Case Study 3
Re-formulation and Process Improvement of a Labor Intensive and Expensive Manufacturing Process

The original process involved wet granulation and sugar coating and took approximately one-week to manufacture.  The resultant product yielded varying dissolution profiles.

API comprises approximately 40% of the tablet.  Initial direct compression resulted in poor weight uniformity and capping problems.

Xcelience statistically optimized the ingredients and their amounts to produce an elegant product which was successfully transferred to the manufacturing facility.

The reformulated product uses a direct compression and aqueous film coated process.  It takes approximately 1.5 days to manufacture and yields a robust, rugged product, with reproducible and stable physical and chemical properties