Study progression in application of process analytical technologies on film coating

Peng, Tingting; Huang, Ying; Mei, Liling; Wu, Lifu; Chen, Longkai; Pan, Xin; Wu, Chuanbin

doi:10.1016/j.ajps.2014.10.002

Cited by 12 publications

(3 citation statements)

References 58 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…PAT tools are used for the monitoring and process control of the coating process. Typically, tools include spectroscopic techniques, such as NIRS and Raman spectroscopy, as well as imaging techniques, including TPI [ 259 ]. El Hagrasy et al used PAT tools, such as Raman spectroscopy, for monitoring the coating process.…”

Section: Application Of Pat Framework For Control Strategy Of the Unit Operationsmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

View full text Add to dashboard Cite

Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.

show abstract

Section: Application Of Pat Framework For Control Strategy Of the Unit Operationsmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…Various PAT tools have been used to monitor the coating process of solid dosage forms and maintain the high quality of final products. These tools include spectroscopic techniques, imaging techniques, and microscopic techniques: (i) spectroscopic techniques include near-infrared spectrum (NIRS), Raman spectroscopy, and laser-induced breakdown spectroscopy (LIBS); (ii) imaging techniques include terahertz pulse imaging (TPI), near-infrared imaging, and magnetic resonance imaging (MRI); and (iii) microscopic techniques include confocal laser scanning microscope (CLSM), atomic force microscope (AFM), and scanning electron microscope (SEM) [ 109 ]. Among spectroscopic techniques, NIRS is one of the most widely used process analysis technologies; it is rapid, non-destructive, and cost-effective.…”

Section: Recent Technology and Tools Used To Characterize Coated Tmentioning

confidence: 99%

Pharmaceutical Application of Tablet Film Coating

et al. 2020

View full text Add to dashboard Cite

Tablet film coating is a common but critical process providing various functionalities to tablets, thereby meeting diverse clinical needs and increasing the value of oral solid dosage forms. Tablet film coating is a technology-driven process and the evolution of coated dosage forms relies on advancements in coating technology, equipment, analytical techniques, and coating materials. Although multiple coating techniques are developed for solvent-based or solvent-free coating processes, each method has advantages and disadvantages that may require continuous technical refinement. In the film coating process, intra- and inter-batch coating uniformity of tablets is critical to ensure the quality of the final product, especially for active film coating containing active pharmaceutical ingredients in the coating layer. In addition to experimental evaluation, computational modeling is also actively pursued to predict the influence of operation parameters on the quality of the final product and optimize process variables of tablet film coating. The concerted efforts of experiments and computational modeling can save time and cost in optimizing the tablet coating process. This review provides a brief overview of tablet film coating technology and modeling approaches with a focus on recent advancements in pharmaceutical applications.

show abstract

“…In coating processes, the quality of the product can be influenced by many process parameters and their interactions, i.e., inlet and outlet air temperature, spray rate, pan speed, negative pressure of the drum, etc. The monitoring of the process by using process analytical technology (PAT) can help to detect deviations and problems during the process and in consequence increase the quality of the final product [ 2 ]. The importance of the implementation of PAT was emphasized in a guidance by the Food and Drug Administration (FDA) in 2004 [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Raman Spectroscopy as a PAT-Tool for Film-Coating Processes: In-Line Predictions Using one PLS Model for Different Cores

2020

View full text Add to dashboard Cite

Although Raman spectroscopy has been described as a potential process analytical technique for tablet coating, it has rarely been transferred from academic studies to commercial manufacturing applications. The reasons for this are probably not only the high level of process understanding and experience with multivariate data analysis required, but also the product-dependent elaborate model-building. Hence, this study represents a feasibility study to investigate, whether subtraction of core spectra is a suitable approach to generate versatile models for one specific coating that can be applied on a multitude of different tablet cores. Raman spectroscopy was used to predict the application of coatings on three different tablet cores using PLS regression. The obtained spectra were preprocessed, and differential spectra were calculated by subtraction of the core spectrum from each inline spectrum. Normalization ensured comparability between the spectral data of the different cores. It was shown that in general it is possible to build models for a specific coating suspension that can predict the application of this suspension on different cores. In the presence of a strong Raman marker (TiO2), promising results were obtained. Without the presence of a strong Raman marker this modeling approach is to be considered critical.

show abstract

Study progression in application of process analytical technologies on film coating

Cited by 12 publications

References 58 publications

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Pharmaceutical Application of Tablet Film Coating

Raman Spectroscopy as a PAT-Tool for Film-Coating Processes: In-Line Predictions Using one PLS Model for Different Cores

Contact Info

Product

Resources

About