In-line moisture measurement during granulation with a four-wavelength near infrared sensor: an evaluation of particle size and binder effects

Rantanen, Jukka; Räsänen, Eetu; Tenhunen, Jussi; Känsäkoski, Markku; Mannermaa, Jukka-Pekka; Yliruusi, Jouko

doi:10.1016/s0939-6411(00)00096-5

Cited by 98 publications

(60 citation statements)

References 16 publications

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“…An entire NIR spectrum is not necessary for water determination, and often the 419 use of only a few NIR wavelengths around the water band enables reliable and high-speed detection 420 of moisture. In another study, Rantanen et al (2000) evaluated the factors affecting in-line NIR 421 moisture measurements with the above mentioned four-wavelength sensor. They found that particle 422 size effects influence the spectral baseline and that the applied binder influences the NIR 423 measurement.…”

Section: Wet Granulation 406mentioning

confidence: 99%

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Beer

Burggraeve

Fonteyne

et al. 2011

International Journal of Pharmaceutics

477

216

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Section: Wet Granulation 406mentioning

confidence: 99%

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Beer

Burggraeve

Fonteyne

et al. 2011

International Journal of Pharmaceutics

477

216

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“…2) revealing drug bead peaks of somewhat greater intensity at 1,182, 1,686, and 2,264 nm, compared with neat theophylline powder, and with minimal interferences from the placebo beads at those wavelengths. The NIR spectral change in peak intensity and positional shift towards the longer wavelengths could be due to physical differences in particle size or density between the powders and beads, which could cause the light to be reflected or absorbed differently from the bead surface compared to a powder surface (2,52). It was also desired to evaluate whether NIRS was sensitive enough to discriminate between the different dosages of theophylline and cimetidine that would be used in this study.…”

Section: Nir Characterization Of Componentsmentioning

confidence: 99%

“…PAT can provide real-time data to enable improved process understanding and lead to better manufacturing process control, and this information can ultimately reduce end-product testing and its associated costs (1)(2)(3)(4)(5). NIRS has also found utility in the laboratory as well; a recent article discusses PAT applications for the use of NIRS in monitoring polymorphic changes atline during preparation of beads containing either nitrofurantoin or anhydrous theophylline (6).…”

Section: Introductionmentioning

confidence: 99%

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

et al. 2011

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Abstract. The purpose of this study was to utilize near-infrared spectroscopy and chemical imaging to characterize extrusion-spheronized drug beads, lipid-based placebo beads, and modified release tablets prepared from blends of these beads. The tablet drug load (10.5-19.5 mg) of theophylline (2.25 mg increments) and cimetidine (3 mg increments) could easily be differentiated using univariate analyses. To evaluate other tablet attributes (i.e., compression force, crushing force, content uniformity), multivariate analyses were used. Partial least squares (PLS) models were used for prediction and principal component analysis (PCA) was used for classification. The PLS prediction models (R 2 >0.98) for content uniformity of uncoated compacted theophylline and cimetidine beads produced the most robust models. Content uniformity data for tablets with drug content ranging between 10.5 and 19.5 mg showed standard error of calibration (SEC), standard error of cross-validation, and standard error of prediction (SEP) values as 0.31, 0.43, and 0.37 mg, and 0.47, 0.59, and 0.49 mg, for theophylline and cimetidine, respectively, with SEP/SEC ratios less than 1.3. PCA could detect blend segregation during tableting for preparations using different ratios of uncoated cimetidine beads to placebo beads (20:80, 50:50, and 80:20). Using NIR chemical imaging, the 80:20 formulations showed the most pronounced blend segregation during the tableting process. Furthermore, imaging was capable of quantitating the cimetidine bead content among the different blend ratios. Segregation testing (ASTM D6940-04 method) indicated that blends of coated cimetidine beads and placebo beads (50:50 ratio) also tended to segregate.

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“…Rantanen et al (1998Rantanen et al ( , 2000 qualitatively predicted granulation end-points for a range of diOE erent formulations, with an associated error of 0.2 % . As a result of its sensitivity to changes in chemical composition, Rasanen et al (2001) used NIR to study polymorphic conversion of anhydrous theophylline to theophylline monohydrate during wet granulation.…”

Section: Process Monitoringmentioning

confidence: 99%

Predictive and correlative techniques for the design, optimisation and manufacture of solid dosage forms

Hardy

Cook

2003

Journal of Pharmacy and Pharmacology

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There is much interest in predicting the properties of pharmaceutical dosage forms from the properties of the raw materials they contain. Achieving this with reasonable accuracy would aid the faster development and manufacture of dosage forms. A variety of approaches to prediction or correlation of properties are reviewed. These approaches have variable accuracy, with no single technique yet able to provide an accurate prediction of the overall properties of the dosage form. However, there have been some successes in predicting trends within a formulation series based on the physicochemical and mechanical properties of raw materials, predicting process scale-up through mechanical characterisation of materials and predicting product characteristics by process monitoring. Advances in information technology have increased predictive capability and accuracy by facilitating the analysis of complex multivariate data, mapping formulation characteristics and capturing past knowledge and experience.

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In-line moisture measurement during granulation with a four-wavelength near infrared sensor: an evaluation of particle size and binder effects

Cited by 98 publications

References 16 publications

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate System for Modified Release

Predictive and correlative techniques for the design, optimisation and manufacture of solid dosage forms

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