AVAILABLE DATA  

Elevated Temperature and/or Humidity

The stability of OPSUMIT film-coated tablets in blister packs was investigated at 40°C and 75% relative humidity for up to 6 months.¹ Under these conditions, no significant change in the appearance, color, average mass, water content, or dissolution profile was observed.

In another study, the stability of OPSUMIT tablets in blister packs was investigated at 25°C and 60% relative humidity as well as 30°C and 75% relative humidity, for up to 24 months.¹ Over this time period, no significant changes in the appearance, color, average mass, water content, or dissolution profile occurred.

The stability of OPSUMIT film-coated tablets when opened daily for 20 minutes in Climatic Zone IV (hot humid/tropical zone as per the ICH stability zones i.e. 30°C and 75% humidity),² over a period of 5 weeks in comparison with OPSUMIT stored under normal temperature conditions in the lab (18°C to 25°C) was tested.¹ Bottles stored under both conditions were opened for 20 minutes once a week for 5 weeks and the stability of the tablets determined thereafter. Stability was measured in terms of the appearance of the tablets, their content and related substances and dissolution profile. The study concluded that OPSUMIT film-coated tablets were stable for 5 weeks in Climatic Zone IV (30°C and 75% humidity). This data suggests that the daily opening of the bottles by the patients in such conditions should have no impact on the appearance, content, and delivery of the active pharmaceutical product (macitentan) in the tablets.

Freeze-Thaw Cycling

The stability of OPSUMIT tablets stored in high-density polyethylene (HDPE) bottles was tested in a temperature cycling study.¹ OPSUMIT tablets stored in HDPE bottles were subjected to -20°C for 2 days, followed by 60°C for 2 days; this temperature cycle was repeated 3 times. Appearance, dissolution and assay and related substance testing was performed at the beginning and end of each cycle. The results of the study suggest that the product specification of OPSUMIT, after being stored in HDPE bottles and subjected to 3 two-day freeze (-20°C) to two-day thaw (60°C) cycles, is preserved.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, Derwent^® (and/or other resources, including internal databases) was conducted on 05 December 2024.