Gastroprotected omeprazole microgranules, method for obtaining same and pharmaceutical preparations
AssigneeEthypharm
InventorsPatrice Debregeas, Gérard Leduc, Pascal Oury, Pascal Suplie
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Abstract
The invention concerns omeprazole microgranules each comprising an active layer containing the active principle, and an outer gastroprotecting layer containing a gastroprotecting agent, characterized in that the omeprazole is combined with at least a hydrophobic substance.
Claims25
Omeprazole microgranules, each comprising an active layer comprising the active principle and an external gastroprotective layer comprising a gastroprotective agent, characterized in that they are devoid of alkaline compounds in the form of salts and that the active layer comprises a hydrophobic substance.
Microgranules, wherein each microgranule comprises
- (A) a layer of active principle comprising omeprazole, a binder chosen from any pharmaceutically acceptable binder, a hydrophobic substance and a solubilizing substance;
- (B) a first protective layer comprising one or more pharmaceutically acceptable diluent substances and a binder;
- (C) a second hydrophobic protective layer comprising a coating agent and a hydrophobic plasticizer;
- and
- (D) a gastroprotective layer comprising an enteric film-forming agent, a plasticizer, and a hydrophobic substance.
A composition comprising 36.2% by mass neutral core, 9.0% by mass omperazole, 11.2% by mass hydroxypropylmethylcellulose, 0.9% by mass dimethicone, 0.9% by mass polysorbate, 20.3% by mass mannitol 25, 0.9% by mass diacylated monoglyceride, 1.2% by mass talc, 16.2% by mass methacrylic acid copolymer, 1.6% by mass triethyl citrate, and 1.6% by mass glyceride.
Dependencies are inferred from the claim text.