Stability and Compatibility Studies of Levothyroxine Sodium in Solid Binary Systems-Instrumental Screening.
excipient
instrumental analysis
levothyroxine sodium
preformulation study
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
10 Jan 2020
10 Jan 2020
Historique:
received:
13
11
2019
revised:
04
01
2020
accepted:
07
01
2020
entrez:
16
1
2020
pubmed:
16
1
2020
medline:
16
1
2020
Statut:
epublish
Résumé
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 SiO
Identifiants
pubmed: 31936742
pii: pharmaceutics12010058
doi: 10.3390/pharmaceutics12010058
pmc: PMC7022666
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : undefined <span style="color:gray;font-size:10px;">undefined</span>
ID : PN-III-P1-1.1-TE-2016-1165 project (RECOTHER)
Références
Eur J Endocrinol. 2013 Nov 22;170(1):95-9
pubmed: 24123095
Int J Pharm. 2003 Oct 2;264(1-2):35-43
pubmed: 12972334
Endocrine. 2017 Jan;55(1):6-18
pubmed: 27981511
J Pharm Biomed Anal. 2016 Jun 5;125:33-40
pubmed: 26999320
Clin Pharmacokinet. 2019 Jul;58(7):827-833
pubmed: 30949873
Endocr Pract. 2014 Sep;20(9):901-6
pubmed: 24793916
Mol Biol Rep. 2014 May;41(5):3521-7
pubmed: 24515386
Arq Bras Endocrinol Metabol. 2011 Oct;55(7):429-34
pubmed: 22147090
J Pharm Biomed Anal. 2011 Feb 20;54(3):433-8
pubmed: 20947276
J Clin Pharm Ther. 1990 Oct;15(5):331-6
pubmed: 2289935
Materials (Basel). 2019 Sep 27;12(19):
pubmed: 31569620
AAPS PharmSciTech. 2010 Jun;11(2):818-25
pubmed: 20454876
Biol Pharm Bull. 2015;38(4):625-8
pubmed: 25832643
Eur Endocrinol. 2013 Mar;9(1):40-47
pubmed: 30349610
AAPS PharmSciTech. 2019 Jan 2;20(1):39
pubmed: 30604134
Curr Med Res Opin. 2019 Jan;35(1):147-150
pubmed: 30406687
AAPS PharmSciTech. 2010 Sep;11(3):1359-67
pubmed: 20740332
Pharm Dev Technol. 2015 May;20(3):314-9
pubmed: 24295156
Int J Pharm. 2017 May 30;524(1-2):414-423
pubmed: 28396245