NOVEL ORAL MEDICATION DELIVERY SYSTEM FOR FAMOTIDINE

A famotidine wafer that rapidly disperses on the tongue without water is a novel alternative to other histamine(2) (H-2)-antagonist dosage f orms. Benefits associated with such a dosage form include convenience and potentially improved compliance for patients who dislike or have d ifficulty taking tablets and capsules. This report describes the resea rch of three studies on the famotidine wafer dosage form. In the first trial, the bioequivalence and tolerability of the new 40-mg famotidin e wafer and the marketed 40-mg famotidine tablet were studied in a 2-p eriod crossover study (n = 18). The two formulations were bioequivalen t as assessed by area under the plasma concentration versus time curve and maximum plasma concentration of famotidine. The plasma concentrat ion of famotidine associated with 50% inhibition of pentagastrin stimu lated gastric acid secretion (EC(50); 10 ng/mL) was attained on averag e within 0.5 hours post-dose for the wafer and tablet. In a second tri al, the tolerability of the famotidine 20-mg and 40-mg wafers or place bo given twice daily (bid) for 14 days were evaluated (n = 192). Both wafer strengths were well and equally tolerated. In a third trial of 4 50 subjects, the 40-mg wafer was preferred over tablets by 75% of the subjects, when they were asked to consider the method of administratio n and paver. When used as an alternative to tablets and other conventi onal dosage forms, the wafers have the potential therapeutic benefit o f improved compliance. It is concluded that similar systemic exposure, excellent tolerability, palatability, and preference make the famotid ine wafer a clinically acceptable and convenient dosage form for patie nts on H-2-antagonist therapy.