What is the stability and shelf life of reconstituted Hyaluronidase (enzyme)

Stability and Shelf Life of Reconstituted Hyaluronidase

Reconstituted hyaluronidase has a short shelf life and should be used within 6 hours after reconstitution when stored at 4°C to maintain optimal enzymatic activity.

Storage Requirements and Degradation Timeline

Hyaluronidase is an enzyme that breaks down hyaluronic acid and is commonly used in various medical applications, including as an adjunct to local anesthetics and for managing hyaluronic acid filler complications. The stability of this enzyme after reconstitution is critical for maintaining its efficacy.

Temperature Considerations

• Store reconstituted hyaluronidase at 4°C (refrigerated) to minimize potency loss 1
• Avoid room temperature storage, which causes rapid deterioration of enzymatic activity
• Never store at temperatures above 4°C for extended periods as this accelerates degradation

Time-Based Degradation

• Hyaluronidase begins losing activity immediately after reconstitution
• The enzyme loses significant activity within 3-6 hours after injection into tissues 2
• For clinical applications requiring full potency, use within 6 hours of reconstitution

Applications and Stability Implications

In Aesthetic Medicine

• For filler complications (especially vascular occlusion), fresh reconstitution is critical to ensure maximum enzymatic activity 3
• In emergency situations, using freshly reconstituted hyaluronidase is essential for effective dissolution of hyaluronic acid fillers 4

In Anesthesia Practice

• When mixed with local anesthetics to enhance diffusion, hyaluronidase should be freshly prepared to ensure optimal spreading effect 1
• The mixing of hyaluronidase with infiltrative anesthesia is safe but requires attention to preparation timing 1

Practical Recommendations for Clinical Use

Reconstitution Protocol

1. Reconstitute immediately before intended use whenever possible
2. Use appropriate diluent as specified by manufacturer
3. Store at 4°C if immediate use is not possible
4. Discard any unused portion after 6 hours

Avoiding Common Pitfalls

• Do not batch prepare: Avoid reconstituting multiple vials in advance
• Do not freeze reconstituted solution: Freezing and thawing cycles further degrade enzymatic activity 1
• Avoid repeated warming: Removing from refrigeration multiple times accelerates degradation
• Monitor for clarity: Visible turbidity may indicate contamination or degradation

Special Considerations

Emergency Situations

• In vascular occlusion emergencies from HA fillers, use freshly reconstituted hyaluronidase for maximum efficacy 5
• Keep dry powder formulations available for immediate reconstitution in emergency kits

Allergic Reactions

• The risk of allergic reactions to hyaluronidase exists but is relatively rare (reported in approximately 1% of cases) 4
• Cross-reactivity between bee venom and hyaluronidase exists; avoid use in patients with bee sting allergy 1

By understanding the short stability window of reconstituted hyaluronidase and following proper storage protocols, clinicians can maximize the effectiveness of this important enzyme in various medical applications.