Delivering insulin, therapeutics and perhaps even vaccines . . . by pill

X-ray images at top left show the drug-delivery capsule in the intestine, before and after the arms expand. At right, the arms are unfolded to reveal the microneedles. Image courtesy of the researchers

Coated pill carries microneedles that deliver insulin and other drugs to the lining of the small intestine.

Many drugs, especially those made of proteins, cannot be taken orally because they are broken down in the gastrointestinal tract before they can take effect. One example is insulin, which patients with diabetes have to inject daily or even more frequently.

In hopes of coming up with an alternative to those injections, MIT engineers, working with scientists from Novo Nordisk, have designed a new drug capsule that can carry insulin or other protein drugs and protect them from the harsh environment of the gastrointestinal tract. When the capsule reaches the small intestine, it breaks down to reveal dissolvable microneedles that attach to the intestinal wall and release drug for uptake into the bloodstream.

“We are really pleased with the latest results of the new oral delivery device our lab members have developed with our collaborators, and we look forward to hopefully seeing it help people with diabetes and others in the future,” says Robert Langer, the David H. Koch Institute Professor at MIT and a member of the Koch Institute for Integrative Cancer Research.

In tests in pigs, the researchers showed that this capsule could load a comparable amount of insulin to that of an injection, enabling fast uptake into the bloodstream after the microneedles were released.

Langer and Giovanni Traverso, an assistant professor in MIT’s Department of Mechanical Engineering and a gastroenterologist at Brigham and Women’s Hospital, are the senior authors of the study, which appears today in Nature Medicine. The lead authors of the paper are recent MIT PhD recipient Alex Abramson and former MIT postdoc Ester Caffarel-Salvador.

Microneedle delivery

Langer and Traverso have previously developed several novel strategies for oral delivery of drugs that usually have to be injected. Those efforts include a pill coated with many tiny needles, as well as star-shaped structures that unfold and can remain in the stomach from days to weeks while releasing drugs.

“A lot of this work is motivated by the recognition that both patients and health care providers prefer the oral route of administration over the injectable one,” Traverso says.

Earlier this year, they developed a blueberry-sized capsule containing a small needle made of compressed insulin. Upon reaching the stomach, the needle injects the drug into the stomach lining. In the new study, the researchers set out to develop a capsule that could inject its contents into the wall of the small intestine.

Most drugs are absorbed through the small intestine, Traverso says, in part because of its extremely large surface area — 250 square meters, or about the size of a tennis court. Also, Traverso noted that pain receptors are lacking in this part of the body, potentially enabling pain-free micro-injections in the small intestine for delivery of drugs like insulin.

To allow their capsule to reach the small intestine and perform these micro-injections, the researchers coated it with a polymer that can survive the acidic environment of the stomach, which has a pH of 1.5 to 3.5. When the capsule reaches the small intestine, the higher pH (around 6) triggers it to break open, and three folded arms inside the capsule spring open.

Each arm contains patches of 1-millimeter-long microneedles that can carry insulin or other drugs. When the arms unfold open, the force of their release allows the tiny microneedles to just penetrate the topmost layer of the small intestine tissue. After insertion, the needles dissolve and release the drug.

“We performed numerous safety tests on animal and human tissue to ensure that the penetration event allowed for drug delivery without causing a full thickness perforation or any other serious adverse events,” Abramson says.

To reduce the risk of blockage in the intestine, the researchers designed the arms so that they would break apart after the microneedle patches are applied.

The new capsule represents an important step toward achieving oral delivery of protein drugs, which has been very difficult to do, says David Putnam, a professor of biomedical engineering and chemical and biomolecular engineering at Cornell University.

“It’s a compelling paper,” says Putnam, who was not involved in the study. “Delivering proteins is the holy grail of drug delivery. People have been trying to do it for decades.”

Insulin demonstration

In tests in pigs, the researchers showed that the 30-millimeter-long capsules could deliver doses of insulin effectively and generate an immediate blood-glucose-lowering response. They also showed that no blockages formed in the intestine and the arms were excreted safely after applying the microneedle patches.

“We designed the arms such that they maintained sufficient strength to deliver the insulin microneedles to the small intestine wall, while still dissolving within several hours to prevent obstruction of the gastrointestinal tract,” Caffarel-Salvador says.

Although the researchers used insulin to demonstrate the new system, they believe it could also be used to deliver other protein drugs such as hormones, enzymes, or antibodies, as well as RNA-based drugs.

“We can deliver insulin, but we see applications for many other therapeutics and possibly vaccines,” Traverso says. “We’re working very closely with our collaborators to identify the next steps and applications where we can have the greatest impact.”

Learn more: New capsule can orally deliver drugs that usually have to be injected

 

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Detecting patient antibiotic levels in real-time with microneedle biosensors

Microneedle biosensors use a series of microscopic ‘teeth’ to penetrate the skin

Scientists have successfully used microneedle biosensors to accurately detect changes in antibiotic levels in the body, for the first time.

Small, non-invasive patches worn on the skin can accurately detect the levels of medication in a patient’s system, matching the accuracy of current clinical methods.

In a small-scale clinical evaluation, researchers at Imperial College London have shown for the first time how microneedle biosensors can be used to monitor the changing concentration of antibiotics.

Their findings, published in The Lancet Digital Health, show the sensors enable real-time monitoring of changes in antibiotic concentration in the body, with similar results to those obtained from blood tests.

Our biosensors … could tell us how much of a drug is being used by the body and provide us with vital medical information, in real time – Dr Timothy Rawson Department of Infectious Disease

The team believes the technology could change how patients with serious infections are treated by showing how quickly their bodies ‘use up’ medications they are given.

The researchers add that if future development and testing proves successful and the technology reaches the clinic, it could help to cut costs for the NHS, reduce drug-resistant infections and improve treatment for patients with life-threatening infections and improve the management of less serious ones.

They add that biosensors could reduce the need for blood sampling and analysis as well as offer more efficient, personalised drug delivery that could potentially be delivered outside of the hospital setting for outpatients.

Real-time monitoring

Dr Timothy Rawson, from Imperial’s Department of Infectious Disease and who led the research, said: “Microneedle biosensors hold a great potential for monitoring and treating the sickest of patients. When patients in hospital are treated for severe bacterial infections the only way we have of seeing whether antibiotics we give them are working is to wait and see how they respond, and to take frequent blood samples to analyse levels of the drugs in their system – but this can take time.

“Our biosensors could help to change that. By using a simple patch on the skin of the arm, or potentially at the site of infection, it could tell us how much of a drug is being used by the body and provide us with vital medical information, in real time.”

Microneedle biosensors use a series of microscopic ‘teeth’ to penetrate the skin and detect changes in the fluid between cells.

These teeth act as electrodes to detect changes in pH and can be coated with enzymes which react with a drug of choice, altering the local pH of the surrounding tissue if the drug is present.

The technology has been used for continuous monitoring of blood sugar, but the Imperial group has, for the first time, shown its potential for use in monitoring changes to drug concentrations.

In a small proof-of-concept trial, the Imperial team trialled the sensors in 10 healthy patients who were given doses of penicillin. Sensor patches (1.5 cm sq) were placed on their forearms and connected to monitors, with measurements taken frequently – from 30 minutes before receiving oral penicillin, to four hours afterwards. Blood samples were taken at the same time points for comparison.

Data collected from nine patients revealed that the sensors could accurately detect the changing concentration of penicillin in patients’ bodies. The researchers found that while penicillin concentrations varied widely from patient to patient, the overall readings from the biosensors were similar to those from blood samples – showing a marked decrease in drug concentration over time.

According to the team, the early findings are positive, but they explain the study is limited by the very small sample size and the was only tested on a single antibiotic, in healthy patients.

Optimising antibiotic dosage

The researchers explain that along with further testing in larger patient groups to strengthen the initial findings, they will look to see how the sensors could help to optimise the dosing of penicillin and similar antibiotics. They add that the sensors could form the basis of a ‘closed loop system’, like an insulin pump – where antibiotics are administered to patients and levels continuously monitored to ensure they receive a sufficient dose.

Professor Tony Cass, from the Department of Chemistry said: “This small, early-stage trial has shown that the sensor technology is as effective as gold standard clinical analysis in detecting changes to the concentrations of penicillin in the human body. When further developed, this technology could prove critical for the monitoring and treatment of patients with severe infections. More widely it could be used to monitor many other drugs and personalise treatment in many diseases”

This technology could prove critical for the monitoring and treatment of patients with severe infections.Professor Tony CassDepartment of Chemistry

The technology was developed through research supported by funding from the National Institute for Health Research (NIHR) and Fondation Merieux. Volunteers were recruited and treated at the NIHR Imperial Clinical Research Facility at Imperial College Healthcare NHS Trust. This collaborative work will be advanced further through Imperial’s National Centre for Antimicrobial Research and Optimisation (CAMO)

Professor Alison Holmes, from Imperial’s Department of Infectious Disease and director of the NIHR Health Protection Research Unit in HCAI and AMR at Imperial and the CAMO, said: “This technology is an example of the close collaboration between scientists, medics and engineers going on in institutions across the UK, which could change the way we treat patients. Antibiotic resistance and drug-resistant infections are among the biggest threats to human health in the world today.”

Professor Holmes added: “Technological solutions such as our microneedle biosensor could prove crucial in improving how we use and protect the arsenal of life-saving antibiotics we have available to treat patients. Ultimately, these types of collaborative, multidisciplinary solutions could lead to earlier detection and better treatment of infections, helping to save more lives and protect these invaluable medicines for generations to come.”

Learn more: Microneedle biosensors accurately detect patient antibiotic levels in real-time

 

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Developing fast on-site plant disease detection tools

via North Carolina State University

Researchers have developed a new technique that uses microneedle patches to collect DNA from plant tissues in one minute, rather than the hours needed for conventional techniques. DNA extraction is the first step in identifying plant diseases, and the new method holds promise for the development of on-site plant disease detection tools.

“When farmers detect a possible plant disease in the field, such as potato late blight, they want to know what it is right away; rapid detection can be important for addressing plant diseases that spread quickly,” says Qingshan Wei, an assistant professor of chemical and biomolecular engineering at North Carolina State University and co-corresponding author of a paper on the work.

“One of the obstacles to rapid detection is the amount of time it takes to extract DNA from a plant sample, and our technique provides a fast, simple solution to that problem,” Wei says.

“Some plant diseases have similar leaf symptoms, such as late blight caused by the famed Irish famine pathogen Phytophthora infestans, and Phytophthora blight caused by a sister species P. nicotianae,” says Jean Ristaino, William Neal Reynolds Distinguished Professor of Plant Pathology at NC State and co-corresponding author of the paper. “The gold standard for disease identification is a molecular assay. Our new technique is important because you can’t run an amplification or genotyping assay on strains of P. infestans, or any other plant disease, until you’ve extracted DNA from the sample.”

Typically, DNA is extracted from a plant sample using a method called CTAB extraction, which has to be done in a lab, requires a lot of equipment, and takes at least 3 to 4 hours. CTAB extraction is a multi-step process involving everything from tissue grinding to organic solvents and centrifuges.

By contrast, the new DNA extraction technique involves only a microneedle patch and an aqueous buffer solution. The patch is about the size of a postage stamp and is made of an inexpensive polymer. The surface on one side of the patch is made up of hundreds of needles that are only 0.8 millimeters long.

A farmer or researcher can apply the microneedle patch to a plant they suspect is diseased, hold the patch in place for a few seconds, then peel it off. The patch is then rinsed with the buffer solution, washing genetic material off of the microneedles and into a sterile container. The entire process takes about a minute.

“It is exciting to see the new application of microneedle patch technology in agriculture and plant science,” says Zhen Gu, a professor of bioengineering at the University of California, Los Angeles and co-corresponding author of the paper, who developed several microneedle-based drug delivery systems for human health.

“In experimental testing, we found that the microneedle technique does result in slightly higher levels of impurities in the sample, as compared to CTAB,” Wei says. “However, the microneedle technique’s purity levels were comparable to other, validated laboratory methods of DNA extraction. Most importantly, we found that the slight difference in purity levels between the microneedle and CTAB samples did not interfere with the ability to accurately test the samples by a PCR or LAMP assay.”

“The fact that microneedles extract a smaller sampling volume seems not to be an issue,” says Rajesh Paul, a Ph.D. student at NC State and first author of the paper. “The microneedle technique successfully extracted pathogen DNA from all field-collected infected tomato leaves in a recent blind test.”

“DNA extraction has been a significant hurdle to the development of on-site testing tools,” Wei says. “We are now moving forward with the goal of creating an integrated, low-cost, field-portable device that can perform every step of the process from taking the sample to identifying the pathogen and reporting the results of an assay.”

Learn more: New Microneedle Technique Speeds Plant Disease Detection

 

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A long-acting microneedle contraceptive skin patch

Regents Professor Mark Prausnitz holds an experimental microneedle contraceptive skin patch. Designed to be self-administered by women for long-acting contraception, the patch could provide a new family planning option. (Credit: Christopher Moore, Georgia Tech)

A new long-acting contraceptive designed to be self-administered by women may provide a new family planning option, particularly in developing nations where access to health care can be limited, a recent study suggests. The contraceptive would be delivered using microneedle skin patch technology originally developed for the painless administration of vaccines.

Long-acting contraceptives now available provide the highest level of effectiveness, but usually require a health care professional to inject a drug or implant a device. Short-acting techniques, on the other hand, require frequent compliance by users and therefore are often not as effective. In animal testing, an experimental microneedle contraceptive patch provided a therapeutic level of contraceptive hormone for more than a month with a single application to the skin.

When the patch is applied for several seconds, the microscopic needles break off and remain under the surface of the skin, where biodegradable polymers slowly release the contraceptive drug levonorgestrel over time. Originally designed for use in areas of the world with limited access to health care, the microneedle contraceptive could potentially provide a new family planning alternative to a broader population.

The research was reported January 14 in the journal Nature Biomedical Engineering and was supported by Family Health International (FHI 360), funded under a contract with the U.S. Agency for International Development (USAID).

“There is a lot of interest in providing more options for long-acting contraceptives,” said Mark Prausnitz, a Regents Professor in the School of Chemical and Biomolecular Engineering at the Georgia Institute of Technology and the paper’s corresponding author. “Our goal is for women to be able to self-administer long-acting contraceptives with the microneedle patch that would be applied to the skin for five seconds just once a month.”

Long-acting contraceptives are now available in formats such as patches that must be worn continuously, intrauterine devices (IUDs) that must be placed by trained health care professionals, and drugs injected with hypodermic needles. If the microneedle contraceptive patch is ultimately approved for use, it could become the first self-administered, long-acting contraceptive that does not involve a conventional needle injection. Like other long-acting contraceptive techniques, the microneedle contraceptive patch would disrupt the menstrual cycles of women using it.

Because the tiny needles must remain in the skin for the time-release of the hormone, researchers led by Georgia Tech postdoctoral research scholar Wei Li developed a mechanical technique that would allow the drug-containing microneedles to break free from the patch’s backing material. To accomplish that, the researchers molded tiny air bubbles into the top of the microneedles, creating a structural weakness. The resulting microneedles are strong enough to be pressed into the skin, but when the patch is then shifted to one side, the shear force breaks off the tiny structures in the skin. The patch backing can then be discarded.

Experimental patches designed to deliver a sufficient amount of the hormone for humans have been developed, but not yet tested, noted Prausnitz, who holds the J. Erskine Love Jr. Chair in Chemical and Biomolecular Engineering at Georgia Tech. Researchers are also studying whether a single patch could carry enough hormone to provide contraception for as long as six months.

“The microneedle patch delivery platform being developed by Mark Prausnitz and his colleagues for contraception is an exciting advancement in women’s health,” said Gregory S. Kopf, director of R&D Contraceptive Technology Innovation at FHI 360. “This self-administered long-acting contraceptive will afford women discreet and convenient control over their fertility, leading to a positive impact on public health by reducing both unwanted and unintended pregnancies.”

The microneedles are molded from a blend of a biodegradable polymers, poly(lactic-co-glycolic acid) and poly(lactic acid), commonly used in resorbable sutures, said Steven Schwendeman, the Ara Paul Professor and chair of the Department of Pharmaceutical Sciences at the University of Michigan and a collaborator on this project. Lactic and glycolic acids are present naturally in the body, contributing to the biocompatibility of the polymer material, he said.

“We select polymer materials to meet specific design objectives such as microneedle strength, biocompatibility, biodegradation and drug release time, and formulation stability,” Schwendeman explained. “Our team then processes the polymer into microneedles by dissolving the polymer and drug in an organic solvent, molding the shape, and then drying off the solvent to create the microneedles. The polymer matrix when formed in this way can slowly and safely release contraceptive hormone for weeks or months when placed in the body.”

Testing with rats evaluated only the blood levels of the hormone and did not attempt to determine whether it could prevent pregnancy. “The goal was to show that we could enable the concentration of the levonorgestrel to stay above levels that are known to cause contraception in humans,” Prausnitz explained.

In developing the experimental contraceptive microneedle patch, the researchers leveraged earlier work on dissolving microneedle patches designed to carry vaccines into the body. A Phase I clinical trial of influenza vaccination using rapidly dissolving microneedles has been conducted in collaboration with Emory University.

That study suggested that the microneedle patches could be safely used to administer the vaccine. Because the microneedles are so small, they enter only the upper layers of the skin and were not perceived as painful by study participants.

“We do not yet know how the contraceptive microneedle patches would work in humans,” Prausnitz said. “Because we are using a well-established contraceptive hormone, we are optimistic that the patch will be an effective contraceptive. We also expect that possible skin irritation at the site of patch application will be minimal, but these expectations need to be verified in clinical trials.”

The contraceptive patches tested on the animals contained 100 microneedles. To deliver an adequate dose of levonorgestrel to a human will require a larger patch, which has been fabricated but not yet tested. The researchers would like to develop a patch that could be applied once every six months.

“There is a lot of interest in minimizing the number of health care interventions that are needed,” Prausnitz said. “Therefore, a contraceptive patch lasting more than one month is desirable, particularly in countries where women have limited access to health care. But because microneedles are by definition small, there are limits to how much drug can be incorporated into a microneedle patch.”

Learn more: Long-Acting Contraceptive Designed to be Self-Administered Via Microneedle Patch

 

 

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Getting your flu vaccination via a new microneedle patch

Applying a dissolving microneedle patch. The microneedles dissolve within minutes after insertion into skin to release encapsulated drug or vaccine. Georgia Tech.

A National Institutes of Health-funded study led by a team at the Georgia Institute of Technology and Emory University has shown that an influenza vaccine can produce robust immune responses and be administered safely with an experimental patch of dissolving microneedles.

The method is an alternative to needle-and-syringe immunization; with further development, it could eliminate the discomfort of an injection as well as the inconvenience and expense of visiting a flu clinic.

“This bandage-strip sized patch of painless and dissolvable needles can transform how we get vaccinated,” said Roderic I. Pettigrew, Ph.D., M.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which funded the study. “A particularly attractive feature is that this vaccination patch could be delivered in the mail and self-administered. In addition, this technology holds promise for delivering other vaccines in the future.”

The researchers received funding through an NIBIB Quantum Grant and from the National Institute of Allergy and Infectious Diseases.

The study, published online June 27, 2017, in The Lancet, was led by Nadine Rouphael, M.D., associate professor of medicine and Mark J. Mulligan, M.D., distinguished professor of medicine, Emory University School of Medicine, in collaboration with Mark R. Prausnitz, Ph.D., Regents Professor and J. Erskine Love Chair in Chemical and Biomolecular Engineering, Georgia Institute of Technology. A team led by Prausnitz designed the dime-sized patch of microneedles used in the study.

The vaccine patch consists of 100 solid, water-soluble needles that are just long enough to penetrate the skin. “The skin is an immune surveillance organ,” Prausnitz said. “It’s our interface with the outside world, so it’s very well equipped to detect a pathogen and mount an immune response against it.”

Adhesive helps the patch grip the skin during the administration of the vaccine, which is encapsulated in the needles and is released as the needle tips dissolve, within minutes. The patch is peeled away and discarded like a used bandage strip.

The researchers enrolled 100 adult participants, dividing them into four random groups: vaccination with microneedle patch given by a health care provider; vaccination with microneedle patch self-administered by the study participant; vaccination with intramuscular injection given by a health care provider; and placebo microneedle patch given by a health care provider. The researchers used an inactivated influenza vaccine formulated for the 2014-15 flu season to inoculate participants other than those in the placebo group.

The researchers found that vaccination with the microneedle patches was safe, with no serious related adverse events reported. Some participants developed local skin reactions to the patches, described as faint redness and mild itching that lasted two to three days.

The results also showed that antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. More than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations.

No significant difference was seen between the doses of vaccine delivered by the health care workers and the volunteers who self-administered the patches, showing that participants were able to correctly self-administer the patch. After vaccination, imaging of the used patches found that the microneedles had dissolved in the skin, suggesting that the used patches could be safely discarded as non-sharps waste. The vaccines remained potent in the patches without refrigeration for at least one year.

The prospective vaccine technology could offer economic and manufacturing advantages. The manufacturing cost for the patch is expected to be competitive with prefilled syringe costs. The patch, however, can dramatically reduce the cost of vaccination, since self-administration can eliminate the need to have health workers oversee the process.  It can be easily packaged for transportation, requires no refrigeration, and is stable.

Prausnitz is co-founder of a company that is licensing the microneedle patch technology. He is an inventor on licensed patents and has ownership interest in companies developing microneedle products, including Micron Biomedical. These potential conflicts of interest have been disclosed and are overseen by Georgia Institute of Technology and Emory University.

The team plans to conduct further clinical trials to pursue the technology’s ultimate availability to patients. They also are working to develop microneedle patches for use with other vaccines, including measles, rubella and polio.

Learn more: Researchers develop microneedle patch for flu vaccination

 

 

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