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Abstract
Thermal analysis and quantitative characterization were done to evaluate the compatibility between DIF and various solid lipids explored like Compritol ATO 888, cetyl palmitate; CP, stearic acid; SA, glyceryl monostearate; GMS and hydrogenated castor oil. Till date, there are no reports on evaluation of DIF-lipid excipient compatibility. The techniques employed were differential scanning calorimetry; DSC, Fourier transform infrared spectroscopy; FTIR, optical microscopy, X-ray powder diffraction; XRPD studies and isothermal stress testing studies; IST. The results of DSC studies depicted displacement of DIF melting peak in binary mixtures suggesting some interaction between them. However, during IST studies less than 2% change in drug content was observed in all stressed samples of binary mixtures. Hence, the results demonstrated that all the selected solid lipids were compatible with DIF. Further, final SLN formulation was stable for 3 months. In conclusion, DSC and IST techniques were successfully employed to evaluate the DIF-lipid excipient compatibility.
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