and the possibility of immediate withdrawal of the treatment. Although the majority of the opioids used in clinical practice do not have ideal physicochemical properties that would allow them to reach therapeutic plasma levels by passive skin permeation, many advances have been made in the Transdermal Delivery of these agents with the advent of novel approaches including prodrugs, codrugs, microneedle (MN)-enhanced Delivery, and other new formulation technologies. Many research and development avenues exist for the growth potential of the opioid Transdermal drug Delivery market in the next decade.

  • challenges and opportunities in dermal Transdermal Delivery
    Therapeutic Delivery, 2010
    Co-Authors: Kalpana S Paudel, Courtney L Swadley, Nicole K. Brogden, Priyanka Ghosh, Mikolaj Milewski, Audra L. Stinchcomb
    Abstract:

    Transdermal drug Delivery is an exciting and challenging area. There are numerous Transdermal Delivery systems currently available on the market. However, the Transdermal market still remains limited to a narrow range of drugs. Further advances in Transdermal Delivery depend on the ability to overcome the challenges faced regarding the permeation and skin irritation of the drug molecules. Emergence of novel techniques for skin permeation enhancement and development of methods to lessen skin irritation would widen the Transdermal market for hydrophilic compounds, macromolecules and conventional drugs for new therapeutic indications. As evident from the ongoing clinical trials of a wide variety of drugs for various clinical conditions, there is a great future for Transdermal Delivery of drugs.

  • Challenges and opportunities in dermal/Transdermal Delivery.
    Therapeutic delivery, 2010
    Co-Authors: Kalpana S Paudel, Courtney L Swadley, Nicole K. Brogden, Priyanka Ghosh, Mikolaj Milewski, Audra L. Stinchcomb
    Abstract:

    Transdermal drug Delivery is an exciting and challenging area. There are numerous Transdermal Delivery systems currently available on the market. However, the Transdermal market still remains limited to a narrow range of drugs. Further advances in Transdermal Delivery depend on the ability to overcome the challenges faced regarding the permeation and skin irritation of the drug molecules. Emergence of novel techniques for skin permeation enhancement and development of methods to lessen skin irritation would widen the Transdermal market for hydrophilic compounds, macromolecules and conventional drugs for new therapeutic indications. As evident from the ongoing clinical trials of a wide variety of drugs for various clinical conditions, there is a great future for Transdermal Delivery of drugs.

Guohua Li - One of the best experts on this subject based on the ideXlab platform.

  • in vitro Transdermal Delivery of therapeutic antibodies using maltose microneedles
    International Journal of Pharmaceutics, 2009
    Co-Authors: Guohua Li, Chandra Sekhar Kolli, Advait Badkar, Sandeep Nema, Ajay K. Banga
    Abstract:

    This paper investigates the microneedle-mediated in vitro Transdermal Delivery of human IgG as a model protein and demonstrates its applicability to deliver a monoclonal antibody. Microchannels created by the treatment of maltose microneedles in full thickness hairless rat skin were visualized using methylene blue staining. Cryostat sections were prepared and stained using hematoxylin and eosin to locate the depth of penetration. In vitro penetration studies were conducted using freshly excised full thickness hairless rat skin and various parameters like needle length, number of needles and effect of donor concentration were examined. Pathway of IgG transport across skin was confirmed by immunohistochemical (IHC) studies. A monoclonal antibody was delivered under optimized conditions. Methylene blue was taken up by microchannels indicating disruption of the stratum corneum and cryosections showed that microneedles just reached the dermis. Human IgG Delivery increased with increase in arrays of microneedles, concentration and length of microneedles. IHC studies demonstrated that IgG follows microchannels for transport across the skin. Transdermal Delivery was also demonstrated for the monoclonal antibody. In conclusion, maltose microneedles provide a means for the Transdermal Delivery of macromolecules.

  • In vitro Transdermal Delivery of therapeutic antibodies using maltose microneedles
    International Journal of Pharmaceutics, 2009
    Co-Authors: Guohua Li, Chandra Sekhar Kolli, Advait Badkar, Sandeep Nema, Ajay K. Banga
    Abstract:

    This paper investigates the microneedle-mediated in vitro Transdermal Delivery of human IgG as a model protein and demonstrates its applicability to deliver a monoclonal antibody. Microchannels created by the treatment of maltose microneedles in full thickness hairless rat skin were visualized using methylene blue staining. Cryostat sections were prepared and stained using hematoxylin and eosin to locate the depth of penetration. In vitro penetration studies were conducted using freshly excised full thickness hairless rat skin and various parameters like needle length, number of needles and effect of donor concentration were examined. Pathway of IgG transport across skin was confirmed by immunohistochemical (IHC) studies. A monoclonal antibody was delivered under optimized conditions. Methylene blue was taken up by microchannels indicating disruption of the stratum corneum and cryosections showed that microneedles just reached the dermis. Human IgG Delivery increased with increase in arrays of microneedles, concentration and length of microneedles. IHC studies demonstrated that IgG follows microchannels for transport across the skin. Transdermal Delivery was also demonstrated for the monoclonal antibody. In conclusion, maltose microneedles provide a means for the Transdermal Delivery of macromolecules. © 2008 Elsevier B.V. All rights reserved.

Sei Kwang Hahn - One of the best experts on this subject based on the ideXlab platform.

  • Transdermal Delivery of hyaluronic acid human growth hormone conjugate
    Biomaterials, 2012
    Co-Authors: Jeonga Yang, Jung Hee Kwon, Ji Hye Shin, Kwan Yong Choi, Sei Kwang Hahn
    Abstract:

    Abstract Hyaluronic acid (HA) is one of the major components of extracellular matrix (ECM). Keratinocyte and fibroblast are known to have HA receptors in the skin. Fibroblast also has human growth hormone (hGH) receptors. In this work, HA–hGH conjugate was developed as a receptor mediated Transdermal Delivery system of protein drugs. HA–hGH conjugate was synthesized by specific coupling reaction between aldehyde modified HA and the N-terminal amine group of hGH. We could confirm the proliferative effect of HA on keratinocyte and fibroblast, and the biological activity of HA–hGH conjugate in fibroblast with an elevated expression level of phosphorylated Janus kinase 2 (p-JAK2). Interestingly, fluorescence microscopy clearly visualized the dramatically enhanced penetration of HA–hGH conjugate through the dorsal skin of mice after topical treatment with FITC labeled HA–hGH conjugate. According to pharmacokinetic analysis, HA–hGH conjugate appeared to be delivered through the skin into the blood stream possibly by the receptor mediated Transdermal Delivery. This work confirms the feasibility of using the HA–hGH conjugate as a model system for the receptor mediated Transdermal Delivery of protein drugs and their further exploitation for various cosmetic and tissue engineering applications.