No abstract

The diverse range of opportunities offered by ISEs has been broadly used in a number of pharmaceutical applications, with topics presented ranging from bioanalysis of drugs and metabolites, to green chemical analysis, impurity profiling, and drugs' dissolution in biorelevant media. Attractively, solid-contact ISEs (SC-ISEs) have been implemented in many approaches due to their ability to offer stable and miniaturizable sensors. In this contribution, gold SC-ISEs were used in bare and thiol-doped forms for the analysis of the two co-formulated drugs namely, naproxen sodium and diphenhydramine hydrochloride in tablets. The unique ability of thiol to form a hydrophobic self-assembled monolayer on gold surface, resulted in more sensitive, stable, and drift-free potentiometric signals. The special advantages offered by the gold-thiol electrodes empowered us to utilize them as real-time analyzers to investigate the protein-binding behavior of the studied drugs by continuous in-situ monitoring of the drug in presence of serum albumin. The proposed sensors could offer a prediction of the pharmacokinetics of each component drug, giving the healthcare professionals the opportunity to provide a personalized medicine for the patients according to their different protein-binding characteristics.

Conventional pharmaceutical manufacturing is generally accomplished via batch processing followed by laboratory testing conducted on some representative samples collected to evaluate batch quality. However, today significant opportunities exist for improving pharmaceutical quality assurance through innovation in process development and analysis. FDA's guidance for pharmaceutical industry has defined Process Analytical Technology (PAT) as a system for designing, analyzing, and controlling manufacturing through timely measurements, with the goal of ensuring final product quality. Nevertheless, pharmaceutical companies are encouraged to develop and implement innovative PAT tools for designing, analyzing, and controlling manufacturing through real-time strategies (i.e., during processing) of critical quality attributes of raw and final product. The goal of PAT is that quality cannot be tested into products; it should be built-in or should be by design. Furthermore, FDA stated that sensor-based measurements could pave the way to built-in product quality assurance which is the key to PAT development. From this perspective, this scientific approach presents screen-printed ISEs (SPEs) as a potential real-time analyzer and PAT-tool. Diatrizoate sodium (DTA) was chosen as a model analyte, it is a widely used X-ray contrast agent that is susceptible to degradation into a cytotoxic and mutagenic compound, that can be also used as its precursor. Two SPEs were fabricated and used successfully in the analysis of both DTA and its potential impurity. The proposed SPEs have the advantage of being real-time analyzers that could be fully integrated into the production cycle giving a key to a promising competent PAT-tool.

No abstract

No abstract