A novel formulation of L-thyroxine (L-T4) reduces the problem of L-T4 malabsorption by coffee observed with traditional tablet formulations
Abstract
The purpose of this work is to evaluate if the coffee-associated malabsorption of tablet levothyroxine (L-T4) is reduced by soft gel capsule. We recruited 8 patients with coffee-associated L-T4 malabsorption including one hypothyroid patient. For 6 months, the patients were switched to the capsule maintaining the L-T4 daily dose. Patients took the capsule with water, having coffee 1 h later (proper habit, PH) on days 1-90, or with coffee ≤ 5 min later (improper habit, IH) on days 91-180. After 6 months, 2 patients volunteered for an acute loading test of 600 μg L-T4 (capsule) ingested with water (PH) or with coffee (IH). In the single hypothyroid patient, the post-switch TSH ranged 0.06-0.16 mU/L (PH) versus 5.8-22.4 mU/L pre-switch (PH) and 0.025-0.29 mU/L (IH) versus 26-34 mU/L pre-switch (IH). In the other 7 patients, post-switch TSH was 0.41 ± 0.46 (PH) versus 0.28 ± 0.20 pre-switch (PH) (P = 0.61) and 0.34 ± 0.30 (IH) versus 1.23 ± 1.47 pre-switch (IH) (P < 0.001). Importantly, TSH levels in PH versus IH habit did not differ post-switch (P = 0.90), but they did pre-switch (P < 0.0001). The proportions of post-switch TSH levels <0.10 mU/L with PH (33.3 %) or with IH (33.3 %) were borderline significantly greater than the corresponding pre-switch levels with PH (10.3 %) (P = 0.088) or with IH (0 %) (P = 0.0096). In the two volunteers, the L-T4 loading test showed that coffee influenced L-T4 pharmacokinetics minimally. Soft gel capsules can be used in patients who are unable/unwilling to change their IH of taking L-T4.
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Use of gel capsules, instead of standard LT4, allowed suppression of serum TSH during chronic therapy in patients with thyroid disease that could not be achieved by ingestion of standard LT4 with Italian style coffee (112).
“Use of gel capsules, instead of standard LT4, allowed suppression of serum TSH during chronic therapy in patients with thyroid disease that could not be achieved by ingestion of standard LT4 with Italian style coffee (112).”
From Guidelines for the Treatment of Hypothyroidism: Prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement (2014) · cites this paper as [112]
There is some evidence that gel capsules are absorbed preferentially in selected circumstances, such as during consumption with coffee and during use of proton pump inhibitors (PPIs).
“There is some evidence that gel capsules are absorbed preferentially in selected circumstances, such as during consumption with coffee and during use of proton pump inhibitors (PPIs).”
From Guidelines for the Treatment of Hypothyroidism: Prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement (2014) · cites this paper as [112]
Novel LT4 preparations are designed to reduce the high TSH levels induced by malabsorption due to calcium and iron supplements, PPIs, coffee, and breakfast.
“Furthermore, novel LT4 preparations are designed to reduce the high TSH levels induced by malabsorption due to calcium and iron supplements, PPIs, coffee, and breakfast (97–101).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [101]
In 2013, Vita et al found that coffee had little effect on LT4 capsule pharmacokinetics.
“In 2013, Vita et al found that coffee had little effect on LT4 capsule pharmacokinetics (101).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [101]
In an acute loading test in two patients, coffee did not modify pharmacokinetics of LT4.
“In contrast, an acute loading test in two patients found that coffee did not modify the pharmacokinetics of LT4 [ 78 ].”
From Factors influencing the levothyroxine dose in the hormone replacement therapy of primary hypothyroidism in adults (2022) · cites this paper as [78]
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- Authors
- Vita, R., Saraceno, G., Trimarchi, F., & Benvenga, S.
- Affiliations
- University of Messina (IT)
- Corresponding author
- Vita, Roberto
- Venue
- Endocrine
- Published
- 2012-08-30
- Volume
- 43
- Issue
- 1
- Pages
- 154-160
- ISSN
- 0969-711X (ISSN-L)
- 1355-008X
- 1559-0100
- OpenAlex
- W2054639785
- Cited by
- 91
- References
- 19
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 4 · 2023: 5 · 2022: 10 · 2021: 7 · 2020: 2 · 2019: 6 · 2018: 7 · 2017: 10 · 2016: 10 · 2015: 7 · 2014: 6 · 2013: 8 · 2012: 1
- FWCI
- 5.64
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Endocrine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Keywords
- levothyroxine, coffee, drug malabsorption, soft gel capsules, tablet formulation, hypothyroidism, thyroid-stimulating hormone, pharmacokinetics
- MeSH terms
- Adult, Capsules, Chemistry, Pharmaceutical, Coffee, Drug Carriers, Female, Gels, Goiter, Nodular, Humans, Hypothyroidism, Intestinal Absorption, Male, Middle Aged, Neoplasm Recurrence, Local, Antithyroid Agents, Thyroid Gland, Thyrotropin, Thyroxine, Thyroid Nodule, Food-Drug Interactions, Cross-Over Studies, Hormone Replacement Therapy
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