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KMID : 0369819920220010049
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Jorunal of Korean Pharmaceutical Sciences
1992 Volume.22 No. 1 p.49 ~ p.54
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Preparation of Temazepam Soft Elastic Gelatin Capsule ( Softgel ) and Bioavailability in Rabbits
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박기배/Park GB
정의차/조정기/이광표/Jung EC/Cho JK/Lee KP
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Abstract
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This study was carried out for the purpose of developing an effective temazepam soft elastic gelatin capsule (softgel) which exhibits an excellent bioavailability and of comparing the rate and extent of absorption of temazepam from the marked elixir and prepared softgel using hydrophilic liquid such as polyethylene glycol 400 as a suspending agent by rotary die method. Both softgel and elixir containing 3 mg of temazepam were given to 7 healthy male New Zealand White rabbits in a single oral dose cross-over study. Plasma temazepam concentrations were measured by HPLC. The mean peak concentrations of temazepam following a single oral dosing as softgel and elixir dosage form were 13.84 and 13.25 ng/ml, respectively. And the mean time to peak concentration was 1.29 hr for the softgel and 1.07 hr for the elixir. There was no significant difference in the extent of drug absorption (AUC) for the two different dosage froms (p>0.05). While the softgel exhibited mean lag time of 0.63 hr, the elixir did not show any lag time. Statistical moment parameters such as the mean residence time and variance of the mean residence time did not differ significantly for the two formulations.
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KEYWORD
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temazepam, bioavailability, pharmacokinetics, absorption, soft elastic gelatin capsule
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