Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note

Vo, Anh; He, Herman; Zhang, Jiaxiang; Martin, S. T.; Chen, Rui; Repka, Michael A.

doi:10.1208/s12249-018-1091-3

Cited by 32 publications

(20 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The study showed the in-line NIR was able to provide chemical information such as the blending ratio and interactions between the API and polymer, as well as physical properties of the sample such as color, temperature, and density. As NIR is a non-destructive and fast monitoring tool, it can also be used for both product development and manufacturing (143).…”

Section: In-line Process Monitoring Tools To Improve Processing Parammentioning

confidence: 99%

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

Tan

Davis

Miller³

et al. 2020

AAPS PharmSciTech

View full text Add to dashboard Cite

Thermal processing has gained much interest in the pharmaceutical industry, particularly for the enhancement of solubility, bioavailability, and dissolution of active pharmaceutical ingredients (APIs) with poor aqueous solubility. Formulation scientists have developed various techniques which may include physical and chemical modifications to achieve solubility enhancement. One of the most commonly used methods for solubility enhancement is through the use of amorphous solid dispersions (ASDs). Examples of commercialized ASDs include Kaletra®, Kalydeco®, and Onmel®. Various technologies produce ASDs; some of the approaches, such as spray-drying, solvent evaporation, and lyophilization, involve the use of solvents, whereas thermal approaches often do not require solvents. Processes that do not require solvents are usually preferred, as some solvents may induce toxicity due to residual solvents and are often considered to be damaging to the environment. The purpose of this review is to provide an update on recent innovations reported for using hot-melt extrusion and KinetiSol® Dispersing technologies to formulate poorly water-soluble APIs in amorphous solid dispersions. We will address development challenges for poorly water-soluble APIs and how these two processes meet these challenges.

show abstract

Section: In-line Process Monitoring Tools To Improve Processing Parammentioning

confidence: 99%

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

Tan

Davis

Miller³

et al. 2020

AAPS PharmSciTech

View full text Add to dashboard Cite

show abstract

“…It is difficult to use KF as an analytical method to analyze the time-dependent characteristics of water absorption since the analytic procedure is not simple and is destructive. On the other hand, NIRS has recently been used quantitatively in the quality control of pharmaceutical preparations, [9][10][11][12][13][14][15][16][17] quantification of active pharmaceutical ingredients or excipients, 12,15,16) and measurement of the water content in food, pharmaceutical, and industrial products. 9,10,[18][19][20]22) NIRS is more advantageous and user-friendly than KF as it is a simple, rapid, nondestructive analytical method.…”

Section: Regular Articlementioning

confidence: 99%

Measurement of the Water Content in Semi-solid Formulations Used to Treat Pressure Ulcers and Evaluation of Their Water Absorption Characteristics

Hoshino

Azuma

Yamada

et al. 2019

CHEMICAL & PHARMACEUTICAL BULLETIN

View full text Add to dashboard Cite

We investigated the water contents in commercial semi-solid preparations used for pressure ulcer (PU) treatment using near-IR spectroscopy (NIRS) and compared the results with those measured using the Karl Fischer (KF) method. The aim of this study was to determine a standard method and select the appropriate topical preparation with the optimal moisture for PU treatment. The water absorption properties of bases and formulations were evaluated with a time-dependent factor using Transwell as the model membrane. KF and NIRS were applicable as measurement methods of the water content in semi-solid formulations. NIRS was shown to be a useful, simple, nondestructive tool that is more advantageous than the KF method. The water absorption characteristics tested using Transwell revealed that the rate of and capacity for water absorption are determined not only by the absorption ability of the polymer base but also by other factors, such as the osmotic pressure exerted by additives. KF and NIR measurements can be used to choose external skin preparations to control the amount of water in PU treatment.

show abstract

“…e selected spectral scanning range was 12000-4000 cm − 1 , and the measured characteristics were the fundamental frequencies of molecular vibration, particularly the frequency doubling and combined frequency absorption bands of the stretching and bending vibration [36][37][38][39].…”

Section: Nir Spectral Featuresmentioning

confidence: 99%

An Approach to Rapid Determination of Tween-80 for the Quality Control of Traditional Chinese Medicine Injection by Partial Least Squares Regression in Near-Infrared Spectral Modeling

Chen

Zhang³

et al. 2019

Journal of Spectroscopy

View full text Add to dashboard Cite

This study established an approach to rapidly determine the Tween-80 in traditional Chinese medicine (TCM) injection by using near-infrared (NIR) spectroscopy. Totally 133 standard solutions of Tween-80 were prepared and randomly divided into calibration set and validation set, containing 109 and 24 samples, respectively. Spectral data were preprocessed and then subjected to establish a predictive model using partial least-squares (PLS). The standard error of cross validation (SECV), standard deviation of calibration (SEC), and the determination coefficient (R) of the established model were 0.0561, 0.0526, and 0.9986, respectively. The model was successfully applied to determine Tween-80 contents in 25 XBJ Injections and 40 FFSX Injections, and it produced satisfactory quantitative analysis results with average relative deviations 0.60% and 0.16%, respectively, for 25 XBJ Injections and 40 FFSX Injections, and the maximum relative deviations 8.57% and 7.60%, respectively. This work shows that NIR model displayed quite good predictive ability for Tween-80 quantitative analysis, which could potentially be applied to rapid determination of Tween-80 in the production process of TCM injections and other TCM products.

show abstract

Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note

Cited by 32 publications

References 8 publications

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

Measurement of the Water Content in Semi-solid Formulations Used to Treat Pressure Ulcers and Evaluation of Their Water Absorption Characteristics

An Approach to Rapid Determination of Tween-80 for the Quality Control of Traditional Chinese Medicine Injection by Partial Least Squares Regression in Near-Infrared Spectral Modeling

Contact Info

Product

Resources

About