In Brief: Magnesium citrate powder in laxatives
This article was originally published in The Tan Sheet
Executive Summary
Magnesium citrate powder in laxatives: U.S. Pharmacopeia revision committee approves draft monograph for magnesium citrate powder oral solution. The monograph is published in the May-June Pharmacopeial Forum, Purdue Frederick tells FDA in a May 6 resubmitted citizen petition. The petition seeks inclusion of the ingredient in the laxative monograph. The company submitted its original petition in October 1994. Two months later, FDA denied the request, expressing concerns about solubility and the safety of the dosage form. The agency also suggested that the company develop a USP monograph and resubmit the petition ("The Tan Sheet" Jan. 9, 1995, p. 10). The petition requests clarification that the saline active ingredient magnesium citrate may be supplied in any dosage form, including a solid mixture to be reconstituted prior to oral administration...