H Hahm1, J Kujawa, L Augsburger. 1. Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore 21201-1180, USA.
Abstract
OBJECTIVE: To evaluate and compare the quality of a sample of melatonin products, as measured by the United States Pharmacopeial Convention (USP) General Tests and Assays for Nutritional Supplements (other than Microbial Limits) and certain other tests. DESIGN: Five immediate-release, two sublingual, and two controlled-release products were randomly gathered from a health food store, groceries, and pharmacies in the Baltimore-Washington metropolitan area. MAIN OUTCOME MEASURES: Weight variation, disintegration (not applicable for controlled-release products), and drug dissolution, based on USP standards. Twelve-hour dissolution profiles were obtained from the controlled-release products. All tablets were also evaluated for friability following the USP procedure and for hardness following unofficial procedures. RESULTS: All products passed the weight variation test. Two products showed excessive friability. Three immediate-release products failed both the disintegration and the dissolution tests. One of the three products demonstrated a threefold difference in hardness. One controlled-release product released 90% of melatonin in four hours in the dissolution test; the other released 90% of its content in 12 hours. CONCLUSION: Some products showed evidence of poor formulation and/or poor quality control as indicated by excessive friability, failure to disintegrate and dissolve, and excessive variation in hardness. In vitro release profiles of the two controlled-release products were substantially different. The poor quality of some supplements should be a concern to consumers and health care providers.
OBJECTIVE: To evaluate and compare the quality of a sample of melatonin products, as measured by the United States Pharmacopeial Convention (USP) General Tests and Assays for Nutritional Supplements (other than Microbial Limits) and certain other tests. DESIGN: Five immediate-release, two sublingual, and two controlled-release products were randomly gathered from a health food store, groceries, and pharmacies in the Baltimore-Washington metropolitan area. MAIN OUTCOME MEASURES: Weight variation, disintegration (not applicable for controlled-release products), and drug dissolution, based on USP standards. Twelve-hour dissolution profiles were obtained from the controlled-release products. All tablets were also evaluated for friability following the USP procedure and for hardness following unofficial procedures. RESULTS: All products passed the weight variation test. Two products showed excessive friability. Three immediate-release products failed both the disintegration and the dissolution tests. One of the three products demonstrated a threefold difference in hardness. One controlled-release product released 90% of melatonin in four hours in the dissolution test; the other released 90% of its content in 12 hours. CONCLUSION: Some products showed evidence of poor formulation and/or poor quality control as indicated by excessive friability, failure to disintegrate and dissolve, and excessive variation in hardness. In vitro release profiles of the two controlled-release products were substantially different. The poor quality of some supplements should be a concern to consumers and health care providers.
Authors: Nalaka S Gooneratne; Alena Y Z Edwards; Chen Zhou; Norma Cuellar; Michael A Grandner; Jeffrey S Barrett Journal: J Pineal Res Date: 2012-02-21 Impact factor: 13.007