Novel Drug Manufacturing Technique Removes Excess Additives, Reduces Serious Allergic Reactions

A breakthrough technique in the manufacture of injectable drugs removed surfactants in an effort to reduce serious allergic reactions and other side effects. This technique could make injectable medicines safer.1

“We're excited because this process can be scaled up, which could make existing injectable drugs safer and more effective for millions of people suffering from serious diseases and ailments,” said Jonathan F. Lovell, PhD, assistant professor in the Biomedical Engineering Department at the University at Buffalo, Buffalo, New York, and corresponding author of the study.

Surfactants are compounds that lower surface tension and can act as detergents, emulsifiers, foaming agents, dispersants, or wetting agents. Pharmaceutical companies use surfactants to emulsify the drug into a liquid solution, though surfactants can cause serious allergic reactions or side effects. Medications that could be improved include many anticancer medications and testosterone.

Researchers dissolved 12 drugs individually into a surfactant called Pluronic. When they lowered the temperature of the solution to 4° C, they were able to remove excess Pluronic with a membrane. The drugs for which they took this approach included cabazitaxel (anticancer), testosterone, and cyclosporine (an immunosuppressant used during organ transplants).

This process resulted in drugs with 100 to 1000 times less excessive additive. In addition, the approach did not necessitate trying to build a drug from scratch or trying to make drug compounds small enough to be injected, both of which are challenging to accomplish.

“For the drugs we looked at, this is as close as anyone has gotten to introducing pure, injectable medicine into the body,” said Lovell.

“Essentially, it's a new way to package drugs.”

These results show that many injectable medications could be improved with a process that is easy to adopt. The researchers are planning additional experiments to refine the procedure.

“Minimizing the amount of excipient not only holds potential to enable higher dosing due to reduced adverse side effects but also minimizes unexpected carrier effects that can modulate drug function,” concluded the authors.

A grant from the National Institutes of Health supported this research.

Reference

1. Zhang Y, Song W, Geng J, et al. Therapeutic surfactant-stripped frozen micelles [published online May 19, 2016]. Nat Commun. doi:10.1038/ncomms11649.

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