Preventive approach Iodine micronutrient formulation for prebirth Iodine

Preventive approach: Iodine micronutrient formulation for pre-birth

Iodine in pregnancy • Adequate intake of this mineral is needed for maternal thyroid hormone production, and thyroid hormone is needed for myelination of the central nervous system and is thus essential for normal fetal brain development.

Changes in thyroid function in pregnancy E TBG TSH FT 4 iodine TPO Ab HCG FT 4 TSH placental DI III Delange: Int. J. Endocrinol. Metab. 2: 1, 2004 goiter Tg TSH

Iodine deficiency • If iodine deficiency leads to inadequate production of thyroid hormone during pregnancy, irreversible brain damage in the fetus may occur • Severe maternal iodine deficiency has also been associated with increased incidence of miscarriage, stillbirth, and birth defects

Importance of iodine in brain development 50, 000 brain cells produced/second in the developing fetal brain 100 billion brain cells in adult One million billion connections between these brain cells: Determine IQ

• Iodine deficiency is now accepted as the most common cause of preventable brain damage in the world. • Thus, adequate intake of the mineral throughout pregnancy is critical

American Thyroid Association's Recommendation To achieve a total of 250 μg iodine ingestion daily, in North America all women who are planning pregnancy, pregnant, or breastfeeding, should supplement their diet with a daily oral supplement that contains 150 μg of iodine. Thyroid 2011; 21: 1081 -1125

Formulation Challenges • Content uniformity • Stability • Detection (slight amount of iodine in a complex matrix)

Content uniformity • The content uniformity test is to ensure that every dosage form contains equal amount of drug substance • 150 mcg in each tablet and 150 g iodine in 180 kg matrix

Stability • Elemental iodine readily sublimes and is then rapidly lost to the atmosphere through diffusion • Iodine tablets have to pass accelerated (6 months, 40°C/75% RH) and long term (12 months , 25°C/60% RH) stability test. • To need a stable form