Near-infrared spectroscopic applications in pharmaceutical particle technology

Razuc, Mariela Fernanda; Grafia, Ana Luisa; Gallo, Loreana; Ramírez-Rigo, María Verónica; Romañach, Rodolfo J.

doi:10.1080/03639045.2019.1641510

Cited by 44 publications

(20 citation statements)

References 262 publications

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“…CPEs tend to have improved physicochemical properties as compared to the simple physical mixtures of components [ 4 ]. The main advantages of these solid powder dispersions include uniform particle size and shape distribution, increased density, higher sphericity, and greater porosity; this results in improved flow and compression properties [ 5 ]. In addition, they generally have a higher dilution potential, defined as the minimum amount of substance added to the active pharmaceutical ingredient (API), while forming a readily compressible mixture [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Comparison of Flow and Compression Properties of Four Lactose-Based Co-Processed Excipients: Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®

et al. 2021

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The utilization of co-processed excipients (CPEs) represents a novel approach to the preparation of orally disintegrating tablets by direct compression. Flow, consolidation, and compression properties of four lactose-based CPEs—Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®—were investigated using different methods, including granulometry, powder rheometry, and tablet compaction under three pressures. Due to the similar composition and the same preparation technique (spray drying), the properties of CPEs and their compacts were generally comparable. The most pronounced differences were observed in flowability, undissolved fraction after 3 min and 24 h, energy of plastic deformation (E2), ejection force, consolidation behavior, and compact friability. Cellactose® 80 exhibited the most pronounced consolidation behavior, the lowest values of ejection force, and high friability of compacts. CombiLac® showed excellent flow properties but insufficient friability, except for compacts prepared at the highest compression pressure (182 MPa). MicroceLac® 100 displayed the poorest flow properties, lower ejection forces, and the best mechanical resistance of compacts. StarLac® showed excellent flow properties, the lowest amounts of undissolved fraction, the highest ejection force values, and the worst compact mechanical resistance. The obtained results revealed that higher compression pressures need to be used or further excipients have to be added to all tested materials in order to improve the friability and tensile strength of formed tablets, except for MicroceLac® 100.

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Section: Introductionmentioning

confidence: 99%

Comparison of Flow and Compression Properties of Four Lactose-Based Co-Processed Excipients: Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®

et al. 2021

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“…NIRS offers a tool for a simple yet non-destructive analysis of samples' composition based on molecular-level properties that acquires both qualitative and quantitative data. 15 NIR spectra arises due to the presence of groups like CH, NH, OH, SH, PH etc that can be used to discriminate materials, chemically. Similarly, it is sensitive to physical information, that said, untying or decoding individual contributions requires use of powerful chemometric tools.…”

Section: Near Infrared Spectroscopy (Nirs) and Chemometrics Based On Pcamentioning

confidence: 99%

Quantitative Microscopy: Particle Size/Shape Characterization, Addressing Common Errors Using ‘Analytics Continuum’ Approach

Saravanan

Muthudoss

Khullar

et al. 2021

Journal of Pharmaceutical Sciences

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Particle size/shape characterization of active pharmaceutical ingredient (API) is integral to successful product development. It is more of a correlative property than a decision-making measure. Though microscopy is the only technique that provides a direct measure of particle properties, it is neglected for reasons like non-repeatability and non-reproducibility which is often attributed to a) fundamental error, b) segregation error, c) human error, d) sample randomness, e) sample representativeness etc. Using the "Sucrose" as model sample, we propose "analytics continuum" approach that integrates optical microscope PSD measurements complimented by NIR spectroscopy-based trending analysis as a prescreening tool to demonstrate sample randomness and representativeness. Furthermore, plethora of statistical tests are utilized to infer population statistics. Subsequently, an attribute-based control chart and bootstrap-based confidence interval was developed to monitor product performance. A flowchart to serve as an elementary guideline is developed, which is then extended to handle more complex situations involving API crystallized from two different solvent systems. The results show that the developed methodology can be utilized as a quantitative procedure to assess the suitability of API/excipients from different batches or from alternate vendors and can significantly help in understanding the differences between material even on a minor scale.

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“…In the realm of food and pharmaceuticals, NIR spectroscopy has reached a point to where it is readily available in both screening technologies and in process monitoring applications [136,137]. As a screening technology, NIR can be used in a laboratory setting and at "point-of-use" as a portable technology [138].…”

Section: Nir In Food and Pharmaceutical Raw Materialsmentioning

confidence: 99%

“…The use of spectral ranges [143] and pre-processing [144] also help to enhance model performance [145] and the method parameters such as those commonly reported for chromatographic methods [146] are also reported: specificity, accuracy, linearity and precision. For process NIR applications, some of the areas where NIR brings considerable utility is in moisture content, particle sizing, form identification, density, and blend uniformity [137]. NIR has also been useful to monitor coating thickness [147], and in a recent application was used as part of a combined-data-approach to predict the active ingredient dissolution performance of enterically-coated microspheres [148].…”

Section: Nir In Food and Pharmaceutical Raw Materialsmentioning

confidence: 99%

QCM Sensor Arrays, Electroanalytical Techniques and NIR Spectroscopy Coupled to Multivariate Analysis for Quality Assessment of Food Products, Raw Materials, Ingredients and Foodborne Pathogen Detection: Challenges and Breakthroughs

Bwambok

Siraj

Macchi

et al. 2020

Sensors

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Quality checks, assessments, and the assurance of food products, raw materials, and food ingredients is critically important to ensure the safeguard of foods of high quality for safety and public health. Nevertheless, quality checks, assessments, and the assurance of food products along distribution and supply chains is impacted by various challenges. For instance, the development of portable, sensitive, low-cost, and robust instrumentation that is capable of real-time, accurate, and sensitive analysis, quality checks, assessments, and the assurance of food products in the field and/or in the production line in a food manufacturing industry is a major technological and analytical challenge. Other significant challenges include analytical method development, method validation strategies, and the non-availability of reference materials and/or standards for emerging food contaminants. The simplicity, portability, non-invasive, non-destructive properties, and low-cost of NIR spectrometers, make them appealing and desirable instruments of choice for rapid quality checks, assessments and assurances of food products, raw materials, and ingredients. This review article surveys literature and examines current challenges and breakthroughs in quality checks and the assessment of a variety of food products, raw materials, and ingredients. Specifically, recent technological innovations and notable advances in quartz crystal microbalances (QCM), electroanalytical techniques, and near infrared (NIR) spectroscopic instrument development in the quality assessment of selected food products, and the analysis of food raw materials and ingredients for foodborne pathogen detection between January 2019 and July 2020 are highlighted. In addition, chemometric approaches and multivariate analyses of spectral data for NIR instrumental calibration and sample analyses for quality assessments and assurances of selected food products and electrochemical methods for foodborne pathogen detection are discussed. Moreover, this review provides insight into the future trajectory of innovative technological developments in QCM, electroanalytical techniques, NIR spectroscopy, and multivariate analyses relating to general applications for the quality assessment of food products.

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Near-infrared spectroscopic applications in pharmaceutical particle technology

Cited by 44 publications

References 262 publications

Comparison of Flow and Compression Properties of Four Lactose-Based Co-Processed Excipients: Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®

Comparison of Flow and Compression Properties of Four Lactose-Based Co-Processed Excipients: Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®

Quantitative Microscopy: Particle Size/Shape Characterization, Addressing Common Errors Using ‘Analytics Continuum’ Approach

QCM Sensor Arrays, Electroanalytical Techniques and NIR Spectroscopy Coupled to Multivariate Analysis for Quality Assessment of Food Products, Raw Materials, Ingredients and Foodborne Pathogen Detection: Challenges and Breakthroughs

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