What is the maximum duration a cyclodextrin (cyclodextrin) tube suppository can be exposed to temperatures above 86 degrees Fahrenheit and still remain usable?

Storage Guidelines for Cyclodextrin Tube Suppositories Above 86°F

Cyclodextrin tube suppositories should not be stored above 86°F (30°C) for any extended period, and should be refrigerated if ambient temperatures exceed this threshold to maintain their efficacy and structural integrity. 1

Temperature Storage Requirements

The stability of pharmaceutical products, including suppositories, is highly temperature-dependent. For cyclodextrin-based suppositories, the following guidelines should be followed:

• Storage temperature should be maintained between 59°F-86°F (15°C-30°C) as recommended by the United States Pharmacopoeia (USP) 1, 2
• If room temperatures exceed 86°F (30°C), the suppositories should be immediately moved to refrigeration 1
• Exposure to temperatures above 86°F can lead to:
  • Altered melting point
  • Reduced drug release
  • Compromised therapeutic efficacy
  • Structural changes affecting absorption 3

Impact of Temperature Excursions

Research on fatty-base suppositories (which can be compared to cyclodextrin suppositories) demonstrates that even short-term storage at elevated temperatures (25-30°C) for one month resulted in:

• Significantly reduced drug release in vitro
• Elevated melting point (approximately 2°C higher)
• Decreased plasma drug levels in vivo 3

Storage Recommendations

To maintain optimal efficacy of cyclodextrin tube suppositories:

1. Store unopened suppositories in a refrigerator with no risk of freezing 1
2. After initial use, store at ambient temperature (59°F-86°F or 15°C-30°C) 1
3. If ambient temperatures exceed 86°F, immediately transfer to refrigeration 1
4. Allow refrigerated suppositories to warm slightly before use for patient comfort 1
5. Avoid exposure to direct heat, light, or excessive agitation 1

Clinical Implications

Temperature excursions above 86°F can significantly impact the therapeutic effectiveness of cyclodextrin suppositories:

• The cyclodextrin complex structure may be compromised, affecting drug solubility and release 4, 5
• Higher storage temperatures can alter the physical properties of the suppository base, affecting melting characteristics and drug release 3
• The inclusion complexes formed between cyclodextrins and active ingredients are temperature-sensitive and may dissociate at elevated temperatures 6

Common Pitfalls to Avoid

• Assuming brief exposure to high temperatures is harmless - even short exposures can alter suppository properties
• Failing to check storage conditions during transportation and delivery
• Neglecting to transfer suppositories to refrigeration when ambient temperatures rise above 86°F
• Using suppositories that have been exposed to temperatures above 86°F for extended periods, as they may have reduced efficacy

In summary, while cyclodextrin suppositories are designed to be stable at room temperature, any exposure to temperatures above 86°F should be minimized, and refrigeration should be used when ambient temperatures exceed this threshold to maintain product integrity and therapeutic efficacy.