FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to a tabletted multiunit dosage form containing an active compound specified in omeprazole, one of its individual enantiomers, omeprazole alkali salt and one of its individual enantiomers. In a dosage form, individually enteric coated units of a core material optionally mixed with alkali compounds are mixed with tablet excipients and compressed as a tablet. An enteric coating layer has a surface with the Vickers hardness less than 8, and possesses mechanic properties so that compressing single units mixed with the excipients into the multiunit tabletted dosage unit does not reduce an acid resistance of the enteric coated units by more than 10%. The invention also refers to a method for preparing the tabletted multiunit dosage form which implies preparing a number of the core material units containing the active substance optionally mixed with the alkali compound, optionally applying a separating layer on the core material, applying the enteric coating layer on the core material, mixing with the excipients and compressing.
EFFECT: what is declared is a method for inhibiting the gastric acid inhibiting or treating mammalian and human gastrointestinal diseases by administering an effective dose of the multiunit tabletted dosage form, and a blister pack.
18 cl, 2 tbl, 22 ex
Authors
Dates
2014-10-20—Published
1995-06-07—Filed