Study of compatibility of filter materials with solution of meloksmkama for injections
One of pharmaceutical design of parenterally solutions times is establishment of influence of filter materials on quality of preparation and choice of optimum filter membranes on the basis of these researches, establishment of optimum size of pores, and sequence of filtration of solution through filters with the different size of pores, that provides the necessary cleaning of injection solution from the mechanical including and microorganisms. The purpose of work was a leadthrough of pharmaceutical development of solution of meloksikama for injections, some aspects of which are lighted up in this article. A research object were «Meloksikam, solution for injection 10 mgs/ml for 1,5 ml in ampoules» and filter membranes, made from a kapron (type of «MIFIL», Byelorussia), nylon (type of «Ultipor N 66», Pall, Germany), poliefirsul'fona (type of «PROPOR PES», Domnik Khanter, England). Control of standards was conducted on methods, to described in DFU and normative document on preparation.
Compatibility of solution of meloksikama is well-proven 10 mgs/ml with materials of filters from a kapron (type of «MIFIL», Byelorussia), from a nylon (type of «Ultipor N 66», Pall, Germanу), poliefirsul'fona (type of «PROPOR PES», Domnick Hunter, England). The optimum mode of filtration and assortment of suitable to the use filter materials is chosen taking into account the cross-coupling of components of solution, рН environment and material of filter.
For determination of efficiency of filtration, there was a certain index of filtrated of FI (Filtrability Index) and maximal volume of the filtered solution of Vmax. It is set that for achievement of greater efficiency of filtration it is necessary to combine preliminary filtration through membranes with the threshold of detention of 0,6 mkm and steralizing – through membranes with the threshold of detention of 0,2 mkm.
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