Oral pharmaceutical dosage forms comprising a proton pump inhibitor and an antacid agent or alginate
AssigneeAstra Aktiebolag
InventorsHelene Depui, Agneta Hallgren
Life of this patent
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Abstract
An oral pharmaceutical dosage form comprising an acid susceptible proton pump inhibitor and one or more antacid agents or an alginate in a fixed formulation, wherein the proton pump inhibitor is protected by an enteric coating layer and an optional separating layer in between the proton pump inhibitor and the enteric coating. The fixed formulation is in the form of multilayered tablets, sachets or multiple unit tableted dosage forms. The multiple unit dosage form is most preferred. The new fixed formulation is especially useful in the treatment of disorders associated with dyspepsia such as heartburn.
Claims27
An oral pharmaceutical composition comprising, as a first component, an acid susceptible proton pump inhibitor, and as a separate second component, at least one substance selected from the group consisting of antacid agents, alginates and mixtures thereof, and as an optional third component, pharmaceutically acceptable excipients, wherein:
- (a) the composition is in the form of a multiple unit tablet;
- (b) the first component is in the form of pellets covered with an enteric coating layer,
- (c) the second component is separated from the first component by the enteric coating layer covering the first component;
- and
- (d) the enteric coating layer has mechanical properties such that the acid resistance of the enteric coated pellets is not significantly affected by compression of the pellets with the other tablet components during tableting.
A process for the manufacture of a composition in the form of a multiple unit tableted dosage form having separate layers and comprising, as a first component in one layer, an acid susceptible proton pump inhibitor, and as a second component in a separate second layer, at least one substance selected from the group consisting of antacid agents, alginates and mixtures thereof, wherein the process comprises the steps of:
- (a) preparing the proton pump inhibitor in the form of enteric coating layered pellets;
- (b) mixing the enteric coated pellets with pharmaceutically acceptable excipients;
- (c) precompressing and further providing the mixture with the second layer;
- and
- (d) compressing the layered mixture into a tablet.
A process for the manufacture of a composition in the form of a multiple unit tableted dosage form comprising, as a first component, an acid susceptible proton pump inhibitor, and as a separate second component, at least one substance selected from the group consisting of antacid agents, alginates and mixtures thereof, wherein the process comprises the steps of:
- (a) preparing the proton pump inhibitor in the form of enteric coating layered pellets;
- (b) mixing the enteric coated pellets with the second component;
- and
- (c) compressing the dry mixture into a multiple unit tablet without affecting any significant change of the acid resistance of the enteric coating layer.
Dependencies are inferred from the claim text.