Quay has been involved in the development of a product of an already marketed compound, for a new indication. The new treatment requires targeted release in three phases during passage through the G.I.T.


A ‘mini-tab’ delivery system was selected for the formulation development approach for the following reasons:
  1. One central core to be produced (reduced development time).
  2. Targeted delivery to be achieved by the application of polymer systems with existing, already established, pH dependant release potential (established regulatory compliance)
  3. Combinations of ‘mini-tabs’ with different release profiles can be filled into hard gelatin capsules to allow dosage adjustments to be made during early clinical studies, without the requirement to develop further dosage strengths or to develop new drug product.
  4. The product can be produced on standard pharmaceutical tabletting and coating equipment, and therefore development costs can be kept to a minimum during scale up as specialist equipment is not required
Example of release profile produced using three different coating systems delivered in combination: