Development of a comprehensive near infrared spectroscopy calibration model for rapid measurements of moisture content in multiple pharmaceutical products

Mainali, Dipak; Li, Jane; Yehl, Peter; Chetwyn, Nicholas

doi:10.1016/j.jpba.2014.03.001

Cited by 16 publications

(9 citation statements)

References 28 publications

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“…8 The lyophilized cake heights used in these studies were greater than these minimum requirements. While literature has shown that one model can be developed for multiple configurations for tablets, 6 typically for lyophilized biologics (at the time of this publication) each product, formulation and container closure requires an individual model, which can be time consuming and resource intensive. The NIR method can also be prone to issues with lyophilized cake shrinkage due to excipient crystallization or from moisture increase while on stability.…”

Section: Discussionmentioning

confidence: 99%

“…The method utilizes the absorption of water in the combination O-H stretching and bending region (1887-1960 nm) and for the first overtone (1408-1470 nm) region of the NIR spectrum. 6,7 Using these known regions of water absorption, a moisture model can be developed for biopharmaceutical products based on other common test methods, such as Karl Fischer. 8 Once the moisture model is developed, the residual moisture content can then be determined by the NIR peak amplitude based on the established model.…”

Section: Introductionmentioning

confidence: 99%

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Near Infrared and Frequency Modulated Spectroscopy as Non-Invasive Methods for Moisture Assessment of Freeze-Dried Biologics

Affleck

Khamar

Lowerre

et al. 2021

Journal of Pharmaceutical Sciences

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Near-infrared (NIR) and frequency modulated spectroscopy (FMS) were employed, for non-invasive moisture determination of a lyophilized biologic drug product (DP). Development of NIR and FMS provides a rapid non-invasive means of residual moisture measurement, and would be beneficial compared with traditional time consuming, product destructive methods such as Karl Fischer (KF). A model therapeutic enzyme in a sucrose-based formulation was employed for proof of concept studies, and NIR and FMS methods were compared side by side for residual moisture analysis. Moisture models were created using lyophilized vials and comparisons were made between the methods using different moisture preparation approaches:1) direct water droplet addition to the vial headspace, 2) use of elevated temperature (80°C), and 3) using various levels of moisture in stoppers generated during the washing and drying procedures, then lyophilizing using the stoppers and placing the sealed vials on stability. The results for direct water addition gave an average percent error for residual moisture of 5.7% for NIR and 9.4% for FMS when compared to KF. The elevated temperature method resulted in an average percent error for residual moisture of 54% for NIR and 43% for FMS compared to KF. The stopper moisture stability study, for FMS, provided an average percent error for residual moisture of 31% compared to KF. The error was greater for the elevated temperature and stopper methods, due to the low moisture values, which resulted in greater error. At this lower range of moisture (<1%) both NIR and FMS were less accurate, but from 1 to 5% their accuracy increased, based on the models used in this study. NIR and FMS methods can be used to complement KF at these lower moisture levels and models could be further improved with additional data points. NIR and FMS methods have advantages and disadvantages for residual moisture analysis when compared to each other, but both provided an accurate measurement of drug product moisture (depending on the method used for moisture increase), they can be used as process analytical technology (PAT), and both can be used for fast non-invasive moisture determination.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Near Infrared and Frequency Modulated Spectroscopy as Non-Invasive Methods for Moisture Assessment of Freeze-Dried Biologics

Affleck

Khamar

Lowerre

et al. 2021

Journal of Pharmaceutical Sciences

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show abstract

“…These include shelf life and ease of transport. The traditional wet chemistry method of water content determination is Karl Fischer (KF) titration, which is time consuming, destructive, and laborious (Mainali et al, 2014). Therefore, various spectroscopic techniques have been widely developed to extract information concerning the moisture content of pharmaceutical samples in a non-destructive manner.…”

Section: Moisture Contentmentioning

confidence: 99%

“…Therefore, various spectroscopic techniques have been widely developed to extract information concerning the moisture content of pharmaceutical samples in a non-destructive manner. Recently, Mainali (2014) studied the potential of NIR spectroscopy for the measurement of moisture content in tablets. The KF method was used as the reference method for water content determination and FT-NIR (1000-2500 nm) was used for spectral collection of tablet samples prepared with different APIs and excipients.…”

Section: Moisture Contentmentioning

confidence: 99%

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Kandpal

Park

Tewari

et al. 2015

Journal of Biosystems Engineering

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Spectroscopy is an emerging technology for the quality assessment of pharmaceutical samples, from tablet manufacturing to final quality assurance. The traditional methods for the quality management of pharmaceutical tablets are time consuming and destructive, while spectroscopic techniques allow rapid analysis in a non-destructive manner. The advantage of spectroscopy is that it collects both spatial and spectral information (called hyperspectral imaging), which is useful for the chemical imaging of pharmaceutical samples. These chemical images provide both qualitative and quantitative information on tablet samples. In the pharmaceutics, spectroscopic techniques are used for a variety of applications, such as analysis of the homogeneity of powder samples as well as determination of particle size, product composition, and the concentration, uniformity, and distribution of the active pharmaceutical ingredient in solid tablets. This review paper presents an introduction to the applications of various spectroscopic techniques such as hyperspectroscopy and vibrational spectroscopies (Raman spectroscopy, FT-NIR, and IR spectroscopy) for the quality and safety assessment of pharmaceutical solid dosage forms. In addition, various chemometric techniques that are highly essential for analyzing the spectroscopic data of pharmaceutical samples are also reviewed.

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“…Due to its flexibility in measurement, the technique is suitable for analysis of the samples in different pharmaceutical forms. NIR spectroscopy has been applied in determining water content [7,8], active principal ingredients (API) [9,10], and excipients [11] of pharmaceutical products. Furthermore, NIR spectroscopy has a characteristic that it can capture both chemical and physical information of the samples.…”

Section: Introductionmentioning

confidence: 99%

Discriminant analysis of Chinese patent medicines based on near-infrared spectroscopy and principal component discriminant transformation

Wang

Liu

et al. 2015

Spectrochimica Acta Part A: Molecular and Biomolecular Spectros

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Development of a comprehensive near infrared spectroscopy calibration model for rapid measurements of moisture content in multiple pharmaceutical products

Cited by 16 publications

References 28 publications

Near Infrared and Frequency Modulated Spectroscopy as Non-Invasive Methods for Moisture Assessment of Freeze-Dried Biologics

Near Infrared and Frequency Modulated Spectroscopy as Non-Invasive Methods for Moisture Assessment of Freeze-Dried Biologics

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Discriminant analysis of Chinese patent medicines based on near-infrared spectroscopy and principal component discriminant transformation

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