COMPATIBILITY STUDIES OF RASAGILINE MESYLATE WITH SELECTED EXCIPIENTS FOR AN EFFECTIVE SOLID LIPID NANOPARTICLES FORMULATION
Keywords:
Solid lipid nanoparticles, Rasagiline mesylate, Compatibility studies, Isothermal stress testing, Scanning electron microscopyAbstract
Objective: Compatibility study is an important element that should be performed at the early development stage of stable and effective solid dosage form.
Methods: The compatibility studies of drug with different polymers and surfactant were investigated by using different methods Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC) and Isothermal Stress Testing (IST). The compatibility study of Rasagiline mesylate was performed with Chitosan, Stearic acid and Poloxamer 407. Drug and polymer mixtures were prepared in 1:1 ratio and the compatibility study was performed at25°C±2/60%±5RHand 40°C±2/75%±5RHfor one month. The resulting compatible drug and excipients were used in the formulation of solid lipid nanoparticles by Microemulsion method.
Results: FTIR Spectroscopy results suggest that there is good compatibility between the drug and polymers. DSCresults showed that interaction between Rasagiline mesylate and Chitosan,the other excipients were compatible with RM and the IST study results clearly indicate the stable nature of the Rasagiline mesylate. The prepared RM-SLNs formulation shows a mean particle size within the nanometre range. SEM confirmed the size and shape of RM-SLNs. The results of zeta potential indicates a narrow size distribution. The RM-SLNs were found to be with acceptable morphometric properties, narrow size distribution, high entrapment efficiencyand good stability after 3 months of storage at different conditions (25°C±2/60%±5RH and 40°C±2/75%±5RH).
Conclusion: The FTIR, DSC and IST results shown that Stearic acid and Poloxamer 407were found to be compatible with Rasagilinemesylate. The Rasagiline mesylate loaded nanoscale solid lipid particles was successfully formulated with compatible excipients and it was found to be stable after accelerated stabilitystudies.
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References
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