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Quality of extemporaneously compounded nitroglycerin ointment
Daniel L Azarnoff1, J C Lee, Charles Lee
1D.L. Azarnoff Associates, LLC, Burlingame, California 94010-2011, USA. dan@azarnoffassociates.com
Diseases of the Colon and Rectum
|May 4, 2007
Summary
Compounded nitroglycerin ointment for anal fissures often fails quality standards. Nearly half of tested samples showed incorrect potency or content uniformity, potentially risking patient treatment effectiveness and safety.
Area of Science:
- Pharmaceutical compounding quality control
- Dermatological drug efficacy and safety
Background:
- Nitroglycerin ointment (0.2-0.4%) is clinically supported for anal fissure treatment.
- No United States Pharmacopoeia (USP)-approved nitroglycerin ointment is available.
- 84,000 prescriptions for compounded nitroglycerin ointment were issued in 2004.
Purpose of the Study:
- To assess the quality of extemporaneously compounded nitroglycerin ointment.
- Evaluate adherence to USP standards for compounded medications.
Main Methods:
- Prescriptions for 0.3% nitroglycerin ointment were filled at retail pharmacies.
- Samples were analyzed in an analytical laboratory using a validated method.
Main Results:
- 20.8% of samples failed USP content uniformity requirements (90-110% of label claim).
- 29.2% of samples were subpotent, and 1 was suprapotent, based on USP potency requirements (90-115% of label claim).
- Overall, 45.8% of samples were misbranded and of poor quality due to potency and/or content uniformity issues.
Conclusions:
- Nearly half of compounded nitroglycerin ointments did not meet USP standards for potency and content uniformity.
- Compounding quality issues raise concerns about patient safety and effective pain relief for anal fissures.
- The severe, debilitating pain of chronic anal fissures necessitates reliable and high-quality medication.
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