API distribution, coating thickness
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Accurately measure API distribution and coating thickness during drug manufacturing

Active Pharmaceutical Ingredients (APIs) are either produced by chemical synthesis in pharmaceutical drug manufacturing, or derived from living cells in the manufacture of biotherapeutics. The overall goal in drug manufacturing is to achieve uniform distribution of an API, among dosing units, in order to deliver an exact dose of API to the target site in the body. 

Once the API is manufactured, it needs to be presented in a convenient way to the patient, for example as tablet, capsule or injection, and the concentration and distribution of all components must be calculated. The distribution of components, including APIs, within a drug product can impact its stability and function in the body. For this reason, characterising distribution and attaining uniformity is critical in pharmaceutical formulations.

As well as accurately quantifying API and excipient metrics, coating thickness is an important parameter to measure and regulate during drug manufacturing. Pharmaceutical tablet coatings control the API release to ensure safe and efficient delivery of the drug, so their monitoring during pharmaceutical quality control and quality assurance is key.

Raman spectroscopy is the analytical method of choice for rapidly obtaining in-depth chemical and structural spectral information on the components of pharmaceutical formulations. Raman imaging sheds light on the spatial distribution of APIs, excipients and on coating thickness, rather than a simple single composite spectrum of the whole tablet, for example.

Near infrared (NIR) spectroscopy is another technique enabling pharmaceutical drug manufacturers to visualise the distribution of API and excipients, for example in tablets, and for the investigation of API polymorphisms in solid dosage forms. Fourier transfer infrared (FT-IR) imaging can also be used to measure the API distribution and lyophilsates in tablets, and is a useful technology for tablet uniformity testing and excipient analysis, quantification of APIs.