Process for manufacturing a pharmaceutical chewing gum

Abstract

The present invention provides a process for preparing a chewing gum tablet, in which a chewing gum composition is cooled to a temperature at which the composition is brittle, and the composition is ground while brittle to form a fine powder. In a preferred process, the composition is cooled by mixing with a coolant, such as solid carbon dioxide, and the mixture is ground to a powder. The powder can be mixed with a pharmaceutical active ingredient capable of topical absorption in the buccal cavity or in the mucous layer of the upper or lower intestinal tract, and formed into a tablet. Preferably, the mixture of the powder, pharmaceutical active ingredient, and other additives such as coating agents, binders, additional active ingredients, and sweeteners, are granulated in a fluidized bed granulator prior to forming the mixture into a tablet. The resulting tablet provides a dosage form of the pharmaceutical active ingredient having a more accurate and uniform dose of the active ingredient.