Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy

Vanarase, Aditya U.; Alcalà, Manel; Rozo, Jackeline I. Jerez; Muzzio, Fernando J.; Romañach, Rodolfo J.

doi:10.1016/j.ces.2010.01.036

Cited by 196 publications

(83 citation statements)

References 21 publications

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“…In 2010, Vanarase et al [11] constructed an NIR-PLS model to determine the API concentration of flowing powder in-line. The spectra were collected from blends, passing under the NIR probe head on a chute at the outlet of a continuous blender.…”

Section: Continuous Blendingmentioning

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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Section: Continuous Blendingmentioning

confidence: 99%

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Fonteyne

Vercruysse

Leersnyder

et al. 2015

TrAC Trends in Analytical Chemistry

144

View full text Add to dashboard Cite

show abstract

“…e usual source of disturbance at the inlet of the mixture is re�lling of the feeder [48]. e �owrate �uctuations at the blender inlet should be minimized so that the properties of the output stream from the blender are not affected.…”

Section: Effect Of Noisementioning

confidence: 99%

Mathematical Development and Comparison of a Hybrid PBM-DEM Description of a Continuous Powder Mixing Process

Sen

Dubey

Singh

et al. 2013

Journal of Powder Technology

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is paper describes the development of a multidimensional population balance model (PBM) which can account for the dynamics of a continuous powder mixing/blending process. e PBM can incorporate the important design and process conditions and determine their effects on the various critical quality attributes (CQAs) accordingly. e important parameters considered in this study are blender dimensions and presence of noise in the inlet streams. e blender dynamics have been captured in terms of composition of the ingredients, (relative standard deviation) RSD, and (residence time distribution) RTD. PBM interacts with discrete element modeling (DEM) via one-way coupling which forms a basic framework for hybrid modeling. e results thus obtained have been compared against a full DEM simulation which is a more fundamental particle-level model that elucidates the dynamics of the mixing process. Results show good qualitative agreement which lends credence to the use of coupled PBM as an effective tool in control and optimization of mixing process due to its relatively fewer computational requirements compared to DEM.

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“…By combining NIR spectroscopy and multivariate methods, critical quality characteristics of powders and solid dosage forms can be extracted in a straightforward manner (10). Many pharmaceutical processes are relatively easily accessible using NIR in combination with fiber optics (11)(12)(13). They can be monitored without changing the process setup and barely require manual effort (14,15).…”

Section: Introductionmentioning

confidence: 99%

Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy

et al. 2012

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Abstract. Blending of powders is a crucial step in the production of pharmaceutical solid dosage forms. The active pharmaceutical ingredient (API) is often a powder that is blended with other powders (excipients) in order to produce tablets. The blending efficiency is influenced by several external factors, such as the desired degree of homogeneity and the required blending time, which mainly depend on the properties of the blended materials and on the geometry of the blender. This experimental study investigates the mixing behavior of acetyl salicylic acid as an API and α-lactose monohydrate as an excipient for different filling orders and filling levels in a blender. A multiple near-infrared probe setup on a laboratoryscale blender is used to observe the powder composition quasi-simultaneously and in-line in up to six different positions of the blender. Partial least squares regression modeling was used for a quantitative analysis of the powder compositions in the different measurement positions. The end point for the investigated mixtures and measurement positions was determined via moving block standard deviation. Observing blending in different positions helped to detect good and poor mixing positions inside the blender that are affected by convective and diffusive mixing.

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Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy

Cited by 196 publications

References 21 publications

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Mathematical Development and Comparison of a Hybrid PBM-DEM Description of a Continuous Powder Mixing Process

Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy

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