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Cincinnati, OH, United States

Ausio Pharmaceuticals LLC | Date: 2012-08-13

A house mark for a full line of pharmaceuticals and pharmaceutcial preparations; dietary supplements; dietary suuplements for use as food ingredients.

Ausio Pharmaceuticals LLC | Date: 2012-08-13

A house mark for a full line of pharmaceuticals and pharmaceutcial preparations.

Ausio Pharmaceuticals Llc | Date: 2015-10-14

An anhydrous crystalline form of S-equol has been discovered. Form I, the anhydrous crystalline form of S-equol has been isolated and characterized for the first time. As compared to other forms of S-equol, such as the known hydrate or other solvate forms, the anhydrous crystalline form of S-equol has improved properties.

Schwen R.,Ausio Pharmaceuticals LLC | Jackson R.,Ausio Pharmaceuticals LLC | Proudlock R.,Charles River Laboratories
Food and Chemical Toxicology | Year: 2010

Intervention studies in man have shown that dietary soy isoflavones may provide certain health benefits. One of the possible reasons for this benefit is that the daidzein contained in soy is converted to S-equol. As part of a drug development program for S-equol, three genotoxicity studies were conducted. The studies comprised bacterial mutation, chromosomal aberration, and in vivo bone marrow micronucleus tests conducted according to Good Laboratory Practices (GLP). No evidence of genotoxic activity was observed in the in vitro tests at concentrations up to those associated with cell toxicity. In addition, no evidence of cytotoxicity or genotoxicity was seen in the rat bone marrow micronucleus test in animals dosed at levels up to the standard limit of 2000. mg/kg. It is concluded that S-equol is not active in the standard battery of genotoxicity assays recommended by the International Conference on Harmonisation (ICH) for registration of new pharmaceuticals. The current results support the further development of S-equol. © 2010 Elsevier Ltd.

Schwen R.J.,Ausio Pharmaceuticals LLC | Nguyen L.,Charles River Laboratories | Plomley J.B.,Charles River Laboratories | Jackson R.L.,Ausio Pharmaceuticals LLC
Food and Chemical Toxicology | Year: 2012

S-equol is a natural product that is produced by the microbial biotransformation of daidzein, an isoflavone found in soy. Evidence suggests that the health benefits of soy may be related to one's ability to produce S-equol, thus S-equol is being developed for the treatment of vasomotor symptoms in postmenopausal women. The toxicokinetics of S-equol were evaluated in Sprague-Dawley rats and cynomolgus monkeys; S-equol was rapidly absorbed with C max occurring between 0.5h and 1.0h in the rat and 3h in the monkey. AUC was linear over the doses tested with no differences between male and female animals. Conjugated S-equol was the major metabolite in plasma with less than 1% present as the unconjugated form. S-equol showed a weak induction of liver cytochrome P450s in vivo, and did not significantly inhibit the major human cytochrome P450s in vitro. S-equol was highly protein bound (>95%) in rat, monkey and man in a concentration-independent manner. Orally administered S-equol did not significantly change uterine weight or morphology in either the rat or monkey even at the highest doses tested. These studies show that S-equol has pharmacokinetic parameters suitable for drug development with a low potential for uterotropic effects. © 2012 Elsevier Ltd.

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