Pharmaceutical formulation of omeprazole
AssigneeAstra Aktiebolag
InventorsInga Siv Bengtsson, Kurt Ingmar Lovgren
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Abstract
A new oral pharmaceutical formulation containing a novel physical form of a magnesium salt of omeprazole, a method for the manufacture of such a formulation, and the use of such a formulation in medicine.
Claims22
A stable oral formulation comprising:
- a core containing a magnesium salt of omeprazole said salt having more than 70% crystallinity as determined by x-ray powder diffraction;
- a subcoating layer;
- and
- an enteric coating layer, whereby the thickness of the enteric coating layer does not effect the release of omeprazole into solution at the pH predominantly present in the small intestine.
A process for the manufacture of a formulation of a pharmaceutical composition for the oral administration of magnesium omeprazole comprising the steps of:
- (a) forming a core material containing magnesium omeprazole salt said salt having at least 70% crystallinity as determined by x-ray powder diffraction;
- (b) applying in the presence of water at least one subcoating layer onto the core;
- (c) further applying in the pittance of water at least one enteric coating layer onto the subcoated core;
- and drying the prepared formulation.
An improved oral pharmaceutical composition containing a core of omeprazole salt with a subcoating and an enteric coating wherein the improvement comprises magnesium omeprazole salt having more than 70% crystallinity as determined by x-ray powder diffraction.
Dependencies are inferred from the claim text.