FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to pharmaceutics. Object 1 is a method for stabilizing the release profile of a dosage form, according to which a surfactant and glyceryl distearate are included in a dosage form containing an active pharmaceutical ingredient, and the dosage form is cured, where the surfactant has an HLB value of less than about 10 and is selected from sorbitan fatty acid esters and combinations thereof, and where curing is carried out at a temperature in the range of about 30 °C to about 60 °C for about 3 hours to about 7 days. Objects 2–4 are embodiments of a method for preparing a dosage form with a stabilized release profile with the inclusion of an active pharmaceutical ingredient, at least one surfactant with an HLB value of less than 10 and glyceryl distearate, including curing of the dosage form.
EFFECT: maintaining the release profile of the active pharmaceutical ingredient of the dosage form containing a surfactant and glyceryl distearate for 1, 2 and 3 months.
28 cl, 3 dwg, 8 tbl, 1 ex
