Pharmaceutical tablets consist of an Active Pharmaceutical Ingredient (API) with excipients including fillers, binders, and lubricants. In tablet manufacturing, blending is the process where APIs and various excipients are blended together to form a homogenous mixture. The blending process control is very important for final tablet quality, and yet blending process control can still be very challenging when it comes to detection or characterization of raw material variations and final blend homogeneity. The USFDA guidance on pharmaceutical manufacturing process control indicates that each batch incorporated into a blend should meet established purity specifications when involving APIs; also, blending validation should show homogeneity of the blended batch for dry blended APIs.
In this study, Raman spectroscopy, along with chemometrics, was used to establish the analytical method to quantify the API Naltrexone HCI in blended powder mixtures as well as in the final product 3mg tablets.
Quantitative analysis of APIs in blending mixtures and tablets