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.