FIELD: pharmaceutical technology, pharmacy.
SUBSTANCE: invention relates to a cross-linked high-amylose starch comprising at least 70 wt.-% of amylose and can be used as an excipient in a pharmaceutical composition with sustained-releasing wherein indicated excipient is pressed with a pharmaceutical agent to form a tablet. Cross-linked high-amylose starch is prepared in the following stages: (a) cross-linking and chemical modification of high-amylose starch; (b) gelatinization, and (c) drying to obtain a powder of indicated excipient-regulating release. Cross-linking is carried out with a cross-linking agent chosen in the amount from 0.005 to 0.3 g per 100 g of dry high-amylose starch. Using the chemical treatment of high-amylose starch carried out before gelatinization allows preparing product with indices of regulating release. Using the modified starch in a tablet as a matrix provides practically linear pattern of release wherein releasing time is from 2 to 24 h.
EFFECT: improved preparing methods, valuable pharmaceutical properties of compositions.
37 cl, 23 dwg, 2 tbl, 15 ex
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Authors
Dates
2006-04-20—Published
2001-06-26—Filed