PURPOSE: To develop polymeric films containing dual combinations of anti-HIV 
drug candidate tenofovir, maraviroc and dapivirine for vaginal application as 
topical microbicides.
METHODS: A solvent casting method was used to manufacture the films. Solid phase 
solubility was used to identify potential polymers for use in the film 
formulation. Physical and chemical properties (such as water content, puncture 
strength and in vitro release) and product stability were determined. The 
bioactivity of the film products against HIV was assessed using the TZM-bl assay 
and a cervical explant model.
RESULTS: Polymers identified from the solid phase solubility study maintained 
tenofovir and maraviroc in an amorphous state and prevented drug 
crystallization. Three combination film products were developed using cellulose 
polymers and polyvinyl alcohol. The residual water content in all films was <10% 
(w/w). All films delivered the active agents with release of >50% of film drug 
content within 30 min. Stability testing confirmed that the combination film 
products were stable for 12 months at ambient temperature and 6 months under 
stressed conditions. Antiviral activity was confirmed in TZM-bl and cervical 
explant models.
CONCLUSIONS: Polymeric films can be used as a stable dosage form for the 
delivery of antiretroviral combinations as microbicides.