• Title, Summary, Keyword: Domperidone

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Renal Action of Domperidone in Dog (돔페이돈의 신장작용)

  • 고석태;최홍석
    • YAKHAK HOEJI
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    • v.37 no.6
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    • pp.561-570
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    • 1993
  • Renal action of domperidone known as dopamine receptor blocker and effect of domperidone on renal function of dopamine were investigated in dog. Domperidone, when administered into vein, produced diuretic action by the improvement of renal hemodynamic state, when given into a renal artery, elicited diuretic action accompanied with natriuresis in only experimental kidney, whereas domperidone given into carotid artery exhibited antidiuretic action by the decrease of Na$^{+}$ excretion in urine. Diuretic action of dopamine was not influenced by domperidone given into vein or into a renal artery, was blocked by domperidone given into carotid artery. Above results suggest that domperidone produced both peripheral diuretic and central antidiuretic action, and domperidone do not block diuretic action by renal hemodynamic improvement of dopamine in kidney.

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Bioequivalence Study of Toriem® Tablet to Motilium-M® Tablet (Domperidone Maleate 12.72 mg) Evaluated by Liquid Chromatography/Tandem Mass Spectrometry

  • Ryu, Ju-Hee;Choi, Sang-Jun;Lee, Myung-Jae;Lee, Jin-Sung;Kang, Jong-Min;Tak, Sung-Kwon;Seo, Ji-Hyung;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.1
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    • pp.65-71
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    • 2009
  • The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium-$M^{(R)}$ Tablet (Janssen Korea Ltd., reference product) and $Toriem^{(R)}$ Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on $C_{18}$ reverse-phase column using an isocratic elution. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z $426.1{\rightarrow}119.1$ and the m/z $837.4{\rightarrow}158.2$ transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from $0.05{\sim}50$ ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ($2{\times}12.72\;mg$ domperidone maleate) in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. $AUC_{0-t}$ (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were within acceptable range of log 0.8 to log 1.25 (e.g., $log\;0.92{\sim}log\;1.05$ for $AUC_{0-t}$, $log\;0.81{\sim}log\;1.05$ for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that $Toriem^{(R)}$ tablet is bioequivalent to Motilium-$M^{(R)}$ tablet.

Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Korean Volunteers

  • Kim, Sung-Chull;Lee, Jun-Woo;Yoo, An-Na;Chang, Hyun-Sung;Lee, Kyung-Hee;Park, Jong-Min;Nam, Doo-Hyun
    • Biomolecules & Therapeutics
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    • v.11 no.2
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    • pp.145-150
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    • 2003
  • The bioequivalence of two tablet formulations of 12.72mg domperidone maleate (Sinil "$Perinal^{\circledR}$" tablets vs. Janssen Korea "Motilium-$M^{\circledR}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at spccified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{\rightarrow}48},\; C_{max},\;T_{max}$ and $t_{1/2}$ were determined from plasma concentration-time profile of two formulations. Any significant statistical differences were not observed between these two formulations. On the evaluation of bioequivalence according to Korea Food and Drug Administration Guideline, 90% confidence limits after logmithmic transformation fell within the acceptable range (log 0.8∼log 1.25). Based on these data, it can be concluded that two domperidone maleate tablets showed comparable pharmacokinetic profiles, which means that the Sinil "$Perinal^{\circledR}$" tablet is bioequivalent to the Janssen Korea ""Motilium-M$^{\circledR}$".

Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Human Volunteers

  • Lee, Jun-Woo;Kim, Sung-Chull;Yoo, An-Na;Chang, Hyun-Sung;Lee, Kyung-Hee;Park, Jong-Min;Nam, Doo-Hyun
    • Proceedings of the PSK Conference
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    • pp.307.2-308
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    • 2003
  • The bioequivalence of two 12.72 mg domperidone maleate tablets (Sinil “perinal$\^$ⓡ/” tablets vs. Janssen Korea “Motirium-M$\^$ⓡ/” tablets) was assessed in healthy volunteers after oral administration of two tablets in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for domperidone base using a validated HPLC method. (omitted)

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Role of Dopamine upon Spontaneous Contraction of Isolated Rat Uterus in Diestrus State (Dopamine이 흰쥐 자궁의 자발적 수축에 미치는 영향)

  • Park, Hyoung-Jin;Sim, Yeo-Rim;Jo, Yang-Hyeok
    • The Korean journal of physiology & pharmacology
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    • v.17 no.2
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    • pp.103-107
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    • 1983
  • This experiment was undertaken to see whether dopamine has any effect on a uterine function and whether the uterus has a dopamine receptor. We used 14 female rats in the diestrus state which was identified by a vaginal smear. Under ether anesthesia, 3 pieces(1 cm length) from each side of the uterus were dissected out and mounted in 3 tissue chambers (4 cm diameter, 10 cm height) that contained Krebs-Ringer solution. The solution was continuously aerated with 95% $O_2$ containing 5% $CO_2$ and kept $37^{\circ}C$ consistantly during the whole experimental period. The spontaneous contractile activity of the isolated uterus was recorded using a force transducer. After a recovery period of 15 min in the chamber, the following experiments were carried out. In 7 rats, each piece of the uterus was received dopamine at concentrations of $10^{-4}$, $10^{-5}$ or $10^{-6}\;M$ for 10 min and then followed by domperidone at a concentration of $10^{-5}\;M$. In another 7 rats, each piece was received domperidone, a specific peripheral dopamine receptor antagonist, was administered at a concentration of $10^{-5}\;M$ for 5 min prior to dopamine at concentrations of $10^{-4}$, $10^{-5}$, or $10^{-6}\;M$. Dopamine inhibited the spontaneous uterine contraction dose-dependently (r=0.99, p<.01). The inhibited contractility by dopomine was significantly (P<.05) resumed by post-treatment of domperidone. Pre-treatment of domperidone also blocked significantly(p<.05) the inhibitory effect of dopamine. It is concluded from these results that dopamine has inhibitory role upon the spontaneous uterine contraction of the rat in the diestrus state and domperidone antagonized the inhibitory effect of dopamine. These results suggest strongly that dopamine may exert the inhibitory effect via the dopamine receptor in the rat uterus.

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Effects of Domperidone, Scopolamine Butylbromide and Cimetidine on Absorption and Bioavailability of Ciprofloxacin in Rats (랫트에 있어서 시프로플록사신의 흡수와 생체이용율에 미치는 돔페리돈, 스코폴라민부틸브로마이드 및 시메티딘의 영향)

  • Yim, Hye-Suk;Park, Gee-Bae;Lee, Do-Ike;Lee, Kwang-Pyo
    • Journal of Pharmaceutical Investigation
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    • v.22 no.2
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    • pp.125-131
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    • 1992
  • The effects of domperidone, scopolamine butylbromide and cimetidine on the absorption and bioavailability of ciprofloxacin were studied in female rats. Ciprofloxacin was given in a single oral dose of 30 mg/kg to control group. Ciprofloxacin was concurrently administered with domperidone $(T_1\;group)$, scopolamine butylbromide $(T_2\;group)$, and cimetidine $(T_3\;group)$ to rats, respectively. Significantly changed pharmacokinetic parameters observed in $T_2$group when compared with control group were first-order absorption rate constant, $Ka(4.43{\pm}0.85$\;versus\;2.86{\pm}0.41\;hr^{-1},\;p<0.05)$, time needed to reach peak concentration, $T_{max}\;(32.27{\pm}2.46\;versus\;51.75{\pm}5.51\;min,\;p<0.05)$, area under the plasma concentration-time curve, AUC $(332{\pm}19\;versus\;477{\pm}27\;{\mu}g{\cdot}min/ml,\;p<0.05)$ and absolute bioavailability, Fabs $(60.6{\pm}3.6\;versus\;87.0{\pm}5.0%,\;p<0.05)$. On the other hand, domperidone and cimetidine did not significantly affect the absorption of ciprofloxacin. It is suggested that when scopolamine butylbromide is selected for clinical use, there is need for awareness of the reduction in absorption rate and the enhancement in absorption extent of ciprofloxacin.

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Bioequivalence Assessment of DM Tablet to Motilium-$M^{(R)}$ Tablet (모티리움엠정(말레인산 돔페리돈 12.72 mg)에 대한 디엠정의 생물학적동등성 평가)

  • Cho, Seong-Wan;Kim, Young-Il;Lee, Jong-Oh;Bang, Joon-Seok;Jeong, Ji-Hoon
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.2
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    • pp.106-113
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    • 2008
  • The aim of this study was to evaluate the bioequivalence of two domperidone preparations. Bioequivalence assessment was conducted on 34 healthy volunteers who received two tablets (Domperidone Maleate, 12.72 mg/tablet) in the fasting state, in a randomized balanced $2{\times}2$ cross-over study design. This whole study was performed according to the implementation guidelines of the Korea Food Drug Administration. After dosing of two tablets, blood samples were collected serially for a period of 36 hours. Plasma was analyzed for domperidone 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 36 hr) was calculated through the trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma domperidone concentration-time data of each volunteer. No significant sequence effect was found for the bioavailability 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 0.8007 to log 1.1240 and log 0.8645- log 1.2483, respectively. These values were within the acceptable bioequivalence intervals between 0.80 and 1.25. Therefore, this study demonstrated that two formulations have bioequivalence with respect to the rate and extent of absorption.

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Bioequivalence Assessment of Shinpoong "$\textrm{Dompi}^{?}$" Tablets Containing Domperidone Maleate in Healthy Korean Volunteers

  • Yoo , An-Na;Kim, Sung-Chul;Lee, Kyung-Hee;Park, Jong-Min;Nam, Doo-Hyun
    • Proceedings of the PSK Conference
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    • pp.242.1-242
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    • 2003
  • The bioequivalence of two tablet formulations of 12.72 mg domperidone maleate (Shinpoong "$\textrm{Dompi}^{?}$" tablets vs. Janssen Korea "$\textrm{Dompi}^{?}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{\longrightarrow}48}$, $C_{max}$, $T_{max}$$t\frac{1}{2}$ were determined from plasma concentration-time profile of two formulations. (omitted)

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The Effects of Jungri-tang Gamibang on Carbachol-accelerated Mouse Small Intestinal Transit

  • Kim, Dae-Jun;Byun, Joon-Seok
    • The Journal of Korean Medicine
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    • v.30 no.6
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    • pp.9-16
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    • 2009
  • Objectives: To clarify the effects of Jungri-tang Gamibang on accelerating small intestinal movement induced by the stimulation of cholinergic neurotransmission. Methods: 500, 250 and 125mg Jungri-Tang Gamibang or 20mg domperidone were dissolved or suspended in distilled water and orally pretreated on the carbachol-accelerated small intestinal transit mice once a day for 7 days at a volume of 10ml/kg (of body weight) using a Zonde needle attached to 1 ml syringes containing test drugs. Result: Significantly (p<0.01) increase of % regions of activated charcoal transit in the small intestine was detected in carbachol control compared to that of intact control. However, significant (p<0.01) decreases of % regions of activated charcoal transit were dose-dependently observed in all Jungri-Tang Gamibang extracts or domperidone-pretreated groups. Conclusions: it was concluded that Jungri-tang Gamibang enhancement in the normal intestinal motility and normalization in the accelerated intestinal motility might interfere with a variety of muscarinic, adrenergic and histaminic receptor activities or with the mobilization of calcium ions required for smooth muscle contraction non-specifically.

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Effect of Dopamine on Propagation and Frequency of Slow Wave in Cat Isolated Stomach Muscle (적출한 고양이 위(胃) 근절편에서 서파의 전파 및 발생빈도에 미치는 Dopamine의 영향)

  • Jo, Yang-Hyeok;Sim, Sang-Soo;Kim, Myung-Suk;Kim, Chung-Chin;Choi, Hyun
    • The Korean journal of physiology & pharmacology
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    • v.20 no.1
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    • pp.9-15
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    • 1986
  • The effect of dopamine on the propagation and the frequency electrical activities (slow wave) of the stomach was studied in isolated stomach muscle strips of 145 cats, The gastric slow wave monopolarly recorded by four capillary electrodes (Ag-AgCl) in Krebs-Ringer solution $(ph\;7.4,\;temperature\;36{\pm}0.5^{\circ}C)$ bubbled with 5% $CO_2$ in $O_2$. Dopamine caused concentration-dependent changes of direction of slow wave propagation with decline in development of irregular propagation by domperidone pretreatment. Dopamine also increased the variation of slow wave frequency concentration-dependently. The variation of slow wave frequency induced by dopamine was significantly inhibited by pretreatment with domperidone and phentolamine but not with propranolol, hexamethonium and tetrodotoxin. It is therefore suggested that dopamine plays a role in the genesis of gastric electrical abnormality acting on dopamine receptors and partly on ${\alpha}-adrenergic$ receptors in cats.

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