FIELD: pharmaceuticals.
SUBSTANCE: soft gelatin capsules with improved stability of active pharmaceutical ingredients and methods of their preparation are provided. In some embodiments, the soft gelatin capsule includes a filler composition and a soft gelatin capsule shell. In some embodiments, the soft gelatin capsule fill composition includes one or more active pharmaceutical ingredients (APIs); from 2 to 15% by weight of povidone; from 30 to 60% by weight of polyethylene glycol; and from 0.5 to 5% by weight propylene glycol, wherein the filler composition has a pH value of 3.75 or less. In some embodiments, the soft gelatin capsule shell is made of a soft gelatin capsule shell composition containing an acid component.
EFFECT: obtaining improved stability of active pharmaceutical compound in soft gelatin capsules.
36 cl, 17 dwg, 2 tbl, 1 ex
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