Determining API domain sizes in pharmaceutical tablets and blends upon varying milling conditions by near-infrared chemical imaging

Šašić, Slobodan; Kong, Angela; Kaul, Gautam

doi:10.1039/c3ay26531e

Cited by 22 publications

(12 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…NIR-CI was used to determine the presence of API agglomerates in the blends and tablets manufactured under different milling conditions. [37] After an initial blending step of the API and excipients, two batches were manufactured using different mill screen sizes (0.8 or 1.2 mm) and were compared to an unmilled batch. The milling step was followed by a final lubrication blend step with magnesium stearate to obtain the blend samples and further compressed into the tablet samples.…”

Section: Milling Processmentioning

confidence: 99%

“…NIR‐CI was used to determine the presence of API agglomerates in the blends and tablets manufactured under different milling conditions . After an initial blending step of the API and excipients, two batches were manufactured using different mill screen sizes (0.8 or 1.2 mm) and were compared to an unmilled batch.…”

Section: Nir‐ci Applications To the Western Solid Dosage Formsmentioning

confidence: 99%

See 1 more Smart Citation

PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

Zhou

et al. 2015

Drug Testing and Analysis

View full text Add to dashboard Cite

Near-infrared chemical imaging (NIR-CI) is an emerging technology that combines traditional near-infrared spectroscopy with chemical imaging. Therefore, NIR-CI can extract spectral information from pharmaceutical products and simultaneously visualize the spatial distribution of chemical components. The rapid and non-destructive features of NIR-CI make it an attractive process analytical technology (PAT) for identifying and monitoring critical control parameters during the pharmaceutical manufacturing process. This review mainly focuses on the pharmaceutical applications of NIR-CI in each unit operation during the manufacturing processes, from the Western solid dosage forms to the Chinese materia medica preparations. Finally, future applications of chemical imaging in the pharmaceutical industry are discussed.

show abstract

Section: Milling Processmentioning

confidence: 99%

Section: Nir‐ci Applications To the Western Solid Dosage Formsmentioning

confidence: 99%

PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

Zhou

et al. 2015

Drug Testing and Analysis

View full text Add to dashboard Cite

show abstract

“…6 Also, during pharmaceutical development, polymorphism, that is, the existence of several crystalline forms for the same chemical compound, 7 is an important parameter to be monitored, as it can affect not only the shelf life of the formulation but also its safety and performance in the organism. Vibrational spectroscopic techniques such as near infrared (NIR) and Raman have proved to be very useful, providing important information in different pharmaceutical studies [8][9][10][11][12][13][14][15] either in the point mode (single spectrum per sample) 12,13 or associated with microscopes (vibrational imaging). [8][9][10][11]14,15 The latter allows the mapping of a given sample surface, so that, in addition to the chemical information, spatial information is also obtained.…”

Section: Introductionmentioning

confidence: 99%

“…Vibrational spectroscopic techniques such as near infrared (NIR) and Raman have proved to be very useful, providing important information in different pharmaceutical studies [8][9][10][11][12][13][14][15] either in the point mode (single spectrum per sample) 12,13 or associated with microscopes (vibrational imaging). [8][9][10][11]14,15 The latter allows the mapping of a given sample surface, so that, in addition to the chemical information, spatial information is also obtained. Moreover, it is known that these techniques can provide information on the structural organization of molecules, and for this reason, they are useful for studies of the polymorphism and structural stability of pharmaceuticals under stress conditions, as shown by Piqueras et al 7 in the analysis of polymorphic carbamazepine forms by Raman imaging and multivariate curve resolution alternating least squares (MCR-ALS).…”

Section: Introductionmentioning

confidence: 99%

Extraction of information about structural changes in a semisolid pharmaceutical formulation from near‐infrared and Raman images by multivariate curve resolution–alternating least squares and ComDim

Mitsutake

Neves

Rutledge

et al. 2020

Journal of Chemometrics

View full text Add to dashboard Cite

Solid dispersions are an interesting option to improve the solubility of Class II (high permeability, low water solubility) drugs of the Biopharmaceutical Classification System without the use of organic solvents. However, structural changes (polymorphism) may be present in both active pharmaceutical ingredients (API) and excipients, which require evaluation during pharmaceutical development. Thus, the aim of this work was to demonstrate the feasibility of using Raman and near-infrared (NIR) mapping associated with multivariate curve resolution-alternating least squares (MCR-ALS) and common components and specific weights analysis (CCSWA or ComDim) chemometric methods to assess the solid dispersions of atorvastatin calcium in Gelucire ® 48/16 under controlled (3.0 ± 1.0 C, sealed flask) and accelerated (33.0 ± 1.0 C, 75% of relative humidity, open flask) aging conditions. MCR-ALS allowed the identification of the amorphous and crystalline fractions of the drug within the solid dispersion, which is not easily achieved by traditional techniques such as differential scanning calorimetry and X-ray diffraction, especially for semisolid formulations. ComDim results indicated that Raman seemed more sensitive to the presence of the API, whereas NIR was found to be more sensitive to alterations in the spectra of the excipient. The use of the ComDim method is not yet widespread in the pharmaceutical area; therefore, this paper shows its potential to support pharmaceutical development in preformulation stages for stability studies.

show abstract

“…In particular, the detailed knowledge of the Particle Size Distribution (PSD) and Particle Size and Shape Distribution (PSSD) becomes an issue of extreme relevance when developing materials with advanced functionalities. This is for example the case of electroluminescent perovskites 9 , heterogeneous catalysts 10 , nanomaterials for optoelectronics 11 , photovoltaics 12 , drug delivery 13 , or in industrially relevant processes, such as filtration 14 , coating 15 , dyes and inks 16 , cosmetics 17 and active pharmaceutical ingredients formulation 18 .…”

Section: Introductionmentioning

confidence: 99%

Nanoparticle size distribution from inversion of wide angle X-ray total scattering data

Ferri

Bertolotti

Guagliardi

et al. 2020

Sci Rep

View full text Add to dashboard Cite

An increasingly important issue in nanoscience and nanotechnology is the accurate determination of nanoparticle sizing. Wide angle X-ray total scattering (WAXtS) data are frequently used to retrieve the particle Size Distributions (pSDs) of nanocrystals of highly technological relevance; however, the PSD shape typically relies on an a-priori assumption. Here, we propose a modified version of the classical iterative Lucy-Richardson (LR) algorithm, which is simple, fast and highly reliable against noise, and demonstrate that the inversion of WAXTS data can be profitably used for recovering accurate pSD regardless of its shape. computer simulations based on the use of the Debye Scattering equation (DSe) modelling WAXtS data show that the algorithm is capable of recovering accurate PSDs even when the sample is made of a mixture of different polymorphs and/or exhibits microstrain effects. When applied to the inversion of WAXTS data taken on real samples, the method requires accurate modelling of the nanoparticle crystal structure, which includes structural defects, microstrain and surface induced distortions. provided that this information is correctly fed to the program, the inversion algorithm reconstructs the WAXtS data with high accuracy and recovers highly robust (against noise) pSDs. two examples reporting the characterization of Magnetite-Maghemite and commercial P25-Titania nanopowders, are discussed. We demonstrate that pre-assumption of wrong pSD shape leads to inaccurate number-based average sizes in highly polydisperse samples. Nanoparticle sizing and nanoparticle structural characterization have become, over the last decades, topics of increasing interest due to their intimate relationship to nanoscience and nanotechnology 1-6. Nanoparticles or NanoCrystals (NCs) usually exhibit a crystalline or a partially ordered atomic arrangement, with local structural distortions, defects, and remarkable surface effects (due to their large surface area to volume ratio) that can be tailored by proper functionalization. All these structural features, together with the NCs morphology and size, determine their physical-chemical properties and, ultimately, their functionality 7,8. In particular, the detailed knowledge of the Particle Size Distribution (PSD) and Particle Size and Shape Distribution (PSSD) becomes an issue of extreme relevance when developing materials with advanced functionalities. This is for example the case of electroluminescent perovskites 9 , heterogeneous catalysts 10 , nanomaterials for optoelectronics 11 , photovoltaics 12 , drug delivery 13 , or in industrially relevant processes, such as filtration 14 , coating 15 , dyes and inks 16 , cosmetics 17 and active pharmaceutical ingredients formulation 18. Among the experimental techniques that deal with nanoparticle sizing, imaging and scattering optical methods are among the most popular ones. Imaging methods, such as confocal optical 19 or transmission electron 20 microscopy, work by analyzing individually each single particle and therefore provide ...

show abstract

Determining API domain sizes in pharmaceutical tablets and blends upon varying milling conditions by near-infrared chemical imaging

Cited by 22 publications

References 14 publications

PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

Extraction of information about structural changes in a semisolid pharmaceutical formulation from near‐infrared and Raman images by multivariate curve resolution–alternating least squares and ComDim

Nanoparticle size distribution from inversion of wide angle X-ray total scattering data

Contact Info

Product

Resources

About