Clonidine HCl is a drug of choice for long term hypertension. The objective of the present work was to develop and evaluate a metered dose transdermal spray (MDTS) formulation for transdermal delivery of Clonidine HCl. Trial batches were prepared and evaluated to check feasibility of Clonidine HCl for transdermal delivery. Final batches were prepared using central composite design comprising of Clonidine HCl, Octyl salicylate, propylene Glycol and Iso propyl alcohol. Prepared Clonidine HCl Transdermal Spray formulations were evaluated for evaporation time, pH, vapour pressure, spray pattern, spray angle, drug content, profiling of the spray characteristics, average weight per metered dose, in-vitro release study, and Ex-vivo permeation study was carried out using rat abdominal skin. Skin irritation study was performed by modified draize test using albino rats for optimized formulation and optimized formulation was kept for accelerated stability study as per ICH guidelines. Absence of any physical and chemical incompatibility in preformulation and compatibility study indicated that Clonidine HCl was compatible with container closure system and with excipients. All formulations were evaluated for different evaluation tests and results were found in acceptable limits. Optimized formulation was obtained by experimental data analysis. In Ex-vivo permeation study drug release of 300 mcg achieved from optimized formulation at the end of 24 hours and it followed higuchi kinetic release model. Optimized formulation was further proved non-irritant and found stable in accelerated stability study. The result obtained showed that the Clonidine HCl metered dose transdermal spray formulation can be an innovative and promising therapeutic system.
Loading....