Effect of Molecular Weight, Temperature, and Additives on the Moisture Sorption Properties of Polyethylene Glycol

Polyethylene glycol (PEG) is a hygroscopic polymer that undergoes the phenomenon of deliquescence once a critical relative humidity (RH0) is reached. The purpose of this study was to test the hypothesis that the deliquescence behavior of PEG will be affected by the polymer molecular weight, temperat...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2010-01, Vol.99 (1), p.154-168
Main Authors: Baird, Jared A., Olayo-Valles, Roberto, Rinaldi, Carlos, Taylor, Lynne S.
Format: Article
Language:English
Subjects:
Adsorption
Biological and medical sciences
Chemical Phenomena
Chromatography, Gel
deliquescence
Drug Carriers - chemistry
Drug Stability
Excipients - chemistry
General pharmacology
Humidity
Medical sciences
Microscopy
mixtures
moisture
Molecular Weight
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
polyethylene glycol
Polyethylene Glycols - chemistry
Steam
Temperature
Water - chemistry
X-Ray Diffraction
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Summary:Polyethylene glycol (PEG) is a hygroscopic polymer that undergoes the phenomenon of deliquescence once a critical relative humidity (RH0) is reached. The purpose of this study was to test the hypothesis that the deliquescence behavior of PEG will be affected by the polymer molecular weight, temperature, and the presence of additives. The deliquescence relative humidity for single component (RH0) and binary mixtures (RH0,mix) were measured using an automated gravimetric moisture analyzer at 25 and 40°C. Changes in PEG crystallinity after exposure to moisture were qualitatively assessed using powder X-ray diffraction (PXRD). Optical microscopy was used to visually observe the deliquescence phenomenon. For single component systems, decreasing PEG MW and elevating the temperature resulted in a decrease in the observed RH0. Physical mixtures of acetaminophen and anhydrous citric acid with both PEG 3350 and PEG 100,000 exhibited deliquescence (RH0,mix) at a relative humidity below that of either individual component. Qualitative changes in crystallinity were observed from the X-ray diffractograms for each PEG MW grade at high relative humidities, indicating that phase transformation (deliquescence) of the samples had occurred. In conclusion, it was found that the deliquescence behavior of PEG was affected by the polymer MW, temperature, and the presence of additives. This phenomenon may have important implications for the stability of PEG containing formulations. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:154–168, 2010
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.21808