Monitoring concept of single-frequency ultrasound and its application in dynamic crystallization processes

Pertig, D.; Fardmostafavi, M.; Stelzer, Torsten; Ulrich, Joachim

doi:10.1016/j.apt.2015.03.001

Cited by 7 publications

(12 citation statements)

References 21 publications

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“…Effects such as temperature, liquid concentration, and scattering caused by crystals are taken into account in the ultrasound velocity and the attenuation measured by SFUS. 27,28 Only the possible effect of viscosity 43,44 has not yet been considered in SFUS independently. 27,28 Therefore, the effect of viscosity was investigated by analyzing the influence of more complex formulation matrixes of LID on the accuracy of SFUS.…”

Section: Methodsmentioning

confidence: 99%

“…27,28 Only the possible effect of viscosity 43,44 has not yet been considered in SFUS independently. 27,28 Therefore, the effect of viscosity was investigated by analyzing the influence of more complex formulation matrixes of LID on the accuracy of SFUS. In these tests, the inactive pharmaceutical ingredient NaCMC, a commonly used viscosity modifier, was added to the formulation matrix of the LID solution (Table 1).…”

Section: Methodsmentioning

confidence: 99%

“…Moreover, the application of the individual PATs might by accompanied by obstacles regarding electrically nonconducting (e.g., for conductivity measurement), dense, concentrated, or optically opaque solutions. 22,27,28 Comparatively, the ultrasound-based technologies have advantages because most materials are ultrasonically transparent and hence allow the analysis of a broad variety of sample types (solution, suspension, lotion, emulsion, etc.). 16,18,27−29 In the past decade, several studies have pioneered the use of ultrasound spectroscopy in the quantification of drug concentration in different types of formulations.…”

Section: Introductionmentioning

confidence: 99%

“…Most of the PATs shown in Figure are limited to measure either the solid or liquid phase. Moreover, the application of the individual PATs might by accompanied by obstacles regarding electrically nonconducting (e.g., for conductivity measurement), dense, concentrated, or optically opaque solutions. ,, Comparatively, the ultrasound-based technologies have advantages because most materials are ultrasonically transparent and hence allow the analysis of a broad variety of sample types (solution, suspension, lotion, emulsion, etc. ). ,,− In the past decade, several studies have pioneered the use of ultrasound spectroscopy in the quantification of drug concentration in different types of formulations. ,, Contrary to ultrasound spectroscopy, SFUS, an ultrasound-based PAT operating at only one single frequency and smaller in physical size, has been studied intensively as a fast, reliable, and cost-effective PAT in crystallization processes to measure liquid concentration and suspension density. ,,,− However, to the best of our knowledge, in situ, real-time monitoring of drug concentration in liquid pharmaceutical formulations (solution/suspension) has not been assessed by means of SFUS.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Evaluation of PAT Methods for Potential Application in Small-Scale, Multipurpose Pharmaceutical Manufacturing Platforms

Stelzer

Wong

Chen

et al. 2016

Org. Process Res. Dev.

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Small-scale (refrigerator-sized, 1.0 (width) × 0.7 (length) × 1.8 m (height)), multipurpose pharmaceutical manufacturing platforms (PMP) necessitate unique high demands on process analytical technologies (PAT), for instance, in in situ, real-time monitoring of liquid formulations (solution and suspension) to determine the strength prior to the release from PMPs that are not comparable to lab-scale or industrial-scale needs. Commercially available plug-and-play PATs were evaluated for their potential application in PMPs regarding versatility, flexibility, reliability, and physical size (including the control box). The results presented here indicate that single-frequency ultrasounds currently surpass commercially available plug-and-play PATs in ways such as focused beam reflectance measurements, conductivity, and turbidity as well as UV–vis, Fourier transform infrared, near-infrared, and Raman spectroscopy for the purpose of in situ, real-time concentration monitoring of aqueous and alcohol-based solutions and suspension-formulated drugs in one single PAT device, as it is preferred in PMPs to maintain a small footprint.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of PAT Methods for Potential Application in Small-Scale, Multipurpose Pharmaceutical Manufacturing Platforms

Stelzer

Wong

Chen

et al. 2016

Org. Process Res. Dev.

View full text Add to dashboard Cite

show abstract

“…So far, only optical imaging measurement techniques, together with sophisticated image processing algorithms, manage to determine efficiently the particle shape of a particulate phase [13,30]. Other noninvasive niche methods rely, for instance, on the use of supersonic wave probes for the characterization of the dispersed phase [31][32][33].…”

Section: Particulate Measurement Techniquesmentioning

confidence: 99%

A Novel Shadowgraphic Inline Measurement Technique for Image-Based Crystal Size Distribution Analysis

et al. 2020

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A novel shadowgraphic inline probe to measure crystal size distributions (CSD), based on acquired greyscale images, is evaluated in terms of elevated temperatures and fragile crystals, and compared to well-established, alternative online and offline measurement techniques, i.e., sieving analysis and online microscopy. Additionally, the operation limits, with respect to temperature, supersaturation, suspension, and optical density, are investigated. Two different substance systems, potassium dihydrogen phosphate (prisms) and thiamine hydrochloride (needles), are crystallized for this purpose at 25 L scale. Crystal phases of the well-known KH2PO4/H2O system are measured continuously by the inline probe and in a bypass by the online microscope during cooling crystallizations. Both measurement techniques show similar results with respect to the crystal size distribution, except for higher temperatures, where the bypass variant tends to fail due to blockage. Thiamine hydrochloride, a substance forming long and fragile needles in aqueous solutions, is solidified with an anti-solvent crystallization with ethanol. The novel inline probe could identify a new field of application for image-based crystal size distribution measurements, with respect to difficult particle shapes (needles) and elevated temperatures, which cannot be evaluated with common techniques.

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Real-time concentration monitoring using a compact composite sensor array for in situ quality control of aqueous formulations

Rosa

Báez

Romañach

et al. 2021

Journal of Pharmaceutical and Biomedical Analysis

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Monitoring concept of single-frequency ultrasound and its application in dynamic crystallization processes

Cited by 7 publications

References 21 publications

Evaluation of PAT Methods for Potential Application in Small-Scale, Multipurpose Pharmaceutical Manufacturing Platforms

Evaluation of PAT Methods for Potential Application in Small-Scale, Multipurpose Pharmaceutical Manufacturing Platforms

A Novel Shadowgraphic Inline Measurement Technique for Image-Based Crystal Size Distribution Analysis

Real-time concentration monitoring using a compact composite sensor array for in situ quality control of aqueous formulations

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