Stability Issues and Their Resolution
Real-world case studies provide valuable insights into stability issues encountered in pharmaceutical development and manufacturing, as well as effective strategies for resolution. By examining these examples, pharmaceutical professionals can learn from past experiences and apply best practices to mitigate stability challenges in their own projects.
Case Study 1: Degradation of Liquid Formulation
Issue: A pharmaceutical company observed unexpected degradation of a liquid formulation during stability testing, leading to changes in color and odor.
Resolution: Investigation revealed that the degradation was caused by interaction between the drug substance and the formulation excipients under certain storage conditions. The company reformulated the
Case Study 2: Moisture Absorption in Solid Dosage Form
Issue: A manufacturer experienced moisture absorption in solid dosage forms, resulting in tablet softening and loss of
Resolution: Root cause analysis identified inadequate packaging and storage conditions as the primary contributors to moisture ingress. The manufacturer implemented improved packaging materials and modified storage conditions to minimize moisture exposure. Stability testing of the optimized formulation demonstrated enhanced moisture protection and maintained tablet integrity and dissolution performance.
Case Study 3: pH Drift in Aqueous Solution
Issue: An aqueous solution exhibited pH drift during stability testing, raising concerns about product stability and compatibility.
Resolution: Investigation revealed that pH drift was caused by chemical degradation of the active ingredient under acidic conditions. The company optimized the formulation buffer system and adjusted the manufacturing process to control pH more effectively. Stability testing of the modified formulation demonstrated stable pH over the desired storage period.
Conclusion
Case studies provide valuable insights into stability issues encountered in pharmaceutical development and manufacturing, as well as effective strategies for resolution. By analyzing real-world examples, pharmaceutical professionals can gain a better understanding of stability challenges and learn from successful approaches to mitigate risks and ensure product quality and stability.