Process Analytical Chemistry

Blaser, Wayne W.; Bredeweg, Robert A.; Harner, Richard S.; LaPack, Mark A.; Leugers, Anne.; Martin, Daniel P.; Pell, Randy J.; Workman, Jerry; Wright, Larry G.

doi:10.1021/ac00108a004

Cited by 56 publications

(28 citation statements)

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“…The use of vibrational spectroscopy, such as near-infrared (NIR) and Raman spectroscopy for monitoring chemical reactions or other unit operations, are the most mature of these. [12][13][14] Noninvasive measurements for these processes can now be performed through the use of fiber optics. Several literature examples of process analytical chemistry and process monitoring using NIR spectroscopy to obtain both qualitative [15][16][17] and quantitative 8,[18][19][20] analytical information have been reported.…”

Section: Introductionmentioning

confidence: 99%

Quantitative analysis of film coating in a pan coater based on in-line sensor measurements

et al. 2005

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A method was developed that enables in-line analysis of film coating thickness on tablets during a pan coating operation. Real-time measurements were made using a diffusereflectance near-infrared (NIR) probe positioned inside the pan during the coating operation. Real-time spectra of replicate batches were used for modeling film growth. Univariate analysis provided a simple method for in-line monitoring of the coating process using NIR data. An empirical geometric 2-vector volumetric growth model was developed, which accounts for differential growth on the face and band regions of biconvex tablets. The thickness of the film coat was determined by monitoring the decrease of absorption bands characteristic of a component of the tablet core and monitoring the increase of bands characteristic of a component in the coating material. There was good correlation between values estimated from the NIR data and the measured tablet volumetric growth. In-line measurements allow the coating process to be stopped when a predetermined tablet coating thickness is achieved.

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Section: Introductionmentioning

confidence: 99%

Quantitative analysis of film coating in a pan coater based on in-line sensor measurements

et al. 2005

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“…The terms in-line, on-line, at-line, off-line, non-invasive are often used variably in literature. Usual definitions are as follows (Callis et al 1987;Blaser et al 1995;Beebe et al 1998;Hassel & Bowman 1998;: in-line, the sample interface is located in the process stream; on-line, automated sampling and sample transfer to an automated analyser; atline, manual sampling with local transport to analyser located in manufacturing area; off-line, manual sampling with transport to remote or centralized laboratory. Many PAT applications will aim at real-time measurement directly from processes.…”

Section: Applications Of Nir In Drug Development and Manufacturingmentioning

confidence: 99%

Near infrared spectroscopy in the development of solid dosage forms

Räsänen

Sandler

2007

Journal of Pharmacy and Pharmacology

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The use of near infrared (NIR) spectroscopy has rapidly grown partly due to demands of process analytical applications in the pharmaceutical industry. Furthermore, newest regulatory guidelines have advanced the increase of the use of NIR technologies. The non-destructive and non-invasive nature of measurements makes NIR a powerful tool in characterization of pharmaceutical solids. These benefits among others often make NIR advantageous over traditional analytical methods. However, in addition to NIR, a wide variety of other tools are naturally also available for analysis in pharmaceutical development and manufacturing, and those can often be more suitable for a given application. The versatility and rapidness of NIR will ensure its contribution to increased process understanding, better process control and improved quality of drug products. This review concentrates on the use of NIR spectroscopy from a process research perspective and highlights recent applications in the field.

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“…Recently, spectroscopy in combination with multivariate calibration models has become an important tool for fast and non-invasive analysis in pharmaceutical, petrochemical and food sectors [1][2][3][4]. Principal component regression (PCR) and partial least squares (PLS) [5] are traditional linear calibration techniques.…”

Section: Introductionmentioning

confidence: 99%