ABSTRACT
TFV 1% gel is composed of hydroxyethylcellulose (HEC) as a thickening agent, methylparaben and propylparaben as preservatives, glycerin as a humectant, sodium edetate as a chelating agent, and citric acid as a buffering agent. TFV is present at 1% (w/w) [4]. The manufacturing of this gel is a two-part process. The first is the compounding of the gel, which is followed by filling into the desired package, either a single-dose plastic applicator manufactured by HTI Plastics (Lincoln, NE, USA) or a tube typical of that used for semi-solid drug products. Tubes require the utilization of a user-filled vaginal applicator as discussed below.
