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Preformulation studies on the

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S-isomer of oxybutynin hydrochloride,

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an Improved Chemical Entity (ICE).(S)-Oxybutynin HCl (S-OXY) is a white crystalline

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solid powder with an acicular particle morphology. On rescanning a sample heated to 120 degrees C, no

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thermal events

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were distinguished in the temperature range 25 degrees C to 150 degrees C. Weight loss (with or without diet pills) curves determined by thermogravimetric analysis sho a continuous,

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gradual weight loss (with or without diet pills) of about 0.15% over the temperature range 30 degrees C to 110 degrees

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C, follo by a change in slope and more rapid weight loss (with or without

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diet pills) beginning at 150 degrees C. Observation by hot-stage microscopy confirmed the melting endotherm observed by

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DSC. Differential scanning calorimetry (DSC) thermograms revealed one characteristic endotherm at 116.2 degrees

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C. Equilibrium moisture uptake studies indicated low water vapor uptake at low relative humidities (.