An orodispersable tablet of
spironolactone for
oral administration is disclosed comprising 10-30%w / w
spironolactone or pharmaceutically acceptable salts thereof, at least one
diluent, and one or more pharmaceutically acceptable
excipient, wherein the tablet can disintegrate in the oral / buccal cavity upon contact with
saliva in less than 3 minutes, preferably in less than 2 minutes. The tablet preferably comprises
spironolactone or pharmaceutically acceptable salts thereof, at least one
diluent, a disintegrant, a binder, a solubilizer, a
lubricant, and one or more pharmaceutically acceptable excipients. A preferred formulation comprises 10-30%w / w spironolactone, 40-80%w / w combination of
microcrystalline cellulose and
maize starch, 0.5-15%w / w crospovidone, 1-10%w / w povidone / polyvidone /
polyvinylpyrrolidone, 0.01-1%w / w
polysorbate, 0.1-8%w / w
magnesium stearate, 0.1-8%w / w colloidal
anhydrous silica, and 0.05-3.5%w / w
sodium saccharin. The
orodispersible tablet of spironolactone or pharmaceutically acceptable salts thereof is formulated for acceptable
palatability and taste-masking of the bitter
drug in order to enhance
patient compliance, especially among paediatric and geriatric individuals with
dysphagia. The
orodispersible tablet of spironolactone may be manufactured by a wet
granulation method. A method of preparing an orally dispersable pharmaceutical composition of spironolactone is also outlined.