• Title/Summary/Keyword: Dissolution profiles

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Bioequivalence of Famvir Tablet 750 mg to Famcivir Tablet 750 mg (Famciclovir 750 mg) (팜비어 정 750밀리그람(팜시클로버 750밀리그람)에 대한 팜시버 정 750밀리그람의 생물학적동등성)

  • Kim, Se-Mi;Yoon, Hwa;Yoo, Hee-Doo;Kim, Kyung-Ran;Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.38 no.3
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    • pp.199-205
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    • 2008
  • Famciclovir, 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine, is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, Famvir tablet 750 mg (Novartis Korea Ltd.) and Famcivir tablet 750 mg (Hanmi Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $23.38{\pm}1.72$ years in age and $68.59{\pm}7.84\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 750 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations ere similar at water. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{(R)}$ tablet 750 mg, were -0.53%, 1.12% and -24.82% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log\;0.9569{\sim}log\;1.0423$ and $log\;0.8763{\sim}log\;1.2136$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir tablet 750 mg was bioequivalent to Famvir tablet 750 mg.

Phosphorus Phases in the Surface Sediment of the South Sea (남해 표층 퇴적물에서의 인의 존재상)

  • SON Jaekyung;LEE Tongsup;YANG Han Soeb
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.32 no.5
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    • pp.680-687
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    • 1999
  • To understand the role of shelf sediment in phosphorus biogeochemical cycle, we carried out sequential sediment extraction (SEDEX) of P and porewater analysis on 14 core samples collected in the South Sea of Korea, SEDEX classified P-pools into 5 phases and results are grouped into two categories: reactive P (loosely sorbed-P and Fe bound-P) and refractory P (detrital inorganic-p, authigenic mineral-P and organic-P). Total P concentrations are decreased with sediment depth in all samples as a result of dissolution to porewater. Reactive P comprises about $20\~50\%$ of total P, and iron bound-P is the major form consisting $70\~80\%$ of reactive P-pool. Iron bound-P decreases sharply with depth. Depth profiles of dissolved P concentration in porewater show mirror image of iron bound-P, revealing the role of FeOOH as a regulator of reactive P supply to overlying water column. Authigenic mineral-P consists less than $5\%$ of total P, thus removal of reactive P by converting into refractory P seems inefficient in shelf sediment. This implies that continental shelf sediment sequesters P temporarily rather than permanently. Results show local variation. Nakdong estuary receiving large amount of terrigenous input shows the highest concentration of total P and reactive P. Here iron oxyhydroxides at the surface sediment control the water column flux of P from sediment. Although total P content at the surface is comparable (500$\~$600 ${\mu}g{\cdot}g^{-1}$) between the South Sea and East China Sea, the former contains more iron bound-P and less derital inorganic-P than the latter. Reasons for the difference seem due in part to particle texture, and to biological productivity which depends roughly on the distance from land.

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