Dosage form comprising an alkaline agent and an enteric coating layer

A dosage form, comprising:

• a core, comprising a biologically active ingredient which is stable to a degree of at least 95% at a pH of 3 for 2 hours at 22° C.,
• an intermediate coating layer (ICL) onto or above the core, comprising an alkaline agent, and
• an enteric coating layer (ECL) onto or above the ICL, comprising an enteric polymer,
• wherein a relation in percent of the alkaline agent in the ICL to the enteric polymer in the ECL is 5 to 95% when calculated by the formula:
• quantity
• ⁢
• of
• ⁢
• the
• ⁢
• alkaline
• ⁢
• agent
• ⁢
• in
• ⁢
• grams
• ⁢
• in
• ⁢
• the
• ⁢
• ICL
• ×
• 100
• (
• quantity
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• of
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• the
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• alkaline
• ⁢
• agent
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• in
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• grams
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• in
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• the
• ⁢
• ⁢
• ICL
• +
• quantity
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• of
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• the
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• enteric
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• polymer
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• in
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• grams
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• in
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• the
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• ECL
• )
• ,
• wherein the alkaline agent is selected from the group consisting of calcium oxide, calcium carbonate, magnesium carbonate, magnesium oxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, and a combination thereof, and
• wherein the enteric polymer in the ECL is selected from the group consisting of an anionic (meth)acrylate copolymer, an anionic cellulose, an anionic polysaccharide, a polyvinyl acetate phthalate, and a mixture thereof,
• wherein the biologically active ingredients in the core consists only of active ingredients which are stable to a degree of at least 95% at a pH of 3 for 2 hours at 22° C.