Single process for manufacturing spheres with a lipid base (HCO)

Abstract

Pellets and spheres are manufactured in the pharmaceutical industry by various processes which are not always easily automated. In this paper, a ‘single pot process’ is described using rotary fluid bed granulation with lipid fillers. This technology is based on wet granulation of powder components, continuously suspended in a fluidized air with a tangentially sprayed liquid solution. After a previous work devoted to selection of matrix filler, this work focuses on lipid component: hydrogenated castor oil, used as matrix filler associated with theophylline as tracer. Spheres manufactured can be introduced either directly into a hard gelatine capsule or compressed as tablets. The influence of the formulation and process parameters on the sphere manufacture in terms of feasibility is studied with in vitro tests. Spraying time and weight of liquid sprayed are found to be the most relevant parameters that governed the final quality of the sphere.

Keywords::

• Lipid spheres
• fluid bed spheronization
• rotor process
• hydrogenated castor oil
• Theophylline
• in vitro studies