Saranjit Singh

Stability data that do not follow the expected trend in comparison with other stability batches or previous results collected during a stability study are considered out-of-trend (OOT) results. OOT stability results recently have gained the attention of regulatory agencies and as a result, the approach for identifying and investigating OOT results has become a topic of increased discussion. One example is a 2003 article by the PhRMA Chemistry, Manufacturing, and Controls Statistics and Stability Expert Teams, which was intended to initiate dialogue on how to address OOT results (1).

The authors investigated the moisture gain of products containing ethambutol that were packaged in strip and blister packs as well as unpackaged formulations.

A new approach for reducing pellicle formation involves the use of a combination of glycine and citric acid during the preparation of film mass or solution.

The authors recount the findings of a study that examined the sensitivity of cross-linked gelatin materials to variables such as bloom strength, type, and source.

Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.

The authors describe a methodology to evaluate various gelatin raw materials with respect to their stability and resistance to cross&#173linking.