Curatek Pharmaceuticals Holding, Inc.

National Medical Supply, LLC

James E Juul

Robert J Borgman

A composition having gel-like consistency contains metronidazole, terconazole, a physiologically acceptable thickener and water. The composition is useful for treating bacterial vaginosis as well as vulvovaginal candidiasis.

Vaginal gel

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 citric acid. The composition is free from terconazole crystals at an ambient temperature of about 20&#xb0; C. Methods of preparing the composition are also described. The compositions provide for improved therapeutic release of terconazole.

Terconazole composition and method

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&#xb0; C. Methods of preparing the composition are also described. The compositions provide for improved therapeutic release of terconazole.

An aqueous nitroimidazole composition comprises metronidazole, tinidazole or a combination thereof at a concentration greater than the solubility of the free base form of the nitroimidazole in water at 20&#xb0; C., and a nitroimidazole crystallization-inhibiting amount of at least one organic acid. The organic acid preferably is a lower alkyl carboxylic acid (e.g., acetic acid), a polybasic acid (e.g., citric acid, tartaric acid, malic acid, polyacrylic acid, and the like), or a combination thereof. The composition can further include a thickening agent, to form a gel. The composition is free from organic co-solvents, water-soluble vitamins, and cyclodextrins; and free from nitroimidazole crystals at an ambient temperature of about 20&#xb0; C. Methods of preparing the composition are also described.

Nitroimidazole composition and method

A pharmaceutical composition having a gel consistency at room temperature and suitable for the treatment of a vaginal infection comprises, on a total composition weight basis, about 0.1 to about 3 weight percent of benzydamine hydrochloride, about 16 to about 35 weight percent of a polyoxyalkylene block copolymer, and about 2 to about 30 weight percent of propylene glycol, in water having a pH value in the range of about 3.5 to about 7. The weight ratio of water to polyoxyalkylene block copolymer in the composition is less than about 4:1. Optionally, the gel compositions can also contain glycerin, physiologically tolerable preservatives and buffers, as well as other pharmaceutically acceptable excipients.

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Wauconda, IL, United States of America

James E Juul