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
References
B Complex and Elemental Contents of Pigeon Peas (Cajanus Cajan) Anachem Journal,
15(1), 85-95, DOI:https://doi.org/10.5281/zenodo.14567423
Nkachukwu M. B ,Okwuego P. O ,Ifeakor C. O , Offiah V. O (2025) Spectroscopic Analysis of
Leachables and Extractables from Selected Pharmaceutical Packaging: Assessing Ink and
Adhesive Migration in Drug Labels and Containers in Nigeria. International Journal of
Trend in Scientific Research and Development (IJTSRD) Volume 9 Issue 2. ijtsrd.com e-
ISSN: 2456 – 6470
Nwankwo N.V, Chinweuba A.J, Nwadiogbu O.J, Okwuego P.O, Odika I. M. (2025) Pesticide
Levels in Two Fish Species from a Section of the Niger River, Anambra State, Nigeria.
Asian Journal of Fisheries and Aquatic Research Vol. 27, Issue 4, Page 45-55, no.
AJFAR.133708 ISSN: 2582-3760
Ochie O.S., Okonkwo S.I. P. O. Okwuego (2025) Synthesis and Characterization of
Nanostructured Sorbents Derived from Rice Husks using FTIR, SEM, TEM and XRD
Approaches. International Research Journal of Pure and Applied ChemistryVolume 26,
Issue 1, Page 38-48, Article no. IRJPAC.129516ISSN: 2231-3443, NLM ID: 101647669
Okonkwo S.1, Ughanze B.N, Okonkwo C.K, Ezigbo V.O, Okafor, E.C , Okwuego P.O, Okonkwo
A.T, Okonkwo V. S.(2025) Determination of the Chemical and Morphological Structure
of Liposomes Encapsulating Lycopene Derived from Tomatoes Using FTIR, SEM, TEM,
and Ultrasound Imaging Techniques Volume 03 | Issue 04 | Article Id IJPS/250304235
Okorie E.A, Offiah V, O, Oragwu P.I, Okwuego P.O (2025) Assessment of Heavy Metals and
Polycyclic Aromatic Hydrocarbons in Soil and Water in Selected Mining Areas of Ebonyi
State,
Nigeria.
Journal
of
Global
Ecology
and
Enviroment.
Doi:
10.56557/jogee/v21i29123
Okwuego P. O (2022) Oil Removal by Structured Natural Sorbents Made from Pumpkin Stem
Fibres. COOU Journal of Physical Sciences (6)1 https://cjps.coou.edu.ng/
Okwuego P. O, (2023) Optimization of oil spill cleanup using composites fibres (ES) modified
kola nut pod.
Adhesive Migration in Selected Drug Products in Nigeria International Journal Of
Research And Innovation In Applied Science (IJRIIAS) ISSN NO. 2454-6194 DOI:
https://doi.org/10.51584/IJRIASs.10040007
Oragwu I.P, Okolo. A, J, Okwuego P.O, Ntokah. K. .(2024) Characterization of Some Local Clay
Minerals and Fabrication into Ceramic Floor-Tiles American Journal of Polymer Science
and Technology DOI: 10.11648/j.ajpst Vol. 10. Issue 4 ISSN 2575-5986
Sylvia Ifeyinwa Okonkwo, Benedicta Nonye Ughanze, Emmanuella Chinyere Okafor, Charles
Kenechukwu Okonkwo 1, Vera Obiageli Ezigbo, Peter Obinna Okwuego, Adachukwu
Theresa Kene-Okonkwo, Valentine Somtochukwu Okonkwo and S.C Okonkwo (2025)
Synthesis and characterization of chitosan-stabilized lycopene nanoparticles for prostate
cancer therapy: Integrating sonography for enhanced imaging and treatment monitoring,
World
Journal
of
Advanced
Research
and
Reviews,
2007-2017
DOI:
https://doi.org/10.30574/wjarr.2025.25.3.0822
