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Stability and Compatibility Studies of Levothyroxine Sodium in Solid Binary Systems-Instrumental Screening
- Source :
- Pharmaceutics, Pharmaceutics, Vol 12, Iss 1, p 58 (2020), Volume 12, Issue 1
- Publication Year :
- 2019
-
Abstract
- 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.
- Subjects :
- food.ingredient
lcsh:RS1-441
Pharmaceutical Science
Excipient
02 engineering and technology
Talc
01 natural sciences
Gelatin
Article
lcsh:Pharmacy and materia medica
chemistry.chemical_compound
food
medicine
Magnesium stearate
preformulation study
Fourier transform infrared spectroscopy
Thermal analysis
excipient
021001 nanoscience & nanotechnology
010406 physical chemistry
0104 chemical sciences
chemistry
Attenuated total reflection
Anhydrous
levothyroxine sodium
instrumental analysis
0210 nano-technology
medicine.drug
Nuclear chemistry
Subjects
Details
- ISSN :
- 19994923
- Volume :
- 12
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Pharmaceutics
- Accession number :
- edsair.doi.dedup.....3e9fb559455330afd4f097ecb0d704ce