Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison.

PURPOSE: The objective of the study was to investigate the relative bioavailability between the generic tacrolimus products that are presently authorized in Spain by adjusted indirect comparison. This was based on demonstration of bioequivalence with the reference product (Prograf, Astellas Pharma), which makes these generic tacrolimus products prescribable, switchable and therapeutically equivalent to the reference product; yet, according to Spanish legislation, only prescribers can switch tacrolimus-containing products. METHODS: Data from independent bioequivalence studies that compare each generic product with the reference product were combined by adjusted indirect comparisons to investigate the relative bioavailability between generic drug products, since there is no direct bioequivalence study comparing generics to each other. RESULTS: Eight generic tacrolimus products in the form of capsules are presently authorized in Spain, but only five are marketed. These eight products represent only three different generic product developments. One product is authorized with four different names/companies, while another is authorized under three different names/companies. The adjusted indirect comparisons between generic products show bioequivalence within the conventional 80-125 % confidence interval acceptance criteria for area under the curve (AUC) and maximum concentration (Cmax). CONCLUSION: Not only are the generic products bioequivalent with the reference product, but also with each other.

Polyphenolic profile as a useful tool to identify the wood used in wine aging.

Although oak wood is the main material used in cooperage, other species are being considered as possible sources of wood for the production of wines and their derived products. In this work we have compared the phenolic composition of acacia (Robinia pseudoacacia), chestnut (Castanea sativa), cherry (Prunus avium) and ash (Fraxinus excelsior and F. americana) heartwoods, by using HPLC-DAD/ESI-MS/MS (some of these data have been showed in previous paper), as well as the changes that toasting intensity at cooperage produce in each polyphenolic profile. Before toasting, each wood shows a different and specific polyphenolic profile, with both qualitative and quantitative differences among them. Toasting notably changed these profiles, in general, proportionally to toasting intensity and led to a minor differentiation among species in toasted woods, although we also found phenolic markers in toasted woods. Thus, methyl syringate, benzoic acid, methyl vanillate, p-hydroxybenzoic acid, 3,4,5-trimethylphenol and p-coumaric acid, condensed tannins of the procyanidin type, and the flavonoids naringenin, aromadendrin, isosakuranetin and taxifolin will be a good tool to identify cherry wood. In acacia wood the chemical markers will be the aldehydes gallic and ß-resorcylic and two not fully identified hydroxycinnamic compounds, condensed tannins of the prorobinetin type, and when using untoasted wood, dihydrorobinetin, and in toasted acacia wood, robinetin. In untoasted ash wood, the presence of secoiridoids, phenylethanoid glycosides, or di and oligolignols will be a good tool, especially oleuropein, ligstroside and olivil, together verbascoside and isoverbascoside in F. excelsior, and oleoside in F. americana. In toasted ash wood, tyrosol, syringaresinol, cyclolovil, verbascoside and olivil, could be used to identify the botanical origin. In addition, in ash wood, seasoned and toasted, neither hydrolysable nor condensed tannins were detected. Lastly, in chestnut wood, gallic and ellagic acids and hydrolysable tannins of both the gallotannin and ellagitannin type, can be used as chemical markers.

Polyphenols in red wine aged in acacia (Robinia pseudoacacia) and oak (Quercus petraea) wood barrels.

Polyphenolic composition of two Syrah wines aged during 6 or 12 months in medium toasting acacia and oak 225L barrels was studied by LC-DAD-ESI/MS. A total of 43 nonanthocyanic phenolic compounds were found in all wines, and other 15 compounds only in the wines from acacia barrels. Thus, the nonanthocyanic phenolic profile could be a useful tool to identify the wines aged in acacia barrels. Among all of them the dihydrorobinetin highlights because of its high levels, but also robinetin, 2,4-dihydroxybenzaldehyde, a tetrahydroxydihydroflavonol, fustin, butin, a trihydroxymethoxydihydroflavonol and 2,4-dihydroxybenzoic acid were detected at appreciable levels in wines during aging in acacia barrels, and could be used as phenolic markers for authenticity purposes. Although longer contact time with acacia wood mean higher concentrations of phenolic markers found in wines, the identification of these wines will also be easy after short aging times due the high levels reached by these compounds, even after only 2 months of aging.

Molecular identification of two strains of Cercospora rodmanii isolated from water hyacinth present in Yuriria lagoon, Guanajuato, Mexico and identification of new hosts for several other strains.

Water hyacinth is a beautiful monocotyledon plant that has been dispersed all over the world by humans. The plant has been present in Mexico since 1907, and many water bodies have become infested with it since then. In 2001, we initiated a survey in Yuriria lagoon in southern Guanajuato state to isolate fungi able to biocontrol the plant. We isolated 25 morphologically distinct fungal cultures, of which two were identified as members of the genus Cercospora. Cercospora species are among the most prevalent and destructive of plant pathogens and can be found on leaves, pedicels, stems, fruits, and bracts. Only two species of Cercospora, Cercospora piaropi, and Cercospora rodmanii, have been described on water hyacinth; however, the classification of these species has been controversial. Several molecular approaches have been used for Cercospora identification, and some candidate genes have been identified for use in Cercospora species determination. Although the nrRNA genes alone do not show sufficient resolution for species determination, histone H3, translation elongation factor1-α, ß-tubulin, actin, and calmodulin have been shown in previous studies to have an adequate number of nucleotide changes to allow species identification. In the present study, we used partial sequences of the histone H3, actin, and calmodulin genes to identify our two isolates as C. rodmanii. Our two strains are not specific to water hyacinth, as they are also pathogenic to beet and sugar beet. Similar host ranges were found for C. rodmanii strains isolated from Tabasco in México, Zambia, and Brazil, however, the specificity for water hyacinth persists in Cercospora piaropi Tharp and C. rodmanii Conway, the latter being the most pathogenic.

[Postural treatment for patients with a spinal cord lesion]. / Tratamiento postural del lesionado medular.

In rehabilitation following a spinal cord lesion, it is vital to observe the treatment given to these patients regarding postural treatment, when moving them or when transferring them. A spinal cord injured patient has a dependence on his/her caretaker; the degree of this dependence depends on the type of spinal cord injury suffered. Physical consequences have such an important bearing on a patient with this type of injury that correct posture when lying down, adjusting bed position, or moving a patient require that nurses take extreme precautions and care when carrying out these actions. Nursing treatment, either during acute phase of treatment, rehabilitation, or the treatment given by therapists when a patient has returned home are basic and fundamental. The long-term limitations due to the degree of the lesion a patient has suffered are determining factors in the treatment which a patient will receive.