A stable composition with a benzimidazole derivative, such as Omeprazole,
which does not contain a separating layer between the active compound and
an enteric coating layer. Instead, the enteric coating layer is applied
as a solution with a pH value of at least 6.5, and more preferably in a
range of from about 7 to about 10, directly to the benzimidazole
derivative substrate. This solution, with the optional addition of a
plasticizer, can be directly coated onto the substrate without any
necessity for an intermediate layer. Furthermore, in this pH range, the
enteric coating is optionally applicable in an aqueous solution, thereby
obviating the need for organic solvents for dissolving the enteric
coating material. The resultant formulation maintains the stability of
the benzimidazole derivative during storage and at the same time protects
the product during passage through the acidic environment of the stomach.
The problem of interaction between the enteric coat and the alkaline core
is thus completely eliminated as the enteric coat at this stage is no
longer acidic.