Title : Development and characterization of a dual-drug loaded intranasal suspension for potential treatment in multiple sclerosis
Abstract:
Objective: Current multiple sclerosis therapies primarily target inflammation but fail to repair neurodegeneration. Fingolimod offers potent immunomodulation, while clemastine promotes remyelination. However, oral administration is limited by systemic toxicity and poor CNS bioavailability. This study developed a novel intranasal nanosuspension co-loading fingolimod hydrochloride (FTY) and clemastine fumarate (CF) to bypass the blood-brain barrier. The objective was to utilize the olfactory pathway for synergistic immunomodulation and myelin repair while minimizing the systemic adverse effects associated with oral therapy.
Methods: A dual-drug intranasal suspension containing fingolimod hydrochloride and clemastine fumarate was formulated and optimized. A simultaneous RP-HPLC method was developed and validated for drug quantification. Physicochemical characterization included FTIR and NMR for compatibility, XRD for crystallinity, and TEM for particle morphology.
Results: A simultaneous RP-HPLC method was developed and validated for the estimation of FTY and CF, showing high linearity and precision. This method was successfully applied to the in vitro drug assay, yielding robust entrapment efficiency and drug loading. Physicochemical characterization via FTIR and DSC confirmed drug-excipient compatibility, while XRD diffractograms indicated the amorphous state of the drugs within the matrix. Morphological evaluation by SEM and TEM revealed uniform, spherical particles, confirming the structural integrity and suitability of the suspension for olfactory-mediated delivery.
