(HALO)BUTYL OLIGOMERS IN PHARMACEUTICAL RUBBERS

摘要

(Halo)butyl rubbers are a class of materials, commonly used in the manufacture of closures for pharmaceutical use. These materials are used because of their excellent elasticity and reseal properties, such as sterility assurance of the container/closure system, pierceability, gliding properties (in case of moving parts, such as plungers in a Pre-Filled Syringe (PFS)), compatibility with a broad range of sterilization techniques (steam, gamma irradiation), the minimal drug/packaging interaction during storage and their low permeability properties. Typical parts of a Parenteral Container/Closure system that are made out of halobutyl rubbers are stoppers (vials), plungers (PFS, cartridges), needle shields (PFS), tip caps (PFS) and sealing discs (cartridges)____ The ingredients of (halo)butyl rubbers (such as the elastomer, filler, cure system (initiator, accelerator), stabilizers, anti-oxidants, plasticizers, waxes, processing aids, retarder, pigments...) will contribute to the desired physical properties of the closure. However, because of the complexity of the composition of a (halo)butyl rubber, a lot of (potential) drug impurities may arise when these materials are in contact with the drug product over an extended period of time. In recent years, all rubber closure manufacturers have put a lot of effort in developing cleaner grades of pharmaceutical rubbers by optimizing the process, using cleaner ingredients, limiting the amount of ingredients or by coating the rubbers with an inert film.