[Controlled release of pseudoephedrine HCl from pellets].

This study describes the development work on a dosage form, which should release the drug pseudoephedrine HCl over twelve hours. Pellets were chosen as the dosage form. The pellets contained 20, respectively, 45 percent pseudoephedrine HCL and were produced using a high shear mixer-granulator. These pellets were coated in a fluidized bed and in a high shear mixer-granulator equipped with a microwave drying installation. The results of the experiments indicate that it is possible to produce pellets in a high shear mixer-granulator. Strong pellets with a narrow size distribution were obtained. A high shear mixer-granulator appears, therefore, to be a valuable alternative to the more commonly used pellet-forming technique of extrusion-sphere formation. The pellets could be coated as well in a fluidized bed as in a high shear mixer-granulator equipped with a microwave drying installation. A major advantage of the high shear mixer-granulator equipped with a microwave drying installation is the possibility to perform several unit operations such as mixing, pellet formation drying, and coating in one piece of equipment. With respect to the requirement of getting a release of pseudoephedrine HCl over twelve hours, the pellets containing 20 percent pseudoephedrine HCl fulfilled this requirement. For pellets containing 45 percent pseudoephedrine HCl it appears to be hard to obtain a sufficient delay in release using the commonly used coating formulations. This can be attributed to the very good solubility of pseudoephedrine HCl in water. Optimization of the coating formulation by changing the nature and concentration of the plasticizer may solve the problem.