Near Infrared Spectroscopy for Monitoring the Hardness of Roller Compacted Ribbons

Bijlani, Vishal; Delgado-Lopez, Miriam; Adeyeye, Christianah Moji; Drennen, James K.

doi:10.1255/nirn.680

Cited by 8 publications

(2 citation statements)

References 5 publications

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“…A number of earlier works have addressed the issue of measuring tablet hardness via NIR spectroscopy. 15,17,[19][20][21] It was found in these studies that variation in tablet hardness is manifested in NIR spectra as a nonlinear baseline shift that increases with wavelength. The wavelength dependency is attributed to the multiple-scatter effect that causes higher baseline absorbance at longer wavelengths.…”

Section: Hardnessmentioning

confidence: 99%

Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release

et al. 2005

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This article is the second of a series of articles detailing the development of near-infrared (NIR) methods for solid dosage-form analysis. Experiments were conducted at the Duquesne University Center for Pharmaceutical Technology to demonstrate a method for developing and validating NIR models for the analysis of active pharmaceutical ingredient (API) content and hardness of a solid dosage form. Robustness and cross-validation testing were used to optimize the API content and hardness models. For the API content calibration, the optimal model was determined as multiplicative scatter correction with Savitsky-Golay first-derivative preprocessing followed by partial leastsquares (PLS) regression including 4 latent variables. API content calibration achieved root mean squared error (RMSE) and root mean square error of cross validation (RMSECV) of 1.48 and 1.80 mg, respectively. PLS regression and baseline-fit calibration models were compared for the prediction of tablet hardness. Based on robustness testing, PLS regression was selected for the final hardness model, with RMSE and RMSECV of 8.1 and 8.8 N, respectively. Validation testing indicated that API content and hardness of production-scale tablets is predicted with root mean square error of prediction of 1.04 mg and 8.5 N, respectively. Explicit robustness testing for high-flux noise and wavelength uncertainty demonstrated the robustness of the API concentration calibration model with respect to normal instrument operating conditions.

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Section: Hardnessmentioning

confidence: 99%

Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release

et al. 2005

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“…2 Recently, NIR spectroscopy has found increasing use in pharmaceutical analysis for the identification and quality testing of raw materials, 3,4 the monitoring of blending, 5 granulation, 6 moisture content, 5 active substance content, [7][8][9] roller compaction, 10 drying operations 11 and many other applications. It is an important component of a PAT toolbox, and is the key for enabling Real-Time Release of pharmaceutical tablets.…”

Section: Introductionmentioning

confidence: 99%

The application of NIR spectroscopy with chemometric analysis for monitoring the powder blending process

Maric¹,

Petrovic²,

Nikolić³

et al. 2014

JSCS

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This paper reports the use of near infrared (NIR) spectroscopy as a process analytical technology (PAT) tool for monitoring the metformin (N,N--dimethylimidodicarbonimidic diamide) hydrochloride and poly(vinyl pyrrolidone) (PVP) mixing process, which is the first stage in tablet production. Blend homogeneity was tested using the non-invasive NIR spectroscopy method and the partial least squares (PLS) regression model was applied for the analysis of the obtained spectra. Simultaneously, the critical parameter (metformin hydrochloride content) was monitored by a classical analytical technique, the validated HPLC method, commonly used for this purpose. Based on the high sensitivity of the model developed in this study, as well as the established correlation among the results obtained by different methods, it could be concluded that the proposed rapid and non-invasive technique could be an effecttive tool for the monitoring of one of the critical manufacturing steps in the production solid dosage forms.

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A systematic framework to monitor mulling processes using Near Infrared spectroscopy

Panikar

Singh

et al. 2016

Advanced Powder Technology

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Near Infrared Spectroscopy for Monitoring the Hardness of Roller Compacted Ribbons

Cited by 8 publications

References 5 publications

Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release

Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release

The application of NIR spectroscopy with chemometric analysis for monitoring the powder blending process

A systematic framework to monitor mulling processes using Near Infrared spectroscopy

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