Novel pharmaceutical formulation containing a proton pump inhibitor and an antacid
OwnerRobert Niecestro, Unchalee Kositprapa +4inventors
InventorsRobert Niecestro, Unchalee Kositprapa, Yoon Oh, Avinash Nangia, John R. Cardinal, Elliot F. Hahn
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Abstract
The subject invention is multi layer pharmaceutical dosage form comprising at least two layers whereby a proton pump inhibitor is in one distinct layer and an aluminum, magnesium or calcium antacid salt is in a second distinct layer.
Claims28
A multi-layered pharmaceutical dosage form comprising:
- a. at least one proton pump inhibitor layer comprising a proton pump inhibitor, an alkaline agent, and an additional pharmaceutical excipient wherein the proton pump inhibitor layer is free of enteric coating;
- and
- b. at least one antacid layer comprising an aluminum, magnesium or calcium antacid salt and a pharmaceutically acceptable excipient, wherein the proton pump inhibitor layer and the antacid layer are distinct from each other.
The pharmaceutical dosage form as defined in claim 22 wherein the granules are prepared by roller compaction.
A method for preparing a multi-layered pharmaceutical tablet dosage formulation comprising the steps of:
- (a) preparing a proton pump inhibitor layering mixture comprising a proton pump inhibitor, an alkaline agent and a taste masking agent;
- (b) preparing an antacid layering mixture comprising an aluminum, magnesium or calcium antacid salt, at least one pharmaceutically acceptable excipient and a taste masking agent;
- (c) feeding the proton pump inhibitor layering mixture into a tablet die to create at least one proton pump inhibitor layer;
- (d) feeding the antacid layering mixture into a tablet die to create at least one antacid layer;
- (e) combining the proton pump inhibitor layer and antacid layer to form a single unitary tablet with separate and distinct layers that contain at least one proton pump inhibitor layer and at least one antacid layer and wherein the tablet is free of enteric coatings.
A method for preparing a multi-layered pharmaceutical capsule dosage formulation comprising the steps of:
- (f) preparing a proton pump inhibitor layering mixture comprising a proton pump inhibitor, an alkaline agent and a taste masking agent;
- (g) preparing an antacid layering mixture comprising an aluminum, magnesium or calcium antacid salt, at least one pharmaceutically acceptable excipient and a taste masking agent;
- (h) feeding the proton pump inhibitor layering mixture into a capsule shell to create at least one proton pump inhibitor layer;
- (i) feeding the antacid layering mixture into a capsule shell to create at least one antacid layer to form a single unitary capsule with separate and distinct layers that contain a proton pump inhibitor and an antacid wherein the capsule is free of enteric coatings.
Dependencies are inferred from the claim text.