Development and validation of a method for the analysis of hydroxyzine hydrochloride in extracellular solution used in in vitro preclinical safety studies

2015 ◽  
Vol 115 ◽  
pp. 69-73 ◽  
Author(s):  
Willy Briône ◽  
Mari Brekelmans ◽  
Freek van Eijndhoven ◽  
Eric Schenkel ◽  
Theo Noij
Keyword(s):  
Extracellular Solution ◽  
Safety Studies ◽  
Development And Validation ◽  
Preclinical Safety

scholarly journals Development and validation of an in vitro model system to study peripheral sensory neuron development and injury

2018 ◽  
Vol 8 (1) ◽  
Author(s):  
Iwan Jones ◽  
Tushar Devanand Yelhekar ◽  
Rebecca Wiberg ◽  
Paul J. Kingham ◽  
Staffan Johansson ◽  
...  
Keyword(s):  
Sensory Neuron ◽  
In Vitro Model ◽  
Model System ◽  
Neuron Development ◽  
In Vitro Model System ◽  
Vitro Model ◽  
Development And Validation ◽  
Peripheral Sensory

Development and validation of an in vitro release method for topical particulate delivery systems

2015 ◽  
Vol 485 (1-2) ◽  
pp. 202-214 ◽  
Author(s):  
Maja Lusina Kregar ◽  
Marjana Dürrigl ◽  
Andrea Rožman ◽  
Želimir Jelčić ◽  
Biserka Cetina-Čižmek ◽  
...  
Keyword(s):  
In Vitro Release ◽  
Delivery Systems ◽  
Particulate Delivery ◽  
Development And Validation ◽  
Release Method ◽  
Vitro Release

scholarly journals Development and Validation of an Eco-friendly HPLC-UV-DAD Method for the Determination of Allopurinol in Pharmaceuticals with Application to In vitro Dissolution Studies

2021 ◽  
Vol 11 (5) ◽  
pp. 13089-13101
Keyword(s):  
Factorial Design ◽  
Matrix Effects ◽  
Dissolution Kinetics ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Dissolution Studies ◽  
Dissolution Tests ◽  
Development And Validation

In this study, a sustainable HPLC-UV-DAD method was developed and validated for the determination of allopurinol in tablets and optimization of the dissolution test using factorial design. The separation of the analyte from the sample matrix was achieved in 3.01 minutes in a C8 column (4.6 mm X 150 mm X 5 μm), using mobile phase 0.1 mol L-1 HCl (25%) + ethanol (50%) + ultrapure water (25%) by UV detection at 249 nm. The method presented satisfactory analytical parameters of validation (specificity, selectivity, linearity, stability, precision, accuracy, and robustness), showing no matrix effects. The dissolution test was optimized by complete factorial design 23 and, the optimal conditions were: HCl 0.001 mol L-1, apparatus II (paddle) and 75 rpm. The analytical procedures and dissolution tests were applied to allopurinol tablets marketed in Bahia, Brazil, to evaluate the dissolution studies. The pharmaceuticals had similar dissolution profiles and first-order dissolution kinetics. This new and sustainable HPLC-UV-DAD method is friendly to the environment and can be used for the routine pharmaceutical analysis of allopurinol in fixed dosage forms.

scholarly journals Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2

Diagnostics ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 206
Author(s):  
Chiara E. Ghezzi ◽  
Devon R. Hartigan ◽  
Justin P. Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Medical Devices ◽  
Clinical Studies ◽  
Cost Effective ◽  
Care Providers ◽  
Nasal Tissue ◽  
Significant Difference ◽  
Injection Molded ◽  
Development And Validation

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

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