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P R McClain

Publications and source records attributed to P R McClain.

5 recordsLinked to original sources

Effects of particulate matter from carbenicillin disodium solution on human macrophages in vitro.

The effects of particulate matter from reconstituted carbenicillin disodium on cultures of human macrophages was studied. Particulate matter from commercially available carbenicillin disodium was collected on 0.1 micrometer membrane filters. Monocytes/macrophages obtained from human peripheral blood were cultivated on the particle bearing surface of the filter in culture medium. The cells were incubated in tissue cultures dishes at a concentration of 2 x 10(6) cells per dish. Experimental and control cultures were observed over six days for changes in morphology, cell membrane integrity, phagocytic capacity, and viability. Exposure of the cells to the particles was not cytotoxic. Cell membrane integrity remained intact as shown by no increase of LDH in the extracellular fluid. The phagocytic capacity of the cell system was not impaired as assessed by observing the intracellular levels of glucose-6-phosphate dehydrogenase. Morphological changes as monitored by phase contrast and bright field microscopy were consistent with increased cellular activity. Particulate matter from carbenicillin disodium may not be toxic to human macrophages in vitro for up to six days. At the concentrations used in this study, particulate matter did not lower the phagocytic capacity of human macrophages in vitro.

Carbenicillin↗

Study of particulate matter in carbenicillin disodium using scanning electron microscopy and microbeam x-ray spectrography.

A scanning electron microscopy membrane filtration study was conducted to determine the particulate contamination of samples of carbenicillin disodium which had been manufactured by bulk filling and by lyophilization. The bulk-filled product contained more contaminating particles than the lyophilized product. In both products, the number of particles increased logarithmically with decreasing particle size in the range measured (exceeding 0.1 micron). X-ray spectrographic analysis of particles larger than 0.5 micron revealed that the major particulate contaminates in both products were composed primarily of elements below atomic number 10. It is concluded that packaging of carbenicillin disodium by lyophilization of a solution results in significantly less submicrometer particulate contamination than packaging by sterile bulk filling of spray-dried powder.

Carbenicillin↗