This invention provides a
quetiapine fumarate tablet composition and its preparation method. The composition contains the following components:
quetiapine fumarate-hydroxypropyl-β-
cyclodextrin co-treated product, povidone,
calcium hydrogen phosphate,
microcrystalline cellulose,
sodium carboxymethyl starch,
lactose monohydrate,
magnesium stearate, and
omeprazole. This invention also provides a method for
processing a large-particle-size, highly fluid, highly soluble, and stable active pharmaceutical ingredient (API). This involves adding the API to a hydroxypropyl-β-
cyclodextrin solution, homogenizing the resulting suspension, and spray-
drying to prepare the
quetiapine fumarate-hydroxypropyl-β-
cyclodextrin co-treated product. The resulting intermediate
powder obtained by wet
granulation of the above-mentioned API-containing product exhibits superior flowability, smaller
relative standard deviation of content uniformity, and a faster
tableting rate after compression compared to tablets prepared solely from large-particle-size APIs, which is highly beneficial for industrial-scale production.