Systematic identification of thermal degradation products of HPMCP during hot melt extrusion process
Karandikar, Hrushikesh M. Ambardekar, Rohan Kelly, Adrian L.
Karandikar, Hrushikesh M.
Ambardekar, Rohan
Kelly, Adrian L.
Publication Date
2015
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Keywords
Acetic acid, Benzoates, Chromatography, Drug compounding, Gas chromatography-mass spectrometry, Hot temperature, Magnetic resonance spectroscopy, Methylcellulose, Phthalic acids, Phthalic anhydrides, Spectrophotometry, Succinic acid, Thermogravimetry, Degradation products and mechanism, Hme, Hpmcas, Hpmcp, Thermal degradation
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Abstract
A systematic identification of the degradation products of hydroxypropyl methylcellulose phthalate (HPMCP) during hot melt extrusion (HME) has been performed. A reverse phase HPLC method was developed for the extrudates of both hydroxypropyl methylcellulose acetate succinate (HPMCAS) and HPMCP polymers to quantify their thermal hydrolytic products: acetic acid (AA), succinic acid (SA) for HPMCAS and phthalic acid (PA) for HPMCP, without hydrolysing the polymers in strong alkaline solutions. The polymers were extruded in the temperature range of 160-190 degrees C at different screw rotation speeds and hydrolytic impurities were analysed. Investigation of extruded HPMCP showed an additional thermal degradation product, who is structural elucidation revealed to be phthalic anhydride (PAH). Moreover, two environmental analytical impurities, dimethyl phthalate and methyl benzoate formed in situ were recorded on GC-MS and their origin was found to be associated with PAH derivatization. Using the experimental data gathered during this study, a degradation mechanism for HPMCP is proposed.
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Karandikar HM, Ambardekar R, Kelly AL et al (2015) Systematic identification of thermal degradation products of HPMCP during hot melt extrusion process. Internatioanl Journal of Pharmacology. 486(1-2): 252-258.
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