Product reformulation, stability requirements

Regulatory considerations also play a part in a decision whether or not to use the direct compression process. Several years may elapse between the finalizing of a tablet formulation and its marketing. During this period, stability testing of the product will have occurred. The formulator must be confident that a chosen direct compression diluent will still be available for a considerable time after product marketing otherwise reformulation with all its attendant delay and expense will be required. A number of direct compression diluents have been marketed that were withdrawn after only a few years because of lack of market penetration. 

---