Case study 3 : Formulation Development to simplify process

• Situation : Current Sustained release product from API (unstable due to temperature and humidity) having 3 dose strengths with 2 formula resulting in costly manufacturing process
• Challenges : API is stabilized in an acidic environment and current product uses Cysteine HCl as stabilizer and drug release was controlled by HPMC matrix. The high acidity of Cysteine HCl degrades HPMC over time and therefore causes sudden release of drug – making it difficult to formulate a stable formulation with wet granulation process. The high acidity from Cysteine HCl also causes corrosion to compression machine and tooling (dies and punches) -requires special tooling to compression
• Ipca Solution
  • Use of novel excipients such as Carbopol which are acidic in nature and would stabilize the API without severely affecting HPMC used for the matrix
  • No special tooling required for such product
  • Dry compaction method used here, simplifies the formulation process without exposing API to temperature and moisture;