Tableted oral pharmaceutical dosage form, with enteric coating, containing a compound of benzimidazole labile in an acid medium
OwnerJavier Lizcano Garcia, Jaume Sangra Perez +2inventors
InventorsJavier Lizcano Garcia, Jaume Sangra Perez, Pere Joan Solanas Ibarra, Antonio Lopez Cabrera
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Abstract
The pharmaceutical dosage form consists of a plurality of units containing a benzimidazole compound labile in an acid medium as the active principle, each unit being comprised of an inert core, a layer containing the active principle and an intermediate layer. These units, mixed with compression excipients, compressed and coated with an enteric coating, provide a tableted pharmaceutical dosage form suitable for oral administration for preventing and treating disorders related to abnormal secretion of gastric acid.
Claims8
A tableted oral pharmaceutical dosage form, covered with an enteric coating, consisting of a plurality of units that contain a benzimidazole compound labile in an acid medium as the active principle, comprising:
- (a) A plurality of units containing a benzimidazole compound labile in an acid medium as the active principle that contain:
- i) an inert core;
- ii) an active layer deposited on said inert core i), formed by a benzimidazole compound labile in an acid medium, a non-alkaline water-soluble inert polymer and one or more pharmaceutically acceptable inert excipients;
- and
- iii) an intermediate layer consisting of an inert non-alkaline coating formed by a non-alkaline, water-soluble inert polymer and one or more pharmaceutically acceptable inert excipients, with said intermediate layer being disposed over the aforementioned active layer ii) that covers the inert core i);
- (b) one or more pharmaceutically acceptable inert excipients, of which one or more are compression excipients;
- and
- (c) an enteric coating layer that coats said plurality of units containing a benzimidazole compound labile in an acid medium as the active principle and said pharmaceutically acceptable inert excipients (b).
Dependencies are inferred from the claim text.