Thursday, July 20, 2017

Levothyroxine : Storage Stability

Availability
  • Levothyroxine 100mcg
Manufacturers Recommendation
  • Not to be stored above 25oC
  • 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.

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