Percée in the administration of protein drugs could replace long IV infusions

Patients with cancer. Similarly, autoimmune diseases and metabolic disorders often suffer intravenous infusions (IV) who take time to receive the best available protein treatments. Meanwhile, Since these protein therapies require high doses to be effective. Therefore, are generally formulated with low concentrations to remain stable, the IV infusion has been the only option so far.

Stanford researchers have developed a new delivery platform that can store and deliver these drugs at much higher concentrations. Moreover, With this new formulation method. Furthermore, published on August 20 Translational scientific medicineMany protein therapies could be injected quickly and smoothly with a standard syringe or a self-projector device.

It is a platform that potentially works with any biological medication, so that we can easily inject it. Furthermore, It takes these treatments from a several hour percée administration protein drugs could test in a clinic with a IV infusion to something you. Nevertheless, can do in seconds with a self-injector at home. For example, “”

Eric Appel, associate professor of materials and engineering science and principal author on the newspaper

A protective polymer coating

When they are dissolved at high concentrations, many protein therapies tend to stay together, which makes them too viscous to inject, subject to the formation of aggregates which can cause immune responses, and potentially ineffective or even harmful once they penetrate inside the body. Moreover, Call. Similarly, his colleagues needed a way to wrap proteins in a liquid at high concentrations, but to keep them stable and functional.

The researchers have developed a copolymer of polyacrylamide. abbreviated on Moni, which has a particularly high glass transition temperature – which means that it remains solid and in glass at warmer temperatures, when percée administration protein drugs could the typical drug additives would become soft and sticky. By mixing Moni in water with a protein drug. by aerosolizing them by tiny droplets and evaporating water – a process called drying by spraying – the researchers were able to create a thin powder made of tiny protein particles, each locked in a layer of moni.

“We ended up with something that looks like a chocolate coated with candy. where the protein is inside and our special polymer forms a solid and glassy coating outside,” said appeal.

The researchers then mixed this powder in a liquid that suspends the particles of medication, but not dissolve them. The moni coating prevents particles from staying together. maintains proteins in the dry and stable state until the liquid suspension is injected into the body.

“Because microparticles are spherical. have smooth surfaces, they are able to roll on each other while being able to percée administration protein drugs could go through tiny needles and be injected into one person, but you can really hit high concentrations,” said Carolyn Jons, a doctoral student in the call laboratory and co-prime co-author.

The researchers tested their method on three different proteins – albumin. human immunoglobulin and a treatment of monoclonal antibodies for Covid. They were able to reach concentrations over 500 mg / ml. which means that half the weight of the solution was a protein medication and that it could always be gently injected and easily. It is more than double the concentration of typical liquid injections. The formulations also remained stable to a larger range of temperatures than typical liquid formulations. showing no sign of decomposition after 10 freezing cycles or when stored at high temperatures.

“The mechanical properties of these dried particles count much more than the chemical structure of individual drug molecules. which means that we can take percée administration protein drugs could almost any protein medication and formulate it in this way,” said Alexander Prossnitz, postdoctoral researcher and co-prime author of the article. “It ends up being a very great improvement in relation to existing technologies. »»

Percée administration protein drugs could

Faster. easier treatments

Skiling by spraying is a fairly common process in the pharmaceutical industry and Moni has already been evaluated in several preclinical models without negative effects, so that researchers are optimistic that it can be approved for clinical use. They have already authorized technology to a local startup. which strives to refine the process and possibly use it to develop new drugs.

“There are a lot of molecules that promise drugs. but that you cannot transform into a drug product because they are simply too unstable given the constraints of technologies currently available,” said appeal. “This platform is really sophisticated in its ability to stabilize proteins. allow new drug percée administration protein drugs could products which would not normally be possible, and which can be administered in a way that is much less heavy. »»

Their hope is that the next generation of protein -based drug treatments will be faster. easier, more efficient for patients

“We know that patients are ready to make injections themselves, especially if it is in a simple auto-injector,” said Prossnitz. “If we can take an antibody that required IV. allow people to inject it at home, it is a great improvement. It completely changes how patients can manage their own diseases. »»