A new formulation of levothyroxine engineered to meet new specification standards.

We describe a reformulation of a widely used levothyroxine product (Euthyrox * ). The new tablet fulfils all criteria according to the new specification regulations for dosage accuracy over a shelf life of 3 years in all climate zones, and for bioequivalence compared to the conventional formulation used for many years. In addition, a clinical trial demonstrated equivalent exposure between three different tablet strengths of the new formulation, amounting to the same total dose (dose form proportionality). As a consequence, switching from the conventional to the new formulation can be undertaken on a 1:1 dose-for-dose basis, without re-titration or additional thyroid function testing. The new formulation, which is more stable, will assist in the accurate dosage and titration of levothyroxine in the management of hypothyroidism. PMID: 30406687 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research