Thermal behavior and compatibility analysis of the new chemical entity LPSF/FZ4

• We determined the thermal behavior of isolated LPSF/FZ4.
• We used the isothermal and non-isothermal methods.
• We reported the time of the stability of LPSF/FZ4 was measured in 4 months.
• We also performed a compatibility study associated with excipients.
• We reported the possible interactions of the prototype with lactose.

In this study, differential scanning calorimetry and thermogravimetry were employed to determine the thermal behavior of LPSF/FZ4 isolated and associated with excipients (amide, β-cyclodextrin, cellulose, lactose, stearate of magnesium, aerosil, sodium lauryl sulfate, polysorbate and polyvinylpyrrolidone). Thus, the purity of the prototype calculated was 98%. Isothermal and non-isothermal methods were used to determine the kinetic parameters of decomposition, finding a first-reaction order and activation energy (Ae) of 98.22 kJ mol−1. Also, the time of the stability of LPSF/FZ4 was measured in 4 months. The compatibility study showed possible interactions of the prototype with lactose due to a change in its heat of fusion, a reduction of more than 40 °C in its stability and a reduction of approximately 30% in Ae of its decomposition reaction. The study demonstrated the importance of using thermal analytical methods to characterize new drugs to enable the development and quality control of pharmaceutical products.