• Korean Journal of Clinical Pharmacy
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• v.19 no.1
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• pp.23-31
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• 2009

The aim of this study was to evaluate the pharmacokinetic parameters of two risedronate preparations. The clinical assessment was conducted on 46 healthy volunteers who received one tablet (Risedronate sodium 35 mg/tablet) in the fasting state, in a randomized balanced $2{\times}2$ cross-over study design. After dosing of one tablet containing 35 mg risedronate sodium, blood samples were collected serially for a period of 48 hours. Plasma was analyzed for risedronate by using LC/MS/MS assay method. The analysis system was validated in specificity, accuracy, precision, and linearity. $AUC_t$, (the area under the plasma concentration-time curve from the zero-time to 48 hr) was calculated through the trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) were compiled from the plasma risedronate concentration-time data of each volunteer. No significant sequence effect was found for the pharmacokinetic parameters indicating that the cross-over design was properly performed. The 90 % - Confidence intervals of the $AUC_t$ ratio and the $C_{max}$ were from log 0.8752 to log 1.1888 and log 0.8457 to log 1.1478, respectively. These values were within the acceptable intervals between 0.80 and 1.25. Therefore, this study demonstrated that no statistically significant difference was identified with respect to the rate and extent of absorption.

• Journal of the Korean Society for Precision Engineering
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• v.25 no.5
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• pp.148-154
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• 2008

Pharmacotherapy was mainly used to treat osteoporosis. However, some researches showed that pharmacotherapy could induce unexpected adverse effects. Some studies showed that whole body vibration affected beneficially osteoporosis. This paper studied the effect of whole body vibration fur osteoporosis compared with the effect of pharmacotherapy. 10 female rats were used and allocated into 4 group, CON, SHAM, DRUG, and WBV. Rats except SHAM group were ovariectomised to induce osteoporosis. Rats in WBV group were stimulated in whole body vibration at magnitude of $1mm_{peak-peak}$ and frequency 45Hz, for 8 weeks (30 min/day, 5 days/week). Rat in DRGU group was orally administered the Actonel (0.58mg/Kg), for 8 weeks (5days/week). The $4^{th}$ lumbar in rats were scanned at a resolution of $35{\mu}m$ at baseline, before stimulation, and 8 weeks after stimulation by In-vivo micro computed tomography. For detecting and tracking changes of biomechanical characteristics (morphological and mechanical characteristics) in lumbar trabecuar bone of rats, structural parameters were measured and calculated from acquiring images and finite element analysis was performed. In the results, loss of quantity and change of structure of trabecular bone in WBV group were smaller than those in both CON and SHAM groups. In addition, mechanical strength in WBV group was stronger than that in both CON and SHAM groups. In contrast, biomechanical characteristics in WBV group were similar with those in DRUG group. These results showed that reasonable whole body vibration was likely to treat osteoporosis and be substituted partly for drug treatment.