In Vitro Permeation Test (IVPT) for Pharmacokinetic Assessment of Topical Dermatological Formulations

Santos, Leandro L.; Swofford, Nathaniel J.; Santiago, Brandon G.

doi:10.1002/cpph.79

Cited by 17 publications

(5 citation statements)

References 45 publications

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“…The FDA recommends that IVPT receptor medium sample analysis procedures should be validated in a manner compatible with the current FDA Guidance for Industry on Bioanalytical Method Validation and follows the product‐specific guidance for certain topical products such as Acyclovir cream 13 . Sponsors also note that validation of MS/MS‐based analytical methods for IVPT studies could maximize data quality 14 . In the current study, both methods for the IVPT experiments, using PBS buffer in the first instance and 4% BSA in PBS buffer in the second instance as receptor media, were both fully validated for the following validation parameters: specificity, accuracy, precision, sensitivity, reproducibility and stability 15 .…”

Section: Methodsmentioning

confidence: 82%

“…13 Sponsors also note that validation of MS/MS-based analytical methods for IVPT studies could maximize data quality. 14 In the current study, both methods for the IVPT experiments, using PBS buffer in the first instance and 4% BSA in PBS buffer in the second instance as receptor media, were both fully validated for the following validation parameters: specificity, accuracy, precision, sensitivity, reproducibility and stability. 15 The matrix effects for each analyte and IS were measured quantitatively using a matrix factor which was defined as the ratio of the analyte peak area of the post-processed samples versus the analyte peak area of pure or neat standards.…”

Section: Methods Validationmentioning

confidence: 99%

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An advanced automation platform coupled with mass spectrometry for investigating in vitro human skin permeation of UV filters and excipients in sunscreen products

Zhang

Yang

Ashraf

et al. 2022

Rapid Comm Mass Spectrometry

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Rationale Systemic absorption of UV‐filtering chemicals following topical application of sunscreens may present a safety concern. The Food and Drug Administration (FDA) had recommended an in vitro skin permeation test (IVPT) to evaluate the potential of this safety risk for the evaluation of sunscreens prior to clinical studies. Therefore, a sensitive and robust bioanalytical method(s) were required for IVPT studies of different topical sunscreen products. Methods An analytical procedure to quantitate sunscreen UV‐filtering components and excipients in IVPT samples including avobenzone, octocrylene, oxybenzone, ecamsule, methylparaben and propylparaben was developed employing a RapidFire 360 robotic sample delivery system coupled with a triple quadrupole mass spectrometer. The analytical procedure was developed and validated according to the requirements of the FDA Bioanalytical Method Validation Guidance for Industry (2018). Results The analytical method provided a turnaround time of 12 seconds per sample and was determined to be accurate, precise, specific, and linear over the corresponding analytical ranges. The validated method was successfully applied for two IVPT studies for evaluating the skin permeation potential of UV‐filtering chemicals and assisting with the selection of the sunscreen products for the clinical study conducted by the FDA. Conclusions This work highlights the first analytical procedure that has applied a non‐chromatographic‐MS/MS automation platform to an in vitro biopharmaceutics study. The analytical platform simultaneously quantitated four UV filters and two excipients in complex media to evaluate their permeation in IVPT studies. The sample throughput and analytical performance of advanced automation platforms indicate their analytical procedure has the potential to significantly advance the efficiency of IVPT studies to evaluate permeation of a wide variety of UV chemical filters and excipients for topical OTC sunscreen products.

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Section: Methodsmentioning

confidence: 82%

Section: Methods Validationmentioning

confidence: 99%

An advanced automation platform coupled with mass spectrometry for investigating in vitro human skin permeation of UV filters and excipients in sunscreen products

Zhang

Yang

Ashraf

et al. 2022

Rapid Comm Mass Spectrometry

View full text Add to dashboard Cite

show abstract

“…lipophilicity range) (Choi et al 2019). Dermal absorption may be characterised using the In Vitro Permeation Test (IVPT) that uses ex-vivo human skin or pig skin (Santos et al 2020). If needed, additional kinetic processes, such as transporter-mediated influx or efflux in the intestine, liver and kidney are included in the model structure.…”

Section: Important Input Parametersmentioning

confidence: 99%

Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment

et al. 2022

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With an increasing need to incorporate new approach methodologies (NAMs) in chemical risk assessment and the concomitant need to phase out animal testing, the interpretation of in vitro assay readouts for quantitative hazard characterisation becomes more important. Physiologically based kinetic (PBK) models, which simulate the fate of chemicals in tissues of the body, play an essential role in extrapolating in vitro effect concentrations to in vivo bioequivalent exposures. As PBK-based testing approaches evolve, it will become essential to standardise PBK modelling approaches towards a consensus approach that can be used in quantitative in vitro-to-in vivo extrapolation (QIVIVE) studies for regulatory chemical risk assessment based on in vitro assays. Based on results of an ECETOC expert workshop, steps are recommended that can improve regulatory adoption: (1) define context and implementation, taking into consideration model complexity for building fit-for-purpose PBK models, (2) harmonise physiological input parameters and their distribution and define criteria for quality chemical-specific parameters, especially in the absence of in vivo data, (3) apply Good Modelling Practices (GMP) to achieve transparency and design a stepwise approach for PBK model development for risk assessors, (4) evaluate model predictions using alternatives to in vivo PK data including read-across approaches, (5) use case studies to facilitate discussions between modellers and regulators of chemical risk assessment. Proof-of-concepts of generic PBK modelling approaches are published in the scientific literature at an increasing rate. Working on the previously proposed steps is, therefore, needed to gain confidence in PBK modelling approaches for regulatory use.

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“…According to reports, APTT, PT and TT are widely applied in the preliminary detection of coagulation and screening of new drugs, as well as anticoagulant evaluation of biomaterials in vitro [20,30,31]. APTT is a momentous index for endogenous coagulation screening [30,31], and PT is a general indicator of exogenous coagulation pathway [20], while TT stands for extracorporeal plasma thrombin time. All membranes and SCACS were analysed by APTT, PT and TT, and the results are presented in figure 10c.…”

Section: Activated Partial Thromboplastin Time Prothrombin Time and Thrombin Timementioning

confidence: 99%

Preparation of modified polysulfone material decorated by sulfonated citric chitosan for haemodialysis and its haemocompatibility

2021

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Polysulfone (PSF) works potentially in haemodialysis due to its great mechanical and chemical stability, but performs poorly in haemocompatibility. For promoting the unpleasant haemocompatibility, sulfonated citric chitosan (SCACS) with the structure and groups similar to heparin was primarily synthesized by acylation and sulfonation. Furthermore, the chloroacylated PSF was pretreated by electrophilic chloroacetyl chloride to achieve more active sites for further reaction; the following membranes underwent the amination and were named amination polysulfone (AMPSF) membranes. Moreover, SCACS with abundant carboxyl and sulfonic groups was covalently grafted at the surface of pretreated PSF membranes, called PSF-SCACS membranes. The PSF-SCACS membranes were successfully synthesized and characterized by 1 H NMR, ATR-FTIR and XPS. In addition, the water contact angle of PSF-SCACS membranes decreased by 47° and the morphologies of the membranes changed little compared with the unmodified PSF membranes. The haemocompatible testing results, including protein adsorption, platelet adhesion, haemolysis rate, plasma recalcification time, activated partial thromboplastin time (APTT), prothrombin time (PT) and thrombin time (TT), demonstrated that the PSF-SCACS membranes possessed excellent haemocompatible performances, and SCACS played an important role in the modification.

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In Vitro Permeation Test (IVPT) for Pharmacokinetic Assessment of Topical Dermatological Formulations

Abstract: In vitro permeation test Support Protocol: Dermatoming of ex vivo human skin Basic Protocol 2: Bioanalytical methodology in the context of the in vitro permeation test

Cited by 17 publications

References 45 publications

An advanced automation platform coupled with mass spectrometry for investigating in vitro human skin permeation of UV filters and excipients in sunscreen products

An advanced automation platform coupled with mass spectrometry for investigating in vitro human skin permeation of UV filters and excipients in sunscreen products

Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment

Preparation of modified polysulfone material decorated by sulfonated citric chitosan for haemodialysis and its haemocompatibility

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