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Open AccessArticle

Stability and Compatibility Studies of Levothyroxine Sodium in Solid Binary Systems—Instrumental Screening

by Ionuț Ledeți 1,†, Mirabela Romanescu 1,†, Denisa Cîrcioban 1,†, Adriana Ledeți 1,*,†, Gabriela Vlase 2,†, Titus Vlase 2,†, Oana Suciu 3,*,†, Marius Murariu 4,*,†, Sorin Olariu 4,†, Petru Matusz 5,†, Valentina Buda 6,† and Doina Piciu 7,8,†
1
Department of Pharmacy I, Faculty of Pharmacy, Victor Babes University of Medicine and Pharmacy, 300011 Timișoara, Romania
2
Research Centre for Thermal Analysis in Environmental Problems, West University of Timișoara, 300115 Timișoara, Romania
3
Department of Medicine XIV, Faculty of Medicine, Victor Babes University of Medicine and Pharmacy, 300011 Timișoara, Romania
4
Department of Medicine X, Faculty of Medicine, Victor Babes University of Medicine and Pharmacy, 300011 Timișoara, Romania
5
Department of Medicine I, Faculty of Medicine, Victor Babes University of Medicine and Pharmacy, 300011 Timișoara, Romania
6
Department of Pharmacy II, Faculty of Pharmacy, Victor Babes University of Medicine and Pharmacy, 300011 Timișoara, Romania
7
Department of Nuclear Medicine, Prof. Dr. Ion Chiricuță Institute of Oncology, 400015 Cluj-Napoca, Romania
8
Department of Oncology, Faculty of Medicine, Iuliu Hațieganu University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania
*
Authors to whom correspondence should be addressed.
All authors contributed equally to this work.
Pharmaceutics 2020, 12(1), 58; https://doi.org/10.3390/pharmaceutics12010058
Received: 13 November 2019 / Revised: 4 January 2020 / Accepted: 7 January 2020 / Published: 10 January 2020
(This article belongs to the Special Issue Drug Stability and Stabilization Techniques)
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. View Full-Text
Keywords: levothyroxine sodium; excipient; preformulation study; instrumental analysis levothyroxine sodium; excipient; preformulation study; instrumental analysis
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Ledeți, I.; Romanescu, M.; Cîrcioban, D.; Ledeți, A.; Vlase, G.; Vlase, T.; Suciu, O.; Murariu, M.; Olariu, S.; Matusz, P.; Buda, V.; Piciu, D. Stability and Compatibility Studies of Levothyroxine Sodium in Solid Binary Systems—Instrumental Screening. Pharmaceutics 2020, 12, 58.

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