Microgranules insoluble in gastric fluid, method for obtaining same and pharmaceutical preparations
AssigneeEthypharm
InventorsBruno Criere, Pascal Suplie, Pascal Oury
Life of this patent
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Abstract
A pharmaceutical formulation of a gastric proton pump inhibitor, with the exception of omeprazole, is disclosed. The formulation is in the form of microgranules insoluble in gastric fluid having improved stability over time. The formulation comprises several hydrophobic substances chosen in order to increase the stability of the active principle while obtaining the desired dissolution profile.
Claims22
A microgranule comprising a gastric proton pump inhibitor, with the exception of omeprazole, comprising an active layer comprising the proton pump inhibitor and an outer layer for protection in gastric fluid, wherein:
- (A) the active layer is applied to a neutral nucleus;
- (B) the active layer comprises at least one hydrophobic substance chosen from silicone oils and present in the active layer in an amount of between 5 and 40% by weight of the gastric proton pump inhibitor;
- (C) and the layer for protection in gastric fluid comprises at least one hydrophobic substance chosen from glycerides and present in the layer for protection in gastric fluid in an amount of 5 to 20% by weight of the protective layer;
- and further wherein the microgranule has no alkaline compound and no ionic surfactant.
A microgranule comprising a gastric proton pump inhibitor, with the exception of omeprazole, comprising an active layer comprising the proton pump inhibitor and an outer layer for protection in gastric fluid, wherein:
- (A) the active layer is applied to a single neutral nucleus;
- (B) the active layer comprises at least one hydrophobic substance chosen from silicone oils and present in the active layer in an amount of between 5 and 40% by weight of the gastric proton pump inhibitor;
- (C) and the layer for protection in gastric fluid comprises at least one hydrophobic substance chosen from glycerides and present in the layer for protection in gastric fluid in an amount of 5 to 20% by weight of the protective layer;
- and further wherein the microgranule has no alkaline compound and no ionic surfactant.
Dependencies are inferred from the claim text.