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https://www.readbyqxmd.com/read/28720851/microneedle-patch-delivery-of-influenza-vaccine-during-pregnancy-enhances-maternal-immune-responses-promoting-survival-and-long-lasting-passive-immunity-to-offspring
#1
E Stein Esser, Joanna A Pulit-Penaloza, Haripriya Kalluri, Devin McAllister, Elena V Vassilieva, Elizabeth Q Littauer, Nadia Lelutiu, Mark R Prausnitz, Richard W Compans, Ioanna Skountzou
Influenza virus causes life-threatening infections in pregnant women and their newborns. Immunization during pregnancy is the most effective means of preventing maternal and infant mortality/morbidity; however, influenza vaccination rates of pregnant women remain under 50%. Furthermore, the availability of vaccines in low-resource populations is limited. Skin immunization with microneedle patches (MN) is a novel and safe vaccination platform featuring thermostable vaccine formulations. Cold-chain independence and the potential for self-administration can expand influenza vaccination coverage in developing countries...
July 18, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28666680/the-safety-immunogenicity-and-acceptability-of-inactivated-influenza-vaccine-delivered-by-microneedle-patch-tiv-mnp-2015-a-randomised-partly-blinded-placebo-controlled-phase-1-trial
#2
Nadine G Rouphael, Michele Paine, Regina Mosley, Sebastien Henry, Devin V McAllister, Haripriya Kalluri, Winston Pewin, Paula M Frew, Tianwei Yu, Natalie J Thornburg, Sarah Kabbani, Lilin Lai, Elena V Vassilieva, Ioanna Skountzou, Richard W Compans, Mark J Mulligan, Mark R Prausnitz
BACKGROUND: Microneedle patches provide an alternative to conventional needle-and-syringe immunisation, and potentially offer improved immunogenicity, simplicity, cost-effectiveness, acceptability, and safety. We describe safety, immunogenicity, and acceptability of the first-in-man study on single, dissolvable microneedle patch vaccination against influenza. METHODS: The TIV-MNP 2015 study was a randomised, partly blinded, placebo-controlled, phase 1, clinical trial at Emory University that enrolled non-pregnant, immunocompetent adults from Atlanta, GA, USA, who were aged 18-49 years, naive to the 2014-15 influenza vaccine, and did not have any significant dermatological disorders...
August 12, 2017: Lancet
https://www.readbyqxmd.com/read/28642154/a-boosting-skin-vaccination-with-dissolving-microneedle-patch-encapsulating-m2e-vaccine-broadens-the-protective-efficacy-of-conventional-influenza-vaccines
#3
Wandi Zhu, Winston Pewin, Chao Wang, Yuan Luo, Gilbert X Gonzalez, Teena Mohan, Mark R Prausnitz, Bao-Zhong Wang
The biodegradable microneedle patch (MNP) is a novel technology for vaccine delivery that could improve the immunogenicity of vaccines. To broaden the protective efficiency of conventional influenza vaccines, a new 4M2e-tFliC fusion protein construct containing M2e sequences from different subtypes was generated. Purified fusion protein was encapsulate into MNPs with a biocompatible polymer for use as a boosting vaccine. The results demonstrated that mice receiving a conventional inactivated vaccine followed by a skin-applied dissolving 4M2e-tFliC MNP boost could better maintain the humoral antibody response than that by the conventional vaccine-prime alone...
September 10, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28627734/role-of-cytoskeletal-mechanics-and-cell-membrane-fluidity-in-the-intracellular-delivery-of-molecules-mediated-by-laser-activated-carbon-nanoparticles
#4
Stefany Y Holguin, Caleb F Anderson, Naresh N Thadhani, Mark R Prausnitz
Exposure of cells and nanoparticles to near-infrared nanosecond pulsed laser light can lead to efficient intracellular delivery of molecules while maintaining high cell viability by a photoacoustic phenomenon known as transient nanoparticle energy transduction (TNET). Here, we examined the influence of cytoskeletal mechanics and plasma membrane fluidity on intracellular uptake of molecules and loss of cell viability due to TNET. We found that destabilization of actin filaments using latrunculin A led to greater uptake of molecules and less viability loss caused by TNET...
June 19, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28375775/engineering-microneedle-patches-for-vaccination-and-drug-delivery-to-skin
#5
REVIEW
Mark R Prausnitz
Microneedle patches (MNPs) contain arrays of solid needles measuring hundreds of microns in length that deliver drugs and vaccines into skin in a painless, easy-to-use manner. Optimal MNP design balances multiple interdependent parameters that determine mechanical strength, skin-insertion reliability, drug delivery efficiency, painlessness, manufacturability, and other features of MNPs that affect their performance. MNPs can be made by adapting various microfabrication technologies for delivery of small-molecule drugs, biologics, and vaccines targeted to the skin, which can have pharmacokinetic and immunologic advantages...
June 7, 2017: Annual Review of Chemical and Biomolecular Engineering
https://www.readbyqxmd.com/read/28355552/energy-transfer-mechanisms-during-molecular-delivery-to-cells-by-laser-activated-carbon-nanoparticles
#6
Aritra Sengupta, Michael D Gray, Sean C Kelly, Stefany Y Holguin, Naresh N Thadhani, Mark R Prausnitz
Previous studies have shown that exposure of carbon black nanoparticles to nanosecond pulsed near-infrared laser causes intracellular delivery of molecules through hypothesized transient breaks in the cell membrane. The goal of this study is to determine the underlying mechanisms of sequential energy transfer from laser light to nanoparticle to fluid medium to cell. We found that laser pulses on a timescale of 10 ns rapidly heat carbon nanoparticles to temperatures on the order of 1200 K. Heat is transferred from the nanoparticles to the surrounding aqueous medium on a similar timescale, causing vaporization of the surrounding water and generation of acoustic emissions...
March 28, 2017: Biophysical Journal
https://www.readbyqxmd.com/read/28285193/tolerability-usability-and-acceptability-of-dissolving-microneedle-patch-administration-in-human-subjects
#7
Jaya Arya, Sebastien Henry, Haripriya Kalluri, Devin V McAllister, Winston P Pewin, Mark R Prausnitz
To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days...
June 2017: Biomaterials
https://www.readbyqxmd.com/read/28194704/challenges-and-future-prospects-for-the-delivery-of-biologics-oral-mucosal-pulmonary-and-transdermal-routes
#8
Javier O Morales, Kristin R Fathe, Ashlee Brunaugh, Silvia Ferrati, Song Li, Miguel Montenegro-Nicolini, Zeynab Mousavikhamene, Jason T McConville, Mark R Prausnitz, Hugh D C Smyth
Biologic products are large molecules such as proteins, peptides, nucleic acids, etc., which have already produced many new drugs for clinical use in the last decades. Due to the inherent challenges faced by biologics after oral administration (e.g., acidic stomach pH, digestive enzymes, and limited permeation through the gastrointestinal tract), several alternative routes of administration have been investigated to enable sufficient drug absorption into systemic circulation. This review describes the buccal, sublingual, pulmonary, and transdermal routes of administration for biologics with relevant details of the respective barriers...
February 13, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28125842/thickness-and-closure-kinetics-of-the-suprachoroidal-space-following-microneedle-injection-of-liquid-formulations
#9
Bryce Chiang, Nitin Venugopal, Hans E Grossniklaus, Jae Hwan Jung, Henry F Edelhauser, Mark R Prausnitz
Purpose: To determine the effect of injection volume and formulation of a microneedle injection into the suprachoroidal space (SCS) on SCS thickness and closure kinetics. Methods: Microneedle injections containing 25 to 150 μL Hanks' balanced salt solution (HBSS) were performed in the rabbit SCS ex vivo. Distribution of SCS thickness was measured by ultrasonography and three-dimensional (3D) cryo-reconstruction. Microneedle injections were performed in the rabbit SCS in vivo using HBSS, Discovisc, and 1% to 5% carboxymethyl cellulose (CMC) in HBSS...
January 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28125841/clearance-kinetics-and-clearance-routes-of-molecules-from-the-suprachoroidal-space-after-microneedle-injection
#10
Bryce Chiang, Ke Wang, C Ross Ethier, Mark R Prausnitz
Purpose: To determine clearance kinetics and routes of clearance of molecules from the suprachoroidal space (SCS) of live New Zealand White rabbits. Methods: Suprachoroidal space collapse rate and pressure changes after microneedle injection into SCS were determined. Fluorescent fundus images were acquired to determine clearance rates of molecules ranging in size from 332 Da to 2 MDa. Microneedle injections of fluorescein were performed, and samples were taken from various sites over time to determine amount of fluorescein exiting the eye...
January 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28075069/ebola-vaccination-using-a-dna-vaccine-coated-on-plga-pll-%C3%AE-pga-nanoparticles-administered-using-a-microneedle-patch
#11
Hung-Wei Yang, Ling Ye, Xin Dong Guo, Chinglai Yang, Richard W Compans, Mark R Prausnitz
Ebola DNA vaccine is incorporated into PLGA-PLL/γPGA nanoparticles and administered to skin using a microneedle (MN) patch. The nanoparticle delivery system increases vaccine thermostability and immunogenicity compared to free vaccine. Vaccination by MN patch produces stronger immune responses than intramuscular administration.
January 2017: Advanced Healthcare Materials
https://www.readbyqxmd.com/read/27849435/targeted-drug-delivery-within-the-eye-through-the-suprachoroidal-space
#12
Samirkumar R Patel, Mark R Prausnitz
No abstract text is available yet for this article.
December 2016: Journal of Ocular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27742547/distribution-of-particles-small-molecules-and-polymeric-formulation-excipients-in-the-suprachoroidal-space-after-microneedle-injection
#13
Bryce Chiang, Nitin Venugopal, Henry F Edelhauser, Mark R Prausnitz
The purpose of this work was to determine the effect of injection volume, formulation composition, and time on circumferential spread of particles, small molecules, and polymeric formulation excipients in the suprachoroidal space (SCS) after microneedle injection into New Zealand White rabbit eyes ex vivo and in vivo. Microneedle injections of 25-150 μL Hank's Balanced Salt Solution (HBSS) containing 0.2 μm red-fluorescent particles and a model small molecule (fluorescein) were performed in rabbit eyes ex vivo, and visualized via flat mount...
December 2016: Experimental Eye Research
https://www.readbyqxmd.com/read/27524283/rabies-vaccination-in-dogs-using-a-dissolving-microneedle-patch
#14
Jaya M Arya, Kristopher Dewitt, Maya Scott-Garrard, Yu-Wei Chiang, Mark R Prausnitz
Because humans get rabies primarily through dog bites, stray dog population control and mass or mandatory vaccination of domestic dogs and other animals has virtually eliminated human rabies in industrialized countries. However, thousands of people in developing countries die of rabies each year due to the inability to control dog populations and implement mass vaccination because of financial, logistical and other challenges. The availability of an easier-to-administer and more cost-effective vaccine may help to address some of these issues...
October 10, 2016: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/27327766/tetanus-vaccination-with-a-dissolving-microneedle-patch-confers-protective-immune-responses-in-pregnancy
#15
E Stein Esser, AndreyA Romanyuk, Elena V Vassilieva, Joshy Jacob, Mark R Prausnitz, Richard W Compans, Ioanna Skountzou
Maternal and neonatal tetanus claim tens of thousands lives every year in developing countries, but could be prevented by hygienic practices and improved immunization of pregnant women. This study tested the hypothesis that skin vaccination can overcome the immunologically transformed state of pregnancy and enhance protective immunity to tetanus in mothers and their newborns. To achieve this goal, we developed microneedle patches (MNPs) that efficiently delivered unadjuvanted tetanus toxoid to skin of pregnant mice and demonstrated that this route induced superior immune responses in female mice conferring 100% survival to tetanus toxin challenge when compared to intramuscular vaccination...
August 28, 2016: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/27165808/dna-uptake-intracellular-trafficking-and-gene-transfection-after-ultrasound-exposure
#16
Ying Liu, Jing Yan, Philip J Santangelo, Mark R Prausnitz
Ultrasound has been studied as a promising tool for intracellular gene delivery. In this work, we studied gene transfection of a human prostate cancer cell line exposed to megahertz pulsed ultrasound in the presence of contrast agent and assessed the efficiency of fluorescently labelled DNA delivery into cell nuclei, which is necessary for gene transfection. At the sonication conditions studied, ~30% of cells showed DNA uptake 30min after sonication, but that fraction decreased over time to ~10% of cells after 24h...
July 28, 2016: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/26976663/circumferential-flow-of-particles-in-the-suprachoroidal-space-is-impeded-by-the-posterior-ciliary-arteries
#17
Bryce Chiang, Yoo Chun Kim, Henry F Edelhauser, Mark R Prausnitz
Microneedle injection into the suprachoroidal space (SCS) enables targeted drug delivery for treatment of posterior segment diseases. This study sought to identify and characterize anatomical barriers to circumferential spread of particles in the SCS of rabbit and human cadaver eyes. These barriers could make targeting specific regions within the SCS challenging. A hollow microneedle (33-gauge, 750 μm long) was used to inject fluorescent particles into albino New Zealand White rabbit eyes ex vivo at six different positions around the limbus and a limited number of conditions in vivo...
April 2016: Experimental Eye Research
https://www.readbyqxmd.com/read/26926241/long-term-stability-of-influenza-vaccine-in-a-dissolving-microneedle-patch
#18
Matthew J Mistilis, Jessica C Joyce, E Stein Esser, Ioanna Skountzou, Richard W Compans, Andreas S Bommarius, Mark R Prausnitz
This study tested the hypothesis that optimized microneedle patch formulations can stabilize trivalent subunit influenza vaccine during long-term storage outside the cold chain and when exposed to potential stresses found during manufacturing and storage. Formulations containing combinations of trehalose/sucrose, sucrose/arginine, and arginine/heptagluconate were successful at retaining most or all vaccine activity during storage at 25 °C for up to 24 months as determined by ELISA assay. The best formulation of microneedle patches contained arginine/heptagluconate, which showed no significant loss of vaccine activity during the study...
April 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/26797026/intracellular-delivery-of-molecules-using-microfabricated-nanoneedle-arrays
#19
Seonhee Park, Seong-O Choi, Seung-joon Paik, Seungkeun Choi, Mark Allen, Mark Prausnitz
Many bioactive molecules have intracellular targets, but have difficulty crossing the cell membrane to reach those targets. To address this difficulty, we fabricated arrays of nanoneedles to gently and simultaneously puncture 10(5) cells and thereby provide transient pathways for transport of molecules into the cells. The nanoneedles were microfabricated by etching silicon to create arrays of nanoneedles measuring 12 μm in height, tapering to a sharp tip less than 30 nm wide to facilitate puncture into cells and spaced 10 μm apart in order to have at least one nanoneedle puncture each cell in a confluent monolayer...
February 2016: Biomedical Microdevices
https://www.readbyqxmd.com/read/26772422/parameters-affecting-intracellular-delivery-of-molecules-using-laser-activated-carbon-nanoparticles
#20
Prerona Chakravarty, Christopher D Lane, Thomas M Orlando, Mark R Prausnitz
UNLABELLED: Previous studies showed that carbon nanoparticles exposed to nanosecond laser pulses cause intracellular uptake of molecules. In this study, prostate cancer cells incubated with carbon-black (CB) nanoparticles and fluorescent marker compounds were exposed to 10ns laser pulses at 1064nm wavelength, after which intracellular uptake was measured by flow cytometry. Calcein and dextran (150kDa) were delivered into >50% of cells, whereas larger dextrans (≤2000kDa) were taken up by ~10% of cells...
May 2016: Nanomedicine: Nanotechnology, Biology, and Medicine
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