Levothyroxine : Storage Stability

Availability

• Levothyroxine 100mcg

Manufacturers Recommendation

• Not to be stored above 25^oC
• Container should be kept in the outer carton in order to protect from light.
• Based on manufacturer, tablets can be split as it has scoring. However no information is available on the stability of split dose

Stability based on Studies

• A study which compared the stability of tablets stored in bottles and blisters packs, showed that after 4 months, degradation takes place faster in the opened bottles compared to the blisters but remains well within the acceptable limit.
• Dissolution profiles of batches packaged in bottles show a larger decrease during an in-use period of 3 months than the blister batches to which they were compared.
• During the in-use shelf-life after opening of the bottles, the tablets may be exposed to variable environmental conditions.
• The blister package remains closed until the tablets are removed per unit, which keeps the environmental conditions to which the tablets are exposed more stable than in an opened bottle
• Samples were both stored in a stability chamber at 25°C±2°C/60%±5% RH.

References:

• Euthyrox^® Product Information.
• Public Assessment Report on Duotab 0.025 mg, 0.100 mg and 0.150 mg, tablets (Levothyroxine Sodium) 2015.