New drug-delivery capsule may replace injections

A schematic drawing of a microneedle pill with hollow needles. When the pill reaches the desired location in the digestive tract, the pH-sensitive coating surrounding the capsule dissolves, allowing the drug to be released through the microneedles. Image: Christine Daniloff/MIT, based on images by Carol Schoellhammer and Giovanni Traverso

A schematic drawing of a microneedle pill with hollow needles. When the pill reaches the desired location in the digestive tract, the pH-sensitive coating surrounding the capsule dissolves, allowing the drug to be released through the microneedles.
Image: Christine Daniloff/MIT, based on images by Carol Schoellhammer and Giovanni Traverso

Given a choice, most patients would prefer to take a drug orally instead of getting an injection. Unfortunately, many drugs, especially those made from large proteins, cannot be given as a pill because they get broken down in the stomach before they can be absorbed.

To help overcome that obstacle, researchers at MIT and Massachusetts General Hospital (MGH) have devised a novel drug capsule coated with tiny needles that can inject drugs directly into the lining of the stomach after the capsule is swallowed. In animal studies, the team found that the capsule delivered insulin more efficiently than injection under the skin, and there were no harmful side effects as the capsule passed through the digestive system.

“This could be a way that the patient can circumvent the need to have an infusion or subcutaneous administration of a drug,” says Giovanni Traverso, a research fellow at MIT’s Koch Institute for Integrative Cancer Research, a gastroenterologist at MGH, and one of the lead authors of the paper, which appears in the Journal of Pharmaceutical Sciences.

Although the researchers tested their capsule with insulin, they anticipate that it would be most useful for delivering biopharmaceuticals such as antibodies, which are used to treat cancer and autoimmune disorders like arthritis and Crohn’s disease. This class of drugs, known as “biologics,” also includes vaccines, recombinant DNA, and RNA.

“The large size of these biologic drugs makes them nonabsorbable. And before they even would be absorbed, they’re degraded in your GI tract by acids and enzymes that just eat up the molecules and make them inactive,” says Carl Schoellhammer, a graduate student in chemical engineering and a lead author of the paper.

Safe and effective delivery

Scientists have tried designing microparticles and nanoparticles that can deliver biologics, but such particles are expensive to produce and require a new version to be engineered for each drug.

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New device saves money, reduces testing on animals and will produce more effective medicines

A diagram of the human gastrointestinal tract

A BREAKTHROUGH in drug testing developed by a University of Huddersfield lecturer could lead to cheaper, more effective medicines.  

Dr Hamid Merchant is a member of the team that has created a device which accurately simulates the gastro-intestinal tract and how it absorbs medication.  This means that the cost of clinical trials could be greatly reduced, with savings passed on to customers.

The device is the subject of a patent application – with potential commercial partners already expressing interest – and a working prototype has been constructed at UCL.  It has already been used, under contract, by drug companies in order to test new products.  Dr Merchant now aims to establish a second prototype at the University of Huddersfield.

Dr Merchant explained that the cycle for developing and delivering a new drug involves pre-clinical tests on animals.  If these are deemed safe and satisfactory, clinical trials on humans can then begin.  But differences between animal and human gastrointestinal tracts mean that the pre-clinical tests do not always provide sufficiently reliable information about drug absorption from differing formulations.  This has to be investigated – at considerable expense – during the clinical trial phase.

Therefore, Dr Merchant and his colleagues developed a laboratory device that simulates the human gut and its differing pH gradients, which play a decisive role in determining the manner, in which orally-administered medications are dissolved and then absorbed.  It is now possible to fairly discriminate the formulations of a new drug and identify potential candidates for further development that are likely to be successful during clinical trials.

“By minimising human trials we would reduce the cost of development, which is then charged to patients when the drug comes to the market – if the development costs are lower, then we can make new drugs more affordable,” said Dr Merchant, who has research experience in industry as well as academia.

The testing device, co-developed by Dr Merchant, includes a chamber for holding a solvent medium plus a pH probe and a control unit.  This monitors changes in the pH of the solvent medium in order to test the performance of a drug carrier at different levels of acidity or alkalinity, mimicking the conditions of the gastrointestinal tract.  The device is particularly suitable for testing and developing dosage forms for oral delivery of drugs and can also simulate the variability between individuals.

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FDA approves PillCam video camera that you swallow

The PillCam Colon has been approved for us in the US by the FDA

Colonoscopies can be an uncomfortable procedure for patients who may already be worried about what results will be found.

When the results are inconclusive, a patient’s options can be limited, causing further distress. The US Food and Drug Administration (FDA) has now approved a device for use after an incomplete procedure that is minimally invasive and can achieve similar imaging results to a colonoscopy. PillCam Colon is a pill-sized camera that is swallowed and passes through a patient’s gastrointestinal tract.

Given Imaging‘s PillCam Colon was created specifically with the purpose of checking for colon cancer and is already commercially available in more than 80 countries. The study on which the FDA based its decision focused on identifying hyperplastic polyps and adenomas at least 6 mm in size. It found a 69 percent positive agreement between PillCam Colon results and a colonoscopy, and an 81 percent negative agreement.

A colonoscopy is the examination of a patient’s bowel using a long, thin camera known as an endoscope that is inserted via the rectum. Around 750,000 incomplete colonoscopies occur each year in the US, and are more common in women due to higher incidences of previous pelvic surgery and anatomical challenges for navigation. An incomplete colonoscopy often requires that a patient undergoes an additional procedure, such as an X-ray or CT scan, in order to complete the colorectal examination, incurring extra costs and risks in the process.

The device itself is a pill-sized video camera measuring 12 x 33 mm (0.47 x 1.3 in) that captures color video from both of its ends at 4 or 35 frames per second. An LED provides the necessary illumination for image capture and, once swallowed by the patient, it wirelessly relays footage to a recording device worn by the patient for approximately 10 hours.

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Toxin-Emitting Bacteria Being Evaluated as a Potential Multiple Sclerosis Trigger

300px-Clostridium_perfringens

VARIANT OF COMMON SOIL-BASED PATHOGEN FOUND FOR THE FIRST TIME IN A PATIENT WITH MS

RESEARCHERS FIND EVIDENCE OF SIMILAR INFECTION IN OTHER MS PATIENTS

A research team from Weill Cornell Medical College and The Rockefeller University has identified a bacterium it believes may trigger multiple sclerosis (MS), a chronic, debilitating disorder that damages myelin forming cells in the brain and spinal cord.

Their study, published in PLoS ONE, is the first to identify the bacterium, Clostridium (C.) perfringens type B, in humans.

The scientists say their study is small and must be expanded before a definitive connection between the pathogen and MS can be made, but they also say their findings are so intriguing that they have already begun to work on new treatments for the disease.

“This bacterium produces a toxin that we normally think humans never encounter. That we identified this bacterium in a human is important enough, but the fact that it is present in MS patients is truly significant because the toxin targets the exact tissues damaged during the acute MS disease process,” say the study’s first author, K. Rashid Rumah, an MD/PhD student at Weill Cornell Medical College, and the study’s senior investigator,Dr. Timothy Vartanian, professor of neurology and neuroscience at Weill Cornell Medical College and director of the Judith Jaffe Multiple Sclerosis Center at New York-Presbyterian Hospital/Weill Cornell Medical Center.

“While it is clear that new MS disease activity requires an environmental trigger, the identity of this trigger has eluded the MS scientific community for decades,” Dr. Vartanian says. “Work is underway to test our hypothesis that the environmental trigger for MS lays within the microbiome, the ecosystem of bacteria that populates the gastrointestinal tract and other body habitats of MS patients.”

CONNECTION TO MS IN GRAZING ANIMALS

The study describes discovery of C. perfringens type B in a 21-year-old woman who was experiencing a flare-up of her MS.

The woman was part of the Harboring the Initial Trigger for MS (HITMS) observational trial launched by Dr. Vartanian and K. Rashid Rumah, who works both with Dr. Vartanian and with co-author Dr. Vincent Fischetti at The Rockefeller University.

C. perfringens, found in soil, is one of the most common bacteria in the world. It is divided into five types. C. perfringens type A is commonly found in the human gastrointestinal tract and is believed to be largely harmless.

C. perfringens types B and D carry a gene (epsilon toxin) that emits a protoxin — a non-active precursor form of the toxin — which is turned into the potent “epsilon” toxin within the intestines of grazing animals. The epsilon toxin travels through the blood to the brain, where it damages brain blood vessels and myelin, the insulation protecting neurons, resulting in MS-like symptoms in the animals. While the D subtype has only been found in two people, based on prior studies by other investigators, the B subtype had never been found in humans.

Nevertheless, Rumah and the research team set out to see if subtypes B or D exist in humans and if they are associated with MS. They tested banked blood and spinal fluid from both MS patients and healthy controls for antibody reactivity to the epsilon toxin. Investigators found that levels of epsilon toxin antibodies in MS patients were 10 times higher than in the healthy controls — the blood of only one out of 100 control participants showed an immune reaction to the toxin.

The team also examined stool samples from both MS patients and healthy controls enrolled in the HITMS clinical study, and found that 52 percent of healthy controls carried the A subtype compared to 23 percent of MS patients. “This is important because it is believed that the type A bacterium competes with the other subtypes for resources, so that makes it potentially protective against being colonized by epsilon toxin secreting subtypes and developing MS,” say Rumah and Vartanian.

The search by investigators for evidence of C. perfringens type B paid off in the case of a young MS patient. Co-author Dr. Jennifer Linden, a microbiologist at Weill Cornell Medical College, isolated the actual bacterium from the patient’s stool.

A CHOICE OF APPROACHES FOR TREATMENT

The authors suspect that once a human is infected with C. perfringens type B or D, the pathogen usually lives in the gut as an endospore, a seed-like structure that allows some bacteria to remain dormant for long periods. “The human gastrointestinal tract is host to approximately 1,000 different bacterial species, but is not a hospitable environment for C. perfringens type B or D, so it does not grow well there. It hibernates in a protective spore. When it does grow, we anticipate it generates a small quantity of epsilon toxin, which travels through the blood into the brain,” Dr. Vartanian says. “We believe the bacterium’s growth is episodic, meaning the environmental trigger is always present, and it rears its ugly head from time to time.”

He says researchers do not know how humans are infected with C. perfringens type B or D, but they are studying potential routes of exposure. The scientists are also in the first stages of investigating potential treatments against the pathogen.

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Fecal transplant pill knocks out recurrent C. diff infection, study shows

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Other research shows treatment leads to high patient satisfaction

Swallowing pills containing a concentrate of fecal bacteria successfully stops recurrent bouts of debilitating Clostridium difficile (C. diff) infection by rebalancing the bacteria in the gut, suggests a study being presented at the IDWeek 2013™ meeting today.

Infection from C. diff bacteria is such a concern that the Centers for Disease Control and Prevention (CDC) named it one of the three most urgent threats in its recent landmark report on antibiotic resistance. C. diff sickens half a million Americans and kills 14,000 every year. C. diff infection can occur after people take antibiotics, wiping out the good bacteria in the gastrointestinal (GI) system, allowing C. diff to flourish and leading to severe diarrhea. In some patients, infection continues to recur despite standard treatment with antibiotics. For patients trapped in that cycle, doctors have transplanted feces from healthy donors into their GI system to rebalance the bacteria and stop infections from recurring.

Fecal transplantation typically is delivered by enema, colonoscopy (placing a tube in the colon) or nose tube and is effective in nine out of 10 patients, according to published reports. The IDWeek research suggests the less-invasive pills are a viable and effective delivery method.

“Recurrent C. diff infection is such a miserable experience and patients are so distraught that many ask for fecal transplantation because they’ve heard of its success,” said Thomas Louie, MD, professor of medicine at the University of Calgary, Alberta, and lead author of the pill study. “Many people might find the idea of fecal transplantation off-putting, but those with recurrent infection are thankful to have a treatment that works.”

Indeed, additional research being presented at the meeting showed patients who received fecal transplantation through a tube in the nose were highly satisfied with the treatment, and said they would likely recommend it to a friend.

Fecal Transplantation by Pill

University of Calgary researchers reported a 100 percent success rate – none of the 27 patients who took the tablet-sized pills had a recurrence of C. diff, even though all of them previously had had at least four bouts of the infection. Patients ingested between 24 and 34 capsules containing fecal bacteria, often donated by family members.

To make the pills, researchers processed the feces until it contained only bacteria, and then encapsulated the bacterial concentrate inside three layers of gelatin capsule. This ensured the pills wouldn’t leak or disintegrate until they were past the stomach and into the small intestine – a potential advantage over other methods because it covers more of the GI tract, does not involve invasive and more costly procedures, and is more comfortable for patients, Dr. Louie said.

Dr. Louie said he first made pills for fecal transplantation when one patient failed to respond to the enema method on two occasions and also could not tolerate a nasal tube for medical reasons. The pills are made individually.

“The pills are a one-shot deal and seem to work. They are easier for patients and are well-tolerated,” said Dr. Louie. “It’s an exciting development in the field and could possibly even be used to maintain the balance of bacteria in the GI system in patients at risk for C. diff.””

Patient Satisfaction of Fecal Transplantation

In the study of fecal transplantation tolerance, researchers surveyed 28 patients three months after they had undergone the treatment through a tube fed through the nose and GI system to the small intestine. On a scale of one to 10, average patient scores were: 9.6 for overall satisfaction; 9.9 for ease; and 9.9 for likelihood of recommending the procedure to a family member or friend.

“Patients with C. diff often have 20 or more stools a day, which seriously affects quality of life and so they are very open to this treatment,” said Ravi Kamepalli, MD, an infectious diseases physician at the Regional Infectious Disease-Infusion Center, Lima, Ohio, and lead author of the study. “Human beings are 90 percent bacteria and once that balance is altered with antibiotics, opportunistic infections can cause serious problems. All we are doing with this treatment is resetting the balance.”

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