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MIT researchers have developed a simple, inexpensive technology to deliver powerful drug formulations that are too viscous to be injected using conventional medical syringes.
The technology, which is described in an article published today in the journal Advanced health materials, allows the injection of drugs at high concentration and other therapies subcutaneously. It was developed as a solution for highly effective and extremely concentrated biopharmaceuticals or biologicals, which are typically diluted and injected intravenously.
“Where drug distribution and biologics go, injectability becomes a big bottleneck, preventing formulations that could treat diseases more easily,” says Kripa Varanasi, professor of mechanical engineering at MIT. “Drug makers need to focus on what they do best and formulate drugs, and not be stuck with this injectability problem.”
Foundation executives Bill and Melinda Gates brought the issue of injectability to Varanasi after reading his previous work on dispensing fluids, which caught the attention of industries ranging from aviation to toothpaste makers. One of the foundation’s main concerns, Varanasi said, was to provide high-strength vaccines and biological therapies to people in developing countries who could not travel from remote areas to a medical setting.
In the current pandemic, Varanasi adds, being able to stay at home and self-administer drugs subcutaneously to treat diseases such as cancer or autoimmune disorders is also important in developed countries. such as the United States.
“Self-administration of drugs or vaccines can help democratize access to health care,” he says.
Varanasi and Vishnu Jayaprakash, a graduate student in the Mechanical Engineering Department at MIT who is the first author of the article, devised a system that would make it possible to inject high-concentration drug formulations subcutaneously by reducing the force of injection required, which exceeded what is possible with manual subcutaneous injection with a conventional syringe.
In their system, the viscous fluid to be injected is surrounded by a lubricating fluid, facilitating the flow of the fluid through the needle. With the lubricant, only one-seventh of the injection force was required for the highest viscosity tested, effectively allowing subcutaneous injection of any of the more than 100 drugs otherwise considered too viscous to be administered from. this way.
“We can allow the injectability of these biologics,” Jayaprakash says. “No matter how viscous your medicine is, you can inject it, and that’s what made this approach very interesting for us.”
Biologic drugs include protein-based formulations and are harvested from living cells. They are used to treat a wide range of diseases and disorders, and can bind to specific tissues or immune cells as desired, causing fewer adverse reactions and eliciting particular immune responses that do not occur with others. drugs.
“You can customize very specific proteins or molecules that bind to very specific receptors in the body,” Jayaprakash explains. “They allow a degree of personalization, specificity and immune response that is simply not available with small molecule drugs. This is why people all over the world are turning to biologic drugs. “
Due to their high viscosities, the administration of the drugs by the subcutaneous route has involved methods which have proved to be impractical and expensive. Usually, drugs are diluted and administered intravenously, requiring a visit to the hospital or doctor’s office. Jet injectors, which shoot drugs through the skin without a needle, are expensive and prone to backsplash contamination. Injection of encapsulated drugs often results in their needle clogging and additional complexity in drug manufacturing and release profiles. EpiPen type syringes are also too expensive to be widely used.
To develop their technology, the MIT researchers began by defining theoretical parameters and testing them before designing their device. The device consists of a syringe with two cylinders, one inside the other, with the inner tube delivering the viscous drug fluid and the surrounding tube delivering a thin layer of lubricant to the drug as it enters the tube. needle.
Because the lubricated fluid passes more easily through the needle, the viscous payload experiences minimal shear stress. For this reason, says Jayaprakash, the system could also be useful for the 3D bioprinting of tissues made of natural components and the delivery of cell therapies, both cases where the tissues and cells can be destroyed by shear damage. .
Therapeutic gels – used in bone and joint therapies, as well as for delivering sustained-release drugs, among other uses – could also be more easily administered using the syringe developed by the researchers.
“The technique works as a platform for all of these other applications,” Jayaprakash explains.
Pramod Bonde, associate professor of surgery at the Yale School of Medicine, says the technique could greatly affect the field of medicine.
“This innovative technology has the potential to have a fundamental and far-reaching impact on the way drugs are delivered in the body,” says Bonde.
It’s unclear if the technology will make a difference as researchers research the possibilities and treatments for the Covid-19 vaccine. The researchers say, however, that this expands the options as different drug formulations are considered.
“Once you have the history of the technology out there, the industry could say they could consider things that were previously impossible,” Varanasi says.
As his previous work spurred the creation of four companies, Varanasi says he and his team are hopeful that the technology will be brought to market as well.
“There should be no reason why this approach, given its simplicity, cannot help solve what we’ve heard from the industry is an emerging issue,” he says. “The basic work is done. Now it’s just a matter of applying it to different formulations.
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