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LEDERLE's EXPANDING CALCIUM SUPPLEMENT LINE WITH CALTRATE, JR.,

Executive Summary

LEDERLE's EXPANDING CALCIUM SUPPLEMENT LINE WITH CALTRATE, JR., a supplement for children. Each tablet contains 300 mg of calcium, approximately 30% of the recommended allowance for children over four, according to Lederle's July 20 press release. Caltrate, Jr., packaged in bottles of 60 chewable tablets, joins Lederle's other calcium supplements, Caltrate 600, Caltrate + Iron and Caltrate + D. In another company press release issued the same day, Lederle claimed that its Caltrate 600 has superior performance characteristics to competing brands. "Many calcium carbonate products, especially imitation bargain brands, fail to meet proposed U.S. Pharmacopeia and FDA standards for these tablets," the release states. The observation was based on tests done at Lederle labs and on a study directed by Ralph Shangraw, chairman of the department of pharmaceutics, at the University of Maryland School of Pharmacy. In a statement released earlier this year, Shangraw reported that certain calcium carbonate products fared poorly during dissolution and disintegration tests, which measure the rate of absorption. Generally, the more rapidly the calcium dissolves and disintegrates, the more effectively it will be absorbed in the body. "Many of the commercial calcium carbonate products tested failed to meet present or proposed USP standards for calcium carbonate tablets," he said. "This failure casts doubt on the quality of such products in terms of the bioavailability of calcium." Shangraw also pointed out that, "although many of the suspect products could be labeled generic or housebrand, this study should not be conceived to be an indictment of generic drugs. Generic drug products go through rigorous testing," he continued, "both before and after marketing and must meet compendial standards and FDA requirements. Unfortunately, this is not the case for nutritional supplements." Shangraw said a Drug Product Problem Report was filed with the USP and FDA earlier in the year. According to a summary of the University of Maryland's dissolution studies, 69% of Lederle's Caltrate 600 dissolved in 30 minutes. Marion's Oscal-500, also used as a reference product, showed a dissolution of 87% at 30 minutes.
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