Bioavailability is equivalent for levothyroxine oral solution administered five minutes prior to coffee or under fasting conditions<\/p>\n<\/h3>\n
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FRIDAY, June 17, 2022 (HealthDay News) — Bioavailability is equivalent for a single oral dose of levothyroxine (LT4) sodium solution administered five minutes prior to coffee or under fasting conditions, according to a study presented at the annual meeting of the Endocrine Society, held from June 11 to 14 in Atlanta.<\/em><\/p>\n Kris Washington, Pharm.D., from Vertice Pharma in Berkeley Heights, New Jersey, and colleagues conducted a bioavailability study to assess the rate and extent of absorption of the oral LT4 solution administered with coffee compared to administration under fasting conditions in 40 healthy adults in a two-period, two-treatment, two-sequence, crossover study. In each study period, a single 600-\u00ce\u00bcg oral dose of LT4 solution was administered five minutes before drinking 8 ounces of American coffee (without milk or sweeteners) or under fasting conditions. For 48 hours after drug administration, blood samples were collected for total T4. A 40-day washout period separated treatment periods.<\/p>\n The researchers found there were no serious adverse events or discontinuations due to adverse events. For baseline-adjusted LT4, the geometric LT4 solution mean ratio of area under the receiver operating characteristic curve 0 to 48 hours and maximum serum concentration were 93.98 percent and 95.99 percent, respectively. The corresponding 90 percent confidence intervals fell within the U.S. Food and Drug Administration acceptance range for bioequivalence.<\/p>\n “The results demonstrate that the absorption of levothyroxine sodium oral solution was not affected by the consumption of coffee, potentially offering patients and providers more dosing flexibility,” Washington said in a statement.<\/p>\n This research was conducted by Vertice Pharma, the manufacturer of the oral levothyroxine sodium solution used in the study.<\/p>\n