A single-dose, three-period, six-sequence crossover study comparing the bioavailability of solution, suspension, and enteric-coated tablets of magnesium valproate in healthy Mexican volunteers under fasting conditions

Marcelín‐Jiménez, Gabriel; Ángeles-Moreno, Alionka P.; Contreras-Zavala, Leticia; Morales-Martínez, Miriam; Rivera-Espinosa, Liliana

doi:10.1016/j.clinthera.2009.09.016

Cited by 9 publications

(4 citation statements)

References 10 publications

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“…This result is in agreement with earlier data described in Bergeron et al (2009) [7], Savoie et al (2009) [8] and Marcelín-Jiménez et al (2009) [9], whereas there is no literature known to us proving the opposite. All in all, we consider these results to be a solid scientific basis to recommend that there is no need to investigate the impact of different counter ions when using the same anticoagulant in the method validation of LC-MS/MS for plasma samples.…”

Section: Resultssupporting

confidence: 95%

“…However, there is a lack of consensus between industry and health authorities concerning the potential need for partial validation in case different counter ions for the same anticoagulant are used, for example changing from lithium heparin to sodium heparin. Previous data have already indicated that changing the counter ion using the same anticoagulant has no impact on the assay performance [7][8][9]. However, these studies were limited in size.…”

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confidence: 89%

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Anticoagulant Counter Ion Impact on Bioanalytical LC–MS/MS Assays: Results from Discussions and Experiments Within The European Bioanalysis Forum

et al. 2011

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Section: Resultssupporting

confidence: 95%

mentioning

confidence: 89%

Anticoagulant Counter Ion Impact on Bioanalytical LC–MS/MS Assays: Results from Discussions and Experiments Within The European Bioanalysis Forum

et al. 2011

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“…Studies comparing solutions with capsules or enteric coated tablet formulations have found comparable Mg absorption for these products. However, increases in serum Mg levels were delayed after the consumption of enteric coated tablets [17,32]. Moreover, the formulation of a Mg supplement can affect urinary Mg excretion.…”

Section: Discussionmentioning

confidence: 99%

Magnesium bioavailability from mineral waters with different mineralization levels in comparison to bread and a supplement

Schneider

Greupner

Hahn

2017

Food & Nutrition Research

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The aim of the present study was to compare the magnesium bioavailability from four mineral waters with different types of mineralization (e.g. SO4 2-, HCO3 −, calcium) with the magnesium bioavailability from bread and from a magnesium supplement. A single-center, randomized, controlled trial with a crossover design with 22 healthy men and women was conducted at the Institute of Food Science and Human Nutrition, Leibniz University Hannover, Germany. The participants consumed the six test products providing 100 mg of magnesium each on six examination days with a one-week washout phase in between. The primary outcome variables were the 24 h urinary magnesium excretion, the 24 h urinary magnesium/creatinine ratio, and the area under the curve of serum magnesium levels for 10 h (AUC0-10h). No significant differences among groups were observed for either 24 h urinary magnesium excretion or 24 h urinary magnesium/creatinine ratio. Likewise, statistical group comparisons of AUC0-10h for serum magnesium levels revealed no significant differences among the treatment groups. Accordingly, given equivalent magnesium availability from all test products, neither SO4 2- content nor the content of HCO3 − or of calcium influenced the bioavailability of magnesium. Thus, mineral water with higher concentrations of magnesium constitutes a calorie-free magnesium source that contributes to optimal magnesium supply.

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“…The AUC represents the integral of drug concentration with respect to time, and it provides valuable information about drug absorption, distribution, metabolism, and elimination. Comparing AUC values is crucial in pharmacology as it helps assess the overall exposure and effectiveness of different drugs or formulations, as comparing drug formulations or dosage regimens, comparing different drugs, assessing drug–drug interactions, predicting therapeutic effects, bioequivalence studies, and pharmacokinetic studies [ 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ].…”

Section: Methodsmentioning

confidence: 99%

The First Physiologically Based Pharmacokinetic (PBPK) Model for an Oral Vaccine Using Alpha-Tocopherol as an Adjuvant

Saldanha,

Vale

2023

Pharmaceutics

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Oral vaccines represent many advantages compared to standard vaccines. They hold a simple method of administration and manufacturing process. In addition to these, the way they can induce immune responses makes these a promising technology for the pharmaceutical industry and represents a new hope to society. Physiologically based pharmacokinetics (PBPK) has been used in support of drug development to predict the pharmacokinetics of the compound, considering the patient’s physiology. Despite PBPK studies now being widely used, there are very few models in the literature that support vaccine development. Therefore, the goal of this article was to determine how PBPK could support vaccine development. The first PBPK model for an oral vaccine using alpha-tocopherol as a vaccine adjuvant was built. LogP is the parameter that influences the delivery of alpha-tocopherol into the tissues more. Having a high LogP means it accumulates in adipose tissue and is slowly metabolized. The ideal formulation to include alpha-tocopherol in an oral vaccine would incorporate nanoparticles in a capsule, and the dosage of the compound would be 150 mg in a volume of 200 mL. This article aims to determine if alpha-tocopherol, as a well-known adjuvant for intramuscular injection vaccines, could be used as an adjuvant to oral vaccines. This model was built considering the conditions and requirements needed for designing an oral vaccine. This implies making sure the antigen and adjuvants reach the main target by overcoming the challenges of the gastrointestinal tract. The main parameters that would need to be included in a formulation using alpha-tocopherol as an adjuvant were determined.

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A single-dose, three-period, six-sequence crossover study comparing the bioavailability of solution, suspension, and enteric-coated tablets of magnesium valproate in healthy Mexican volunteers under fasting conditions

Cited by 9 publications

References 10 publications

Anticoagulant Counter Ion Impact on Bioanalytical LC–MS/MS Assays: Results from Discussions and Experiments Within The European Bioanalysis Forum

Anticoagulant Counter Ion Impact on Bioanalytical LC–MS/MS Assays: Results from Discussions and Experiments Within The European Bioanalysis Forum

Magnesium bioavailability from mineral waters with different mineralization levels in comparison to bread and a supplement

The First Physiologically Based Pharmacokinetic (PBPK) Model for an Oral Vaccine Using Alpha-Tocopherol as an Adjuvant

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