Researchers at Pitt have developed a rectal microbicide product in the form of a hypotonic liquid enema containing the antiretroviral drug tenofovir (TFV) for HIV prevention. The researchers aimed to create a more commercially viable and accessible formulation compared to the original liquid enema, so they developed a sachet powder product using spray drying and powder compression techniques.
Description
This technology is the successful development of an improved rectal microbicide product containing tenofovir that addresses critical barriers to accessibility and acceptability for HIV prevention in high-risk populations. The spray-dried sachet powder formulation represents an important advancement that could enhance the real-world impact of this microbicide technology.
Applications
- HIV prevention
Advantages
This spray-dried sachet powder formulation addresses several limitations of the original liquid enema. It is more commercially viable, as it can be easily manufactured, packaged, and distributed without the need for pharmacy compounding. Additionally, the powder format may be more user-friendly and accessible for individuals who regularly use rectal douching before and after anal intercourse, which is a common practice among men who have sex with men and transgender women - the key populations at risk for HIV acquisition through receptive anal intercourse.
Invention Readiness
This technology is at the prototype level. This technology is a combination of spray drying followed by grinding and compression. The researchers prepared a TFV solution at 110 mg/mL with sodium hydroxide and optimized the spray drying parameters (inlet temperature, pump flow, aspirator, nitrogen flow) to maximize powder yield and minimize water content. The resulting spray-dried powder was then combined with sodium chloride crystals and subjected to grinding and compression, which significantly improved the powder flowability.
IP Status
https://patents.google.com/patent/WO2023230223A1Related Publication(s)
Hoang, T., Date, A. A., Ortiz, J. O., Young, T.-W., Bensouda, S., Xiao, P., Marzinke, M., Rohan, L., Fuchs, E. J., Hendrix, C., Gumber, S., Villinger, F., Cone, R. A., Hanes, J., & Ensign, L. M. (2019). Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema. European Journal of Pharmaceutics and Biopharmaceutics, 138, 23–29. https://doi.org/10.1016/j.ejpb.2018.05.030
