Čes. slov. farm. 2010, 59(2):51-58

Manufacture of granulates containing high potency drugs

A. Franc^*, M. Rabišková

Veterinární a farmaceutická univerzita Brno, Farmaceutická fakulta, Ústav technologie léků

Granulation is one of the most widely spread technological procedures in the manufacture of solid oral dosage forms. With regard to the safety of work in the manufacture of tablets containing highly potent active ingredients, devices with a closed construction which during the process of manufacture prevent contamination of the surroundings and decrease health risk for the personnel are more widely used. They include one-step high-speed granulators, fluid granulators and integrated granulating systems connecting high-speed granulation with fluid drying. These devices make it possible to automate the whole process and they are equipped with automatic cleaning. The individual technologies possess certain advantages as well as disadvantages. When considering installation of these devices, it is necessary to evaluate not only the processual parameters such as robustness, length of process, easy maintenance, easy cleaning, and technological background, and also take into consideration the decisive qualitative requirements for the drug in detail. In granulates, they include primarily such parameters as density, flow properties and distribution of particle size, and in tablets, besides routine quality indices, also mechanical endurance and dissolution.

Keywords: one-step granulation; granulation units; high potency drugs; safety

Received: February 25, 2009; Accepted: March 4, 2010; Published: February 1, 2010  Show citation