Combination of ELISA and dried blood spot technique for the quantification of large molecules using exenatide as a model

Lin, Yong-Qing; Khetarpal, Risha; Zhang, Yilu; Song, Hengchang; Li, Shawn S.

doi:10.1016/j.vascn.2011.04.004

Cited by 19 publications

(9 citation statements)

References 17 publications

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“…To date, a wide range of assay techniques, including high-performance liquid chromatography–tandem mass spectrometry (HPLC–MS/MS), − HPLC with UV , and fluorescence detection, , gas chromatography (GC)/MS, enzyme-linked immunosorbent assay (ELISA), polarization immunoassay, and radio-immunoassay, have been extensively applied in TDM. Among these methods, HPLC–MS/MS is preferable due to its high specificity, sensitivity, and precision in quantitative analysis of therapeutic drugs in DBS, whereas this method requires tedious and time-consuming sample extraction and chromatographic separation prior to MS analysis. ,, The recent appearance and development of ambient ionization technique , have greatly promoted the TDM in DBS with highly simplified procedures and acceptable sensitivity. , After interfacing this technique to MS/MS instruments, rapid identification and quantitative analysis of therapeutic drugs can be achieved in a few minutes or even less, and direct MS analysis offers a promising future for high-throughput analysis of therapeutic drugs.…”

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confidence: 99%

Development and Application of Zirconia Coated Paper Substrate for High Sensitivity Analysis of Therapeutic Drugs in Dried Blood Spots

et al. 2016

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Paper spray mass spectrometry has been demonstrated to be promising for direct analysis of therapeutic drugs in dried blood spots (DBS); however, the strong hydrogen bond and van de Waals interactions between paper substrate and analytes containing polar functional groups (e.g., therapeutic drugs) affect greatly the elution behavior and analysis sensitivity of compounds of interest during paper spray. Herein, we developed a one-sided ZrO2 coated paper substrate through a facile vacuum filtration approach using commercial ZrO2 particles as coating material and soluble starch as adhesive agent. Owing to the unique surface properties, as-prepared ZrO2 paper substrate has been shown to have excellent performance for analysis of therapeutic drugs in DBS during paper spray mass spectrometry. In contrast to original cellulose paper substrates, improvements of 43-189-fold in lower limit of quantitation (LLOQ) were obtained for the tested drugs using ZrO2 coated paper for paper spray. In comparing with the previously reported grade SG81 paper and one-sided silica coated paper, the LLOQs of the tested drugs with as-prepared ZrO2 paper decreased 1.5-16.5-fold relative to those from the above two, revealing that ZrO2 coated paper is a good candidate for paper spray in high sensitivity analysis of therapeutic drugs in DBS.

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confidence: 99%

Development and Application of Zirconia Coated Paper Substrate for High Sensitivity Analysis of Therapeutic Drugs in Dried Blood Spots

et al. 2016

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“…For better consolidation of incretins' analytical quantification through ELISA, Table 2 briefly displays ELISA settings and protocol conditions for biological matrices and API formulation matrices [[43], [44], [45], [46], [47], [48], [49], [50], [51], [52], [53], [54]].…”

Section: Quantification Techniquesmentioning

confidence: 99%

Comparison of ELISA and HPLC-MS methods for the determination of exenatide in biological and biotechnology-based formulation matrices

Pinho

Fortuna

Falcão

et al. 2019

Journal of Pharmaceutical Analysis

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The development of biotechnology-based active pharmaceutical ingredients, such as GLP-1 analogs, brought changes in type 2 diabetes treatment options. For better therapeutic efficiency, these active pharmaceutical ingredients require appropriate administration, without the development of adverse effects or toxicity. Therefore, it is required to develop several quantification methods for GLP-1 analogs products, in order to achieve the therapeutic goals, among which ELISA and HPLC arise. These methods are developed, optimized and validated in order to determine GLP-1 analogs, not only in final formulation of the active pharmaceutical ingredient, but also during preclinical and clinical trials assessment. This review highlights the role of ELISA and HPLC methods that have been used during the assessment for GLP-1 analogs, especially for exenatide.

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“…After injection, blood samples were collected using ice-cold tubes containing anticoagulant (heparin solution, 5000 U/mL) at predetermined time points. All the blood samples were rapidly centrifuged at 3500 rpm for 15 min and 100 μL of plasma was analyzed using an Exendin-4 EIA kit (EK-070-94, Phoenix pharmaceuticals, USA) (23).…”

Section: Pharmacokineticsmentioning

confidence: 99%

Formation Mechanism, In vitro and In vivo Evaluation of Dimpled Exenatide Loaded PLGA Microparticles Prepared by Ultra-Fine Particle Processing System

et al. 2019

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Spherical poly (D, L-lactic-co-glycolic acid) microparticles (PLGA-MPs) have long been investigated in order to achieve sustained delivery of proteins/peptides. However, the formation mechanism and release characteristics of the specific shape MPs were still unknown. This study aimed to develop a novel-dimpled exenatide-loaded PLGA-MPs (Exe-PLGA-MPs) using an ultra-fine particle processing system (UPPS) and investigate the formation mechanism and release characteristics. Exe-PLGA-MPs were prepared by UPPS and optimized based on their initial burst within the first 24 h and drug release profiles. Physicochemical properties of Exe-PLGA-MPs, including morphology, particle size, and structural integrity of Exe extracted from Exe-PLGA-MPs, were evaluated. Furthermore, pharmacokinetic studies of the optimal formulation were conducted in Sprague-Dawley (SD) rats to establish in vitro-in vivo correlations (IVIVC) of drug release. Exe-PLGA-MPs with dimpled shapes and uniform particle sizes achieved a high encapsulation efficiency (EE%, 91.50 ± 2.65%) and sustained drug release for 2 months in vitro with reduced initial burst (20.42 ± 1.64%). Moreover, the pharmacokinetic studies revealed that effective drug concentration could be maintained for 3 weeks following a single injection of dimpled Exe-PLGA-MPs with high IVIVC. Dimpled PLGA-MPs prepared using the UPPS technique could thus have great potential for sustained delivery of macromolecular proteins/peptides.

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Combination of ELISA and dried blood spot technique for the quantification of large molecules using exenatide as a model

Cited by 19 publications

References 17 publications

Development and Application of Zirconia Coated Paper Substrate for High Sensitivity Analysis of Therapeutic Drugs in Dried Blood Spots

Development and Application of Zirconia Coated Paper Substrate for High Sensitivity Analysis of Therapeutic Drugs in Dried Blood Spots

Comparison of ELISA and HPLC-MS methods for the determination of exenatide in biological and biotechnology-based formulation matrices

Formation Mechanism, In vitro and In vivo Evaluation of Dimpled Exenatide Loaded PLGA Microparticles Prepared by Ultra-Fine Particle Processing System

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