Abstract
The drug-excipient compatibility study of quetiapine fumarate, with widely used sustained release excipients, was carried out employing differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR). The selected excipients were HPMC K100M, sodium alginate, xanthan gum, Eudragit RSPO, hydrogenated castor oil, carnauba wax, and PEO WSR 303. Equal proportion of drug and excipients was utilized in the interaction study. FT-IR spectra indicated the absence of interaction between drug and excipients. The DSC curve showed a sharp endothermic melting peak at 173.26 °C for quetiapine fumarate. Post melting interaction was observed for carnauba wax, Eudragit RSPO, and hydrogenated castor oil probably due to solubilization of drug in the melted excipient. No interaction was observed for other excipients. The physical mixtures stored at 30 ± 2 °C/65 ± 5% RH did not show any significant degradation of the drug. The concept of systemically conducted preformulation studies will facilitate dossier submission to the drug control authority.
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Acknowledgements
The authors are thankful to Amneal Pharmaceutical India Pvt. Ltd. for providing gift sample of quetiapine fumarate. The authors are also thankful to Alembic Ltd. and Cadila Pharmaceuticals Ltd. for donating excipients.
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Gohel, M.C., Patel, T.M. Compatibility study of quetiapine fumarate with widely used sustained release excipients. J Therm Anal Calorim 111, 2103–2108 (2013). https://doi.org/10.1007/s10973-012-2467-3
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DOI: https://doi.org/10.1007/s10973-012-2467-3