Dual-drug amorphous formulation of gliclazide

Amorphization is a well-established strategy to enhance the dissolution properties of poorly water-soluble drugs. However, amorphous state inherently unstable toward recrystallization. Coamorphous systems drug and small-molecule excipient or two complementary drugs often show an enhanced stability. Diabetes hypertension are frequently coexistent. In this paper study on coamorphization antidiabetic gliclazide (glz) antihypertensive valsartan (val) reported. Amorphous glz recrystallized after 1 d under ambient conditions, whereas coamorphous glz-val containing val in 1:1 1:2 molar ratio was stable for at least four months 20 °C 56% relative humidity. The rate increased order crystalline < glz-val_1:1 glz-val_1:2. Furthermore, ternary glz, were prepared; glz-val_1:1_PVP, glz-val_1:1_HPC, glz-val_1:1_ALM, glz-val_1:1_MCC (PVP = polyvinylpyrrolidone, HPC hydroxypropyl cellulose, ALM α-lactose monohydrate, MCC microcrystalline cellulose). did not affect stability system, while promoted recrystallization glz-val_1:1_ALM during storage freshly prepared glz-val_1:1_PVP contained small amounts glz. Glz-val_1:1_MCC showed compared viable fixed-dose formulation.