Quantification and Risk Assessment of Microplastic Contamination in Film-Coated Tablets During the Manufacturing Process

Abstract

Microplastic (MP) pollution in drug preparations has become a possible human health hazard, with little studies measuring its level in oral dosage preparations. This paper set out to examine the frequency, composition and hazard of microplastics in film-coated tablets during the manufacturing process. Five critical stages (raw material handling, granulation, compression, coating and packaging) were sampled a total of 150 composite samples were taken. Microplastic particles were separated with controlled digestion and filtration, characterized with µ-FTIR spectroscopy, Raman microspectroscopy, and Pyrolysis–GC–MS, and found out that polyethylene (PE) and polypropylene (PP) were the most common polymers and the contamination level was the highest during the coating and packaging stages. The particle size analysis showed that 77% of microplastics were less than 50 µm, which has a possible implication of bioavailability and systemic exposure. The estimate of the daily intake (EDI) showed that the exposure risk was low-moderate in the usual dosing schedules. The investigation reveals the existence of critical points of contamination during the manufacturing process and indicates that the issues of improved quality control measures should be considered such as equipment maintenance, filtration, and polymeric material monitoring. The results offer a background knowledge of microplastic pollution in pharmaceuticals, which can be used to guide regulatory frameworks, Good Manufacturing Practices (GMP), and further studies that aim at mitigating the exposure and the long-term effects of the pollution.