Stability of Ergotamine Tartrate Sublingual Tablets
Charles R. Brownell1, Gerald K. Shiu1* and Abraham Croitoru2
1. Division of Product Quality Research, Office of Testing and Research,
2. Division of Chemistry, Office of Generic Drugs, OPS, CDER, Food and Drug Administration, 4 Research Court, Rockville, Maryland 20850, U.S.A.
ABSTRACT
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.
Key words: ergotamine tartrate tablet, stability