Chantal le Guellec | PubMed Health

PubMed2006

New ipratropium formulation to decrease nebulization time.

A new anticholinergic aerosol containing 0.5mg ipratropium bromide dissolved in 1mL of solution has been produced with the purpose of decreasing nebulization time for patients compared to the traditional formulation which is twice as voluminal (0.5mg/2mL, Boehringer-Ingelheim, France). The aim of this study was to compare aerosol characteristics (inhaled mass, particle size distribution and nebulization time) of these two formulations of ipratropium bromide, nebulized alone and with terbutaline (5mg/2mL, Astra Zeneca, Sweden), to determine whether the new formulation was equivalent to the old one. Four different jet nebulizers were used: PariLC+, Atomisor NL9M, Sidestream and Mistyneb. Statistical analysis of the results showed that for all types of nebulizer, the inhaled mass of ipratropium bromide 0.5mg/1mL was significantly lower than the inhaled mass of ipratropium bromide 0.5mg/2mL, and that there was no statistical difference between the inhaled mass of ipratropium bromide 0.5mg/1mL+terbutaline 5mg/2mL and the inhaled mass of ipratropium bromide 0.5mg/2mL+terbutaline 5mg/2mL. The study also showed that the new formulation of ipratropium bromide (0.5mg/1mL) mixed with terbutaline allowed a 26% decrease in nebulization time compared to the old formulation (0.5mg/2mL) mixed with terbutaline without changing aerosol characteristics (inhaled mass and particle size distribution). This leads to the conclusion that a 2mL minimum volume is required for nebulization, and that nebulization of ipratropium bromide 0.5mg/1mL alone must be avoided.

Aerosols↗

PubMed2005

Higher exposure to mycophenolic acid with sirolimus than with cyclosporine cotreatment.

INTRODUCTION: Therapeutic drug monitoring of mycophenolate mofetil is recommended because of the interindividual variability in the exposition to its active moiety, mycophenolic acid. However, most of the pharmacokinetic studies involved patients cotreated with cyclosporine (INN, ciclosporin). METHODS: We analyzed the pharmacokinetics of mycophenolic acid in 13 renal graft recipients treated with sirolimus in an anticalcineurin-free regimen and compared it with that of 17 patients cotreated with cyclosporine. The area under the concentration versus time curve over a 12-hour period (AUC 0-12 ) of mycophenolic acid was estimated at 2 weeks, 1 month, 2 months, and 3 months after transplantation. RESULTS: At the first 3 time points, patients cotreated with sirolimus had significantly higher mycophenolic acid AUC 0-12 values compared with patients cotreated with cyclosporine, as follows: 81 mg . h/L (SD, 39 mg . h/L) versus 43 mg . h/L (SD, 11 mg . h/L) (P < .001), 72 mg . h/L (SD, 17 mg . h/L) versus 48 mg . h/L (SD, 13 mg . h/L) (P < .001), and 70 mg . h/L (SD, 25 mg . h/L) versus 47 mg . h/L (SD, 17 mg . h/L) (P < .01) at week 2, month 1, and month 2, respectively. At all time points, patients cotreated with sirolimus had significantly higher dose-normalized mycophenolic acid AUC 0-12 values. At months 1 and 2, white blood cell counts were lower in the sirolimus group than in the cyclosporine group, as follows: 4.8 x 10(3)/mL (SD, 1.1 x 10(3)/mL) versus 6.5 x 10(3)/mL (SD, 2.2 x 10(3)/mL) (P < .01) at month 1 and 4.6 x 10(3)/mL (SD, 1.1 x 10(3)/mL) versus 5.9 x 10(3)/mL (SD, 2.0 x 10(3)/mL) (P < .05) at month 2. CONCLUSION: These data show that exposure to mycophenolic acid is higher in patients cotreated with sirolimus than in those cotreated with cyclosporine.

Adult↗