FIELD: medicine.
SUBSTANCE: present invention refers to a controlled-release excipient composition to be used for preparing delayed- or prolonged-release tablets, wherein the composition contains a synergic mixture of essentially non-cross-linked carboxymethyl starch or sodium starch glycolate (SSG) and hydrophilic non-ionogenic cellulose ester, preferentially hydroxypropyl methyl cellulose. Sedimentation is used to specify whether SSG appears to be adequately non-cross-linked for the purposes of the present invention, more specifically: the preparation 0.25 g in deionised water 100 ml every 24 h at 25°C, in case of centrifugation at 6080 G and 25°C for 15 min shall produce a sedimentation volume min. 60 ml. The invention also concerns a formulation of the delayed- or prolonged-release tablet which contains the excipient presented by carboxymethyl starch and cellulose ester, and additionally contains one or more active substances.
EFFECT: developing the controlled-release excipient composition.
7 cl, 7 tbl, 8 ex
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