ABSTRACT

Melt granulation is a size enlargement process in which the addition of a binder that melts or softens at relatively low temperatures (about 60^o C) is used to achieve agglomeration of solid particles in the formulation. The process utilizes materials that are effective as granulating agents when they are in the softened or molten state. This process can be used for the preparation of sustained released dosage forms by using lipophilic polymers, such as glycerol monostearate, a combination of a hydrophobic material such as a starch derivative and stearic acid. It also can be used to prepare fast release melt granules by utilizing water-soluble polymers and surfactants, such as PEG and poloxomers. Melt granulation is one of the most widely applied processing techniques in the array of pharmaceutical manufacturing operations.