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Purpose: Levothyroxine (L-T4) is the drug of choice for treating primary hypothyroidism. L-T4 tablets should be taken at least 30 min before breakfast. Several studies have suggested that serum thyroid profile is not affected by concomitant intake of liquid/softgel L-T4 with meals. Our aim is to review the evidence on therapeutic efficacy and patient compliance with the liquid and softgel formulation of L-T4 taken with meals, also compared with the standard tablet therapy regimen, in hypothyroid patients., Methods: We performed a systematic review of literature by searching PubMed, Embase, and Cochrane Library databases. PRISMA guidelines were applied, and the risk of bias of the included studies was assessed using the RoB 2 and ROBINS tools. The methodological quality was assessed following the GRADE criteria., Results: We included 13 studies, accounting for a total of 1697 patients. The timing of liquid L-T4 intake from breakfast did not affect the therapeutic efficacy of the treatment. No significant differences in the absorption of liquid L-T4 were found when administered together with different foods, beverages, drugs, or other supplements. TSH levels are not influenced by taking softgel L-T4 at breakfast; the efficacy of softgel and liquid formulation is similar when they are taken with a meal, but superior to that of tablet formulation. Shifting from L-T4 tablets taken 30 min before breakfast to liquid/softgel formulation taken with the meal improved medication adherence and perceived quality of life of patients., Conclusion: Liquid and softgel formulation of L-T4 can be taken at breakfast or close to meals, without losing therapeutic efficacy. These formulations could also improve patient compliance and quality of life compared to L-T4 tablet therapy taken 30 min before breakfast., (© 2024. The Author(s).)

Background: Levothyroxine sodium (LT4) is the therapy of choice for hypothyroidism. In the last decade, new LT4 formulations, such as liquid and softgel capsules, became available. Even if some evidence has been reached in the efficacy of liquid LT4 in patients with suboptimal TSH on tablet LT4, the usefulness of softgel LT4 has been rarely studied. This study aimed at evaluating the effect of switching from tablet to softgel LT4 patients without increased need for LT4. TSH was used as proxy of LT4 bioavailability and effectiveness., Methods: During the period from April to August 2017, 19 patients on tablet LT4 treatment for hypothyroidism, mostly due to autoimmune thyroiditis, were enrolled. Subjects with causes of malabsorption or increased requirement of LT4 were previously excluded. Patients finally included were asked to switch from tablet to softgel LT4 formulation at unchanged dose and ingestion fashion (30 min before breakfast). TSH was measured with chemiluminescence immunoassays., Results: According to exclusion and inclusion criteria, 19 patients were finally selected. One of these had headache 4 days later and come back to tablet LT4, and 18 of them (16W/2M; mean age = 55 years; BMI 22.7 kg/m 2 ) completed the study. They were treated with a median LT4 dose of 88 μg/day and showed a median TSH value of 3.33 mIU/L. The rate of cases with TSH ≤ 4.0 mIU/L was 61.1% (11/18 cases). When patients were re-evaluated after 3 months of softgel LT4, we observed that TSH reached levels under 4.0 mIU/L in 16/18 (88.9%) patients, TSH was lower in 11 cases, and in 6 out of 7 patients with pre-switch TSH values over the normal range. Overall, TSH values on softgel LT4 (median 1.90 mIU/L) was significantly lower from that observed during tablet LT4 ( p  = 0.0039)., Conclusion: These data show that hypothyroid patients with no proven malabsorption may have an improved TSH following 3 months from the switch from tablet to softgel LT4 preparation at unchanged dose.

Levothyroxine is recognized as the treatment of choice for hypothyroidism. So far, the tablet levothyroxine has been the formulation almost exclusively used, even though an optimal daily dose of levothyroxine has been unsuccessfully sought and a consensus not achieved. Due to progressive use of a more individually tailored levothyroxine dose, increasing evidence has instead displayed that many gastrointestinal disorders, polypharmacy, and food interference may raise the daily levothyroxine requirement. In recent years, alternative levothyroxine formulations have become available and have rapidly gained attention because of their pharmacokinetic properties. This study aims to provide an overview regarding the use of softgel capsule and/or liquid levothyroxine solution while performing a review of published studies about such topic. A comprehensive computer literature search of the PubMed/MEDLINE, Scopus, and Google Scholar databases has been conducted to find published articles on this topic. The search algorithm was based on the combinations of the following terms: "oral solution" or "soft gel" or "liquid", and "levothyroxine". The computer search resulted in 75 articles; through a critical review of such titles and abstracts and a screening of their references lists, the review included 18 original articles relating to 800 patients treated with alternative formulations. Despite some limits, the results obtained using softgel and liquid levothyroxine were consistent with each other. In selected categories of levothyroxine-treated patients (pediatric, suffering from hypo-achlorhydria, polypharmacy, undergone bariatric surgery, fed through enteric tube) these new formulations have shown promising attributes in improving a treatment that needs to be individually tailored.