Ahmed Shawky Abouzaid
Misr International University, Egypt
Title: Prediction of ibuprofen tablet hardness using a nondestructive near infrared spectroscopy
Biography
Biography: Ahmed Shawky Abouzaid
Abstract
Introduction: Tablet hardness highly affects the tablet quality. A higher hardness would decrease the disintegration time and the effectiveness of the drug. However, a lower hardness would lead to too friable tablets that would not bear the handling required for their packaging. Tablet hardness is usually determined by hardness tester, which is a destructive technique. Therefore, the NIR is currently used as a process analytical technology (PAT) tool to determine the tablet hardness, as it is simple, non-destructive and fast technique widely used in solid dosage manufacturing industry. Changes in the dosage form hardness are seen as sloping spectral baseline shifts in the NIR spectra, in which the absorbance increases as the hardness increases.
Aim: The study aimed to develop and validate NIR reflectance method to determine the ibuprofen tablet hardness. The tablet formulation consisting of ibuprofen (200 mg±5%) as active pharmaceutical ingredient, ludipress, kollidon CL and magnesium stearate were mixed and compressed at varying compression forces (8 kN, 10 kN and 12 kN). Targeted tablet weight was fixed at 350 mg with 10 mm in diameter. Partial least squares (PLS) models for the NIR reflectance spectra was constructed by using calibration laboratory tablets with different hardness values spanning from 12.4 kp to 16.4 kp. The predictive performance of the proposed NIR method was evaluated by traditional chemometric criteria.
Results: The corresponding values for the root mean squared error of calibration (RMSEC), of cross-validation (RMSECV) and of prediction (RMSEP) were equal to 1.81%, 2.51% and 0.99%, respectively.
Conclusion: In conclusion, the proposed NIR method was successfully validated and implemented for the prediction of the external ibuprofen tablet hardness. The most noticeable advantages of the proposed method over the conventional technique (hardness tester) are its non-destructive and rapid characteristics towards the analyzed samples.