Thermal behavior of verapamil in pure and in solid dosage forms

Duda-Seiman, Corina; Vlase, Gabriela; Vlase, Gabriela; Cinca, Rodica; Anghel, Mariana; Doca, N.

doi:10.1007/s10973-011-1460-6

Cited by 5 publications

(1 citation statement)

References 16 publications

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“…For the rapid and accurate evaluation of the possible compatibility of APIs with excipients and therefore selecting excipients with suitable compatibility, a variety of techniques have been used, including thermal methods of analysis, i.e., differential scanning calorimetry (DSC), differential thermal analysis (DTA), and thermogravimetry (TG) as well as hot stage microscopy (HSM), Fourier transform infrared spectroscopy (FTIR), X-ray powder diffraction (XRPD), and scanning electron microscopy (SEM) [3][4][5][6][7]. Among these techniques, thermoanalytical methods have been increasingly used for evaluating compatibility through comparison of thermal curves of API alone with those of physical mixtures containing API and excipients.…”

Section: Introductionmentioning

confidence: 99%

Thermogravimetric detection of incompatibilities between atenolol and excipients using multivariate techniques

Wesołowski

Rojek

2013

J Therm Anal Calorim

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The purpose of this research study was evaluation of the utility of two common multivariate techniques, agglomerative cluster analysis (CA) and principal component analysis (PCA), as supplementary means of detecting incompatibilities, which can occur between active pharmaceutical ingredients and excipients at the preformulation stage of a solid dosage form. For the detection of incompatibilities between atenolol (beta blocker) and selected excipients (mannitol, lactose, starch, methylcellulose, b-cyclodextrin, meglumine, chitosan, polyvinylpyrrolidone and magnesium stearate), the thermogravimetry (TG), differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) were chosen. The results have shown that compatibility between atenolol and an excipient can be identified in a CA dendrogram by two large clusters, from which one groups an excipient and physical mixtures with a high concentration of the excipient. Another cluster encompasses atenolol and mixtures with a high content of the drug. In the PCA plot, all samples are located along the first principal component axis (PC1), beginning from a single component located with the most negative PC1 value, through mixtures with gradually varying concentration of both ingredients, till the second component located close to the most positive PC1 values. The results have shown that CA and PCA fulfil their role as supporting techniques in the interpretation of the data acquired from the TG curves, and the obtained data are compatible with the results of DSC and FTIR analyses.

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