Use of intravenous immunoglobulins in clinical practice: data from three French university hospitals.

Since several years, the use of intravenous immunoglobulins (IVIg) has increased. This growth has encouraged some countries to publish guidelines. In parallel, some countries have conducted audits to know how IVIg are used in clinical practice in the light of the available guidelines.

Ongoing pharmaceutical reforms in France: implications for key stakeholder groups.

The rapid rise in pharmaceutical costs in France has been driven by new technologies and the growing prevalence of chronic diseases as well as considerable prescribing freedom and choice of physician among patients. This has led to the introduction of a number of reforms and initiatives in an attempt to moderate expenditure whilst ensuring universal coverage and rewarding innovation. These reforms include accelerating access to and granting average European prices for new innovative drugs, delisting drugs where there are concerns over their value and instigating rebates for excessive prescribing.

Use of various models for in vitro percutaneous absorption studies of ultraviolet filters.

Background: The percutaneous absorption test aims to estimate the passage of a substance across the skin. The absorption process can be described in three steps: (a) penetration of a substance into the skin layer, followed by (b) penetration from one layer into another (permeation) and finally (c) resorption into the vascular system. In vivo and in vitro models are available but owing to ethical reasons as well as the latter providing greater feasibility, in vitro models are preferred.

Development and validation of HPLC method for the determination of Cyclosporin A and its impurities in Neoral capsules and its generic versions.

Cyclosporin A (CyA) is a cornerstone immunosuppressant for the prophylaxis against allograft rejection after organ transplantation. The most widely prescribed CyA formulation is Neoral soft gelatine capsules (Novartis Pharmaceuticals, Basel, Switzerland). After Novartis patent expiration, several generic formulations have been developed.

A new small volume holding chamber for asthmatic children: comparison with Babyhaler spacer.

When a new holding chamber for administrating inhaled medication is to be marketed, it needs to be compared with existing chambers with two questions in mind: is this chamber well accepted by patients and is there an in vitro equivalence? We compared the new small volume non-electrostatic valved holding chamber, usable with all pressurized metered-dose inhalers and equipped with a funny facemask, Vortex (Pari GmbH, Germany), to the most frequently prescribed holding chamber in France, Babyhaler (GlaxoSmithKline Laboratories). Preferences were studied for 75 families with a child no more than 4 yr old, using standard questionnaires. An in vitro study assessed the delivered dose and the particle size distribution of two HFA beclomethasone dipropionate pressurized metered dose inhalers (Becotide 250 microg per dose and Nexxair 100 microg per dose) by dose uniformity sample apparatus and cascade impactor according to the European Pharmacopoeia.

[Mechanisms and treatment of psoriasis].

Psoriasis is a common dermatosis that affects 3-5% of the European population. Current treatments offer considerable clinical benefits, but their use is limited due to tolerance problems. Recent years have seen the development of new treatments, used separately or in combination to improve the chronic lesions caused by this disease.

[Pharmaceutical development aimed at improving safety for children].

The safety of paediatric drugs should be improved so that the number of child deaths due to the misuse of different kinds of medication can be decreased. Formulations, excipients and containers are the major areas that should be optimised in the pharmaceutical development of a paediatric drug. Today, Afssaps (Agence française de sécurité sanitaire des produits de santé) and the European regulations play a major role in promoting paediatric medications.

Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration.

The assessment of the in vitro disintegration profile of rapidly disintegrating tablets (RDT) is very important in the evaluation and the development of new formulations of this type. So far neither the US Pharmacopoeia nor the European Pharmacopoeia has defined a specific disintegration test for RDT; currently, it is only possible to refer to the tests on dispersible or effervescent tablets for the evaluation of RDT's disintegration capacity. In the present study, we have evaluated the disintegration profile of RDT manufactured by main commercialised technologies, using the texture analyser (TA).

Texture optimization of water-in-oil emulsions.

The aim of this research is to demonstrate the effect of variations in certain parameters of the oily phase (OP) in water-in-oil (W/O) emulsions on rheological and texture properties of finished products. The formulated emulsions were selected according to an optimal experimental procedure. The applied variations were nature of the OP, its volume fraction, the hydrophilic-lipophilic balance (HLB) value, and the surfactant proportion.

The preparation of orally disintegrating tablets using a hydrophilic waxy binder.

The demand for rapidly disintegrating tablets (RDT) has been growing during the last decade especially for elderly and children who have swallowing difficulties. The problem of certain RDT is their low physical resistance and high friability. This work describes a new approach to prepare RDT with sufficient mechanical integrity, involving the use of a hydrophilic waxy binder (Superpolystate, PEG-6-stearate).

Effect of chronic renal failure with metabolic acidosis on alanine metabolism in isolated liver cells.

Background & Aims: Decreased ureagenesis and gluconeogenesis from alanine have been reported during chronic renal failure in rat. This study addressed the respective roles of plasma-membrane transport and intracellular metabolism in these abnormalities of alanine pathways.

Methods: In hepatocytes isolated from uremic and control rats, we investigated: (1) the influence of uremia on gluconeogenesis and ureagenesis during incubations with alanine; (2) the kinetics of alanine plasma-membrane transport; (3) the relationships between intracellular alanine concentrations and its metabolism.

Release of benzimidazole and benzylidene camphor from topical sunscreen formulations.

Absorption of two ultraviolet (UV) filters was evaluated through a lipophilic synthetic membrane (Folioxane) and excised hairless rat skin using a flow-through diffusion cell. Folioxane membrane is an artificial skin used in the treatment of third-degree burns. Diffusion tests were performed with aqueous solutions and galenic formulations (one water-in-oil [W/O] emulsion and two oily gels).

Comparative tablet and rheological properties of new microcrystalline cellulose: direct compression and wet granulation methods.

The overall objective of this study was to compare the rheological properties and tablet characteristics of two new varieties of celluloses (Vivacel 101 and 102), recently produced and commercialized, with the classical varieties of celluloses (Avicel and Elcema). The results showed no significant differences in the rheological properties of Vivacel and Avicel, while significant differences were found between the two celluloses and Elcema. Furthermore, there were no statistically significant differences in the disintegration times and Td values of Vivacel and Avicel.

Hyperkalemia risks in hemodialysed patients consuming fluoride-rich water.

In order to observe the consequences of chronic ingestion of high fluoride-rich water on plasma potassium levels of hemodialysed subjects, we have conducted a retrospective study on 25 patients with chronic renal failure, treated with a substitute method, six of whom (consumers group, group C) were drinkers of a bicarbonate (about 4500 mg/l) and fluoride-rich (9 mg/l) mineral water, the Vichy Saint-Yorre water. With respect to sodium polystyrene sulfonate consumption (n = 17), there was no significant difference between group C and NC (non-consumers group). A significant correlation between plasma fluoride and potassium levels was observed only before dialysis (P < 1 x 10(-7)) but not after dialysis.

Controlled-release behavior of diphenhydramine hydrochloride loaded neutral microgranules and coated using ethylcellulose water dispersion.

The development of a loading method of a water-soluble drug using aqueous binding solution to produce microgranules that were then coated with an aqueous ethylcellulose dispersion to sustain drug release is described. The results, in terms of drug used, showed that besides the fluidized bed parameters, the amount of drug dissolved in the binder solution plays an important role in obtaining a satisfying result during the spraying process. Thus, it seems necessary to determine the critical concentration above which the material started to adhere to the interior of the fluidization column, and the possibility of drug layering onto carrier material is aggravated.

Investigation of fluoride elimination during a dialysis session.

We have conducted a study of the elimination kinetics of fluoride ions by a log linear regression analysis of plasma levels obtained during a bicarbonate hemodialysis session, with a dialyzer in polymercaprin for six patients with chronic renal failure. Using plasma fluoride levels of 35 patients studied for 20 months, we have validated these kinetics for hemodialysis with sodium bicarbonate, acetate-free biofiltration, hemodiafiltration with low flow rate and other dialyzers. Our results show that the decrease in plasma fluoride levels is statistically significant only after the first hour, and the fall reaches approximately 30% after a 4 h dialysis session.

Long-term follow up of ionic plasma fluoride level in patients receiving hemodialysis treatment.

The elimination half-life of fluoride is significantly increased in patients with chronic renal failure. This led us to conduct a study of variations of its plasma levels in 35 patients receiving dialysis treatment. In this population, there is a gaussian distribution of the values before and after the hemodialysis session, with a significant decrease in the averages.

Protein synthesis measurement in cancer patients with 13C valine.

The flooding dose technique is a method that uses tracer amino acids to measure the rate of protein synthesis in tissues in vivo. This technique involves the injection of a large amount of unlabelled amino acid together with the tracer to minimize difference in isotopic enrichment of the free amino acid in plasma and tissue compartments which represent the precursor pool of protein synthesis. Seven patients with localized colorectal carcinoma received a total parenteral nutrition before surgery and protein synthesis was measured in tumour and colon after administration of a large dose of valine (20% atom percent excess).

Isolated rat hepatocyte metabolism is affected by chronic renal failure.

Metabolic changes due to chronic renal failure (CRF) were studied in isolated liver cells. In 14 CRF and 14 sham-operated rats, liver cells were isolated by the Berry and Friend method and incubated with various substrates in order to study gluconeogenesis, ureagenesis, ketogenesis, oxygen consumption as well as cytosolic and mitochondrial adenine nucleotide content. CRF rat hepatocytes exhibited a 25% to 45% decrease in gluconeogenesis and ureagenesis (P < 0.

Splanchnic acid-base status and urea metabolism in uremic rats.

Acidosis may alter hepato-splanchnic amino acid metabolism during uremia.26 uremic rats and 30 controls were studied for portal and arterial acid-base balance and urea synthesis during enteral nutrition. Uremic rats exhibited increased (p < 0.