A Drug Stability Study Using Surface-Enhanced Raman Scattering on Silver Nanoparticles

Hulya Yilmaz,Mustafa Culha

doi:10.3390/app12041807

Abstract

Pharmaceutical product quality is of vital importance for patient safety. Impurities and potential degradation products can cause changes in chemistry, pharmacological and toxicological properties by having a significant impact on product quality and safety. Stress-testing (forced degradation) studies of pharmaceutical preparations became necessary to assure degradation mechanisms and potential degradation products. Consequently, it is crucial to understand the nature of possible degradation products. Surface-enhanced Raman spectroscopy (SERS) is a powerful vibrational spectroscopic technique that can provide valuable information about changes in a molecular structure with its intrinsic finger-print property. In this study, a forced degradation study was conducted on pemetrexed (PMT), an antifolate chemotherapy drug, in order to identify its likely chemical degradation products. The degradation mechanism of PMT was investigated under various experimental conditions; basic (0.1 M NaOH), acidic (0.1 M HCl), and oxidative (3% H2O2v/v). We used silver nanoparticles (AgNPs) of average size 60 nm as SERS substrates. The study shows that SERS can be a fast and reliable technique to study the stability and possible degradation mechanisms of drugs under several different conditions.

Highlights

Drug safety and effectiveness are important concerns due to potential adverse effects through their degradation products on patient health and the environment [1,2]
Excipients used to prepare the pharmaceutical form of a drug and/or inappropriate environmental conditions can promote the degradation of a drug substance [2]
Spectra of aofmolecule be very different depending on the nature of reader,Raman we provide a comparison average can intensity-normalized and baseline-corrected the interaction of a molecule with the substrate surface

Summary

Introduction

Drug safety and effectiveness are important concerns due to potential adverse effects through their degradation products on patient health and the environment [1,2]. Investigation of possible molecular changes in a drug molecule over time without interference from excipients, impurities, and degradation products (DPs) is required [3]. Excipients used to prepare the pharmaceutical form of a drug and/or inappropriate environmental conditions can promote the degradation of a drug substance [2]. The impurities and potential DPs may cause changes in chemistry, and the pharmacological and toxicological properties of drugs having significant impact on product quality and safety [5,6]. The risk factors are associated with the nature of a substance such as degradability, toxicity of a compound, exposure duration, toxicity of

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Conclusion