Coated tablet composition comprising a coat for immediate release glucocorticoid and a core for extended release glucocorticoid for glucocorticoid replacement therapy

摘要

Discloses a coated tablet composition for administration once daily comprising a coating and a tablet core. The coating comprises an immediate release part comprising one or more glucocorticoids and pharmaceutically acceptable release excipients or carriers adapted so that the one or more glucocorticoids are immediately released. The coating contains an amount of 20-40 % of the total hydrocortisone equivalents in the composition. The tablet core comprises an extended release part comprising one or more glucocorticoids in an amount of 60-80% of the total hydrocortisone equivalents in the composition and pharmaceutically acceptable extended release excipients or carriers adapted so that the one or more glucocorticoids are released over an extended period of time of at least about 8 hours. The total daily dose of the glucocorticoids is in the range 1-80 mg. Further disclosed are various embodiments of the composition that detail the amount of total hydrocortisone equivalents released in a given timeframe from either the immediate release part or the extended release part of the composition. Also disclosed is the use the coated tablet composition used in the preparation of a medicament for the treatment of a glucocorticoid deficiency associated disorder.