Phenobarbitone Population Pharmacokinetics from Routine Clinical Data: Role of Patient Characteristics for Estimating Dosing Regimens

Yukawa, Eiji; Higuchi, Shun; Aoyama, Toshinobu

doi:10.1111/j.2042-7158.1992.tb05514.x

Cited by 26 publications

(28 citation statements)

References 15 publications

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“…These results suggest that Ccr is a useful indicator of renal function in the prediction of Css, as indicated in previous reports [10,11].…”

Section: Discussionsupporting

confidence: 89%

“…of a Japanese population, similar to the present study, and reported that the precision of their method was superior to other methods [11]. Because they reported the precision of their predicted Css and dosage of lithium, there may be a discrepancy in the precision of predicted Li-CL between their and the present studies.…”

Section: Citationsupporting

confidence: 72%

“…Although Yukawa et al reported a prediction equation for Li-CL based on population pharmacokinetic analysis of Japanese subjects [11], there have been few reports comparing the precision of these prediction equations within the Japanese population.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Calculation of Lithium Clearance for Clinical use Based on Renal Excretion in Japanese Patients

Motoki¹,

Fukuoka²,

Yamaguchi³

et al. 2016

Int J Clin Pharmacol Pharmacother

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Background: It is recommended to adjust the dosage of lithium carbonate, primarily used in the treatment of mania, based on the serum lithium concentration at steady-state (Css). It has been suggested that factors associated with renal function should be included in the estimation of lithium clearance (Li-CL) due to its elimination via renal excretion. In the present study, parameters affecting Li-CL were investigated in Japanese patients. Methods: Retrospective analysis was performed in patients who had chronically received lithium carbonate, by stepwise regression analysis, with Li-CL as the dependent variable and gender, age, weight and creatinine clearance (Ccr) as independent variables. Ccr was calculated using the Cockcroft-Gault equation, and Li-CL was calculated as the reciprocal value of Css per daily dose. Results: Seventy-two patients were enrolled in this study. Regression analysis revealed that only Ccr was an independent variable (P<0.001), and the following equation was obtained: Li-CL (mL/min) = 0.161 × Ccr (mL/min) + 6.47. This equation was then validated by comparison with previously reported methods using a separate population of patients. The bias and precision of the equation's predictions were evaluated by calculating the mean prediction error, mean absolute error and root mean squared prediction error. Although the Jermain method had the least bias, no significant differences were observed between the present and Jermain methods. Conclusion: Because the equation of the present study includes Ccr as a parameter of renal function, this may better provide appropriate dosing and safety of lithium therapy in Japanese patients.

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“…These results suggest that Ccr is a useful indicator of renal function in the prediction of Css, as indicated in previous reports [10,11].…”

Section: Discussionsupporting

confidence: 89%

Section: Citationsupporting

confidence: 72%

See 1 more Smart Citation

Calculation of Lithium Clearance for Clinical use Based on Renal Excretion in Japanese Patients

Motoki¹,

Fukuoka²,

Yamaguchi³

et al. 2016

Int J Clin Pharmacol Pharmacother

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show abstract

“…The values for clearance determined in the present study are comparable with those previously determined using both traditional [5,7,8] and NONMEM [2] methods. The final model describing clearance included total body weight, the parameter which was also the most important fixed effect parameter, ahead of age, in the large Japanese study [2].…”

Section: Discussionsupporting

confidence: 78%

Determination of phenobarbitone population clearance values for South African children

Botha

Gray

Miller

1995

Eur J Clin Pharmacol

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Non-liner Mixed Effects Modelling (NON-MEM) was used to estimate phenobarbitone population clearance values for South African children, using 52 serum levels gathered from 32 patients during their routine care. NONMEM was also used to evaluate the influence of fixed effects such as weight, age and concomitant medication. The final model describing phenobarbitone clearance was CL = [Exp(0.0288 Wt - 2.53)]M, where CL clearance (l x h(-1)), Exp = the base of the natural logarithm, Wt = patient weight (kg) and M = a scaling factor for concomitant medication with a value of 1 for patients on phenobarbitone monotherapy, 0.62 for those receiving concomitant valproate and 0.87 for those patients receiving concomitant carbamazepine or phenytoin. Mean (95% confidence interval) phenobarbitone clearance values were 7.6 ml x h(-1) x kg(-1) (6.2, 9.0 ml x h(-1) x kg(-1) for the monotherapy group, 5.0 ml x h(-1) x hg(-1) (4.0, 6.0 ml x h(-1) x kg(-1)) in the presence of concomitant valproate and 6.8 ml x h(-1) x kg(-1) (5.6, 8.0 ml x h(-1) x kg(-1)) in the presence of concomitant carbamazepine or phenytoin. These values are similar to those previously reported from both traditional and NONMEM pharmacokinetic studies.

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“…Studies have shown that the pharmacokinetics of PB in children and young adults is age-dependent, and may have an absolute bioavailability of 48.9% among the pediatric population (Yukawa, Higuchi, Aoyama, 1992;Marsot et al, 2013). In addition, comparing oral administration with the intramuscular route, there is a difference of about 60% in terms of bioavailability in newborns (Yukawa et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

Phenobarbital loaded microemulsion: development, kinetic release and quality control

Figueiredo

Neves

Silva

et al. 2016

Braz. J. Pharm. Sci.

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This study aimed to obtain and characterize a microemulsion (ME) containing phenobarbital (PB). The PB was incorporated in the proportion of 5% and 10% in a microemulsion system containing Labrasol ® , ethanol, isopropyl myristate and purified water. The physicochemical characterization was performed and the primary stability of the ME was evaluated. An analytical method was developed using spectrophotometry in UV λ = 242 nm. The kinetics of the in vitro release (Franz model) of the ME and the emulsion (EM) containing PB was evaluated. The incorporation of PB into ME at concentrations of 5 and 10% did not change pH and resistance to centrifugation. There was an increase in particle size, a decrease of conductivity and a change in the refractive index in relation to placebo ME. The ME remained stable in preliminary stability tests. The analytical method proved to be specific, linear, precise, accurate and robust. Regarding the kinetics of the in vitro release, ME obtained an in vitro release profile greater than the EM containing PB. Thus, the obtained ME has a potential for future transdermal application, being able to compose a drug delivery system for the treatment of epilepsy.Uniterms: Microemulsion/physicochemical characterization. Microemulsion/In vitro release. Phenobarbital/microemulsion system/evaluation. Nanotechnology.O objetivo deste trabalho foi obter e caracterizar uma microemulsão (ME) contendo fenobarbital (FEN). O FEN foi incorporado na proporção de 5% e 10% em um sistema microemulsionado composto por labrasol ® , etanol, miristato de isopropila e água purificada. Foi realizada a caracterização físico-química e avaliada a estabilidade preliminar da ME. Desenvolveu-se um método analítico por espectrofotometria em UV λ = 242 nm. Foi avaliada a cinética de liberação in vitro (em modelo de Franz) da ME e da emulsão (EM) contendo FEN. A incorporação do FEN em ME nas concentrações de 5 e 10% não alterou o pH e a resistência à centrifugação. Houve aumento do tamanho da partícula, redução da condutividade e alteração do índice de refração em relação à ME placebo. A ME manteve-se estável nos ensaios de estabilidade preliminar. O método analítico demonstrou ser específico, linear, preciso, exato e robusto. Na cinética de liberação in vitro, a ME obteve um perfil de liberação in vitro superior a EM contendo FEN. Desta forma, a ME obtida tem potencial para uma futura aplicação transdérmica, podendo compor um sistema de liberação de fármacos para tratamento da epilepsia.Uniterms: Microemulsão/caracterização físico-química. Microemulsão/cinética de liberação in vitro. Fenobarbital/sistema microemulsionado/avaliação. Nanotecnologia.

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Phenobarbitone Population Pharmacokinetics from Routine Clinical Data: Role of Patient Characteristics for Estimating Dosing Regimens

Cited by 26 publications

References 15 publications

Calculation of Lithium Clearance for Clinical use Based on Renal Excretion in Japanese Patients

Calculation of Lithium Clearance for Clinical use Based on Renal Excretion in Japanese Patients

Determination of phenobarbitone population clearance values for South African children

Phenobarbital loaded microemulsion: development, kinetic release and quality control

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