Stable pharmaceutical compositions, processes for making the same and methods of their use
OwnerNagesh PALEPUinventor
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Abstract
The present invention is generally related to alcohol free, liquid ranitidine formulations for oral administration. In particular, the present invention is related to stable, syrup formulations having ranitidine as an active ingredient for oral administration, processes for making the same, and methods of their use. The ranitidine of the present invention is stable in non-polar media or media having a relatively low polarity such that the dielectric constant is less than about 60, and is achieved by using certain saccharides, certain relatively high molecular weight starches, and/or certain celluloses instead of alcohol.
Claims20
An alcohol-free aqueous pharmaceutical composition for oral administration comprising ranitidine or a physiologically acceptable salt thereof, and about 1-5% (weight/volume) of a stabilizer selected from the group consisting of hydroxypropyl cellulose and hydroxyethyl starch, wherein the composition has a pH in the range of about 4.85 to about 7.99.
A method for stabilizing an aqueous alcohol-free ranitidine solution comprising the steps of:
- a) providing the aqueous solution of alcohol-free ranitidine or of a salt thereof;
- b) adding to the aqueous solution about 1-5% of a stabilizer selected from the group consisting of hydroxypropyl cellulose and hydroxyethyl starch;
- and
- c) adjusting the pH to about 4.85 to about 7.99.
Dependencies are inferred from the claim text.