Assessment of NIR spectroscopy for nondestructive analysis of physical and chemical attributes of sulfamethazine bolus dosage forms

Abstract

The goal of this study was to assess the utility of near infrared (NIR) spectroscopy for the determination of content uniformity, tablet crushing strength (tablet hardness), and dissolution rate in sulfamethazine veterinary bolus dosage forms. A formulation containing sulfamethazine, corn starch, and magnesium stearate was employed. The formulations were wet granulated with a 10% (wt/vol) starch paste in a high shear granulator and dried at 60 degrees C in a convection tray dryer. The tablets were compressed on a Stokes B2 rotary tablet press running at 30 rpm. Each sample was scanned in reflectance mode in the wavelengths of the NIR region. Principal component analysis (PCA) of the NIR tablet spectra and the neat raw materials indicated that the scores of the first 2 principal components were highly correlated with the chemical and physical attributes. Based on the PCA model, the significant wavelengths for sulfamethazine are 1514, (1660-1694), 2000, 2050, 2150, 2175, 2225, and 2275 nm; for corn starch are 1974, 2100, and 2325 nm; and for magnesium stearate are 2325 and 2375 nm. In addition, the loadings show large negative peaks around the water band regions ( approximately 1420 and 1940 nm), indicating that the partial least squares (PLS) models could be affected by product water content. A simple linear regression model was able to predict content uniformity with a correlation coefficient of 0.986 at 1656 nm; the use of a PLS regression model, with 3 factors, had an r (2) of 0.9496 and a standard error of calibration of 0.0316. The PLS validation set had an r (2) of 0.9662 and a standard error of 0.0354. PLS calibration models, based on tablet absorbance data, could successfully predict tablet crushing strength and dissolution in spite of varying active pharmaceutical ingredient (API) levels. Prediction plots based on these PLS models yielded correlation coefficients of 0.84 and 0.92 on independent validation sets for crushing strength and Q(120) (percentage dissolved in 120 minutes), respectively.

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

“…The content uniformity dataset also showed the highest correlation coefficients and lowest SEC and SEP values. Therefore, it appears that NIRS is superior at predicting chemical properties (e.g., CU) over physical (e.g., compression force or crushing force); these findings are consistent with other research (22). A paired t test showed that there was no significant difference (p>0.05) between the laboratory results and predicted NIR values for content uniformity of theophylline tablets (p=0.44).…”

“…NIRS has also been successfully used in a variety of other analytical chemistry applications such as the detection of degradation products in tablets (7); studying drug moisture content over time and water mobility within the drug crystal lattice (8,9); real-time monitoring of moisture during processing using fluidized bed granulation (10,11) or roller compaction (12), measurement of particle size, and size distribution (13)(14)(15); and determining the tablet drug content and content uniformity (16)(17)(18)(19)(20)(21)(22)(23).…”

“…While there are several articles discussing NIRS prediction of crushing force using tablets produced from homogenous powders or granules (17,22,(26)(27)(28)(29)(30), to our knowledge, no work to date has examined NIRS to study multiparticulate tableted systems; i.e., the unique complexities that multiparticulate tablets pose to the accurate prediction of content uniformity and crushing force has not been adequately studied. These complexities include variability in light scattering effects, baseline shifts due to particle size differences, and the drug content of the different beads present.…”

Retrieving the Bioenergy Potential from Maize Crops Using Hyperspectral Remote Sensing

“…Recently, Mayer et al [14] suggested near infrared spectroscopy (NIRS) as an alternative technique to determine the BMP FM . NIRS is widely used in feed and food quality monitoring [19][20][21][22][23][24][25][26] and is accepted since many years as routine method for determining forage quality parameters of various crops. In the bioenergy sector NIRS has been applied to estimate sulphur content in biodiesel [27], for predicting digestibility of maize silage [28][29][30] and fermentation parameters of silages [31], and for the assessment of in situ degradability parameters of crude protein and dry matter characteristics [32,33].…”

Development of a Rapid Process Monitoring Method for Dry-Coated Tableting Process by Using Near-Infrared Spectroscopy

“…Because of its rapidity and nondestructiveness, near-infrared (NIR) spectroscopy is extensively used as a PAT tool to monitor CQAs. For example, during the tableting process, it can be used to monitor tablet hardness, 2,3) tablet porosity, 3) active pharmaceutical ingredient (API) content, 2,[4][5][6] disintegration time, 7) API release rate, 2,8) and pseudo-polymorphs change of API. 9) NIR chemical imaging is also used to examine the distribution of ingredients 10) and the density profile 3,11) on tablet surfaces.…”