Quality by design, part I: application of NIR spectroscopy to monitor tablet manufacturing process.
To monitor tableting production using near infrared (NIR) spectroscopy, chemometric models were developed to analyze peak compression force, crushing strength and content uniformity. To measure tablet content uniformity, orbifloxacin tablets with drug content ranging from 60 to 90 mg were made and analyzed using ultraviolet (UV) and NIR spectroscopy. To assess the compression force and crushing strength, several batches of tablets were made on a Stokes B2 rotary tablet press and compression force was varied from 360 to 3500 lb. Principal component analysis (PCA) was used to identify tablets with regular and capped tablets breakage patterns. Comparison of statistical parameters showed that partial least squares (PLS) models gave better fit than the multiple linear regression (MLR) models. The best fit PLS models had a standard error of calibration (SEC) and a standard error of prediction (SEP) for content uniformity of 1.13 and 1.36 mg; for compression force of 69.86 and 59.48 lb and for crushing strength 0.55 kP and 0.57 kP, respectively. NIR spectroscopy in combination with multivariate modeling is a rapid and nondestructive technique that could reliably predict content uniformity, compression force and crushing strength for orbifloxacin tablets.
Tabasi
Simin Hassannejad
SH
School of Pharmacy, University of Maryland, 20 N Pine Street, Baltimore, Maryland 21201, USA.
Fahmy
Raafat
R
Bensley
Dennis
D
O'Brien
Charles
C
Hoag
Stephen W
SW
D000900:Anti-Bacterial Agents; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002939:Ciprofloxacin / Q000031:analogs & derivatives; D005240:Feasibility Studies; D008422:Materials Testing; D015999:Multivariate Analysis; D011786:Quality Control; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets
D000900:Anti-Bacterial Agents; D013607:Tablets; D002939:Ciprofloxacin; C095163:orbifloxacin