The present invention is directed to a process for the large-scale manufacture of an antifungal nail lacquer, for the use in the treatment of fungal nail infections. According to the process, the antifungal nail lacquer is produced by homogenisation of the active ingredient amorolfine hydrochloride, solvent(s), plasticizer and a bioadhesive/release polymer, using two distinct dissolution stages which are carried out at below approximately 20 degrees C. In a first dissolution stage, the active ingredient and excipients (excluding the bioadhesive/release polymer) are homogenised at high shear to form a clear homogenous solution and then in a second dissolution stage, the bioadhesive/release polymer is added and blended with the clear homogenous solution using a paddle mixer to form a clear lacquer solution. By using two distinct dissolution stages, complete mixture of all the ingredients is achieved.
