Simultaneous determination of pradefovir, PMEA and tenofovir in HBV patient serum using liquid chromatography–tandem mass spectrometry and application to phase 2 clinical trial

Xiao, Qingqing; Wang, Dan; Yang, Wanqiu; Chen, Lin; Ding, Yi-Tao; Yang, Jian

doi:10.1016/j.jchromb.2016.04.019

Cited by 7 publications

(5 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…55 Although this observation has complicated the further clinical development of pradefovir, it is reported to be still undergoing phase II clinical development in China for the treatment of HBV. 56 2.2.2. MB07133.…”

Section: Pronucleotide Clinical Candidatesmentioning

confidence: 99%

“…Intriguingly, another open-label clinical study that aimed at comparing the long-term safety profiles of pradefovir and adefovir dipivoxil was terminated due to adverse findings from nonclinical carcinogenicity studies . Although this observation has complicated the further clinical development of pradefovir, it is reported to be still undergoing phase II clinical development in China for the treatment of HBV …”

Section: Pronucleotide Clinical Candidatesmentioning

confidence: 99%

See 1 more Smart Citation

Nucleoside Phosphate and Phosphonate Prodrug Clinical Candidates

et al. 2016

View full text Add to dashboard Cite

Nucleoside monophosphates and monophosphonates have been known for a long time to exert favorable pharmacological effects upon intracellular delivery. However, their development as drug molecules has been hindered by the inherent poor druglike properties of the monophosphate and monophosphonate groups. These include inefficient cellular uptake and poor in vivo stability, with this latter drawback being most relevant to monophosphates than monophosphonates. To address these limitations, numerous monophosphate and monophosphonate prodrug strategies have been developed and applied in the discovery of nucleoside monophosphate and monophosphonate prodrugs that can treat viral infections and cancer. The approval of sofosbuvir, a nucleoside monophosphate prodrug, highlighted the success to be had by employing these prodrug technologies in the discovery of nucleotide therapeutics. In this Miniperspective, we discuss the different key monophosphate and monophosphonate nucleoside prodrugs that entered clinical development, some of which may in the future be approved to treat various human diseases.

show abstract

Section: Pronucleotide Clinical Candidatesmentioning

confidence: 99%

Section: Pronucleotide Clinical Candidatesmentioning

confidence: 99%

Nucleoside Phosphate and Phosphonate Prodrug Clinical Candidates

et al. 2016

View full text Add to dashboard Cite

show abstract

“…[ 126 ]; [ 136 ]; [ 137 ]; [ 152 ]; [ 154 ]; [ 155 ]; [ 156 ]; [ 157 ]; [ 158 ]; [ 159 ]; [ 160 ]; [ 161 ]; [ 162 ]; [ 163 ]; [ 164 ]; [ 165 ]; [ 166 ]; [ 167 ]; [ 168 ].…”

Section: Uncited Referencesunclassified

Detection and quantification of Covid-19 antiviral drugs in biological fluids and tissues

Acquavia

Foti

Pascale

et al. 2021

Talanta

View full text Add to dashboard Cite

Since coronavirus disease 2019 (COVID-19) started as a fast-spreading pandemic, causing a huge number of deaths worldwide, several therapeutic options have been tested to counteract or reduce the clinical symptoms of patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, no specific drugs for COVID-19 but many antiviral agents have been authorised by several national agencies. Most of them are under investigation in both preclinical and clinical trials; however, pharmacokinetic and metabolism studies are needed to identify the most suitable dose to achieve the desired effect on SARS-CoV-2. Therefore, the efforts of the scientific community have focused on the screening of therapies able to counteract the most severe effects of the infection, as well as on the search of sensitive and selective analytical methods for drug detection in biological matrices, both fluids and tissues. In the last decade, many analytical methods have been proposed for the detection and quantification of antiviral compounds currently being tested for COVID-19 treatment. In this review, a critical discussion on the overall analytical procedure is provided, i.e (a) sample pre-treatment and extraction methods such as protein precipitation (PP), solid-phase extraction (SPE), liquid–liquid extraction (LLE), ultrasound-assisted extraction (UAE) and QuEChERS (quick, easy, cheap, effective, rugged and safe), (b) detection and quantification methods such as potentiometry, spectrofluorimetry and mass spectrometry (MS) as well as (c) methods including a preliminary separation step, such as high performance liquid chromatography (HPLC) and capillary electrophoresis (CE) coupled to UV-Vis or MS detection. Further current trends, advantages and disadvantages and prospects of these methods have been discussed, to help the analytical advances in reducing the harm caused by the SARS-CoV-2 virus.

show abstract

“…Several analytical methods for determination of antiretrovirals in multicomponent mixtures using spectrophotometry [5–7], HPLC [8–12], LC‐MS/MS [13–15], HPTLC [16,17] have been reported.…”

Section: Introductionmentioning

confidence: 99%

“…However, these spectrophotometric methods require the application of mathematical expressions and calculations to treat spectra data. Also, most of the aforementioned instrumental methods [8–17] reported for the assay of multicomponent retrovirals are not easily accessed by scientists for routine analysis in developing countries.…”

Section: Introductionmentioning

confidence: 99%

Simple thin layer chromatography–ultraviolet spectrophotometric method for quality assessment of binary fixed‐dose‐combinations of lamivudine/tenofovir disoproxil fumarate and lamivudine/zidovudine in tablet formulations

Vaikosen

Kashimawo

Soyinka

et al. 2020

J of Separation Science

View full text Add to dashboard Cite

Antiretroviral fixed-dose-combination drugs are best assayed with high-performance liquid chromatography, or liquid chromatography-tandem mass spectrometry. However, most scientists in developing nations have no access to these expensive instruments. A more affordable quantitative technique is the use of ultraviolet-visible spectroscopy-where often the absorption spectra of these antiretrovirals are overlapping; thus complex derivative methodologies are required for quantification. A simple, rapid, and accurate thin layer chromatography-ultraviolet spectrophotometric method for the quantification of binary mixtures of lamivudine, zidovudine, and tenofovirdisoproxil-fumarate in tablet formulations was developed. Lamivudine/tenofovirdisoproxil-fumarate and lamivudine/zidovudine were extracted and separated on glass thin-layer chromatography plates. Drugs were identified in ultraviolet light at 254 nm and quantified in acidic medium using ultraviolet spectrophotometry. The retardation factors were 0.43, 0.79, and 0.81 for lamivudine, tenofovir-disoproxilfumarate, and zidovudine, respectively, with corresponding absorption maxima at 270, 260, and 265 nm. Linearity ranged from 1 to 40 µg/mL for all drugs (R = 0.9998-0.9999), while recovery studies were 95.10-102.11% and amount in formulations ranged from 97.99 ± 0.63 to 101.47 ± 2.39%. The paired t-test (n = 5) indicated no significant difference between the proposed and high-performance liquid chromatography methods, hence comparable and can be used as an alternative method in routine quality determination of antiretroviral medicines. K E Y W O R D S

show abstract

Simultaneous determination of pradefovir, PMEA and tenofovir in HBV patient serum using liquid chromatography–tandem mass spectrometry and application to phase 2 clinical trial

Cited by 7 publications

References 13 publications

Nucleoside Phosphate and Phosphonate Prodrug Clinical Candidates

Nucleoside Phosphate and Phosphonate Prodrug Clinical Candidates

Detection and quantification of Covid-19 antiviral drugs in biological fluids and tissues

Simple thin layer chromatography–ultraviolet spectrophotometric method for quality assessment of binary fixed‐dose‐combinations of lamivudine/tenofovir disoproxil fumarate and lamivudine/zidovudine in tablet formulations

Contact Info

Product

Resources

About