Dissolution profiles and specifications for dihydroergotoxine sublingual tablets using a new in vitro method.

A dissolution method (paddle method) for determining the dissolution rate profile for 0.5- and 1.0-mg dihydroergotoxine methanesulfonate sublingual tablets was developed. A fluorometric method was used for measuring drug concentration in the dissolution medium, distilled water. It was essential to filter the dissolution sample to avoid interference from undissolved excipients. When different kinds of filters were used with the dissolution samples and standards, different degrees of apparent drug binding to the filter occurred. The dissolution rate profiles for several different products were compared to the innovator's product. The in vitro method and data obtained were used to propose dissolution specifications for these sublingual products.