Table I.
Summary of Characteristics of Prototype Placebo Gel Formulations*
| Formulation ID | Pluronic® F-127 (% w/w) | Noveon® AA-1 (% w/w) | pH at t = 0 | Viscosity at t = 0 (cPs)* | Osmolality at t = 0 (mOsm) | Viscosity in VFS (1:1) (cPs) after 2 h of contact time | Viscosity in VFS and SFS (1:5) (cPs) after 2 h of contact time |
|---|---|---|---|---|---|---|---|
| 15987-16-3 | 0.5 | 0.5 | 5.1 ± 1.5 | 513 ± 3 | 20 ± 1 | Complete dissolution of gel | Complete dissolution of gel |
| 15987-16-1 | 0.9 | 0.5 | 5.3 ± 1.3 | 1,803 ± 10 | 16 ± 2 | Complete dissolution of gel | Complete dissolution of gel |
| 15987-14-1 | 1 | 0.5 | 5.3 ± 2.3 | 1,679 ± 38 | 34 ± 5 | Complete dissolution of gel | Complete dissolution of gel |
| 15987-17-3 | 1.87 | 0.5 | 5.8 ± 1.2 | 1,385 ± 15 | 33 ± 3 | Complete dissolution of gel | Complete dissolution of gel |
| 15987-18-2 | 3.74 | 0.5 | 6.1 ± 3.2 | 1,096 ± 13 | 22 ± 4 | Complete dissolution of gel | Complete dissolution of gel |
| 15987-18-1 | 0.9 | 1 | 5.6 ± 1.7 | 1,563 ± 33 | 13 ± 1 | 616 ± 13 | Complete dissolution of gel |
| 15987-17-1 | 1.87 | 1 | 5.8 ± 3.2 | 1,775 ± 18 | 29 ± 2 | 99 ± 1.52 | Complete dissolution of gel |
| 15987-17-2 | 3.75 | 1 | 6.2 ± 2.7 | 1,351 ± 29 | 29 ± 4 | 298 ± 6 | Complete dissolution of gel |
| 15987-15-1 | 15 | 1 | 6.4 ± 1.5 | 3,780 ± 17 | 175 ± 8 | 1,094 ± 8 | 321 ± 5 |
| SR-2P | 1 | 1 | 5.7 ± 2.1 | 1,741 ± 21 | 21 ± 3 | 279 ± 2 | 67 ± 4 |
* pH of the simulated fluids: vaginal fluid 4.5, semen fluid 7.7, mixture of vaginal and semen fluids 7.5; concentrations after mixing the two components