Investigation of phthalates in medical pharmaceutical products

Phthalates are man-made, endocrine disrupting chemicals that are commonly used in plastics, medical applications, drugs, personal care products, cosmetics, perfumes, home furnishings, dyes, children's toys, food packaging. Animal studies have revealed that phthalates have many adverse health effects. Since phthalates do not dissolve in acidic environments, they are only soluble in neutral or basic environments, they are frequently used in gastro-resistant film coatings of drugs that are not intended to dissolve in the stomach and that need to be dissolved directly in the intestine. Within the scope of this study, phthalates and their amounts in frequently used drugs in our country were determined by GC-MS and the potential health risks of patients using such drugs were evaluated. It was determined that the total phthalate concentrations in the examined drug samples ranged between 0.284 and 3.087 mg kg-1, and the amounts in a single tablet ranged between 8.9.10-5 and 2.4.10-3 mg/tablet. The drugs with the highest total phthalate concentrations were iron deficiency (3,087 and 2,435 mg kg-1) and stomach (reflux) (1,108 mg kg-1) drugs. The fact that the calculated hazard index values were less than one showed that the phthalates detected in the drugs examined did not pose a risk to human health. Key Words: Phthalate, medicine, pharmaceutical, endocrine disruptor, GC-MS