Methodological approach to the selection of filtering materials for injectable medicines in polyethylene ampoules.

Abstract

The aim of the has been studied is to select the optimal filter material to obtain a sterile injectable solution of piracetam 20%. One of the main requirements that apply to injection solutions is sterility and the absence of mechanical impurities. The filtration system must be reliable and easily controlled, since the use of filters that are not strong enough and clog the test solution with particles of the filter material leads to poor quality medicines. Therefore, it is necessary to constantly improve methods of filtration of parenteral drugs. At the stage of pharmaceutical development, the influence of the filter membrane material on the quality of the solution to be filtered has been determined. A practical pattern of the choice of filters in the study of injectable solution of piracetam 20% and filter materials based on polyvinylidene fluoride (PVDF), polyester sulfone (PES) and nylon was provided. Studies have been conducted to identify possible processes of migration and sorption of solution components and filter membranes using instrumental methods of analysis, as well as to determine the sterilizing ability of filters with a membrane rating of not more than 0.2 μm. The possibility of using all investigated filters in the commercial production of the medicine piracetam 20% has been proved. Using the results of this work will eliminate long-term and numerous studies on the selection of filter material during development of the technological stage of filtration in the production of injectable medicines.