A Foilized Polyethylene Pouch for the Prevention of Transmission of HIV from Mother to Child
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Published on: September 6, 2019
Robert Malkin1, Caroline Howard
1Department of Biomedical Engineering, Hudson 136, #90281, Duke University, Durham, NC 27708, USA.
Insights
A new foilized pouch effectively preserves Nevirapine (NVP), an antiretroviral medication, for infants at risk of HIV. This packaging innovation allows for long-term storage at home, crucial for preventing mother-to-child HIV transmission in Africa.
Area of Science:
- Pharmaceutical Sciences
- Public Health
- Materials Science
Background:
- Mother-to-child transmission of HIV remains a significant global health challenge, particularly in regions with high home birth rates.
- Antiretroviral (ARV) medications, such as Nevirapine (NVP), are critical for preventing infant HIV infection but require proper storage and timely administration.
- Existing drug delivery systems are inadequate for the long-term, at-home storage of ARVs needed to prevent transmission during childbirth.
Purpose of the Study:
- To evaluate the efficacy of a novel preserving, foilized, polyethylene pouch for storing Nevirapine (NVP) intended for neonatal administration.
- To assess the stability of NVP and its preservatives within the proposed packaging under various storage conditions over one year.
- To determine the protective qualities of the pouch against environmental factors like moisture, light, and oxygen.
Main Methods:
- Pouches were filled with 0.6 ml of Nevirapine (NVP) and subjected to immediate analysis to assess handling impacts.
- Remaining samples were stored for up to 12 months under controlled conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH).
- Regular measurements included moisture loss, preservative and NVP concentrations, and impurity levels. Flora and fauna challenges were also conducted.
Main Results:
- The foilized pouches demonstrated excellent moisture barrier properties, with less than 0.7% weight loss over 12 months.
- While initial handling affected preservative levels, they remained stable within the package for the entire storage duration.
- Nevirapine (NVP) concentration showed minimal change, averaging only 1.3% across all conditions and time points.
Conclusions:
- The foilized polyethylene pouch is a viable and effective packaging solution for preserving Nevirapine (NVP) for up to one year.
- This innovative packaging can support the critical need for long-term, at-home storage of ARVs to prevent mother-to-child HIV transmission.
- The pouch technology holds potential for preserving other antiretroviral medications, expanding its public health impact.
Abstract:
Many children become HIV+ due to mother-to-child transmission, a risk that can be largely eliminated if infants ingest antiretroviral (ARV) medications immediately after birth. As most mothers in Africa deliver at home, the ARV must be provided at their last antenatal visit, sometimes months before birth. No current drug delivery system allows the mother to store the medication at home long enough to be effective. We propose a preserving, foilized, polyethylene pouch to be pre-dosed and sealed by a pharmacist for later delivery to the newborn.Pouches were filled with 0.6 ml of Nevirapine (NVP). Thirty-three pouches were immediately studied to measure the impact of medication handling (oxygen, light, filling and sealing the pouches). The remaining samples were stored for up to one year at three storage conditions (25°C/60%RH, 30°C/65%RH, and 40°C/75%RH). Every two months, moisture loss, preservative concentration, impurity concentrations and NVP concentration were measured. Flora and fauna challenges were conducted.THE POUCH NEARLY ELIMINATED MOISTURE LOSS: pouches lost less than 0.7% of their weight over twelve months. As expected, exposing the medication to light, oxygen, and handling significantly affected the sacrificial preservative concentrations (Propyl paraben dropped 38%, Methyl paraben dropped 12% at time point zero). However, after the initial time point, preservative levels were stable in the package over twelve months under all storage conditions (4.1% average concentration drop), leaving sufficient preservatives to protect the medication. The concentration of NVP changed an average of only 1.3% over all storage conditions and times points (maximum 1.4%).We conclude that the foilized polyethylene pouch can preserve NVP, and perhaps other ARV's, for up to one year.
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