FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to coated pharmaceutical formulations with a controlled-release active substance and to the use thereof for treating benign prostatic hyperplasia. The formulation contains a therapeutically effective amount of the active substance representing tamsulosin or its pharmaceutically acceptable salt encapsulated in a granulated core, and an insoluble permeable polymer found both in the granulated core and in the coating. Said pharmaceutical formulations may also contain a surfactant and other optional excipients. Besides, the invention refers to a method for preparing the pharmaceutical formulations which involves mixing core ingredients, granulating, pressing and shaping in a sphere, drying and coating.
EFFECT: invention provides the formulations with pH-independent release of the active substance, low inter-individual variability and low biological variability.
14 cl, 7 ex
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Authors
Dates
2012-04-20—Published
2004-12-22—Filed