Assessment of Extractables and Leachables from Pharmaceutical Packaging: Ink and Adhesive Migration in Selected Maternal Health Drugs in Nigeria

Peter Obinna Okwuego; Omoh Theodore Oshokha

doi:10.56201/ijhpr.vol.10.no9.2025.pg108.117

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Assessment of Extractables and Leachables from Pharmaceutical Packaging: Ink and Adhesive Migration in Selected Maternal Health Drugs in Nigeria

Peter Obinna Okwuego, Omoh Theodore Oshokha

Abstract

Pharmaceutical packaging materials, particularly inks and adhesives used on ampoules and labels, can release hazardous substances that compromise drug safety. This study evaluated extractables and leachables (E&L) in selected maternal health drugs magnesium sulphate, oxytocin, and metronidazole commonly sold in Nigeria. Packaging materials and drug contents were analyzed using Gas Chromatography-Mass Spectrometry (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR), Ultraviolet-Visible Spectrophotometry (UV-Vis), Atomic Absorption Spectrophotometry (AAS), and Energy Dispersive X-ray Fluorescence (ED-XRF). Results revealed significant levels of polycyclic aromatic hydrocarbons (PAHs), including naphthalene (7991.20 mg/L), phenanthrene (1167.80 mg/L), and anthracene (531.80 mg/L), as well as butyl acrylate and acrylic acid in ink and adhesive extracts. Heavy metal analysis detected high concentrations of chromium (3080 mg/L), while lead, cadmium, and nickel were negligible. Although leachables were generally absent or detected only at trace levels in drug contents, compounds such as ethylamine, ethylene glycol, and heptadecane nitrile were identified in metronidazole samples. These findings underscore the potential health risks associated with packaging-derived contaminants, particularly under suboptimal storage conditions. The study highlights the urgent need for regulatory enforcement of standardized packaging materials, mandatory E&L testing, and continuous quality surveillance within the Nigerian pharmaceutical sector to safeguard patient health.

Keywords

Extractables and Leachables (E&L)Pharmaceutical PackagingMaternal Health

References

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Assessment of Extractables and Leachables from Pharmaceutical Packaging: Ink and Adhesive Migration in Selected Maternal Health Drugs in Nigeria

Abstract

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