Formulations, methods, kit, and dosage forms for improved stability of an active pharmaceutical ingredient

Abstract

Embodiments of the disclosure relate generally to formulations, methods, kits, and dosage forms for improved stability of an active pharmaceutical ingredient, wherein the active ingredient comprises a compound of the formula: wherein X is N, Y is H or optionally substituted C-Calkyl; Ris morpholine optionally substituted with by C-Calkyl; Ris C-Calkyl optionally substituted by one or more F; Ris halogen; and Ris wherein Ris H, C-Calkyl, halogen, CN or CF; Ris H or halogen; Ris H, halogen or C-Calkyl; and Ris H, C-Calkyl, (C-Calkyl)-NH; and, pharmaceutically acceptable salts and free bases thereof, wherein the active ingredient remains in substantially amorphous form after storage of the pharmaceutical formulation for a predetermined time and conditions. In one embodiment the formulations, methods, kits and dosage forms comprising the active pharmaceutical ingredient with improved stability can be used in the treatment of a condition characterized by the dysregulation of one of both of the RAS/RAF/MEK/ERK and PI3K/AKT/PTEN/mTOR pathways.