Pharmaceutical formulation and process
AssigneeAstraZeneca AB
InventorsPer Johan Lundberg, Kurt Lovgren
Life of this patent
Estimating the term…
Abstract
A new oral pharmaceutical dosage form comprising a core material that contains a proton pump inhibitor, one or more alkaline reacting compounds and optionally pharmaceutical excipients having a water soluble separating layer and an enteric coating layer. The core material as such is alkaline reacting and the separating layer between the alkaline reacting core material and the enteric coating layer is formed in situ as a water soluble salt between the alkaline reacting compound(s) and the enteric coating polymer. The invention also describes a new efficient process for the manufacture of such a dosage form comprising two functionally different layers in one manufacturing step, and its use in medicine.
Claims20
An oral pharmaceutical dosage form comprising a core material that contains a proton pump inhibitor, one or more alkaline reacting compound(s) and optionally pharmaceutically acceptable excipients having a water soluble separating layer and an enteric coating layer characterized in that the core material is alkaline reacting and that the separating layer is being formed in situ during the enteric coating as a water soluble salt between the enteric coating layer polymer(s) and the alkaline reacting compound(s).
A process for the preparation of an oral, enteric coated pharmaceutical dosage form comprising a core material that contains a proton pump inhibitor, one or more alkaline reacting compounds and optionally pharmaceutically acceptable excipients having a water soluble separating layer and an enteric coating layer characterized in that an alkaline reacting core material is prepared and coated with an enteric coating polymer wherein a separating layer between the core material and the enteric coating layer is formed in situ by a reaction between the enteric coating polymer(s) and the alkaline reacting compound(s) in the core material during the application of the enteric coating onto the alkaline reacting core material.
Dependencies are inferred from the claim text.