Germicide wound pad with active, in situ, electrolytically produced hypochlorous acid.

We describe a new wound dressing technology that can actively generate an inorganic germicide agent, in situ, within the wound pad. The technology provides real time control over the quantitative, spatial and temporal delivery of the germicide. The identity of the germicide is hypochlorous acid (HClO). The HClO is produced in a flexible wound pad, made of a composite of thin (micrometer scale) layers of various materials, with different electrochemical properties that enhance HClO production. Active control over the production of HClO is achieved by control of the pH and of the electric potential across the layers. The effectiveness of the Active HClO Pad (AHClOP) concept is demonstrated in a study on sterilization of E. coli in a deep wound contamination simulating gel. The performance of the AHClOP is compared with that of four commercial wound dressings. Results show that the AHClOP can sterilize throughout the gel, while the commercial dressings cannot.

Simultaneous analysis of vitamins B in pharmaceuticals and dietary supplements by capillary electrophoresis hyphenated with triple quadrupole mass spectrometry.

The advanced hyphenated method based on capillary electrophoresis (CE) on-line combined with electrospray ionization (ESI) and tandem mass spectrometry (MS/MS, here triple quadrupole, QqQ) was developed and applied in pharmaceutical analysis in this work. Under the optimized CE separation (background electrolyte: 50 mmol/L formic acid with pH 2.05), ESI ionization (sheath liquid: 0.1% v/v formic acid in 50% v/v aq methanol) and QqQ detection (100-160V fragmentor voltage, 15-25eV collision energy, depending on the type of analyte) conditions, highly efficient, reproducible, accurate, sensitive (sub microg/mL LODs) and selective (each analyte was unequivocally specified by two characteristic MS signals, i.e. qualifier, quantifier) determination of vitamins B was achieved. All vitamins B, namely thiamine, riboflavin, nicotinamide, nicotinic acid, pantothenic acid, pyridoxine, biotin, folic acid and cyanocobalamine, were simultaneously determined in various dosage forms (injection solution, tablets, and effervescent tablets) within ca. 16 min. The main benefits of the proposed CE-ESI-QqQ method in comparison with the CE-UV ones are considerably enhanced sensitivity and selectivity. Other benefits are low cost, simplicity, flexibility and environmental aspects when comparing CE-ESI-QqQ with HPLC-MS. Successful validation and application of the proposed CE-ESI-QqQ method suggest its routine use in highly effective and reliable multi-drug quality control.

Determination of selenium in clinical plasma samples related to atopic dermatitis study by chronopotentiometric stripping method.

Galvanostatic stripping chronopotentiometry (GSC) was developed and applied for the determination of selenium in human plasma. In this work GSC based on composite carbon electrode coated by a gold layer was optimized concerning various electrochemical parameters (coating procedure, electrolysis potential, electrolysis time, dissolution current). Along with this, the sample preparation was optimized with respect to mineralization conditions (type and concentration of decomposition agent, temperature, time). The human plasma samples mineralized in an autoclave under the optimized conditions (160 degrees C, 100 min, 22 mol/l HNO3) were appropriately diluted by background electrolyte solution (0.100 mol/l H2SO4 + 0.001 mol/l HCl) and directly analyzed by the optimized GSC method. The proposed method was characterized by excellent performance parameters, the limit of detection was 0.2 ng/ml, accuracy <5%, reproducibility <4%. The proposed method was applied for the investigation of the relationship between atopic dermatitis and selenium concentration in human plasma. Here, patients suffering from atopic dermatitis were monitored during their treatment with a pharmaceutical preparation containing inorganic selenium (Zinkosel). After six months therapy increased levels of selenium in plasma were detected in 76% of the patients with an improvement of the clinical state in 65% of the patients.

Determination of amlodipine enantiomers in pharmaceuticals using capillary electrophoresis separation and diode array detection.

The present work describes a capillary zone electrophoresis (CZE) separation technique coupled with on-capillary diode array detector (DAD) for highly reliable enantioselective determination of amlodipine (AML) in commercial tablets. For the separation of AML enantiomers, (2-hydroxypropyl)-beta-cyclodextrin (HP-beta-CD) was an appropriate chiral selector providing complete enantioresolution. Optimized separation conditions consisted of 50 mmol/l glycine-acetate buffer, pH 3.2, 50 mg/ml HP-beta-CD. Hydroxyethylcellulose (HEC, 0.2% w/v) served as an electroosmotic flow (EOF) suppressor in this buffer. DAD detection was used for the characterization of the composition of separated zones according to differences in corresponding UV-VIS spectra (scanned in interval 200-800 nm). It was demonstrated, comparing reference and real spectra of the analytes, that the proposed separation method was selective enough to produce pure (non-mixed, i.e. spectrally homogeneous) analyte zones without any interfering compound. Successful validation and application of the proposed CZE-DAD method suggest its routine use in enantioselective control of AML in pharmaceuticals.

Enantiomeric purity control of levocetirizine in pharmaceuticals using anionic cyclodextrin mediated capillary electrophoresis separation and fiber-based diode array detection.

The present work illustrates potential of anionic cyclodextrin (CD) mediated capillary electrophoresis (CE) separation technique coupled with on-capillary diode array detector (DAD) for highly reliable enantioselective determination of dextrocetirizine (DCET) besides its major active compound (levocetirizine, LCET) in pharmaceuticals (commercial tablets). DAD detection was utilized for the characterization of composition of each separated zone via match of corresponding tested (analyte in dosage form) and reference (standard analyte in water) UV-VIS spectrum (scanned in interval 200-800 nm) being expressed mathematically through Pearson's correlation coefficient (PCC). It was demonstrated, comparing the reference and real spectra of CET enantiomers, that the applied separation method was selective enough to produce pure (spectrally homogeneous) zones of interest without any interfering comigrating compound (PCCs values were equal or higher than 0.99). Successful validation of the proposed CE-DAD method suggests its routine use for the control of enantiomeric purity of pharmaceuticals.

Extracorporeal membrane oxygenation for primary allograft failure.

OBJECTIVE: Herein we have reported our experience concerning the usefulness of extracorporeal membrane oxygenation (ECMO) in heart transplant patients. PATIENTS AND METHODS: Between July 2002 and March 2007, 11 heart transplant patients, namely, 8 men and 3 women of overall mean age of 49.4 +/- 13.9 years (range, 19-62 years) with primary graft failure underwent ECMO implantation. Two patients had pulmonary hypertension; 3 had been transplanted with hearts from marginal donors. At the time of implantation, all were in severe cardiogenic shock despite maximal inotropic support. In 6 patients, the ECMO was implanted centrally in the operating room when there was failure of weaning of cardiopulmonary bypass. Among the 5 remaining patients, ECMO was implanted peripherally in the intensive care unit, during the first 60 hours, including 3 cases of hemodynamic instability and 1 of irreversible cardiac graft arrest. The last patient was implanted on day 30 after transplantation because of acute rejection. RESULTS: Mean pump outflow was 2.7 +/- 0.4 L/min/m(2). One patient died on circulatory support due to a cerebral hemorrhage. Ten patients were weaned from ECMO after a mean duration of 9.1 +/- 6.9 days (range, 1-18 days). All of them were successfully discharged. No retransplantation occurred. CONCLUSION: Rapid operating room or bedside placement of ECMO allowed stabilization of hemodynamics with potential myocardial recovery in patients with cardiac graft failure.

Cardiac transplantation from a carbon monoxide intoxicated donor.

Heart transplantation is a demonstrated successful and life-saving treatment for an increasing number of patients. The growth of heart transplantation surgery is limited by the relative lack of suitable donors, and the increasing demand has lead to the expansion of acceptance criteria. Patients succumbing to carbon monoxide (CO) poisoning are usually considered not suitable organ donors and they are routinely rejected in many centers. Although organs from CO poisoning donors have been occasionally used, cardiac transplantation in this scenario remains very uncommon. We report the successful heart transplantation from a CO intoxicated donor, who was previously refused by two other transplantation teams. Standard donor evaluation criteria, transplantation techniques and management were used. Limited cases are described in literature. The present case may increase awareness among emergency department physicians, as well as transplantations teams, that patients dying of CO exposure may be acceptable cardiac donors.

Kidney transplantation combined with other organs in Bologna: an update.

BACKGROUND: We retrospectively reviewed our experience in combined liver-kidney (L-KT) and heart-kidney (H-KT) transplantations. PATIENTS AND METHODS: Between January 1997 and April 2007, we performed 25 L-KT and 5 H-KT. Patient mean age was 51+/-8 years in L-KT and 43+/-11 years in H-KT. The main cause of liver failure was chronic viral hepatitis (14 cases). Etiology of heart failure was dilated cardiomyopathy and hypertrophic cardiomyopathy (4 and 1 patients, respectively). The main causes of renal failure in L-KT were chronic glomerulonephritis (n=8) and polycystic disease (n=7). Etiology of renal failure in H-KT was interstitial nephropathy (n=2), vascular nephropathy (n=2), and chronic glomerulonephritis (n=1). RESULTS: Mean follow-up was 32+/-26 months in L-KT and 24+/-17 months in H-KT. Immunosuppression was cyclosporine-based (n=4) or tacrolimus-based (n=21) in L-KT and cyclosporine-based in H-KT. Acute rejection rate was 8% for both liver and kidney in L-KT; 80% (mild) for heart and 40% for kidney in H-KT. In the L-KT group, there was no primary graft nonfunction (PGNF). Two patients experienced liver delayed graft function (DGF); 1 patient required postoperative dialysis. One-year graft and patient survivals were both 84% and overall graft and patient survival was 76%. In the H-KT group, 3 patients needed postoperative dialysis and 1 required a cardiac assistance device for 48 hours; overall graft and patient survival was 100% with good cardiac and renal functions. CONCLUSION: Our experience confirmed that H-KT and L-KT are safe procedures, offering good long-term results.

Circulatory assist with centrifugal pump as a bridge to recovery: mathematical analysis.

Mechanical circulatory support is an essential issue in the management of patients with end-stage cardiac failure. The aim of this study is to evaluate the efficacy of temporary support with a centrifugal blood pump as bridge to heart function recovery or bridge to transplantation. Heart recovery is achieved by improving ventricular mechanical working conditions with proper modifications of preload and afterload. This article assesses the advantages of a novel 'cardiac chambers' cannulation setting versus the traditional one, in the case of biventricular or isolated right ventricular failure. The study was conducted using a numerical computer model based on the work by Guyton, Sagawa, Westerhof, and Noordergraaf. Simulation of the planned trials was achieved by changing the model parameters, the pump angular velocity, and the inflow and outflow settings.

Determination of dimethindene enantiomers in pharmaceuticals by capillary electrophoresis with carboxyethyl-beta-cyclodextrin.

Cyclodextrin-mediated capillary zone electrophoresis in a hydrodynamically closed separation system with suppressed electroosmotic flow and UV absorbance photometric detection was developed for a high effective separation and quantitation of dimethindene enantiomers in various pharmaceutical formulations (solution, gel, capsules). The running buffer consisted of epsilon-aminocaproic acid (20 mmol/l) adjusted to pH 4.5 with acetic acid, negatively charged carboxyethyl-beta-cyclodextrin (2.5 mg/ml), serving as chiral selector, and 0.1% (w/v) methylhydroxyethylcellulose, serving as an electroosmotic flow suppressor. The proposed method was successfully validated appraising parameters of sensitivity, linearity, precision, accuracy/recovery and robustness and it is useful for routine use.

Comparison of capillary zone electrophoresis and isotachophoresis determination of dimethindene enantiomers in pharmaceuticals using charged carboxyethyl-beta-cyclodextrin as a chiral selector.

Charged cyclodextrin-mediated capillary electrophoretic methods (capillary zone electrophoresis [CZE] and isotachophoresis [ITP]) in a hydrodynamically closed separation system with suppressed electroosmotic flow and UV absorbance photometric detection (for CZE) or conductivity detection (for ITP) were developed for a highly effective separation and quantitation of dimethindene enantiomers in various pharmaceutical formulations (solution, gel, capsules). Optimized electrolyte systems were based on low-mobility buffer constituents (epsilon-aminocaproic acid, beta-alanine, potassium acetate, acetic acid), negatively charged (at pH > 4.5) carboxyethyl-beta-cyclodextrin (CE-beta-CD), serving as chiral selector, and methylhydroxyethylcellulose, serving as an electroosmotic flow suppressor. Complete enantioseparations of dimethindene in the presence of low concentrations of CE-beta-CD (2.5 mg/ml in CZE, 6.0 mg/ml in ITP) clearly indicated a role of charge of this chiral selector in enantioresolution. It also outlined the potential of charged CD-derivatives as chiral selectors for various CE techniques. The proposed methods were successfully validated, appraising parameters of sensitivity, linearity, precision, accuracy/recovery, and robustness, and then, they were applied to pharmaceutical samples. Consistent results obtained by both CE methods indicate their usefulness for routine use.

[Separation of dimetinden enantiomers in drugs by means of capillary isotachophoresis]. / Separacia enantiomérov dimetindenu v liekoch kapilárnou izotachoforézou.

Capillary isotachophoresis was employed to separate and determine dimethinden enantiomers in various dosage forms. Several types of chiral selectors were tested in various electrolyte systems of different composition and different pH. The optimal leading electrolyte was composed of 10 mmol/l potassium acetate and acetic acid to achieve pH 4.8 with an addition of 4 mmol/l carboxyethyl-beta-cyclodextrin as the chiral selector and 0.2% of methylhydroxyethylcellulose (m-HEC) to suppress the electroosmotic flow. The terminating electrolyte was betaalanine of a concentration of 5 mmol/l. The evaluation included the precision, correctness, linearity, robustness, and selectivity of the elaborated ITP method. The pretreatment of the sample prior to analysis consisted in the dissolution and dilution of the appropriate dimethinden-containing dosage form with demineralized water to achieve the required concentration. Such a pretreated sample was directly dosed into the apparatus.

Kidney transplantation combined with other organs: experience of Bologna s. Orsola hospital.

AIM: We report a series of patients who underwent combined heart-kidney transplantation (CHKT) and combines liver-kidney transplantation (CLKT) at a single center. METHODS: From January 1997 to October 2004, 13 CLKT and 2 CHKT were performed. The CLKT indications were as follows: polycystic disease (2), kidney polycystic disease associated with Caroli (1) and cirrhosis-hepatitis C virus (HCVs) (1), chronic glomerulonephritis with cirrhosis-HCV (4), and other diseases (5). From December 2003 to October 2004, 2 patients underwent CHKT for idiopathic cardiomyopathy plus glomerulonephritis and ischemic cardiomyopathy associated with vascular nephritis. RESULTS: In the CLKT group, 1 patient had acute rejection involving both liver and kidney grafts, whereas 1 patient had liver rejection and another 1 had kidney rejection alone. Of the 13 patients, 10 are alive with a mean survival of 583 days (range, 36-2688 days); 2 patients died within 1 month of transplantation (both with polycystic disease) due to ARDS and MOF. Another patient died 6 years and 9 months after CLKT of metastasis from a de novo tumor. In the CHKT group, no patient suffered heart-kidney rejection. They are all alive at 333 and 116 days, with heart and kidney allografts functioning well. CONCLUSION: In the CLKT group, the worst results were for patients with polycystic disease, in whom a more rigorous selection is necessary because of greater technical difficulties. For the remaining patients we had acceptable complications and excellent long-term results. In selected cases, CHKT can provide long-term graft function and patient survival. Our experience indicates that end-stage kidney failure combined with liver or heart failure does not necessarily preclude dual-organ transplantation.

Determination of promethazine hydrochloride in pharmaceuticals by capillary isotachophoresis.

Capillary isotachophoresis (ITP) in cationic regime of the separation with conductometric detection has been used for the separation and determination of promethazine hydrochloride (PRO) in commercial mass-produced pharmaceutical preparations. Several electrolyte systems of different compositions and pH were examined and the optimized ITP electrolyte system consisted of 10 mmol/l of potassium acetate adjusted to pH 4.8 with acetic acid as the leading electrolyte with electroosmotic flow (EOF) suppressing additive, 0.2% (w/v) methylhydroxyethylcellulose (m-HEC), and 5 mmol/l of beta-alanine as the terminating electrolyte. The proposed electrophoretic method was successfully validated. It was convenient for the sensitive, simple, rapid, and highly reproducible assay of promethazine. The calibration graph relating the ITP zone length to concentration of the analyte was rectilinear in the range of 40-200 mg/l of the drug standard, with a coefficient of determination r(2)=0.9992. The relative standard deviation (RSD) was 1.12% (n=6) when determining 100 mg/l of PRO in standard sample. Good quantitation was obtained in short analysis time (a single analysis took 6 min). The recoveries of drug from samples were found to be 97.22% (tablets), 99.72% (injections), and 99.14% (syrup). The minimal sample pretreatment and low running cost make the proposed ITP method a good alternative to commonly used analytical methods.

[Use of capillary isotachophoresis for the determination of pheniramine in granulated powders]. / Vyuzitie kapilárnej izotachoforézy na stanovenie feniramínu v granulovaných práskoch.

The method of capillary isotachophoresis was used to assay pheniramine in granulated powders. Several electrolyte systems of different composition and different pH were tested. Two electrolyte systems were selected for the validation of the method and pheniramine determination in real samples. Precision, accuracy, linearity, robustness, and selectivity of the ITP method for both electrolyte systems were evaluated. The pre-treatment of samples prior to analysis consisted in dissolving pheniramine-containing granulated powder in demineralized water and subsequent diluting with demineralized water to required concentration.

[Isotachophoretic determination of desloratadine in tablets and syrup]. / Izotachoforetické stanovenie desloratadínu v tabletách a sirupe.

Desloratadine was determined in two dosage forms (tablets and syrup) with the use of the method of capillary isotachophoresis. Several electrolyte systems of varying composition and varying pH were tested. Two electrolyte systems were selected for the validation of the method and determination of desloratadine in real samples. In both electrolyte systems, the precision, correctness, linearity, robustness, and selectivity of the ITP method were evaluated. The pre-treatment of the sample prior to analysis consisted in dissolving and diluting the pertinent desloratadine-containing dosage form with demineralized water to the required concentration. This pre-treated sample was fed directly to the apparatus.

[Dimethindene determination in various dosage forms by means of capillary isotachophoresis]. / Stanovenie dimetindenu v rôznych liekových formách kapilárnou izotachoforézou.

Capillary isotachophoresis was employed to determine dimethindene in various dosage forms. Several electrolyte systems of varying compositions and varying pH were tested. For validation of the method and the determination of dimethindene in real samples (gel, drops, capsules), two electrolyte systems were selected. Precision, correctness, linearity, robustness, and selectivity of the ITP method were evaluated for both electrolyte systems. The pre-treatment of the sample prior to analysis consisted in dissolving and diluting the pertinent dosage form containing dimethindene with demineralized water to the required concentration. The sample adjusted in this way was directly dosed into the apparatus.

Extracorporeal right to left atrial bypass to treat right ventricular failure.

Graft right ventricular failure after heart transplantation, secondary to preoperative functional pulmonary hypertension, was successfully managed in a 49-year-old patient using an extracorporeal right to left atrial bypass. We comment on the case and discuss the type of mechanical assistance used.

Activity-rest stimulation of latissimus dorsi for cardiomyoplasty: 1-year results in sheep.

BACKGROUND: In dynamic cardiomyoplasty electro-stimulation achieves full transformation of the latissimus dorsi (LD); therefore, its slowness limits the systolic support. Daily activity-rest could maintain partial transformation of the LD. METHODS: Sheep LD were burst-stimulated either 10 or 24 hours/day. Before and 2, 4, 6, and 12 months after stimulation, LD power output, fatigue resistance, and tetanic fusion frequency were assessed. Latissimus dorsi were biopsied at 6 months, and sheep sacrificed at 12 months. RESULTS: After 1 year of 10 hours/day stimulation LD was substantially conserved and contained large amounts of fast type myosin. From 2 months to 1 year of stimulation the power per muscle of the daily rested LD was greater than that of the left ventricle, being three to four times higher than in the 24-hour/day stimulation. CONCLUSIONS: If extended to humans, these results could be the rationale for the need of a cardiomyostimulator, whose discontinuous activity could offer to patients the long-standing advantage of a faster and powerful muscle contraction.

New bileaflet bioprosthesis: early and mid term results.

A new bovine pericardial bioprosthesis (AMB bioprosthesis) with a bileaflet geometry was designed and developed, with the aim of achieving uniform stress distribution within the prosthesis. The ultimate goal was to limit tissue degeneration to a minimum by attaining optimum fluid dynamics, thereby obtaining an extended clinical durability. The two-leaflet, dome-shaped geometry with a central hinge allowed a very low profile, low ventricular projection in the mitral position, large effective orifice area and low gradients. The design of the thin Delrin stent and the centrally crossing bridge was developed using finite element analysis. Pre-clinical laboratory investigations showed very low trans-valvular gradients and no mechanical or tissue failure after 400 million cycle accelerated wear test. The final model of the prosthesis was manufactured by Baxter-Edwards CVS Division and tested in sheep with good results for up to five months. A limited clinical trial was started in January 1990 and stopped one year later encompassing 12 aortic and six mitral implants. The patients were followed clinically and by echocardiography three, six and 12 months, and four years after surgery. Mean gradients were 4 mmHg in the mitral and 10 mmHg in the aortic position with only minimum regurgitation and no tissue failure. We conclude that early and mid term results with this new pericardial bioprosthesis appear to be favorable and intend to closely monitor further outcome within the limited patient population.