Stability study of famotidine effervescent tablets prepared by a separated granulation technique

Abstract

Famotidine is a highly selective H2-​receptor antagonist widely used in the treatment and prevention of peptic ulcer disease. Famotidine effervescent tablets (ET) with acceptable taste and phys. properties and rapid disintegration time were prepd. by wet granulation using peppermint, tutti frutti or caramel as flavoring agents. Aiming for the prodn. of more stable ET; the formula contg. tutti frutti, which has the most acceptable taste, was chosen to prep. ET utilizing a modified wet granulation technique. This involves the prodn. of two sepd. granulations; one contg. the acidic ingredients with the drug, and the other contg. the basic ones. The stability of the two prepd. formulations, at room temp. (25°)​, were also studied by storing each formula inside three different packaging systems. The first inside a plastic bottle alone, the second were wrapped in aluminum foil while in the third one, the bottle included a desiccant. The decrease in the disintegration time values upon aging was detected as a parameter for the ET stability. The stability study revealed that; tablets prepd. by sepd. granulation showed a pronounced enhancement of stability without significant difference between each of the three packaging systems. Whereas, tablets stored in plastic bottles after wrapping in aluminum foil including a desiccant showed the best stability results for total granulation technique. This indicates fewer requirements of special packaging for tablets prepd. by the promising sepd. granulation method.