Terconazole composition and method

摘要

An aqueous terconazole composition comprises at least about 0.4 percent by weight of terconazole dissolved in water, and a terconazole crystallization-inhibiting amount of an organic acid. Preferably the organic acid is a water soluble alkyl carboxylic acid, a polybasic organic acid, or a combination thereof. The composition is free from terconazole crystals at an ambient temperature of about 20° C. Methods of preparing the composition are also described. The compositions provide for improved therapeutic release of terconazole.

主权项

1. An aqueous terconazole composition consisting of water; at least about 0.4 percent by weight and up to about 3 percent by weight of terconazole dissolved in the water; about 50 to about 150 mole percent of an organic acid based on the number of moles of terconazole dissolved in the composition; a physiologically tolerable preservative; and optionally one or more physiologically acceptable excipients selected from the group consisting of a thickener, a surfactant, a colorant, a fragrance, a water soluble co-solvent and a water miscible co-solvent;
the composition being free from terconazole crystals at an ambient temperature of about 20° C.; and wherein the organic acid is at least one acid selected from the group consisting of acetic acid, citric acid, tartaric acid, and malic acid.