Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy

A non-destructive NIR spectroscopic method was used to acquire on-line spectra of a continuous mixing process, and evaluate the performance of this novel system. Partial least squares (PLS) calibration models were developed and used for real-time determination of active ingredient concentration on t...

Full description

Saved in:
Bibliographic Details
Published inChemical engineering science Vol. 65; no. 21; pp. 5728 - 5733
Main Authors Vanarase, Aditya U., Alcalà, Manel, Jerez Rozo, Jackeline I., Muzzio, Fernando J., Romañach, Rodolfo J.
Format Journal Article
LanguageEnglish
Published Elsevier Ltd 01.11.2010
Subjects
Blends
Calibration
Chemical analysis
Drugs
Ingredients
Mathematical analysis
Mathematical models
Mixing
Near infrared spectroscopy
Particulate processes
Pharmaceuticals
Polymer blends
Powders
Spectroscopy
Near infrared spectroscopy
Particulate processes
Powders
Mixing
Chemical analysis
Pharmaceuticals
Online AccessGet full text

Cover

More Information
Summary:A non-destructive NIR spectroscopic method was used to acquire on-line spectra of a continuous mixing process, and evaluate the performance of this novel system. Partial least squares (PLS) calibration models were developed and used for real-time determination of active ingredient concentration on the blends produced with a continuous mixer. The NIR method was developed for concentrations ranging from 0 to 15% (w/w) of acetaminophen (APAP), the active pharmaceutical ingredient used in the experiments. The calibration model's overall accuracy was 0.41% (w/w), and estimated through the root mean square error of cross validation (RMSECV) for samples predicted using leave-class-out cross validation. In this cross validation, each concentration was defined as a class, and when a sample of a specific concentration was predicted all samples of that concentration were left out of the calibration model. The precision of the calibration model was also estimated at various concentration levels, to facilitate the differentiation between the variation in drug concentration due to the analytical method's measurement uncertainty and the variation in the drug distribution throughout the powder blend. The results obtained are very promising since in three of the five powder mixes, the variation in the drug concentration in the powder blends was similar to that of the analytical method indicating a high degree of blend homogeneity
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ISSN:0009-2509
1873-4405
DOI:10.1016/j.ces.2010.01.036