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DiscovIR-GPC™ Solutions for Pharmaceutical Excipient Analysis

DiscovIR-GPC™ Solutions for Pharmaceutical Excipient Analysis

Excipients are substances added to pharmaceuticals, alongside the active pharmaceutical ingredients (APIs) that play a key role in pharmaceutical formulation and drug delivery.

Excipients have multiple functions, and whilst they can simply function as diluents, carriers and bulking agents, they are also used to confer therapeutic enhancement of the API in the final dosage form (facilitating drug absorption, targeting delivery, enhancing solubility or as a sustained release agent) and are critical for drug efficacy. Excipients also have a key role in drug stability, shelf-life and modulating migration of impurities from the packaging/delivery system into the formulation.
Polymeric excipients such as copovidone (PVP/VA64), are heavily used in formulation, and can serve various functions (e.g., matrix formers, binding agents, or sustained release agents) when added to APIs.

Excipient function is largely dependent on the specific physical properties of the excipient, which are, in turn, determined by its microstructure. Therefore, proper formulation requires that excipient microstructure be exact, and carefully monitored to ensure quality control, safety, and drug stability.

DiscovIR-GPC™ provides valuable insights into the excipient structural/physical properties for the development of novel drug carriers. The enhanced structural information, over the entire MW distribution, enables R&D scientists in pharmaceutical development and formulation groups to gain additional knowledge of excipient/formulation and opens new approaches for the monitoring of possible degradation during scale-up and manufacturing to create safe process windows.  DiscovIR-GPC™ is also a valuable tool for QA/QC groups, who can use the GPC-FTIR as a control tool for routine monitoring of drug formulations, and excipient consistency by checking compositional variations over the molecular weight distribution.

Learn how to upgrade your excipients characterisation with DiscovIR-GPC™

email: enquiries@spectrometrics.com

Description

DiscovIR-GPC™ Solutions for Pharmaceutical Excipient Analysis

New GPC-IR Analysis of Polymeric Excipients in Pharmaceutical Formulations (AppNote031)

Variability Of Polymeric Excipients and Its Effect On Drug Delivery Performance (AppNote033)

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