An oral aerosol via buccal cavity is an attracting site to reach the drug into the systemic circulation bypassing first pass metabolism and improve bioavailability of drug, such as erectile dysfunctioning, angina, migraine, etc. Oral aerosol is incorporating drug into their affected area without first pass metabolism and improve bioavailability. Various combination of drug can also be incorporated to enhance the effectiveness of the therapy. Such kind of delivery system has following advantages such as, dose reduction, less side effect, improved patient compliance and convenience. In the present investigation, a novel formulation of oral aerosol of vardenafil for the treatment of erectile dysfunctioning was developed. Oral aerosol of Vardenafil was prepared using the formula: Vardenafil as a drug, ethanol as a co-solvent, propylene glycol as a viscosity builder, peppermint oil as a flavoring agent, liquefied petroleum gas as a propellant. Formulation was performed in two stages. The first stage i.e. drug concentrate preparation was carried out by generalized procedures of simple mixing. All the ingredients except the propellant were mixed thoroughly in required quantities. The second step i.e. propellant filling was carried out using pressure filling technique. The concentrate was added to the container at room temperature, and the valve was crimped in place. The propellant was then added through the valve. Valve crimping and propellant filling was carried out by two different machines i.e. semi automatic valve crimping and semi automatic propellant filling machine respectively. The prepared oral aerosol of vardenafil was subjected to evaluation parameters such as leak test, flammability, density, valve discharge rate, spray pattern, spray angle and dose uniformity, ex-vivo transmucosal drug diffusion study and stability study. The results were obtained within satisfactory ranges. The optimization was carried out based on two parameters i.e. spray patt
