A Pouch May Be Prevent the Transmission of HIV from Mother to Child

Many children become HIV+ due to mother-to-child transmission during home birth. This risk can be largely eliminated if infants ingest antiretroviral (ARV) medications immediately after birth. Unfortunately, there is currently no mechanism to provide dosed medication at a mothers first and perhaps only, antenatal care visit, months before delivery. We propose a foilized, polyethylene pouch to preserve pre-dosed ARV’s. In this work we show that pharmacists can fill and seal the pouch, the pouch can preserve the medication and HIV+ mothers can empty the pouch into a simulated infant’s mouth. A pharmacists in Moshi Tanzania was trained and then filled and sealed 60 pouches which were tested for their effect on the medication, their mechanical strength (burst and leakage) and their volume accuracy. Under laboratory conditions, pouches from two manufacturers were filled with AZT and NVP (two common ARV’s) and stored in conditions ranging from 25ºC/60% relative humidity (RH) to 40ºC/75% RH for twelve (AZT) or four (NVP) months. Sixty-one HIV+ mothers were asked to tear open pouches and empty the contents into plastic cups of approximately the size and shape of an infant’s mouth. No pharmacist sealed pouches burst or leaked (average percent weight loss maximum 0.080%). The AZT (102.2% of labeled concentration) and NVP (96.4%) in the pharmacist sealed pouches were stable. Pharmacist handling of the mediation did consume some of the sacrificial preservatives (72.4% remaining in AZT and 40.2% remaining for NVP) but not enough to affect the active ingredient. The same impurities were identified in the NVP and AZT samples sealed in Africa and the NVP and AZT samples removed from the bottles indicating that the pouches do not introduce impurities that are not already introduced from the bottle. The pharmacist filled pouches with an overall volume error of 0.13% +/- 6.6%. When the pouches were filled under laboratory conditions, there was no significant change in AZT (97.4% to 97.9%) or NVP (102.3% to 101.9%) concentrations after months of storage. All tested mothers were easily able to empty the contents of the pouch (89.8%: NVP, 89.7%, AZT) into the simulated mouth. We conclude that the pouch can be sealed by pharmacists in in realistic settings, the pouch can preserve the medication for months and HIV+ mothers can open the pouch and empty its contents.