Process characterization of powder blending by near-infrared spectroscopy: Blend end-points and beyond

Shi, Zhenqi; Cogdill, Robert P.; Short, Steven M.; Anderson, Carl A.

doi:10.1016/j.jpba.2008.03.013

Cited by 102 publications

(49 citation statements)

References 24 publications

(25 reference statements)

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“…Therefore, the concentration levels must be monitored directly at various spatial locations. Numerous parameters of the blend homogeneity have been established with regard to thief probes (4), and various methods for determining the end point via NIR in combination with the nominal value are described in the literature (31). For a blend to be considered homogenous, two requirements must be met.…”

Section: Influence Of Loading Ordermentioning

confidence: 99%

“…First, the concentration should be within the same level everywhere, which can be tested by directly comparing the spectra. Secondly, the predicted concentrations should be within the specification of the nominal concentration, according to the fractions filled into the blender, for which a valid prediction model is needed (31). However, NIR is limited by the sampling position and only provides information regarding the surface region of the blend.…”

Section: Influence Of Loading Ordermentioning

confidence: 99%

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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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Section: Influence Of Loading Ordermentioning

confidence: 99%

Section: Influence Of Loading Ordermentioning

confidence: 99%

Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy

et al. 2012

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“…In Figure 9.18, a quantitative determination of API is performed during the blend process. Since 2007, a large number of publications have been written about NIRS and the blend process [150][151][152][153][154][155][156][157][158][159][160]. The use of this spectroscopy for blend monoriting has therefore been fully demonstrated.…”

Section: Powder Blendingmentioning

confidence: 99%

Near Infrared Spectroscopy in Drug Discovery and Development Processes

Roggo¹,

Dégardin²,

Ulmschneider³

2012

Physico-Chemical Methods in Drug Discovery and Development

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“…NIRS could be used to monitor and evaluate the adequacy of mixing for a pharmaceutical formulation [5,6], and drug concentration in the final product. The numerous applications of NIR spectroscopy are not limited to analytical methods required by regulatory agencies, and also include process understanding and troubleshooting [7,8].…”

Section: Introductionmentioning

confidence: 99%

“…This grab sampling involves a significant risk that the sample brought to the lab is not representative of the production process, and it is estimated that the sampling error is much greater than the analytical method error [9][10][11]. NIR spectrometers have been interfaced with manufacturing equipment providing real time measurements that may be used to monitor the production process [2][3][4][5][6].…”

Section: Introductionmentioning

confidence: 99%

A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

Romañach

Román-Ospino

Alcalà

2016

Methods in Pharmacology and Toxicology

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The pharmaceutical industry uses procedures to describe all the instructions needed to perform a process in a consistent manner. Procedures are based on process knowledge and the desire to consistently meet desired specifications. This chapter proposes a procedure for the development of NIR partial least squares (PLS) calibration models for pharmaceutical applications. The chapter captures the lessons learned for more than a decade in studies where NIR spectroscopy has been used for quantitative determinations of drug concentration, moisture, polymorphs, and other important applications. Two examples of recent initiatives to develop NIR calibration models in a more efficient manner reducing the number of calibration samples are also discussed. The procedure differs from previously published guidelines since it is based on specific examples of method validations for pharmaceutical processes and provides clear instructions for method development and validation. The procedure and tutorial should advance the implementation of near infrared spectroscopic (NIRS) quantitative methods in the pharmaceutical industry.

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Process characterization of powder blending by near-infrared spectroscopy: Blend end-points and beyond

Cited by 102 publications

References 24 publications

Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy

Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy

Near Infrared Spectroscopy in Drug Discovery and Development Processes

A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

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