In-line Measurement of a Drug Substance via Near Infrared Spectroscopy to Ensure a Robust Crystallization Process

Zhou, Guangya; Crocker, Louis S.; Xu, Jing; Tábora, José E.; Ge, Zigang

doi:10.1002/jps.20581

Cited by 22 publications

(12 citation statements)

References 17 publications

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“…In solid‐state analysis, NIR spectroscopy has been applied for identification and quantification of polymorphs and amorphous forms in powder mixtures and solid dosage forms such as tablets 44–51 . It has been also used for several process analytical applications, such as moisture detection during wet granulation, 52–54 in freeze‐dried solids, 55 and to describe crystallisation processes 56 . NIR spectroscopy has also become important in the study of solid‐state transformations (described below).…”

Section: Introductionmentioning

confidence: 99%

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

Heinz

Strachan

Gordon

et al. 2009

Journal of Pharmacy and Pharmacology

193

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Objectives Solid-state transformations may occur during any stage of pharmaceutical processing and upon storage of a solid dosage form. Early detection and quantification of these transformations during the manufacture of solid dosage forms is important since the physical form of an active pharmaceutical ingredient can significantly influence its processing behaviour, including powder flow and compressibility, and biopharmaceutical properties such as solubility, dissolution rate and bioavailability. Key findings Vibrational spectroscopic techniques such as infrared, near-infrared, Raman and, most recently, terahertz pulsed spectroscopy have become popular for solidstate analysis since they are fast and non-destructive and allow solid-state changes to be probed at the molecular level. In particular, Raman and near-infrared spectroscopy, which require no sample preparation, are now commonly used coupled to fibreoptic probes and are able to characterise solid-state conversions in-line. Traditionally, uni-or bivariate approaches have been used to analyse spectroscopic data sets; however, recently the simultaneous detection of several solid-state forms has been increasingly performed using multivariate approaches where even overlapping spectral bands can be analysed. Summary This review discusses the applications of different vibrational spectroscopic techniques to detect and monitor solid-state transformations possible for crystalline polymorphs, hydrates and amorphous forms of pharmaceutical compounds. In this context, the theoretical basis of solid-state transformations and vibrational spectroscopy and common experimental approaches are described, including recent methods of data analysis.

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Section: Introductionmentioning

confidence: 99%

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

Heinz

Strachan

Gordon

et al. 2009

Journal of Pharmacy and Pharmacology

193

View full text Add to dashboard Cite

show abstract

“…44 Isolation of the desired polymorph of etoricoxib is ensured using a seeding process, and a near-infrared spectroscopic method has been evaluated as an in-line method for measurement of the solute concentration so that the seeding may be conducted in the most efficient manner. 45 …”

Section: Studies Of Preparative and Isolation Methodsmentioning

confidence: 99%

Polymorphism and Solvatomorphism 2006

Brittain¹

2008

Journal of Pharmaceutical Sciences

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“…31 NIR spectroscopy has also been used to enhance process robustness by detecting and monitoring the desired polymorph in a crystallization process. 32,33 Recently, on -line FBRM, ATR -FTIR spectroscopy, Raman spectroscopy and PLS were used to monitor a complex crystallization system: a racemic free base of a given compound and a chiral acid. The authors fi rst demonstrate that the diastereomeric composition can be estimated using Raman spectral data, slurry density and temperature using a PLS model.…”

Section: Crystallizationmentioning

confidence: 99%

On‐Line PAT Applications of Spectroscopy in the Pharmaceutical Industry

Smith‐Goettler¹

2010

Process Analytical Technology

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In-line Measurement of a Drug Substance via Near Infrared Spectroscopy to Ensure a Robust Crystallization Process

Cited by 22 publications

References 17 publications

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

Polymorphism and Solvatomorphism 2006

On‐Line PAT Applications of Spectroscopy in the Pharmaceutical Industry

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