Case study 2 : Formulation Process Re-Development to support plant in resolving scale up issues

• Situation : 24Hr sustained release profile developed by customer for a highly soluble API. Process involves a very thin SR coating of Ethyl-cellulose (2%) to be applied, with low variance tolerance (± 0.2%). Furthermore, temperature and humidity conditions also affecting coating resulting in high lot to lot variation
• Challenges : Obtaining coating of requisite tolerance required process development of residence time in Wurster coater. A fluctuation in temperature and low humidity during coating affecting film formation around core pellet and requiring different coating level for desired drug release each time. Hence control of temperature in range of 25-30 deg C while maintaining high humidity of 30-40% was required at plant level
• Ipca Solution
  • Residence time of the granules in coater was optimized using a very dilute solution
  • Steam generated from Purified water was used for humidification of the manufacturing suite - steam feed placed in inlet air to the suite with finer control by steam supply within the suite. Control loops set up to attain the right combination of temperature and humidity