Rapid ESI–MS method for examining the thermal decomposition of pharmaceuticals

Zhou, Wenjia; Gilpin, R. K.

doi:10.1002/jps.20082

Cited by 17 publications

(10 citation statements)

References 15 publications

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“…In the latter instance, it was noted that the NH bands did not change, which is inconsistent with the spectra that appear in the manuscript. Moreover, these drugs are not stable and products of its decomposition can enhance undesirable effects [41]. However, in formulations, cyclodextrins can be used to increase both the stability and solubility of mefenamic acid [42] and tolfenamic acid [43].…”

Section: Introductionmentioning

confidence: 99%

Infrared studies of the polymorphic states of the fenamates

Gilpin

Zhou

2005

Journal of Pharmaceutical and Biomedical Analysis

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Section: Introductionmentioning

confidence: 99%

Infrared studies of the polymorphic states of the fenamates

Gilpin

Zhou

2005

Journal of Pharmaceutical and Biomedical Analysis

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“…These results are in agreement with the observations reported by Zhou and Gilpin. 34 The authors reported that when MFA was dissolved in a mobile phase consisting of methanol-water (80:20 v/v) and subjected to thermal decomposition between 130 and 230 C by rapid ESI-MS method, MFA was converted to MFA-H þ which was completely converted to the final decomposition fragment at m/z 224 at a temperature of 230 C. In the present study, however, only 4.3% degradation was observed at 230 C. This was possibly due to the nature of the sample where MFA was present in the solid form rather than a molecularly dispersed form as reported by Zhou and Gilpin. 34 Also, the time scale of thermogravimetric analysis was a magnitude of minutes, whereas, in the case of rapid ESI-MS, it was hours that provided sufficient time and energy for the degradation of MFA.…”

Section: Thermal Analysis Of Mefenamic Acidmentioning

confidence: 99%

Application of Thermodynamic Phase Diagrams and Gibbs Free Energy of Mixing for Screening of Polymers for Their Use in Amorphous Solid Dispersion Formulation of a Non-Glass-Forming Drug

Mamidi

Rohera

2021

Journal of Pharmaceutical Sciences

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The objective of the present investigations was to assess the use of thermodynamic phase diagrams and the Gibbs free energy of mixing, DG mix , for the screening of the polymeric carriers by determining the ideal drug-loading for an amorphous solid dispersion formulation and optimum processing temperature for the hot-melt extrusion of a non-glass-forming drug. Mefenamic acid (MFA) was used as a model nonglass-forming drug and four chemically distinct polymers with close values of the solubility parameters, viz. Kollidon® VA64, Soluplus®, Pluronic® F68, and Eudragit® EPO, were used as carriers. The thermodynamic phase diagrams were constructed using the melting point depression data, Flory-Huggins theory, and Gordan-Taylor equation. The Gibbs free energy of mixing was estimated using the values of the drug-polymer interaction parameter, c, and Flory-Huggins theory. The rank order miscibility of MFA in the four polymeric carriers estimated based on the difference in the values of their solubility parameters, Dd, did not correlate well with the thermodynamic phase diagrams and Gibbs free energy plots. The study highlights the limitation of using the solubility parameter method in screening the polymeric carriers for poorly glass-forming drugs and reiterates the applicability of thermodynamic phase diagrams and Gibbs free energy plots in determining the ideal drug-loading and optimum processing temperature for hot-melt extrusion.

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“…In this last study, the pyrolysis products were extracted and analyzed by MALDI-MS and it was hypothesized that the amino acid chains undergo dehydration through the formation of cyclic oligopeptides. In addition, the use of ESI-MS for the analysis of nonvolatile pyrolysis products was demonstrated with the pyrolysis of dimethylamphetamine [13] and the analysis of thermal decomposition of three common pharmaceuticals: acetaminophen, indomethacin, and mefenamic acid [14]. In all these studies, however, sample preparation was required and involved dissolving and extracting the non-volatile residues with appropriate solvents (ESI) or mixing with matrices (MALDI).…”

Section: Introductionmentioning

confidence: 98%

On-probe pyrolysis desorption electrospray ionization (DESI) mass spectrometry for the analysis of non-volatile pyrolysis products

Zhang¹,

Shin²,

Mayer³

et al. 2007

Journal of Analytical and Applied Pyrolysis

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An on-probe pyrolyzer has been constructed and interfaced with Desorption Electrospray Ionization (DESI) Mass Spectrometry (MS) for the rapid analysis of non-volatile pyrolysis products. The detection and analysis of non-volatile pyrolysis products of peptides, proteins and the synthetic polymer poly(ethylene glycol) are demonstrated with this instrument. The on-probe pyrolyzer can be operated off-line or on-line with the DESI source and was interfaced with a tandem MS (MS/MS) instrument, which allowed for structure characterization of the non-volatile pyrolytic products. Advantages of this system are its simplicity and speed of analysis since the pyrolysis is performed in situ on the DESI source probe and hence, it avoids extraction steps and/or the use of matrices (e.g., as in MALDI-MS analyses).

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Rapid ESI–MS method for examining the thermal decomposition of pharmaceuticals

Cited by 17 publications

References 15 publications

Infrared studies of the polymorphic states of the fenamates

Infrared studies of the polymorphic states of the fenamates

Application of Thermodynamic Phase Diagrams and Gibbs Free Energy of Mixing for Screening of Polymers for Their Use in Amorphous Solid Dispersion Formulation of a Non-Glass-Forming Drug

On-probe pyrolysis desorption electrospray ionization (DESI) mass spectrometry for the analysis of non-volatile pyrolysis products

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