FIELD: pharmacology.
SUBSTANCE: invention relates to a pharmaceutical composition for oral administration, comprising a core containing hydrocortisone and a carrier, and a delayed release polymer layer in contact with the said core. The core contains microcrystalline cellulose in an amount of 75-85% by composition weight. The delayed release polymer is a mixture of a polymer (1) having a composition of poly(methacrylic acid, methyl methacrylate) at a ratio of 1:1, and a polymer (2) having a composition of poly(methacrylic acid, methyl methacrylate) at a ratio of 1:2. Polymers (1) and (2) are presented at a ratio of 1:4 and are taken in an amount of 6-7% by composition weight. Also a method for composition manufacture and its use for treating adrenal insufficiency is described.
EFFECT: release of hydrocortisone in accordance with the circadian release of cortisol to reproduce natural cortisol release.
39 cl, 7 dwg, 2 tbl, 4 ex
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Authors
Dates
2017-05-18—Published
2013-02-12—Filed