Physicochemical stability study of a 25% sodium thiosulphate gel

S. Molignier1, E. Caudron2,3, K. Kemel3, L. Le2,3, C. Laugel3, J. Jost1,4, V. Guigonis5,6, V. Ratsimbazafy1,4

CHU Dupuytren (1 et 5) and Université de Limoges, UMR 1094 (4) et 7276 (6), Limoges, France
COM18-76391 Hôpital européen Georges Pompidou (2) andt Université de Paris Sud (Lip(Sys)2) (3), Paris, France

INTRODUCTION RESULTS
Development of a 25% sodium thiosulfate (STS) gel for the treatment of ectopic calcifications
(presented at GERPAC 2017)
Objective: assess the physicochemical stability of this new preparation Variation in TSS Macroscopic
Absence of the
content at D90: pH: no change Translucent appearance
characteristic
104 ± 2% at 25°C beyond ± 5% white colour remains
MATERIAL AND METHOD sulphurous odor
103 ± 2% at 4°C homogeneous

25% STS gel compounding : Sodium thiosulfate (COOPER France) 25 %

Xanthan gum (COOPER) 2%

Absolute alcohol (COOPER) 10 %

STS (initial concentration %)

Sterile water, VERSYLENE® (FRESENIUS) qsp 100 %
Average %STS 25°C
Permeation agent with microbiological
activity for this content Average %STS 4°C

Study design 25°C and 4°C

D0 D1 D3 D8 D16 D30 D60 D90 D0 D1 D3 D16 D30 D60 D90

Time (day)
Evaluation parameters

Macroscopic Discussion :
STS
STS content
content (n=6)
(n=6) pH (n=3) Color Odor • Results are therefore satisfactory but a variable Mass loss
D1 D3 D8 D16 D30 D60 D90
aspect (%)
loss of gel mass has been observed
1,09
Acceptance criteria • Main hypothesis: evaporation of alcohol 25°C 0,02% 0,13% 0,30%
%
5,26% 2,95% 9,37%
• Solution considered: packaging in tubes to reduce - 0,39
4°C -0,04%1,28% 0,81% 0,99% 2,78%
No alteration of No detection of No change in the potential evaporation surface area in order to 0,11% %

the initial color the characteristic homogeneity by maintain the good conservation of the gel
90-110% of the 95-105% of the visual observation
(translucid white) odor of STS
initial value initial value
by photographic degradation
into the container CONCLUSION
and after application
comparison product The formulation developed was stable for 90 days at 25°C and 4°C, validating a shelf life of one month.
on skin
Alcohol, used as a permeation agent up to 10%, has an antimicrobial activity that prevents a microbiological
stability study from being carried out. Given these favorable results, the gel can be tested in humans.
STS content was assessed by an UV-CLHP method
previously assessed according to the SFSTP guideline
21th GERPAC Conference – October 03-04-05, 2018 – Hyères