Sandoz Ag

Vivek Battu

Amit Gupta

Akash Vijay Lingayat

Anandkrishna Laxmikant Kulkanri

A pharmaceutical formulation is disclosed which includes at least: (1) elagolix sodium, (2) magnesium oxide, and (3) at least one disintegrating agent, such as crospovidone, croscarmellose sodium, sodium starch glycolate, pregelatinized and mixtures thereof. A tablet is also disclosed which includes a tablet core formed from the pharmaceutical formulation. The elagolix sodium tablets of the present disclosure display improved dissolution rates when tested using for example the Tablet Sink Time test. The tablets also exhibit improved storage stability of the elagolix sodium, with a reduction in degradation products during storage.

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Hyderabad Telangana, India

Vivek Battu