The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets

Patel, Himanshu; Stalcup, Apryll; Dansereau, Richard; Sakr, Adel

doi:10.1016/s0378-5173(03)00387-9

Cited by 55Analytical Methods in PharmaceuticalsDrug Solubulity and Delivery SystemsProtein purification and stability

The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets

Patel, Himanshu, Stalcup, Apryll, Dansereau, Richard, Sakr, Adel·2003·International Journal of Pharmaceutics

DOI 10.1016/s0378-5173(03)00387-9

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Abstract

Levothyroxine tablets, 50 microg, have been marketed for many decades but have had numerous recalls due to degradation and failure to meet potency. These experiments were devised to study the effects of various excipients on the stability of levothyroxine sodium pentahydrate in aqueous slurries and in formulated tablets. The active alone was found to be stable in the solid state for 6 months at 40 degrees C/75% RH whether stored in open or closed containers, and was found to be non-hygroscopic under normal processing conditions (>30% RH). In aqueous slurries with an excipient, the stability of the active improved as the pH of the slurry was increased from pH 3 to 11. Tablets manufactured with lactose anhydrous, starch, or microcrystalline cellulose failed to meet USP assay requirements at 3 months at 40 degrees C/75% RH. Tablets manufactured with dibasic calcium phosphate or mannitol met USP assay requirements at 3, but not 6 months when stored at 40 degrees C/75% RH. Tablets manufactured with dibasic calcium phosphate and a basic pH modifier, such as sodium carbonate, sodium bicarbonate, or magnesium oxide, met the USP assay requirements at both 3 and 6 months. Thus, the use of basic pH modifiers is a potential technique for improving the stability of levothyroxine sodium pentahydrate tablets.

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Acid excipients, such as lactose, mannitol, and sorbitol, can induce drug instability in tablets, while basic excipients can be added to improve the stability of LT4 tablets.
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From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [114]

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Authors: Patel, H., Stalcup, A., Dansereau, R., & Sakr, A.
Affiliations: University of Cincinnati (US)
Corresponding author: Sakr, Adel
ORCID: Stalcup, Apryll
Sakr, Adel
Venue: International Journal of Pharmaceutics
Publisher: Elsevier BV
Published: 2003-10
Volume: 264
Issue: 1-2
Pages: 35-43
ISSN: 0378-5173 (ISSN-L)
DOI: 10.1016/s0378-5173(03)00387-9
OpenAlex: W2025192258
Cited by: 55
References: 11
Citations by year: 2026: 2 · 2025: 3 · 2024: 4 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 5 · 2019: 3 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 4 · 2014: 2 · 2013: 4 · 2012: 1
FWCI: 0.35
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: International Journal of Pharmaceutics (publishedVersion)
PubMed (publishedVersion)
Funders: U.S. Food and Drug Administration
Topics: Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
Keywords: tablet stability, pharmaceutical excipients, aqueous slurry, pH modifiers, dibasic calcium phosphate, mannitol, microcrystalline cellulose, starch, hygroscopicity, accelerated storage testing, potency assay, drug degradation
MeSH terms: Adsorption, Calcium Phosphates, Cellulose, Chromatography, High Pressure Liquid, Drug Compounding, Drug Packaging, Drug Stability, Excipients, Hydrogen-Ion Concentration, Kinetics, Lactose, Mannitol, Starch, Tablets, Thyroxine, Water, Wettability

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The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets

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