Table 2.

Final Composition of Prototype Combination Vaginal Gels Containing SPL7013 Dendrimer

Ingredients			Prototype 1 Vaginal Gel (% w/w)	Prototype 2 Vaginal Gel (%w/w)
Purified Water			q.s. to 100%	q.s. to 100%
Methyl Paraben NF			0.18	0.18
Propyl Paraben NF			0.02	0.02
EDTA Disodium USP			0.15	0.15
Carbopol 974P NF			6.2	6.2
Lactic Acid USP			0.6	None
Acetic Acid USP			0.087	None
2N KOH NF			q.s. to pH 3.7	q.s. to pH 3.7
SPL7013 Dendrimer			3.0	3.0
Characterization (n = 3.5 batches)
pH			3.7 ± 0.08	3.7 ± 0.03
Viscosity			9484 ± 1344 cP	8245 ± 1693 cP
Buffering Capacity			0.31 ± 0.02 mEq/g	0.28 ± 0.01 mEq/g
Osmolality			202 ± 13 mOsm/kg	102 ± 4 mOsm/kg