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Ranitidine effervescent tablets

Description:
BACKGROUND OF THE INVENTION
The present invention relates to effervescent ranitidine formulations. More particularly, the present invention relates to a composition, preferably a tablet, containing ranitidine base or ranitidine hydrochloride as the active ingredient, and an effervescent couple. The effervescent couple comprises disodium citrate and sodium bicarbonate. Upon placing the ranitidine tablet in water, a pleasantly flavored ranitidine-containing liquid is produced which is suitable for oral administration.
Ranitidine is generally available as its physiologically acceptable salt, more specifically, Form 2 ranitidine hydrochloride, as uncoated or film coated tablets for oral use. It is also available in the form of a syrup for oral administration. The syrup contains flavorants which mask the unpleasant taste of ranitidine.
It is desirable to make ranitidine available as an effervescent composition, particularly as an effervescent tablet since such a tablet provides many of the advantages of both a tablet and a liquid formulation. Among the benefits of an effervescent tablet are the following:
a. A palatable liquid dosage form is provided as an alternative to the solid form.
b. An effervescent formulation is useful for patients who need or prefer to take a liquid formulation, particularly elderly patients and those with dysphagia.
c. Since a liquid formulation is more palatable than solid dosage form, it is more acceptable to patients and results in greater adherence to the prescribed therapy regimen.
d. A liquid containing the effervescent formulation provides an immediate and sustained increase in intragastric pH. The effervescent mixture also provides an immediate transient increase in pH of the oesophagus and stomach. This buffering action provides immediate relief, yet there is no rebound in acid secretion because ranitidine blocks the H 2 -receptors. This property is especially useful in dyspepsia and...

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