FIELD: medicine.
SUBSTANCE: invention refers to medicine, particularly to a low-dose pharmaceutical composition for oral administration in the form of a capsule containing isotretinoin, a surfactant and an oil carrier. Composition by oral introduction provides bioequivalence in post-meal conditions at doses of 8 mg, 16 mg, 20 mg, 24 mg, 28 mg or 32 mg of isotretinoin compared to a capsule presented on the market, comprising a semi-solid suspension of isotretinoin in range of 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg, respectively. Disclosed composition does not contain wax and granulometric composition of particles of isotretinoin is such that D90 is less than 30 mcm.
EFFECT: implementation of the invention allows to obtain isotretinoin compositions with a low dose and improved bioavailability, as well as less food-prone.
9 cl, 2 tbl, 2 ex
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