摘要
Children can become HIV positive (HIV+) from their mother during home birth. If the infant ingests antiretroviral (ARV), medications immediately after birth, the risk of transmission can be dramatically reduced. We have previously proposed the use of foilized, polyethylene-lined pouches to store ARV’s. Using the pouch, the mother receives the medication at an antenatal care visit, months before delivery, and if she delivers at home, tears open the pouch and drips the medication into her child’s mouth. In this work, we extend the use of the pouch to store a modern ARV, Lamivudine (3TC), often used in multi-drug regimens. Under laboratory conditions, pouches were filled with 3TC and stored at 25?C/60% relative humidity (RH) for twelve months. We found that the 3TC was stable throughout the year (maximum 5.6% of labeled concentration change). The preservatives were somewhat degraded by the act of repackaging the medicine, but sufficient preservatives remained to maintain the medication. The same impurities were identified in the 3TC stored in the pouches and the samples removed from the bottles indicating that the pouches do not introduce new impurities (impurities that are not already introduced by the bottle). We conclude that the pouch can preserve this modern ARV for up to twelve months.
Children can become HIV positive (HIV+) from their mother during home birth. If the infant ingests antiretroviral (ARV), medications immediately after birth, the risk of transmission can be dramatically reduced. We have previously proposed the use of foilized, polyethylene-lined pouches to store ARV’s. Using the pouch, the mother receives the medication at an antenatal care visit, months before delivery, and if she delivers at home, tears open the pouch and drips the medication into her child’s mouth. In this work, we extend the use of the pouch to store a modern ARV, Lamivudine (3TC), often used in multi-drug regimens. Under laboratory conditions, pouches were filled with 3TC and stored at 25?C/60% relative humidity (RH) for twelve months. We found that the 3TC was stable throughout the year (maximum 5.6% of labeled concentration change). The preservatives were somewhat degraded by the act of repackaging the medicine, but sufficient preservatives remained to maintain the medication. The same impurities were identified in the 3TC stored in the pouches and the samples removed from the bottles indicating that the pouches do not introduce new impurities (impurities that are not already introduced by the bottle). We conclude that the pouch can preserve this modern ARV for up to twelve months.
