Is it possible to find presence of lactose in pharmaceuticals? — Preliminary studies by ATR-FTIR spectroscopy and chemometrics

• Distinction among FTIR spectra for tablets with or without lactose is presented.
• Identification of lactose is dependent on the chemometric techniques.
• Second principal component points for differences among TEVA, US Pharmacia and Adamet products.
• Second loading curve reveals some specific features characteristic for lactose.

Lactose and saccharose have the same molecular formula; however, the arrangement of their atoms is different. A major difference between lactose and saccharose with regard to digestion and processing is that it is not uncommon for individuals to be lactose intolerant (around two thirds of the population has a limited ability to digest lactose after infancy), but it is rather unlikely to be saccharose intolerant.The pharmaceutical industry uses lactose and saccharose as inactive ingredients of drugs to help form tablets because of their excellent compressibility properties. Some patients with severe lactose intolerance may experience symptoms of many allergic reactions after taking medicine that contains this substance. People who are specifically “allergic” to lactose (not just lactose intolerant) should not use tablets containing this ingredient.Fourier Transform Infrared (FTIR) spectroscopy has a unique chemical fingerprinting capability and plays a significant important role in the identification and characterization of analyzed samples and hence has been widely used in pharmaceutical science. However, a typical FTIR spectrum collected from tablets contains a myriad of valuable information hidden in a family of tiny peaks. Powerful multivariate spectral data processing can transform FTIR spectroscopy into an ideal tool for high volume, rapid screening and characterization of even minor tablet components.In this paper a method for distinction between FTIR spectra collected for tablets with or without lactose is presented. The results seem to indicate that the success of identifying one component in FTIR spectra collected for pharmaceutical composition (that is tablet) is largely dependent on the choice of the chemometric technique applied.

Described procedure proves that FTIR coupled with chemometric methods is a prevailing technique which can be used when specific analytical topics have to be addressed and non-destructive analysis is needed. Discussed in this paper work can be valuable for people allergic to lactose, as it shows the power of method for finding even the small amount of dangerous from their perspective substance in the tablets what can highly assist in leading the daily lives without unpleasant symptoms.Figure optionsDownload as PowerPoint slide