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Oral Liquid Formulation of Levothyroxine Is Stable in Breakfast Beverages and May Improve Thyroid Patient Compliance
Institut Biochimique SA (IBSA), Centro Insema, Via Cantonale, Manno CH-6928, Switzerland
Alpine Foundation for Life Sciences (AFLS), Alpine Institute for Chemistry and Toxicology, Olivone CH-6718, Switzerland
* Author to whom correspondence should be addressed.
Received: 15 November 2013; in revised form: 29 November 2013 / Accepted: 4 December 2013 / Published: 13 December 2013
Abstract: Patients on treatment with levothyroxine (T4) are informed to take this drug in the morning, at least 30 min before having breakfast. A significant decrease of T4 absorption was reported, in fact, when T4 solid formulations are taken with food or coffee. According to preliminary clinical study reports, administration of T4 oral solution appears to be less sensitive to the effect of breakfast beverages on oral bioavailability. In the present study, stability of T4 oral solution added to breakfast beverages was investigated. A 1 mL ampoule of single-dose Tirosint® oral solution (IBSA Farmaceutici Italia, Lodi, Italy) was poured into defined volumes of milk, tea, coffee, and coffee with milk warmed at 50 °C, as well as in orange juice at room temperature. Samples were sequentially collected up to 20 min and analyzed by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. The results of the study demonstrated that T4 is stable in all beverages after 20 min incubation. Demonstration of T4 stability is a prerequisite for a thorough evaluation of the effect of breakfast beverages on the bioavailability of T4 given as oral solution and for a better understanding of the reasons underlying a decreased T4 bioavailability administered as solid formulations.
Keywords: levothyroxine; T4; liquid formulation; LC-MS/MS; stability; coffee; milk; tea; orange juice; bioavailability
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Bernareggi, A.; Grata, E.; Pinorini, M.T.; Conti, A. Oral Liquid Formulation of Levothyroxine Is Stable in Breakfast Beverages and May Improve Thyroid Patient Compliance. Pharmaceutics 2013, 5, 621-633.
Bernareggi A, Grata E, Pinorini MT, Conti A. Oral Liquid Formulation of Levothyroxine Is Stable in Breakfast Beverages and May Improve Thyroid Patient Compliance. Pharmaceutics. 2013; 5(4):621-633.
Bernareggi, Alberto; Grata, Elia; Pinorini, Maria T.; Conti, Ario. 2013. "Oral Liquid Formulation of Levothyroxine Is Stable in Breakfast Beverages and May Improve Thyroid Patient Compliance." Pharmaceutics 5, no. 4: 621-633.