Addressing Solubility, Storage Issues Associated With Therapies, Vaccines

Poor solubility in therapies can lead to a less-than-optimal drug delivery, including efficacy and safety issues for patients. It has been estimated that approximately 40% of approved medicines and nearly 90% of molecules in development are poorly water-soluble.¹

With these ongoing solubility issues, other sources of drug delivery could alleviate some of these problems.

TFF Pharmaceuticals is a clinical-stage biopharmaceutical company based in Austin, Texas, and they have developed a technology platform called thin film freezing (TFF), which enables existing therapies to be converted into a dry powder form. With the dry powder, it can be delivered directly to the lung, where therapies are most needed, via an inhaler or other administration. This has the potential to both increase effectiveness of therapies and reduce toxic side effects associated with other formulations.

The company sees a variety of applications where the powder can be utilized.

“It has the ability to covert almost any kind of pharmaceutical compound…into a inhalable dry powder formulation that can be given to the lung,” TFF Pharmaceuticals CEO Glenn Mattes, said. “We can also do inhalation through the nasal passages, and we are also working to convert that powder into solutions given topically through the skin or intraocularly through the eye.”

The company has 2 lead compounds in development. One of the compounds is a collaboration with Augmenta Bioworks in developing a dry powder monoclonal antibody treatment (AUG-3387).

TFF is also working with government and military institutions, including the Defense Advanced Research Projects Agency (DARPA), to develop therapeutics that can be transported and administered with ease for future pandemic preparedness and biodefense.

Storage of Therapies, Vaccines in Developing Countries

In thinking about transportation and storage, utilizing powder for therapies may help the developing world. One of the ongoing challenges of drug delivery to the developing world is the ability to store therapies where they might have limited resources. In some countries, they may not have reliable refrigeration or storage centers, thus leaving these places the inability to keep medicines at the ready for patients.

Both the Moderna and Pfizer-BioNtech m-RNA COVID-19 vaccines have special cold storage needs. For the Moderna vaccine, it must be shipped at temperatures between -80°C and -60°C (-112°F and -76°F), can only be kept in a normal freezer at -20°C (-4°F) for two weeks, and unopened vials could only be stored at refrigerated temperatures of between 2-8°C for 5 days, before either being administered to people or thrown away.

TFF is collaborating with mRNA researcher Drew Weissman, MD, PhD, to develop dry powder forms of mRNA vaccines. Weissman was co-awarded the 2021 Lasker-DeBakey Clinical Medical Research Award.

Contagion spoke to Mattes recently about the TFF process, the advantages of using powder, and the development of powder for mRNA vaccines.

Reference

1. Kalepu S, Nekkanti V. Insoluble drug delivery strategies: review of recent advances and business prospects. Acta Pharm Sin B. 2015;5(5):442-453. doi:10.1016/j.apsb.2015.07.003