The high moisture content of ergotamine tartrate sublingual tablets poses potential stability problems and safety concerns. The finished product is confined in a protective aluminum foil and could degrade to generate toxic by-products during moisture evaporation and condensation within the package under some storage conditions. This study was initiated to examine the stability of ergotamine tartrate sublingual tablets under various simulated storage conditions. The physical and chemical stability of the product was evaluated over a period of 12 months. Results indicated that no stability problems arose when the product was stored at constant temperature, either ambient or sub-ambient. Experimental results indicated that storage in an environment where the temperature fluctuated widely might lead to poor product stability and should be avoided.
Brownell, C.R.; Shiu, G.K.; and Croitoru, A.
"Stability of ergotamine tartrate sublingual tablets,"
Journal of Food and Drug Analysis: Vol. 6
, Article 4.
Available at: https://doi.org/10.38212/2224-6614.2915