PAT-tools for process control in pharmaceutical film coating applications

Knop, Klaus; Kleinebudde, Peter

doi:10.1016/j.ijpharm.2013.01.062

Cited by 98 publications

(44 citation statements)

References 46 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Raman has demonstrated value as an in-line PAT for batch or continuous tablet coating processes, providing both process control and real-time coating release [55, 56] and capable of meeting ICH Q2 guidelines for an active coating process [4]. …”

Section: Real-time Release Testingmentioning

confidence: 99%

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

Esmonde-White

Cuellar

Uerpmann³

et al. 2016

Anal Bioanal Chem

245

153

View full text Add to dashboard Cite

Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data analysis models, and applications of Raman spectroscopy, which have expanded the scope of Raman spectroscopy as a process analytical technology. Emerging technologies such as transmission and enhanced reflection Raman, and new approaches to using available technologies, expand the scope of Raman spectroscopy in pharmaceutical manufacturing, and now Raman spectroscopy is successfully integrated into real-time release testing, continuous manufacturing, and statistical process control. Since the last major review of Raman as a pharmaceutical PAT in 2010, many new Raman applications in bioprocessing have emerged. Exciting reports of in situ Raman spectroscopy in bioprocesses complement a growing scientific field of biological and biomedical Raman spectroscopy. Raman spectroscopy has made a positive impact as a process analytical and control tool for pharmaceutical manufacturing and bioprocessing, with demonstrated scientific and financial benefits throughout a product’s lifecycle.

show abstract

Section: Real-time Release Testingmentioning

confidence: 99%

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

Esmonde-White

Cuellar

Uerpmann³

et al. 2016

Anal Bioanal Chem

245

153

View full text Add to dashboard Cite

show abstract

“…[5] Thus, the online analysis and quality control should be studied to identify the critical sources of variability, to manage the process variability, and to improve the quality of industrial products effectively. [67891011]…”

Section: Introductionmentioning

confidence: 99%

Near-infrared spectroscopy as a process analytical technology tool for monitoring the parching process of traditional chinese medicine based on two kinds of chemical indicators

Wang

Liu

et al. 2017

Phcog Mag

View full text Add to dashboard Cite

Background:The active ingredients and thus pharmacological efficacy of traditional Chinese medicine (TCM) at different degrees of parching process vary greatly.Objective:Near-infrared spectroscopy (NIR) was used to develop a new method for rapid online analysis of TCM parching process, using two kinds of chemical indicators (5-(hydroxymethyl) furfural [5-HMF] content and 420 nm absorbance) as reference values which were obviously observed and changed in most TCM parching process.Materials and Methods:Three representative TCMs, Areca (Areca catechu L.), Malt (Hordeum Vulgare L.), and Hawthorn (Crataegus pinnatifida Bge.), were used in this study. With partial least squares regression, calibration models of NIR were generated based on two kinds of reference values, i.e. 5-HMF contents measured by high-performance liquid chromatography (HPLC) and 420 nm absorbance measured by ultraviolet–visible spectroscopy (UV/Vis), respectively.Results:In the optimized models for 5-HMF, the root mean square errors of prediction (RMSEP) for Areca, Malt, and Hawthorn was 0.0192, 0.0301, and 0.2600 and correlation coefficients (Rcal) were 99.86%, 99.88%, and 99.88%, respectively. Moreover, in the optimized models using 420 nm absorbance as reference values, the RMSEP for Areca, Malt, and Hawthorn was 0.0229, 0.0096, and 0.0409 and Rcal were 99.69%, 99.81%, and 99.62%, respectively.Conclusions:NIR models with 5-HMF content and 420 nm absorbance as reference values can rapidly and effectively identify three kinds of TCM in different parching processes. This method has great promise to replace current subjective color judgment and time-consuming HPLC or UV/Vis methods and is suitable for rapid online analysis and quality control in TCM industrial manufacturing process.SUMMARY Near-infrared spectroscopy.(NIR) was used to develop a new method for online analysis of traditional Chinese medicine.(TCM) parching processCalibration and validation models of Areca, Malt, and Hawthorn were generated by partial least squares regression using 5.(hydroxymethyl) furfural contents and 420.nm absorbance as reference values, respectively, which were main indicator components during parching process of most TCMThe established NIR models of three TCMs had low root mean square errors of prediction and high correlation coefficientsThe NIR method has great promise for use in TCM industrial manufacturing processes for rapid online analysis and quality control. Abbreviations used: NIR: Near-infrared Spectroscopy; TCM: Traditional Chinese medicine; Areca: Areca catechu L.; Hawthorn: Crataegus pinnatifida Bge.; Malt: Hordeum vulgare L.; 5-HMF: 5-(hydroxymethyl) furfural; PLS: Partial least squares; D: Dimension faction; SLS: Straight line subtraction, MSC: Multiplicative scatter correction; VN: Vector normalization; RMSECV: Root mean square errors of cross-validation; RMSEP: Root mean square errors of validation; Rcal: Correlation coefficients; RPD: Residual predictive deviation; PAT: Process analytical technology; FDA: Food and Drug Administration; ICH: Intern...

show abstract

“…Several studies investigated process analytical technology (PAT) applications for the monitoring of coating processes. Most techniques directly rely on the detection of the coating material, including near-infrared spectroscopy (NIRS) (6)(7)(8)(9), Raman spectroscopy (10)(11)(12), and Terahertz pulsed imaging (13). In a series of papers, we recently reported the use of optical coherence tomography (OCT) as a powerful method for in-line measurement of coating thickness and variability (14)(15)(16).…”

Section: Introductionmentioning

confidence: 99%

Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer

et al. 2016

View full text Add to dashboard Cite

Abstract. The aim of the present work was to develop a PAT strategy for the supervision of hot melt coating processes. Optical fibers were placed at various positions in the process chamber of a fluid bed device. Experiments were performed to determine the most suitable position for in-line process monitoring, taking into account such requirements as a good signal to noise ratio, the mitigation of dead zones, the ability to monitor the product over the entire process, and reproducibility. The experimental evidence suggested that the position at medium fluid bed height, looking towards the center, i.e., normal to particle movement, proved to be the most reliable position. In this study, the advantages of multipoint monitoring are shown, and an in-line-implementation was created. This enabled the real-time supervision of the process, including the fast detection of inhomogeneities and disturbances in the process chamber, and the compensation of sensor malfunction. In addition, a model for estimating the particle size distribution via NIR was successfully created. This ensures that the quality of the product and the endpoint of the coating process can be determined correctly.

show abstract

PAT-tools for process control in pharmaceutical film coating applications

Cited by 98 publications

References 46 publications

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

Near-infrared spectroscopy as a process analytical technology tool for monitoring the parching process of traditional chinese medicine based on two kinds of chemical indicators

Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer

Contact Info

Product

Resources

About