Foods That Affect Thyroid Hormone 001
What Does Take On Empty Stomach MeanFood and Drugs Association Approved
between various available products. Dissolution of a drug is a crucialstep in its oral absorption and bioavailability. The dissolution of T4 fromthree commercial solid oral dosage forms: Synthroid® (SYN), genericlevothyroxine sodium by Sandoz Inc. (GEN) and Tirosint® (TIR) wasstudied using a sensitive ICP-MS assay. All the three products showedvariable and pH-dependent dissolution behaviors. The absence of surfactant from the dissolution media decreased the percent T4dissolved for all the three products by 26–95% (at 30 min). SYNdissolution showed the most pH dependency, whereas GEN and TIRshowed the fastest and highest dissolution, respectively. TIR was themost consistent one, and was minimally affected by pH and/or by thepresence of surfactant. Furthermore, dissolution of T4 decreasedconsiderably with increase in the pH, which suggests a possiblephysical interaction in patients concurrently on T4 and gastric pHaltering drugs, such as proton pump inhibitors. Variable dissolution of T4 products can, therefore, impact the oral absorption andbioavailability of T4 and may result in bioequivalence problemsbetween various available products.
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Dissolution; ICP-MS; Levothyroxine; pH; Proton pump inhibitors;Bioequivalence; Synthroid
®
; Sandoz; Tirosint
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David A. Escalante,Noura Arem, Ridha Arem, Assessment of interchangeability of twobrands of levothyroxine preparations with a third-generation TSHassay, The American Journal of Medicine, Volume 98, Issue 4, April1995, Pages 374-378, ISSN 0002-9343,10.1016/S0002-9343(99)80316-7. Abstract: purpose To evaluate, in aprospective fashion, the clinical interchangeability between two brandsof levothyroxine, Synthroid (Boots Pharmaceuticals, Inc., Lincolnshire,Illinois) and Levoxine (Daniels Pharmaceuticals, Inc., St. Petersburg,Florida), by using clinical scores of hyperthyroidism andhypothyroidism, free thyroxine index (FTI), sensitivethyroid-stimulating hormone (TSH), and thyrotropin-releasing hormone(TRH) stimulation testing. patients and methods Twenty-three of the 31patients with long-standing primary hypothyroidism (6 men, 25women; age range 30 to 71 years, mean 47.2 ± 2.2 SEM) wereswitched from Synthroid to Levoxine (group 1) and the remainingpatients from Levoxine to Synthroid (group 2). After switching, each
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