Lactose in tablets 2016

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). 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. In this research a method for distinction of tablets with and without lactose based on their FTIR spectra has been developed. Experiments were performed on Furazidin which is a medicine used to treat acute and chronic urinary tract infections and in long-term prevention of the recurrence of these pathological states. The tablets are produced by various companies which use lactose or saccharose as a one of the excipients. The choice of this pharmaceutical was imposed by the fact that plenty of patients taking this drug complained on symptoms related to lactose intolerance even if they selected lactose-free pills (according to patients’ leaflet information).

Materials and methods 120 Furazidin tablets (60 with and 60 without lactose) were analysed at ISMI beamline in ATR mode using PIKE MIRacle device (single reflection ZnSe crystal). Spectra were collected by MCT detector within the range of 4000-520 cm^-1 and with 4 cm^-1 spectral resolution.

Results Studies performed, proved the fact that FTIR spectroscopy combined with proper statistical analysis – in our case Principal Component Analysis could be used as unique tool for differentiation the medications containing the same API (active pharmaceutical ingredient) but different carbohydrates (lactose or saccharose) used to form the tablets.