Fekete P
Acta Pharm Hung. 1993 Mar;63(2):67-78.
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.
对托非索泮（格兰迪新片的活性成分）的物理化学性质、稳定性和不相容性进行了研究。托非索泮的水溶性较低，因此进行了提高其水溶性的实验。研究了托非索泮在酸性介质中的行为，并测定了其在不同pH值下的降解速率。格兰迪新片的组成含有成熟的辅料。制粒也可通过高剪切和流化床工艺进行。片剂的性质（强度、脆碎度、崩解、溶出）与制粒工艺无关。该技术的放大和片剂的商业化生产均成功实现。
