Molecularly Imprinted Polymers for Pharmaceutical Impurities: Design and Synthesis Methods

Abstract

The safety of a medicinal product is determined by its pharmacological and toxicological profile, which depends not only on the active substance’s toxicological properties, but also on the impurities it contains. Because impurities are a problem that must be considered to ensure the safety of a drug product, many studies have been conducted regarding the separation or purification of active pharmaceutical ingredients (APIs) and the determination of impurities in APIs and drug products. Several studies have applied molecularly imprinted polymers (MIPs) to separate impurities in active ingredients and as adsorbents in the sample preparation process. This review presents the design of MIPs and the methods used to synthesise MIPs to separate impurities in APIs and drug product samples, the application of MIPs to separate impurities, and a view of future studies involving MIPs to remove impurities from pharmaceutical products. Based on a comparison of the bulk and surface-imprinting polymerisation methods, the MIPs produced by the surface-imprinting polymerisation method have a higher adsorption capacity and faster adsorption kinetics than the MIPs produced by the bulk polymerisation method. However, the application of MIPs in the analysis of APIs and drug products are currently only related to organic compounds. Considering the advantages of MIPs to separate impurities, MIPs for other impurities still need to be developed, including multi-template MIPs for simultaneous separation of multiple impurities.

Current advances in molecularly imprinted polymers and their release mechanisms in drug delivery systems

“…MIP‐based polymers have a wide range of applications in the medicinal field via gene delivery, tissue engineering, 87,88 biosensors, 89‐93 drug carriers, drug separation/enrichment or drug sensing, 86 used in cardiac diagnostics, autoimmune illnesses, and pathogenic microbial infections, 93 inhibit antimicrobial infections, 88 anticancer for example (Mg‐SMSNs/ DOX‐Ce6 @MIPs), 89 MOF@MIP 92 . These are also used for non‐steroidal anti‐inflammatory drug removal, 94‐96 and to recognize toxic drugs such as dipicolinic acid, 97 sarafloxacin, ciprofloxacin, 98 penicillin acid, 99 mycotoxins 100 and quetiapine 101 . Furthermore, the utilization of MIP in the development of in vitro diagnostics (IVD) offers numerous advantages, including their versatility, fast response, precise identification capabilities, simplified development process, and enhanced stability of the bioassays 93 .…”

Synthesis of a Multi-Template Molecular Imprinted Bulk Polymer for the Adsorption of Non-Steroidal Inflammatory and Antiretroviral Drugs

“…While these studies have made significant contributions to the field, challenges such as template leakage, polymerization heterogeneity, and scalability limitations still exist. Recent advancements, including the development of novel functional monomers [27,28] and the integration of advanced characterization techniques, offer promising solutions to address these challenges and pave the way for the widespread application of MIPs in pharmaceutical formulations and drug delivery systems.…”