Abstract

COMPARISON OF EXTRACTABLE AND LEACHABLE STUDIES OF DIFFERENT STOPPERS MATERIALS USED IN LYOPHILIZED DRUG PRODUCT

Meryem Ozturk*, Gokay Gun, Cuneyt Toprak, Muge Guleli, Enes Dandan, Cem Cal?skan, Erdinc Babuc and Sevgi Kocaoba

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Abstract

Parenteral drugs are drugs that are administered directly or indirectly into the bloodstream with a syringe, usually in sterile single-dose or multiple-dose form, such as ampoules or vials, administered outside the digestive tract. Medicines and medical devices must not contain impurities that can harm the patient. Contamination affecting critical properties of parenteral products can occur in many forms and from many sources. Proper control of contaminants from all surfaces that the drug comes into contact with is critical to drug development. A class of pollutants that has received much attention in recent years are leachable and extractables. Leakable substances; refers to foreign chemicals that may leach from the packaging material into the finished drug during transport, storage, use conditions or accelerated stability studies. Potential leaks revealed in laboratory testing of pharmaceutical primary packaging system components are termed "extractable". extractables and leachables are mostly chemical contaminants on plastic and elastomeric vial closure system components or organic residues on metal and glass surfaces. The aim of the study was to keep the butyl rubber and ethylene tetrafluoroethylene film (ETFE) of the finished product containing cangrelor tetrasodium prepared as lyophilized powder under 25°C and 50°C conditions for 30 days in contact with copalimer-coated butyl rubber stoppers, and in the samples taken by dissolving it again with water for injection (reconstituted drug) is a comparison of leak tests using LC/Q-TOF and GC- MS.

Keywords: Extractables, Leachable, Cangrelor, Lyophilized Powder, Hyphenation Techniques.