An Alternative Approach to Tablet Splitting and Grinding for Medication Administration.

Tablet formulations fail to meet the needs of patients unable to swallow tablets such as pediatric, elderly, and patients that must receive medications via feeding tubes. Our objective was to develop and test a new, simple device (XTEMP-R) and the methodology for converting tablets into a homogeneous suspension for medication administration. We developed a new device comprised of a flexible receptacle, a tight-fitting cap, and a suction cup bottom to convert tablets into liquid preparations. Tuberculosis treatment drugs, TBAJ-876 and TBI-223, were dispersed within the device utilizing water and commonly available suspending vehicles. We investigated the effectiveness of the XTEMP-R device in dispersing tablets. This was accomplished by visual observations, determining the fineness of dispersion, and measuring the total drug recovery from the dispersions in XTEMP-R. We investigated the accuracy and reproducibility of delivering aliquots from these suspensions by determining the dose reproducibility upon suspension and upon redispersion after 24 hours. The effectiveness of the device was also evaluated using commercially available tablets of acetaminophen, amlodipine, glimepiride, metformin, and valsartan. The suspensions were visually uniform without any large particles. The suspensions passed through a #18 sieve confirming that the particles were less than 1000 µm. The average total dose recovery of three suspensions each was determined to be 101.3% and 99.2% for TBI-223 and TBAJ-876, respectively. Reproducibility from aliquots of 2 mL each was 98.9% to 99.7% for three replicates of TBI-223 suspensions, and 102.6% to 103.2% for TBAJ-876 suspensions. Aliquots tested after 24 hours confirmed uniform redispersibility. We have demonstrated that XTEMP-R can be utilized to prepare homogeneous suspensions conveniently and efficiently in less than 10 minutes without any drug loss. Aliquots for partial dose delivery can be withdrawn accurately. These findings demonstrate that XTEMP-R can be used to accurately deliver doses of suspensions for patients who cannot swallow tablets.

Maximum tolerated osmolarity for peripheral administration of parenteral nutrition in pediatric patients.

BACKGROUND: Limited data support a recommended maximum osmolarity for administration of peripheral parenteral nutrition (PPN). In this retrospective, matched-cohort study, we evaluated the incidence of phlebitis or infiltration associated with administration of PPN with an osmolarity >1000 mOsm/L vs ≤1000 mOsm/L. MATERIALS AND METHODS: Patients ≤18 years old who received PPN in a 2-year period were included in the study. Data related to patient demographics, PPN constituents, and adverse effects were analyzed. RESULTS: A total of 352 patients met entry criteria. Overall, 139 (40%) patients experienced phlebitis or infiltration. There were no differences between patients who did or did not develop adverse events in terms of age or weight. Administration of PPN with osmolarity >1000 mOsm/L vs ≤1000 mOsm/L significantly increased infiltration (17% vs 7%; odds ratio [OR, 2.47]; 95% confidence interval [CI], 1.24-4.94; P = .01) and the combined composite end point of phlebitis or infiltration (45% vs 34%; OR, 1.65; 95% CI, 1.07-2.54; P = .02). In multivariate analysis, osmolarity >1000 mOsm/L vs ≤1000 mOsm/L was an independent risk factor for developing complications (OR, 1.67; 95% CI, 1.08-2.52; P = .02). CONCLUSION: Two of every 5 children experienced phlebitis or infiltration during administration of PPN. These adverse effects were more often observed in those who received PPN with osmolarity >1000 mOsm/L vs ≤1000 mOsm/L. With this high incidence of adverse effects, we recommend that if PPN is used, the osmolarity should not exceed 1000 mOsm/L. More important, PPN should only be used temporarily until central access is obtained.

Addressing parents' concerns: do vaccines contain harmful preservatives, adjuvants, additives, or residuals?

Vaccines often contain preservatives, adjuvants, additives, or manufacturing residuals in addition to pathogen-specific immunogens. Some parents, alerted by stories in the news media or information contained on the World Wide Web, are concerned that some of the substances contained in vaccines might harm their children. We reviewed data on thimerosal, aluminum, gelatin, human serum albumin, formaldehyde, antibiotics, egg proteins, and yeast proteins. Both gelatin and egg proteins are contained in vaccines in quantities sufficient to induce rare instances of severe, immediate-type hypersensitivity reactions. However, quantities of mercury, aluminum, formaldehyde, human serum albumin, antibiotics, and yeast proteins in vaccines have not been found to be harmful in humans or experimental animals.