Development and Preclinical Testing of Nasal Aerosol for the Delivery of Novel Spray Dried Polyherbal Formulation to Treat Alzheimer’s Disease
Alzheimer’s disease (AD) is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and eventually the ability to carry out the simplest tasks. The present investigation was undertaken to evaluate anti-alzheimer’s activity of novel herbal aerosol spray formulation containing pure extracts of Curcuma longa, Commiphora wightii and Withania somnifera.Pressurized aerosol packs containing polyherbal spray dried dispersions in the concentration range of 0.5, 1 and 2% w/v dispersed in 10/90, 20/80, 30/70/ 40/60, 50/50) propellant blends of HFA-134a were developed in 3 in 1 aerosol filling machine and evaluated. Behavioural studies were performed in male wistar rats and histopathological studies were performed. The preparations were also assessed for AChE inhibitory activity. Results with P values < 0.05 were considered statistically significant. Chitosan exhibited compatibility with the polyherbal extracts in FT-IR studies. DSC thermogram revealed an endothermic peak of 65ᵒC with chitosan. Spray dried poly herbal extracts exhibited a spherical morphology particle size distribution of 5-50µm with a practical yield of 20-30%. Aerosol formulations exhibited a particle size range below 10µm. average weight per actuation of canister was 7-8mg with a total 210 deliveries per pack. Zeta potential of the formulations was ±0.997. HPTLC fingerprinting showed band ranges at 256 and 366nm. The optimized aerosol spray in behavioral tests exhibited 10mg/kg and 20mg/kg intranasally reversed the scopolamine induced amnesia. Histopathological findings showed decreased Ach activity in male albino wistar rats. Percentage inhibition of formulation and standaed on AChE activity shoed an IC50 of 62% for 10mg/kg aerosol spray and 72% with 20mg/kg aerosol spray dosing.
Keywords: alzhiemer’s disease; herbal; spray dried chitosan; aerosol; nasal spray;
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