McGaw Technology (United States)

ABSTRACT. To circumvent the potentially negative consequences of long-term exposure to unphysiologic acidic lactate-buffered peritoneal dialysis fluids (PDF), neutral pH solutions buffered with bicarbonate/lactate have recently been introduced in phase 2 and 3 clinical trials. This study examines the longitudinal changes in peritoneal macrophage (PMØ) function in patients dialyzed continuously with either lactate (LPD; 40 mM lactate, pH 5.2)-buffered or bicarbonate/lactate (TBL; 25 mM/15 mM bicarbonate/lactate, pH 7.3)-buffered PDF. Before the study, during the run in period of a phase 3 clinical trial, all patients had been taking LPD for at least the previous 18 wk. At the beginning of the study (day 0), both constitutive and serum-treated zymosan (STZ) stimulated tumor necrosis factor alpha (TNF-α) synthesis were assessed in PMØ isolated from 12-h dwell effluent (with 1.36% glucose) in all patients. The patients were subsequently randomized to either continuous TBL or LPD therapy and PMØ function was assessed after further 3- and 6-mo periods in all patients. At all time points measured STZ induced a dose-dependent increase in PMØ TNF-α secretion (P = 0.043 versus control for doses greater than 100 μg/ml). In patients continuously dialyzed with LPD, constitutive PMØ TNF-α synthesis levels (mean ± SEM, pg/106 PMØ per18 h, n = 5 patients) were 154 ± 65, 261 ± 60, and 101 ± 99 at 0, 3, and 6 mo, respectively. Stimulated STZ (1000 μg/ml) levels were 1340 ± 519, 1046 ± 586, and 758 ± 250 at 0, 3, and 6 mo, respectively. In patients dialyzed with TBL, constitutive PMØ TNF-α synthesis levels (pg/106 PMØ per 18 h, n = 5 patients) were 300 ± 136, 106 ± 35, and 213 ± 62 at 0, 3, and 6 mo, respectively. Stimulated STZ (1000 μg/ml) levels were 1969 ± 751, 1541 ± 330, and 2670 ± 671 at 0, 3, and 6 mo, respectively. At 6 mo, STZ-stimulated PMØ TNF-α synthesis was significantly higher in patients treated with TBL compared with those treated with LPD (P = 0.0035). These data suggest that in patients continuously dialyzed with a neutral pH solution, there is a long-term improvement in PMØ function compared with patients on conventional therapy. Better PMØ function suggests improved host defense status and may affect the peritoneum’s susceptibility to infection and potentially reduce the negative consequences of repeated intraperitoneal inflammation on long-term membrane function.

Data-dependent liquid chromatography tandem mass spectrometry was utilized to identify leachables from adhesives used in pharmaceutical products. This approach affords a significant increase in the amount of data obtained from a single experiment. No information about the sample is needed a priori to perform these analyses. The data thus acquired speeded up the selection of the appropriate adhesive and shortened the development time of the drug product. © 1997 John Wiley & Sons, Ltd.

The compatibility of 102 drugs with parenteral nutrient (PN) solutions during simulated Y-site administration was studied. Five milliliters of each of four representative PN solutions was combined in duplicate in a 1:1 ratio with 5-mL samples of solutions of 102 drugs in 5% dextrose injection or 0.9% sodium chloride injection. Visual examinations were performed in fluorescent laboratory light and under high-intensity monodirectional light, and turbidity was measured. Particle sizing and counting were performed for selected solutions. All evaluations were performed at intervals up to four hours; storage was at 23 degrees C. Most of the drugs tested were compatible with the PN solutions. However, 20 drugs exhibited various incompatibilities with one or more of the PN solutions. During simulated Y-site administration, four PN solutions were compatible with 82 of 102 drugs for four hours at 23 degrees C. Twenty drugs were incompatible with one or more of the PN solutions.

Simian virus 40 small-t antigen allows the growth of CV-1 cells in concentrations of theophylline that normally prevent cell cycling. This effect is completely overcome by two ionophores that uncouple mitochondria and by the anti-mitochondrial drug methylglyoxal bis-(guanylhydrazone).

Journal of Parenteral and Enteral NutritionVolume 4, Issue 3 p. 317-317a Letter Rebly to S. Traub Carole Ann spfio, Carole Ann spfio Medical Affairs McGaw Laboratories Irvine, California 92714Search for more papers by this authorGary A. Miller Ph. D., Gary A. Miller Ph. D. Pharmaceutical Research & Development McGaw Laboratories Irvine, California 92714Search for more papers by this authorElizabeth Wood, Elizabeth Wood Quality Assurance McGaw Laboratories Irvine, California 92714Search for more papers by this author Carole Ann spfio, Carole Ann spfio Medical Affairs McGaw Laboratories Irvine, California 92714Search for more papers by this authorGary A. Miller Ph. D., Gary A. Miller Ph. D. Pharmaceutical Research & Development McGaw Laboratories Irvine, California 92714Search for more papers by this authorElizabeth Wood, Elizabeth Wood Quality Assurance McGaw Laboratories Irvine, California 92714Search for more papers by this author First published: 01 May 1980 https://doi.org/10.1177/014860718000400317AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume4, Issue3May 1980Pages 317-317a RelatedInformation

The visual compatibility of 30 drug additives with total parenteral nutrient (TPN) solutions (4.25% amino acids, 25% dextrose injection) was studied. For each drug additive, three TPN solutions were mixed; two were stored for 22 hours at 4 C then allowed to equilibrate to room temperature for two hours. Two 25-ml samples from each TPN solution were examined immediately or after 25 hours for visual appearance, particulate matter levels and pH. A microscope was used to count and measure particles filtered from samples on a 0.8-micrometer filter. Only the TPN solutions containing amphotericin B showed any visual discoloration or precipitation. All amphotericin B samples and the 25-hour ampicillin sodium samples exceeded USP particulate matter specifications. Individual particulate matter levels of the other TPN solutions varied but met USP specifications. With the exception of tetracycline hydrochloride, which dropped the TPN solution's pH 0.9 units, the additives had little effect on pH of the TPN solutions (pH 6.45). Amphotericin B and ampicillin sodium were considered visually incompatible with TPN solutions. All other drug additives tested were visually compatible with TPN solutions.