Aggregation of commercial heparin samples in storage

Area of Science:

• Pharmaceutical Sciences
• Biophysical Chemistry

Background:

• Heparin is a widely used anticoagulant medication.
• The physical state and aggregation of heparin can influence its efficacy.
• Understanding changes in heparin preparations during storage is crucial for quality control.

Purpose of the Study:

• To investigate the size distribution of heparin aggregates in commercial preparations.
• To determine if storage conditions, age, or physical state correlate with biological activity.

Main Methods:

• Quasi-elastic light scattering was employed to analyze heparin aggregate size distribution.
• Commercial heparin samples were stored under various conditions to observe changes.

Main Results:

• Commercial heparin samples exhibited changes in aggregation state during storage.
• Aggregation levels were correlated with storage duration and history, particularly refrigeration and handling.
• Formed aggregates were observed to be stable over time.
• Despite aggregation, heparin samples maintained biological activity within accepted limits.

Conclusions:

• Storage conditions significantly impact the physical aggregation state of commercial heparin.
• Heparin aggregation appears to be a stable process once initiated.
• Current biological activity assays do not reflect the impact of physical state changes due to aggregation.