ABSTRACT
The manufacture and control of oral solutions and oral suspensions present unique problems to the industry. Equipment used for batching and mixing of oral solutions and suspensions is relatively basic. For oral solutions and suspensions, the amount and control of temperature are important from a microbiological as well as a potency aspect. One area that has presented a number of problems includes maintaining the stability of oral liquid products throughout their expiry period. Vitamins with fluoride oral liquid products have had a number of recalls because of vitamin degradation. Problems in the packaging of oral liquids have included the potency of unit dose products and accurate calibration of the measuring devices, such as droppers, that are often provided. For oral suspensions, an additional concern is uniformity, particularly because of the potential for segregation during the manufacture and storage of the bulk suspension, during transfer to the filling line, and during filling.
