Stability and compatibility studies of levothyroxine sodium in solid binary systems-instrumental screening
Open accessAbstract
The influence of excipients on the stability of sodium levothyroxine pentahydrate (LTSS) under ambient conditions and thermal stress was evaluated. Since LTSS is a synthetic hormone with a narrow therapeutic index, the interactions of LTSS with excipients can lead to a drastic diminution of therapeutic activity. Ten commonly used pharmaceutical excipients with different roles in solid formulations were chosen as components for binary mixtures containing LTSS, namely, starch, anhydrous lactose, D-mannitol, D-sorbitol, gelatin, calcium lactate pentahydrate, magnesium stearate, methyl 2-hydroxyethyl cellulose (Tylose), colloidal SiO2 (Aerosil) and talc. As investigational tools, universal attenuated total reflectance- Fourier transform infrared spectroscopy UATR-FTIR spectroscopy and thermal analysis were chosen and used as follows: UATR-FTIR spectra were drawn up for samples kept under ambient conditions, while thermoanalytical tools (TG/DTG/HF data) were chosen to evaluate the inducing of interactions during thermal stress. The corroboration of instrumental results led to the conclusion that LTSS is incompatible with lactose, mannitol and sorbitol, and these excipients should not be considered in the development of new generic solid formulations.
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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.
“Acid excipients, such as lactose, mannitol, and sorbitol, can induce drug instability in tablets (112, 113), while basic excipients can be added to improve the stability of LT4 tablets (114).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [113]
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- Authors
- Ledeți, I., Romanescu, M., Cîrcioban, D., Ledeți, A., Vlase, G., Vlase, T., Suciu, O., Murariu, M., Olariu, S., Matusz, P., Buda, V., & Piciu, D.
- Affiliations
- Department of Pharmacy I, Faculty of Pharmacy, Victor Babes University of Medicine and Pharmacy, 300011 Timișoara, Romania
- Victor Babeș University of Medicine and Pharmacy Timișoara (RO)
- West University of Timişoara (RO)
- Iuliu Hațieganu University of Medicine and Pharmacy (RO)
- Corresponding author
- Suciu, Oana
- Murariu, Marius
- ORCID
- Venue
- Pharmaceutics
- Publisher
- MDPI AG
- Published
- 2020-01-10
- Volume
- 12
- Issue
- 1
- Pages
- 58
- ISSN
- 1999-4923 (ISSN-L)
- PMC
- PMC7022666
- OpenAlex
- W2999352430
- Cited by
- 23
- References
- 36
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 5 · 2022: 4 · 2021: 5 · 2020: 2
- FWCI
- 2.08
- Type
- journal article
- Language
- en
- Open access
- gold
- dx.doi.org
- Licence
- Locations
- Pharmaceutics (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- undefined <span style="color:gray;font-size:10px;">undefined</span> (PN-III-P1-1.1-TE-2016-1165 project (RECOTHER))
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Keywords
- levothyroxine sodium, pharmaceutical excipients, drug-excipient compatibility, drug stability, binary mixtures, thermal stress, lactose, mannitol, sorbitol, thermogravimetric analysis, drug-excipient interaction
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