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Quality of Extemporaneously Compounded Nitroglycerin Ointment

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Diseases of the Colon & Rectum

Purpose

Published clinical trials support the use of 0.2 to 0.4 percent nitroglycerin ointment for the treatment of an anal fissure, although no product is yet available in the United States. In 2004, 84,000 prescriptions were written for compounded nitroglycerin ointment. This study was designed to evaluate the quality of extemporaneously compounded nitroglycerin ointment.

Methods

Prescriptions for 0.3 percent nitroglycerin ointment were filled at retail pharmacies and shipped to analytical laboratory for analysis by their validated method.

Results

Five of 24 (20.8 percent) samples did not meet the United States Pharmacopoeia requirement for content uniformity of 90 to 110 percent and< 6 percent relative standard deviation. Seven of 24 samples (29.2 percent) were subpotent based on the United States Pharmacopoeia requirement of 90 to 115 percent of label claim, and 1 sample was suprapotent. When considered for potency and/or content uniformity, 11 of 24 (45.8 percent) were misbranded and poor quality.

Conclusions

Forty-six percent of the nitroglycerin ointment products compounded by 24 pharmacies did not meet the United States Pharmacopoeia specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues regarding whether patients are put at undue risk relative to the relief of anal fissure pain. The pain associated with chronic anal fissure is severe, often debilitating, and may affect the patient’s ability to work.

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Acknowledgment

The authors thank Jean-Simon Blais, Ph.D., President, KABS Laboratories Inc., St. Hubert, Quebec, Canada, for the analyses of the compounded samples.

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Authors and Affiliations

  1. D.L. Azarnoff Associates, LLC, Burlingame, California

    Daniel L. Azarnoff M.D.

  2. Cellegy Pharmaceuticals, Inc., Quakertown, Pennsylvania

    J. C. Lee Ph.D., Charles Lee B.S., John Chandler M.B.A. & David Karlin M.D.

  3. D.L. Azarnoff Associates, LLC, 433 Airport Boulevard, Suite 225, Burlingame, California, 94010-2011

    Daniel L. Azarnoff M.D.

Authors
  1. Daniel L. Azarnoff M.D.
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  2. J. C. Lee Ph.D.
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  3. Charles Lee B.S.
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  4. John Chandler M.B.A.
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  5. David Karlin M.D.
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Corresponding author

Correspondence to Daniel L. Azarnoff M.D..

Additional information

Cellegy Pharmaceuticals (Brisbane, CA) has a New Drug Application pending at the Food and Drug Administration for its nitroglycerin ointment, Cellegesic™.

Daniel L. Azarnoff, M.D., is a paid consultant to Cellegy Pharmaceuticals, J. C. Lee, Ph.D., Charles Lee, B.S., John Chandler, M.B.A., and David Karlin, M.D. are employees of Cellegy Pharmaceuticals, Inc.

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Azarnoff, D.L., Lee, J.C., Lee, C. et al. Quality of Extemporaneously Compounded Nitroglycerin Ointment. Dis Colon Rectum 50, 509–516 (2007). https://doi.org/10.1007/s10350-006-0818-5

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  • DOI: https://doi.org/10.1007/s10350-006-0818-5

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