Comprehensive Analysis of Leachables and Extractables from Pharmaceutical Packaging: Investigating Ink and Adhesive Migration in Selected Drug Products in Nigeria

P.o Okwuego, Offiah V.o, M.b Nkachukwu and C.O. Ifeakor
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P.o Okwuego: Department of Pure and Industrial Chemistry, Chukwuemeka, Odumegwu Ojukwu University Uli, Jil Lubricants Technologies Ltd, Ogun State Nigeria
Offiah V.o: Department of Pure and Industrial Chemistry, Chukwuemeka, Odumegwu Ojukwu University Uli, Jil Lubricants Technologies Ltd, Ogun State Nigeria
M.b Nkachukwu: Department of Pure and Industrial Chemistry, Chukwuemeka, Odumegwu Ojukwu University Uli, Jil Lubricants Technologies Ltd, Ogun State Nigeria
C.O. Ifeakor: Department of Pure and Industrial Chemistry, Chukwuemeka, Odumegwu Ojukwu University Uli, Jil Lubricants Technologies Ltd, Ogun State Nigeria

International Journal of Research and Innovation in Applied Science, 2025, vol. 10, issue 4, 87-97

Abstract: Leachables and extractables from pharmaceutical packaging can pose serious health risks by contaminating drug formulations. This study employs High-Performance Liquid Chromatography (HPLC) to analyze ink and adhesive migration in two selected pharmaceutical products, Allergin and Bioflex, including their packaging materials and labels. Results reveal significant leaching of toxic compounds such as N-methylacetamide (33.53%), N-ethylacetamide (24.08%), and N-pentylbenzamide (15.67%) from the Allergin drug, all of which pose toxicity risks if consumed above recommended levels. Additionally, beneficial bioactive compounds like chlorogenic acid (9.36%) and hydroquinone (7.87%) were identified, contributing to antimicrobial and antioxidant effects. The packaging material for Allergin showed the presence of catechol (33.64%) and ethyl butyrate (35.54%), suggesting migration from the container into the drug. Similarly, the Bioflex drug contained oxalic acid (63.90%), octanoic acid (12.57%), and chlorogenic acid (23.52%), reinforcing its antibacterial properties but also raising safety concerns due to oxalic acid’s potential toxicity. The Bioflex packaging material was dominated by chlorogenic acid (85.95%), suggesting possible antimicrobial benefits but also raising concerns regarding its migration into the drug. These findings underscore the need for strict regulatory measures and improved packaging safety evaluations to minimize contamination risks and ensure pharmaceutical product integrity in Nigeria.

Date: 2025
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