Pharmaceutical Formulation

Formulation is a major component in the efficacy of a drug. Formulation involves the preparation/mixture of an active pharmaceutical ingredient in/with a physical carrier (i.e., a tablet, spray, inhaler, or syrup) to insure adequate efficacy, delivery, and stability. Heavily used in formulation, polymeric excipients such as copovidone (PVP/VA64) can serve various functions when added to API such as matrix former, binding agent or sustained release agent.

For each excipient, the function is largely dependent on the specific physical properties of the excipient, which are, in turn, determined by excipient microstructure. Therefore, proper formulation requires that excipient microstructure be exact and carefully monitored to ensure quality control, safety, and drug stability.  The hyphenation of liquid chromatography (GPC) and Infrared Spectroscopy (FTIR) can provide pharmaceutical development and formulation groups valuable insight into the excipient structural/physical properties for the development of novel drug carriers. By coupling an infrared detector to a GPC separation system, scientists will gain structural information over the entire MW distribution of the studied excipient/formulation. Additionally, a GPC-FTIR such as the DiscovIR-GPC allows for easy monitoring of possible degradation during scale-up and manufacturing process to create safe process windows.  Further downstream, QA/QC groups can also use the GPC-FTIR as a control tool for routine monitoring of drug formulations and monitor excipient consistency by checking compositional variations over the molecular weight distribution.