SOLID ENTERIC ORAL DOSAGE FORM OF PROINSULIN C-PEPTIDE (VERSIONS) AND METHOD FOR PREPARING IT (VERSIONS) Russian patent published in 2014 - IPC A61K38/28 A61K9/20 

FIELD: medicine.

SUBSTANCE: in the form of tablets, a core of which contains at least, wt %: proinsulin C-peptide - 0.01-5.0, hydroxypropyl cellulose - 1.0-6.0, or hydroxypropyl methylcellulose - 1.0-10.0, or polyvinyl pyrrolidone - 1.0-5.0, magnesium stearate - 0.01-1.0, colloidal silicone dioxide - 0.01-10.0, talc - 0.01-3.0, microcrystalline cellulose - the rest, while a coating represents an enteric film coating containing, wt %: talc - 10.0-20.0, titanium dioxide - 5.0-15.0, triethyl citrate - 7.0-14.0, silicone dioxide - 0.2-2.2, poly(methacrylic acid) - the rest. According to the other version, in the form of capsules a core of which contains at least, wt %: proinsulin C-peptide - 0.01-5.0, hydroxypropyl cellulose - 1.0-10.0, or hydroxypropyl methylcellulose - 1.0-10.0, or polyvinyl pyrrolidone - 1.0-5.0, microcrystalline cellulose - the rest, while the coating consists of an enteric film coating which contains, wt %: talc - 10.0-20.0, titanium dioxide - 5.0-15.0, triethyl citrate - 7.0-14.0, silicone dioxide - 0.2-2.2, poly(methacrylic acid) - the rest, and a solid capsule which contains, wt %: titanium dioxide - 0.1-5.0 and gelatin - up to 100. According to the other version of the capsules, the coating consists of a solid capsule which contains, wt %: titanium dioxide - 1.0-2.0, gellan gum - 1.0-5.0 and hydroxypropyl methylcellulose - the rest. There are also disclosed methods for preparing these dosage forms.

EFFECT: pre-set release of the active substance and maintained stability.

24 cl, 7 ex, 15 tbl