Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: In vitro, in vivo and in silico assessments

O’Shea, Joseph P.; Faisal, Waleed; Ruane‐O’Hora, Therese; Devine, Ken J.; Kostewicz, Edmund; O’Driscoll, Caitriona M.; Griffin, Brendan T.

doi:10.1016/j.ejpb.2015.07.014

Cited by 30 publications

(17 citation statements)

References 33 publications

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“…However, preclinical pharmacokinetic study of drugs in animals is one of the primary parts of drug development processes relevant to accurate evaluation for the dosing, pharmacodynamics and toxicity 27 – 29 , which can reduce the risk of clinical trials in humans 30 , 31 . For instance, fenofibrate, nifedipine and sarpogrelate were investigated by food effect in rat, pig and beagle, respectively, which were instead of human 6 , 17 , 32 . In this investigation, the beagle as an animal model were employed to evaluate the correlation between the pharmacokinetic parameters (under fasted or fed treatment) and the food taking patterns in detail, which acquired the reliable data for the pharmacokinetics of food effect in preclinical studies, and provided a vital reference for pharmacokinetic study in human.…”

Section: Discussionmentioning

confidence: 99%

Identification of beagle food taking patterns and protocol for food effects evaluation on bioavailability

Zhang

Wang

et al. 2018

Sci Rep

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Food is a known primary role to the exposure of the drugs orally administered. Since each animal may have unique food taking pattern and it is difficult to manipulate the food taking to animals, there lacks rationalized protocol for the food effects in pre-clinic study. The objective of this study was to identify the beagle food taking patterns and demonstrate their effects on bioavailability in valsartan. Herein, four types of food taking patterns of beagle were identified via inter-day and intra-day analysis, and named as Persisting, Pulsing, Postponing, Pushing (“4P Modes”), respectively, which were also validated by principal component analysis (PCA). Interestingly, food intake resulted in a reduced area under the concentration-time curve (AUC0–12h), maximum concentration (Cmax) and absorption rate, whilst the reduction varied in “4P Modes” of food taking. General considerations in the design of experiment for food effect to the bioavailability in beagles have been established as: to recognize the food taking patterns in each animal, to confirm the inter-day stability of the food taking behaviors, to trace the food taking patterns in parallel with plasma sampling. In conclusion, the right animals with proper food taking patterns should be assessed and selected for pre-clinic bioavailability evaluations.

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Section: Discussionmentioning

confidence: 99%

Identification of beagle food taking patterns and protocol for food effects evaluation on bioavailability

Zhang

Wang

et al. 2018

Sci Rep

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“…Local ethical approval was granted by University College Cork Animal Experimentation Ethics Committee (AEEC). Oral bioavailability studies were conducted as previously described . Briefly, six male Landrace pigs (12.5–16 kg, mean 14.5 kg) were studied.…”

Section: Methodsmentioning

confidence: 99%

Mesoporous silica-based dosage forms improve bioavailability of poorly soluble drugs in pigs: case example fenofibrate

O’Shea

Nagarsekar

Wieber

et al. 2017

Journal of Pharmacy and Pharmacology

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“…35 A p-value < 0.05 was considered significant. [36][37][38][39][40][41][42] Figure 3. Representative HPLC chromatograms after deproteinization of drug-free rat plasma peaks: fenofibric acid (1) (5.9 min) and (2) (7.7 min).…”

Section: Pharmacokinetic and Statistical Analysesmentioning

confidence: 99%

Synthesis and Evaluation of Fenofibric Acid Ester Derivatives: Studies of Different Formulation with Their Bioavailability and Absorption Conditions

Lv¹,

Wang²,

Xiao³

et al. 2020

J. Braz. Chem. Soc.

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A series of fenofibric acid ester pro-drugs (JF-1-7) were synthesized. The pharmacokinetic properties of these pro-drugs were examined after oral administration to rats at a dose of 20 mg kg-1 to evaluate the relative bioavailability in rats. The bioavailability of the ester compounds, JF-1, 2, 3, 4, 5, 6, and 7, was significantly higher than that of fenofibrate. In particular, JF-2 proved to be most promising. The oral administration (20 mg kg-1) of JF-2 showed a relative bioavailability of approximately 272.8% compared to fenofibrate.

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Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: In vitro, in vivo and in silico assessments

Cited by 30 publications

References 33 publications

Identification of beagle food taking patterns and protocol for food effects evaluation on bioavailability

Identification of beagle food taking patterns and protocol for food effects evaluation on bioavailability

Mesoporous silica-based dosage forms improve bioavailability of poorly soluble drugs in pigs: case example fenofibrate

Synthesis and Evaluation of Fenofibric Acid Ester Derivatives: Studies of Different Formulation with Their Bioavailability and Absorption Conditions

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