In-line quantification of micronized drug and excipients in tablets by near infrared (NIR) spectroscopy: Real time monitoring of tabletting process

Karande, A.D.; Heng, Paul Wan Sia; Liew, Celine Valeria

doi:10.1016/j.ijpharm.2010.06.011

Cited by 69 publications

(28 citation statements)

References 17 publications

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“…Prior to building the calibration, the effect of sampling was evaluated by recording NIR spectra in both static and dynamic conditions. The differences between measurements revealed the importance of ensuring similar sampling conditions for calibration as for actual real-time monitoring [9]. For another application, Karande et al evaluated the effect of different spectral-sampling strategies on the performance of an NIR model, to accurately predict blend components in quaternary mixtures.…”

Section: Calibration Strategy For Calibration In-line Monitoring Methodsmentioning

confidence: 99%

“…They applied SNV, MSC, and first and second derivatives obtained by calculating 15-point quadratic Savitzky-Golay filters, in order to develop a method for the off-line prediction of tablet properties [8]. Sylvester et al developed an in-line NIR-monitoring method for a freeze-drying process using the SNV pre-processing in order to remove multiplicative interferences caused by scatter and particle size variations and the first Savitzky-Golay derivative to reduce baseline shifts and to improve the spectral resolution [9]. The successful development of a real-time method for monitoring continuous powder flow from a tableting machine feeder was described by Alam et al Savitzky-Golay derivatization was first applied for smoothing, followed by SNV for scatter correction [10].…”

Section: Handling Chemical Physical and Environmental Interferencesmentioning

confidence: 99%

“…Using classical methods, such as chromatography the quality of a 1-3 million tablet batch is certified on 20-30 tablets, and many functional excipients that directly influence product performance are not quantified. These limitations are exceeded by implementing process analytical instruments, such as NIR or Raman [9].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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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Section: Calibration Strategy For Calibration In-line Monitoring Methodsmentioning

confidence: 99%

Section: Handling Chemical Physical and Environmental Interferencesmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

show abstract

“…Measurements were conducted in-line in the feed frame. Karande et al [39] placed an NIR probe just after the tablet-ejection area and constructed a PLS model to calculate the concentration of the API and the excipients. This study exposed that it is important to use similar sampling methods and circumstances for the collection of both calibration spectra and real-time process spectra.…”

Section: Direct Compressionmentioning

confidence: 99%

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Fonteyne

Vercruysse

Leersnyder

et al. 2015

TrAC Trends in Analytical Chemistry

144

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Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the advantages of continuous processing, so the critical quality attributes of continuously produced pharmaceuticals need to be monitored in real time. In 2004, the US Food and Drug Administration launched the process analytical technology (PAT) concept to stimulate the pharmaceutical industry to change from off-line to real-time quality testing. This review explores the implementation of PAT tools within continuous pharmaceutical processes (i.e., blending, spray drying, roller compaction, twin-screw granulation and compression), focusing on both opportunities and challenges.

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“…Some monitoring techniques in the tableting process with diffuse reflectance NIR spectroscopy have actually been reported. 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.…”

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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In-line quantification of micronized drug and excipients in tablets by near infrared (NIR) spectroscopy: Real time monitoring of tabletting process

Cited by 69 publications

References 17 publications

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Using Terahertz Reflectance Spectroscopy to Quantify Drug Substance in Tablets

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