[Pharmaceutical technology of Grandaxin]

The physical chemical properties, stability and incompatibility of tofizopam (the active ingredient of Grandaxin tablet) were investigated. Tofizopam has low water solubility therefore experiments were made to increase it. The behaviour of tofizopam in acidic medium was studied and the degradation rates of it were determined at different pH. The composition of Grandaxin tablet contains well established excipients. The granulation can be made by high shear and fluidized bed process as well. The properties of tablets (strength, friability, disintegration, dissolution) are independent from the granulation process. The scaling up of the technology and the commercial production of the tablets are managed successfully.