Process analytical technology in continuous manufacturing of a commercial pharmaceutical product

Vargas, Jenny M.; Nielsen, Sarah; Cárdenas, Vanessa; Gonzalez, Anthony H.; Aymat, Efrain; Almodovar, Elvin; Classe, Gustavo; Colon, Yleana Marie; Sánchez, Eric; Romañach, Rodolfo J.

doi:10.1016/j.ijpharm.2018.01.003

Cited by 98 publications

(33 citation statements)

References 40 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, continuous manufacturing (CM) offers possibilities such as cost-effectiveness, shortened process development, decreased size of manufacturing equipment and flexible batch sizes (Lee et al, 2015;Mollan and Lodaya, 2004;Yin and Clayton, 2014). Several positive examples about the capability of CM lines for the manufacturing of high-quality tablets have previously been published (Ervasti et al, 2015;Taipale-Kovalainen et al, 2018;Van Snick et al, 2017a, 2017bVargas et al, 2018;Vercruysse et al, 2013). The opportunities to improve development and manufacturing by innovations have been understood and supported by regulatory bodies since a decade.…”

Section: Introductionmentioning

confidence: 99%

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Karttunen

Hörmann

Leersnyder

et al. 2019

International Journal of Pharmaceutics

View full text Add to dashboard Cite

Over the recent decade, benefits of continuous manufacturing (CM) of pharmaceutical products have been acknowledged widely. In contrast to batch processes, the product is not physically separated into batches in CM, which creates a few challenges. Product release is done for batches that should have a uniform quality over time, materials need to be tracked along the line, and locations to reject product must be established. To enable these, the residence time distributions (RTDs) of all unit operations must be known. In this paper, three CM tableting lines, each employing a different granulation technique, were investigated. The RTDs of their main unit operations were characterized, utilizing different measurement techniques successfully. All of these RTD measurement techniques could have been performed in any of the lines. The differences were related to the techniques themselves. Overall, external tracer with in-line Near-Infrared detection or color tracer with video recording proved most usable techniques, with few limitations. The RTDs for full lines were calculated by convoluting the unit operation RTDs, which enables material tracking through entire lines. The lines exhibited both truly continuous and quasi-continuous unit operations. Quasi-continuous unit operations divide the material stream into lots that can be utilized for tracking and rejection.

show abstract

Section: Introductionmentioning

confidence: 99%

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Karttunen

Hörmann

Leersnyder

et al. 2019

International Journal of Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…The application of FTIR techniques combined with chemometrics is not new and has been used by the pharmaceutical industry for different purposes as to thoroughly understand the feeding and mixing steps in the continuous manufacturing of solid oral dosage forms (Vargas et al, 2018), continuous blend potency determination in the feed frame of a tablet press (De Leersnyder et al, 2018), in-line and real-time monitoring of pharmaceutical hot melt extrusion (Vo et al, 2018) and as an analytical technique (Eldin and Shalaby, 2011;Said et al, 2011). However, all these works focus in the evaluation and determination in solid matrices and only a few papers described the quantification of pharmaceuticals in other matrices as syrup, suspensions, creams and ointments (Ziémons et al, 2010;Silva et al, 2012;Schlegel et al, 2017).…”

Section: Remarks and Perspectivementioning

confidence: 99%

Environmentally-friendly technology for rapid identification and quantification of emerging pollutants from wastewater using infrared spectroscopy

Quintelas

Melo

Costa

et al. 2020

Environmental Toxicology and Pharmacology

View full text Add to dashboard Cite

The monitoring of emerging pollutants in wastewaters is nowadays an issue of special concern, with the classical quantification methods being time and reagent consuming. In this sense, a FTIR transmission spectroscopy based chemometric methodology was developed for the determination of eight of these pollutants. A total of 456 samples were, therefore, obtained, from an activated sludge wastewater treatment process spiked with the studied pollutants, and analysed in the range of 200 cm −1 to 14,000 cm −1. Then, a k-nearest neighbour (kNN) analysis aiming at identifying each sample pollutant was employed. Next, partial least squares (PLS) and ordinary least squares (OLS) modelling approaches were employed in order to obtain suitable prediction models. This procedure resulted in good prediction abilities regarding the estimation of atrazine, desloratadine, paracetamol, β-estradiol, ibuprofen, carbamazepine, sulfamethoxazole and ethynylestradiol concentrations in wastewaters. These promising results suggest this technology as a fast, eco-friendly and reagent free alternative methodology for the quantification of emerging pollutants in wastewaters.

show abstract

“…Therefore, there have been many attempts in the last few years to integrate PAT and continuous manufacturing within pharmaceutical industries. 169 In many cases, spectroscopicbased tools such as ultraviolet-visible (UV-vis), near-infrared (NIR), Fourier transform infrared (FT-IR), and Raman spectroscopy have been successfully used for real time monitoring and process control, 170 including the monitoring of extraction and crystallization processes, the production of solid dosage forms, and the quantitation of active substances and impurities. 168 However, these approaches often lack specificity and sensitivity for several other PAT applications.…”

Section: Process Analytical Technologymentioning

confidence: 99%

Recent Advances in Chromatography for Pharmaceutical Analysis

et al. 2018

View full text Add to dashboard Cite

Process analytical technology in continuous manufacturing of a commercial pharmaceutical product

Cited by 98 publications

References 40 publications

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Environmentally-friendly technology for rapid identification and quantification of emerging pollutants from wastewater using infrared spectroscopy

Recent Advances in Chromatography for Pharmaceutical Analysis

Contact Info

Product

Resources

About