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World J Gastroenterol. Sep 14, 2013; 19(34): 5645-5650
Published online Sep 14, 2013. doi: 10.3748/wjg.v19.i34.5645
Published online Sep 14, 2013. doi: 10.3748/wjg.v19.i34.5645
Quality of compounded topical 2% diltiazem hydrochloride formulations for anal fissure
Monil Shah, Laura Sandler, Ventrus Biosciences, Inc., New York, NY 10013, United States
Vishwas Rai, Charu Sharma, Lakshmi Raghavan, DermPathe Pharmaceuticals, Branchburg, NJ 08876, United States
Author contributions: Shah M, Sandler L, Rai V, Sharma C and Raghavan L contributed to conception, design, acquisition of data, analysis and interpretation of data, drafting the manuscript, revising it critically for important intellectual content, and final approval of the version to be published.
Supported by Ventrus Biosciences, Inc., New York, NY, United States
Correspondence to: Monil Shah, PharmD, MBA, Ventrus Biosciences, Inc., 99 Hudson Street, 5th Floor, New York, NY 10013, United States. mshah@ventrusbio.com
Telephone: +1-646-7065208 Fax: +1-646-7065101
Received: May 9, 2013
Revised: June 29, 2013
Accepted: August 4, 2013
Published online: September 14, 2013
Processing time: 126 Days and 12.1 Hours
Revised: June 29, 2013
Accepted: August 4, 2013
Published online: September 14, 2013
Processing time: 126 Days and 12.1 Hours
Core Tip
Core tip: The use of topical 2% diltiazem hydrochloride for treating anal fissures is supported by multiple clinical trials and is recommended in published practice parameters. As no commercially manufactured formulation of topical 2% diltiazem has been approved yet by the Food and Drug Administration for the treatment of anal fissure, prescriptions for the medication need to be extemporaneously compounded by retail pharmacies. Employing high-performance liquid chromatography analysis of topical 2% diltiazem formulations compounded by a sampling of pharmacies, we found a notable trend toward lack of content uniformity and misbranding of potency, suggesting that many patients might not receive the anticipated relief of anal-fissure pain.