Near-Infrared Spectroscopy: Applications in the Analysis of Tablets and Solid Pharmaceutical Dosage Forms

Kirsch, John D.; Drennen, James K.

doi:10.1080/05704929508000906

Cited by 87 publications

(36 citation statements)

References 30 publications

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“…In the last decade, near-infrared (NIR) spectroscopy has been increasingly used as an in-line analytical technique for process control purposes in the pharmaceutical industry (7)(8)(9). The recent Process Analytical Technology (PAT) initiative of the US Food and Drug Administration (FDA) also encourages the application of NIR sensors or similar analytical techniques to reduce production cycle times by implementing on-, in-, and/or at-line measurements.…”

Section: Introductionmentioning

confidence: 99%

Investigation of the Variability of NIR In-line Monitoring of Roller Compaction Process by Using Fast Fourier Transform (FFT) Analysis

et al. 2008

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Abstract. The purpose of this research was to investigate the variability of the roller compaction process while monitoring in-line with near-infrared (NIR) spectroscopy. In this paper, a pragmatic method in determining this variability of in-line NIR monitoring roller compaction process was developed and the variability limits were established. Fast Fourier Transform (FFT) analysis was used to study the source of the systematic fluctuations of the NIR spectra. An off-line variability analysis method was developed as well to simulate the in-line monitoring process in order to determine the variability limits of the roller compaction process. For this study, a binary formulation was prepared composed of acetaminophen and microcrystalline cellulose. Different roller compaction parameters such as roll speed and feeding rates were investigated to understand the variability of the process. The best-fit line slope of NIR spectra exhibited frequency dependence only on the roll speed regardless of the feeding rates. The eccentricity of the rolling motion of rollers was identified as the major source of variability and correlated with the fluctuations of the slopes of NIR spectra. The off-line static and dynamic analyses of the compacts defined two different variability of the roller compaction; the variability limits were established. These findings were proved critical in the optimization of the experimental setup of the roller compaction process by minimizing the variability of NIR in-line monitoring.

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Section: Introductionmentioning

confidence: 99%

Investigation of the Variability of NIR In-line Monitoring of Roller Compaction Process by Using Fast Fourier Transform (FFT) Analysis

et al. 2008

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“…As is common practice, a second derivative transformation was applied to resolve overlapping peaks due to multiple overtones and combinations and normalize the baseline shifts 18 (Figure 2 and 3). The calculated first overtone region of alcoholic O-H stretch occurs in the region 1471 to 1617 nm.…”

Section: Nir Spectramentioning

confidence: 99%

Quantifying crystal form content in physical mixtures of (±)-tartaric acid and (+)-tartaric acid using near infrared reflectance spectroscopy

Luner

Patel

2005

AAPS PharmSciTech

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The objective of this study was to use diffuse reflectance near infrared spectroscopy (NIRS) to determine racemic compound content in physical mixtures composed primarily of the enantiomorph and to assess the error, instrument reproducibility and limits of detection (LOD) and quantification (LOQ) of the method. Physical mixtures ranging from 0 to 25% (±)−tartaric acid in (+)−tartaric acid were prepared and spectra of the powder samples contained in glass vials were obtained using a Foss NIRSystems Model 5000 monochrometer equipped with a Rapid Content Analyzer scanning from 1100 to 2500 nm. A calibration curve was constructed by plotting (±)−tartaric acid weight percent against the 2 nd derivative values of log (1/R) vs λ at a single wavelength, normalized with a denominator wavelength (1480 nm/1280 nm). Excellent linearity was observed (R 2 =0.9999). The standard error of calibration (SEC) was 0.07 and the standard error of prediction (SEP) for the validation set was 0.11. Instrument and method errors for samples in the 2% composition range ((±) −tartaric acid in (+)−tartaric acid) were less than 1% RSD and 3% RSD, respectively. The practical LOD and LOQ were 0.1% and 0.5%, respectively, and comparable to the calculated LOD and LOQ. These studies show that NIRS can be used as a rapid and sensitive quantitative method for determining racemate content in the presence of the enatiomerically pure crystal in the solid-state.

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“…This strategy is beneficial because insufficient product quality is detected during the process, which can therefore be adjusted so that the product meets the defined specifications (9). In this context, vibrational spectroscopic techniques such as NIR (12)(13)(14)(15)(16) and Raman spectroscopy (17)(18)(19) have been demonstrated to be useful tools for evaluation of tablet coating quality as they are fast, nondestructive, and versatile and provide chemical as well as physical information on the samples. However, one drawback of such techniques is the lack of spatial information, as average spectra are obtained only from spots of a sample or from more than one tablet during a given integration time (20).…”

Section: Introductionmentioning

confidence: 99%

Rapid Assessment of Tablet Film Coating Quality by Multispectral UV Imaging

Klukkert

Rantanen

et al. 2015

AAPS PharmSciTech

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Abstract. Chemical imaging techniques are beneficial for control of tablet coating layer quality as they provide spectral and spatial information and allow characterization of various types of coating defects. The purpose of this study was to assess the applicability of multispectral UV imaging for assessment of the coating layer quality of tablets. UV images were used to detect, characterize, and localize coating layer defects such as chipped parts, inhomogeneities, and cracks, as well as to evaluate the coating surface texture. Acetylsalicylic acid tablets were prepared on a rotary tablet press and coated with a polyvinyl alcohol-polyethylene glycol graft copolymer using a pan coater. It was demonstrated that the coating intactness can be assessed accurately and fast by UV imaging. The different types of coating defects could be differentiated and localized based on multivariate image analysis and Soft Independent Modeling by Class Analogy applied to the UV images. Tablets with inhomogeneous texture of the coating could be identified and distinguished from those with a homogeneous surface texture. Consequently, UV imaging was shown to be well-suited for monitoring of the tablet coating layer quality. UV imaging is a promising technique for fast quality control of the tablet coating because of the high data acquisition speed and its nondestructive analytical nature.

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Near-Infrared Spectroscopy: Applications in the Analysis of Tablets and Solid Pharmaceutical Dosage Forms

Cited by 87 publications

References 30 publications

Investigation of the Variability of NIR In-line Monitoring of Roller Compaction Process by Using Fast Fourier Transform (FFT) Analysis

Investigation of the Variability of NIR In-line Monitoring of Roller Compaction Process by Using Fast Fourier Transform (FFT) Analysis

Quantifying crystal form content in physical mixtures of (±)-tartaric acid and (+)-tartaric acid using near infrared reflectance spectroscopy

Rapid Assessment of Tablet Film Coating Quality by Multispectral UV Imaging

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