United States Patent:  6,103,274

Assignee:  Rhone-Poulenc Rorer GmbH (Cologne, DE)

Filed:  September 29, 1998

A pharmaceutical, orally applicable composition is disclosed, whereby the composition contains at least one antacid active substance as well as more than 45% by weight of a sugar and/or sugar alcohol and between 12% and 35% by weight of water. The composition has a liquid or a semisolid consistency and is substantially free of preservatives.

SUMMARY OF THE INVENTION

The present invention has as its object to provide a liquid or semisolid pharmaceutical composition with an antacid active substance, whereby the composition has a particularly pleasant taste.

This object is realized according to the invention by a pharmaceutical composition containing at least one antacid substance, a sugar or sugar alcohol, and a pharmaceutically harmless solvent, the composition having a liquid to semisolid consistency and being substantially free of any preservatives.

The inventive composition contains, as the initially mentioned prior art, at least one antacid active substance, or antacid active substance mixture, and moreover further ingredients. An essential aspect of the inventive composition is that the inventive composition has a liquid to semisolid consistency, but the inventive composition is substantially free of preservatives. Moreover the inventive composition contains as further ingredients more than 45% by weight of a sugar and/or a sugar alcohol, relative to the ready-to-use composition, and up to 40% by weight of a pharmaceutically harmless solvent, relative to the ready-to-use composition.

The inventive composition has a number of advantages. A first advantage is that the inventive composition is particularly easy to use due to its liquid to semisolid consistency, since the aforedescribed problems of the known solid composition do not occur because it is not necessary to crush the inventive composition in the mouth. The inventive composition allows, because of its liquid to semisolid consistency, an individual dosage, which is also not so easily realizable in the known compositions. Because the inventive composition is generally free of any preservatives, problems of taste do not occur in the liquid to semi-solid composition of the present invention, as occur in the case of the known suspensions do not occur in such a liquid or semisolid, inventive composition, as is the case for the known suspensions. In the inventive composition the bad taste coming from the antacid active substance, respectively the antacid active substance mixture, is concealed by the fact that the inventive composition contains at least 45% by weight of a sugar and/or a sugar alcohol. The sugar, or sugar alcohol in the inventive composition not only conceals the bad taste of the active substance, but also gives a pleasant taste to the inventive composition even when the inventive composition contains small amounts of a preservative, as for example 0.01% by weight to about 0.1% by weight. It was surprisingly noted that the inventive composition is microbiologically stable and thus autosterile even without any preservative, whereby this advantageous property of the inventive composition occurs due to the high concentration of the sugar or sugar alcohol. Despite the relatively large portion of sugar, or sugar alcohol, the inventive composition does not exhibit sedimentation or clumping of the antacid active substance or the active substance mixture, so that the liquid to semisolid inventive composition is stable in itself. Thus it is not necessary to shake the inventive composition before being taken in order to promote homogeneity of the active substance or the active substance mixture. Furthermore the liquid to semisolid consistency of the inventive composition allows the antacid active substance, or the active substance mixture to spread, after it is taken, very rapidly and homogeneously over the patient's stomach and the intestinal tract, so that the inventive composition leads to rapid pain diminution and to rapid curing. Due to its liquid to semisolid formulation the inventive composition can also be dispensed very precisely and reproducibly, or it can be packed in single doses, so that correspondingly the manufacturing process is standardised.

Claim 1 of 14 Claims

1. A pharmaceutical antacid composition for oral use, comprising:

(a) between 5% and 30% by weight of at least one antacid active substance, selected from the group consisting of aluminum hydroxide, magnesium hydroxide, magnesium trisilicate, magnesium carbonate, magnesium phosphate, calcium carbonate, calcium phosphate, sodium citrate, magnesium oxide, magaldrate, hydrotalcite, sodium hydrogencarbonate, bismuth subcarbonate and mixtures thereof;

(b) more than 45% by weight of a sugar or a sugar alcohol; and

(c) between 12% and 35% by weight of water,

wherein said composition has a liquid or a semisolid consistency and is substantially free of preservatives.

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