Chewable fexofenadine tablets

Abstract

This disclosure is also based on the discovery that it is possible to eliminate the sweetener from a fexofenadine zwitterion dihydrate suspension and still achieve satisfactory taste masking by including the sweetener solely in the external phase. In addition, this disclosure is based on the discovery that it is possible to use an inert matrix containing only mannitol when turning suspensions of fexofenadine zwitterion dihydrate into granules. Accordingly, this disclosure is directed to sugar-free chewable fexofenadine tablets comprising sprayed and dried fexofenadine granules comprising a mannitol matrix and a composition devoid of a sweetener, said composition comprising fexofenadine zwitterion dihydrate, a wetting agent, a binder, an alkalizing agent, and a buffer; and an external phase comprising a flavoring agent, a disintegrant, the wetting agent, a diluent, a sweetener, and one or more lubricant. The disclosure also includes methods of making these tablets. In one embodiment, the method of producing a sugar-free chewable fexofenadine tablet includes: generating fexofenadine granules by spraying and drying a liquid fexofenadine suspension devoid of a sweetener comprising fexofenadine zwitterion dihydrate, a wetting agent, a binder, an alkalizing agent, and a buffer onto a mannitol matrix; and compressing the fexofenadine granules with an external phase comprising a flavoring agent, a disintegrant, the wetting agent, a diluent, a sweetener, one or more lubricant.