A Near-Infrared Spectroscopic Investigation of Relative Density and Crushing Strength in Four-Component Compacts

Short, Steven M.; Cogdill, Robert P.; Wildfong, Peter L.D.; Drennen, James K.; Anderson, Carl A.

doi:10.1002/jps.21473

Cited by 41 publications

(26 citation statements)

References 30 publications

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“…2) revealing drug bead peaks of somewhat greater intensity at 1,182, 1,686, and 2,264 nm, compared with neat theophylline powder, and with minimal interferences from the placebo beads at those wavelengths. The NIR spectral change in peak intensity and positional shift towards the longer wavelengths could be due to physical differences in particle size or density between the powders and beads, which could cause the light to be reflected or absorbed differently from the bead surface compared to a powder surface (2,52). It was also desired to evaluate whether NIRS was sensitive enough to discriminate between the different dosages of theophylline and cimetidine that would be used in this study.…”

Section: Nir Characterization Of Componentsmentioning

confidence: 99%

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

et al. 2011

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Abstract. The purpose of this study was to utilize near-infrared spectroscopy and chemical imaging to characterize extrusion-spheronized drug beads, lipid-based placebo beads, and modified release tablets prepared from blends of these beads. The tablet drug load (10.5-19.5 mg) of theophylline (2.25 mg increments) and cimetidine (3 mg increments) could easily be differentiated using univariate analyses. To evaluate other tablet attributes (i.e., compression force, crushing force, content uniformity), multivariate analyses were used. Partial least squares (PLS) models were used for prediction and principal component analysis (PCA) was used for classification. The PLS prediction models (R 2 >0.98) for content uniformity of uncoated compacted theophylline and cimetidine beads produced the most robust models. Content uniformity data for tablets with drug content ranging between 10.5 and 19.5 mg showed standard error of calibration (SEC), standard error of cross-validation, and standard error of prediction (SEP) values as 0.31, 0.43, and 0.37 mg, and 0.47, 0.59, and 0.49 mg, for theophylline and cimetidine, respectively, with SEP/SEC ratios less than 1.3. PCA could detect blend segregation during tableting for preparations using different ratios of uncoated cimetidine beads to placebo beads (20:80, 50:50, and 80:20). Using NIR chemical imaging, the 80:20 formulations showed the most pronounced blend segregation during the tableting process. Furthermore, imaging was capable of quantitating the cimetidine bead content among the different blend ratios. Segregation testing (ASTM D6940-04 method) indicated that blends of coated cimetidine beads and placebo beads (50:50 ratio) also tended to segregate.

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Section: Nir Characterization Of Componentsmentioning

confidence: 99%

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

et al. 2011

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“…Compared to other studies, where only the compaction pressure was considered as a factor to induce variability in the investigated response, in this case formulation composition was varied also. The calibration set consisted of 29 formulations (mixture design) with each formulation being compressed at different pressures [30]. Lyndgaard et al developed a Raman method to quantify paracetamol content from tablets through blisters.…”

Section: Design Of Experiments Strategymentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Vibrational spectroscopy, namely near infrared (NIR) and Raman spectroscopy, is based on the interaction between the electromagnetic radiation and matter. The technique is sensitive to chemical and physical properties and delivers a wide range of information about the analyzed sample, but in order to extract the information, multivariate calibration of the spectral data is required. The main goal of this work will be to present in detail the available multivariate calibration strategy for development of NIR and Raman spectroscopic methods, which was successfully applied in pharmaceutics.

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“…5,6) Variations in the physical properties of sample generally affect the spectra when diffuse transmission or reflectance NIR spectroscopy is used. 7,8) Especially, the difference in tablet density is shown as a baseline shift in the spectra, 9) leading to an issue that should be solved because this effect complicates the quantification. There is another important aspect in the quantification, which is a penetration depth of an incident beam into a tablet.…”

Section: -4)mentioning

confidence: 99%

Using Terahertz Reflectance Spectroscopy to Quantify Drug Substance in Tablets

Hisazumi

Watanabe

Suzuki

et al. 2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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The purpose of this research is to investigate the applicability of terahertz (THz) reflectance spectroscopy for quantification of drug substance in tablets, so as to demonstrate the feasibility for applying this technique to tableting process monitoring. In order to acquire a suitable absorbance spectrum for this purpose, it was necessary to enhance the reflection intensity. By using an aluminum plate as a mirror at the opposite surface of the tablet, a reasonable absorbance spectrum could be acquired to reflect the bulk information of the tablet. To assess the limit of tablet thickness, linearity between the tablet thickness and the absorbance value was investigated using lactose and mannitol tablets. Since linearity was found within 0.75-5.0 mm for both tablets using 0.4 and 0.8 THz region, it was confirmed that THz reflectance spectroscopy is applicable to tablets within at least 5.0 mm thickness. Mannitol tablets containing sodium salicylate as the model drug substance were used to investigate the quantitative performance of this technique. It was confirmed that the established calibration model was acceptable for this quantification because of the root-mean-squared error of cross-validation (RMSECV) being 1.95%. In order to evaluate the applicability of this technique, content quantitative performance in double layered tablets having active and placebo layers were assessed. Since this calibration model achieved the root-mean-squared error of prediction (RMSEP) of 1.42% for the double layered tablets, this technique was considered feasible even if the drug substance is localized in the tablets.Key words terahertz; reflection; in-line monitoring; process analytical technology; tablet; sodium salicylateThe tablet is one of the popular dosage forms in pharmaceutics, and quantification of drug substance in drug product, including the content uniformity test, is a critical and mandatory quality assurance requirement in tablet manufacturing. Although a conventional HPLC method is the most popular technique for quantification, there are growing interests to examine alternative analytical techniques that are possible to measure drug products in-process with a nondestructive manner. These interests are also in line with the United States Food and Drug Administration (FDA) Process Analytical Technology (PAT) initiative and guidelines.1) As a well-known example of the alternative techniques, near infrared (NIR) spectroscopy is being extensively used for the quantification of drug substance as a PAT tool. 2-4)Typically, only 10-30 tablets are generally employed as the representative for batch manufacturing of several million tablets. In-line monitoring during the tableting process is expected to attain higher quality assurance than the traditional end-product testing, because quantification for each and every unit dose would be expected. A reflectance spectroscopy is usually employed as the in-line monitoring tool, because a detector of a transmission spectrometer cannot be installed into a rotary tableting machine to ...

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A Near-Infrared Spectroscopic Investigation of Relative Density and Crushing Strength in Four-Component Compacts

Cited by 41 publications

References 30 publications

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Using Terahertz Reflectance Spectroscopy to Quantify Drug Substance in Tablets

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