Determination of Water Penetration and Drug Concentration Profiles in HPMC-Based Matrix Tablets by Near Infrared Chemical Imaging

This work describes methodologies based on near infrared chemical imaging (NIR CI) and chemometric data analysis for studying hydration behaviors of prolonged release tablets, which contain a high solubility drug at high load and a hydrophilic polymer hydro-xypropylmethylcellulose (HPMC). Hydration...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2010-07, Vol.99 (7), p.3081-3088
Main Authors: Li, Weiyong, Woldu, Abraham, Araba, Lola, Winstead, Denita
Format: Article
Language:English
Subjects:
Biological and medical sciences
controlled release
Delayed-Action Preparations - chemistry
General pharmacology
hydration
hydrogels
Hypromellose Derivatives
image analysis
Least-Squares Analysis
Medical sciences
Methylcellulose - analogs & derivatives
Methylcellulose - chemistry
near infrared spectroscopy
partial least squares
Pharmaceutical Preparations - administration & dosage
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Principal Component Analysis
Solubility
Spectroscopy, Near-Infrared - methods
Tablets - chemistry
Water - chemistry
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Summary:This work describes methodologies based on near infrared chemical imaging (NIR CI) and chemometric data analysis for studying hydration behaviors of prolonged release tablets, which contain a high solubility drug at high load and a hydrophilic polymer hydro-xypropylmethylcellulose (HPMC). Hydration studies were performed by suspending the tablets in water at ambient temperature. The hydrated tablets were then dissected and scanned by NIR CI. Single wavelength images were obtained for accurately measuring radial dimension of the gel layer and size of the tablet core. By performing a principal component analysis (PCA), the phenomenon of polymer phase transition from the glassy state to rubbery state was detected and visualized. Partial least squares (PLS) models were created for quantitative analysis of the active pharmaceutical ingredient (API) and relative concentration of water in the hydrated tablets. The API concentration profiles are suitable for defining the swelling front in hydrated tablets. Because the NIR CI results are pixel-specific and each pixel has its unique coordinates, it is feasible to analyze and present the results according to spatial locations. The physical and chemical changes at the swelling/diffusion fronts can be demonstrated by overlaying the PCA and PLS results, which shed light on the release mechanism. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:3081-3088, 2010
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.22084