Patent ID: 9730932
Date: 2017-08-15
CPC Classifications: A61J,A61K,B65D

Claim:
1. A packaged pharmaceutical composition comprising: a pharmaceutical composition comprising crystalline Macitentan free base having an X-ray powder diffraction pattern showing peak maxima at 2 theta/° values of 11.4±0.2, 13.0±0.2, 16.1±0.2, and 25.4±0.2 when a radiation wavelength of 1.5419 Å is used; and at least one excipient; and comprising at most 5% by weight of amorphous Macitentan free base, wherein said pharmaceutical composition is an oral solid dosage form packaged in a packaging material having a moisture vapor transmission rate of at least 0.4 g m−2 d−1 as measured according to standard DIN 53122-1, wherein when storing the packaged pharmaceutical composition in the dark at 40° C. at a relative humidity of 75% for a period of at least 14 days, the pharmaceutical composition has increased chemical stability when compared to an identically prepared, packaged and stored solid dosage form pharmaceutical composition having only amorphous Macitentan free base as the active agent.