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dc.contributor.authorKarandikar, Hrushikesh M.*
dc.contributor.authorAmbardekar, Rohan*
dc.contributor.authorKelly, Adrian L.*
dc.contributor.authorGough, Timothy D.*
dc.contributor.authorParadkar, Anant R.*
dc.date.accessioned2016-09-21T15:40:14Z
dc.date.available2016-09-21T15:40:14Z
dc.date.issued2015
dc.identifier.citationKarandikar 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.
dc.identifier.urihttp://hdl.handle.net/10454/9170
dc.descriptionNo
dc.description.abstractA 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.
dc.relation.isreferencedbyhttp://dx.doi.org/10.1016/j.ijpharm.2015.04.007
dc.subjectAcetic acid
dc.subject; Benzoates
dc.subject; Chromatography
dc.subject; Drug compounding
dc.subject; Gas chromatography-mass spectrometry
dc.subject; Hot temperature
dc.subject; Magnetic resonance spectroscopy
dc.subject; Methylcellulose
dc.subject; Phthalic acids
dc.subject; Phthalic anhydrides
dc.subject; Spectrophotometry
dc.subject; Succinic acid
dc.subject; Thermogravimetry
dc.subject; Degradation products and mechanism
dc.subject; Hme
dc.subject; Hpmcas
dc.subject; Hpmcp
dc.subject; Thermal degradation
dc.titleSystematic identification of thermal degradation products of HPMCP during hot melt extrusion process
dc.status.refereedYes
dc.typeArticle
dc.type.versionNo full-text in the repository


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