Hebei Messi Biology Co., Ltd. stated that a granular anhydrous and substantially amorphous mesoporous magnesium carbonate (mesoporous magnesium carbonate) relates to a method for preparing the mesoporous magnesium carbonate, and the use of the granular anhydrous and substantially amorphous mesoporous magnesium carbonate (mesoporous magnesium carbonate) in stabilizing active pharmaceutical ingredients (APIs).
A mesoporous magnesium carbonate material that allows APIs to be loaded with up to 60% by weight of itraconazole by soaking. Itraconazole remains amorphous at up to 30% by weight of API loading. A mesoporous magnesium carbonate material (particle size <50 μm) containing APIs tolfenamic acid and rimonabant.
One aspect of the present invention is a solid, substantially amorphous active pharmaceutical ingredient comprising an API in an amount of at least 20% by weight, the API being mixed with particulate anhydrous and substantially amorphous mesoporous magnesium carbonate (MPMC), wherein the MPMC has:
(i) pores having an average pore diameter in the range of 2 nm to 10 nm;
(ii) an average BET surface area in the range of 250-600 m2/g;
(iii) an average pore volume in the range of 0.5-1.2 cm3/g; and
(iv) an average particle size distribution showing a d10 value of 70-430 μm.