Physico-Chemical Characterization of Paliperidone Palmitate and Compatibility Studies with its Pharmaceutical Excipients

Abstract

Aim: The main aim of the present study was to characterize and perform the compatibility studies of paliperidone with its excipients. Study Design: Physico-chemical characterization and compatibility studies. Place and Duration of the Study: Chalapathi Drug Testing Laboratory, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur-522034 between December 2020 and January 2021. Methodology: Physico-chemical characterization and compatibility studies of paliperidone palmitate with its excipients like HPMC, lactose, magnesium stearate, talc, microcrystalline cellulose was done using the FTIR spectrophotometer, Scanning electron microscopy, X-ray diffraction, Differential scanning calorimeter. Results: Interaction of the paliperidone palmitate with its excipients were studied by this technique. Paliperidone palmitate showed the transition at 117.920C with the specific heat of 101.9J/g. The IR spectrum of paliperidone palmitate and excipients mixture has shown a characteristic stronger band of the N-H at 3412.75cm-1, C-H at 2921.98 cm-1, stretching vibrations of C=O at 1737.47 cm-1, C=C at 1651.94 cm-1, N-O at 1541.16 cm-1 followed by C-F at 1160.46 cm-1. XRD showed good crystalline properties with relative crystallinity index of 60.01%. The photomicrographs obtained by SEM did not evidence any interaction between paliperidone palmitate and the excipients, providing visual support for the results. Conclusion: There were no interactions of drug with selected excipients and found to be compatible. Therefore, it is a mandatory clause for the compound compatibility with various excipients in the formulation which affect the stability and efficacy of the formulation.