Resorbable Biomaterials Based on Calcium Phosphates: Determination of In Vitro Solubility Applying the ISO 10993-14 (First Experiences)

2005 ◽  
Vol 284-286 ◽  
pp. 485-488 ◽  
Author(s):  
Ute Ploska ◽  
Renate Gildenhaar ◽  
Georg Berger

To guarantee of the security of ceramic medical products the identification and quantification of the current degradation products is required by the ISO 10993-14 standard. Two methods - the gravimetrical registration of the mass loss and the quantitative determination of the leached ions by spectrometric methods - are planned. When checking the application of the ISO standard to calcium phosphate ceramics that can be used as implant materials a considerable difference in the results obtained with both methods was observed. It seems to be that precipitation reactions are responsible for that situation. To clear up the influence of precipitation reactions on the results the working procedure of the ISO standard was slightly modified. A first interpretation of the results is tried.

1989 ◽  
Vol 62 (04) ◽  
pp. 1043-1045 ◽  
Author(s):  
Paul F M M van Bergen ◽  
Eduard A R Knot ◽  
Jan J C Jonker ◽  
Auke C de Boer ◽  
Moniek P M de Maat

SummaryWe studied the diagnostic value of recently introduced ELISA’s for the determination of thrombin-antithrombin III (TAT) complexes, fibrin degradation products (FbDP), fibrinogen degradation products (FgDP) and total degradation products (TDP) for deep venous thrombosis (DVT) in plasma of 239 consecutive outpatients, suspected for DVT by their family doctor. DVT was confirmed by impedance plethysmography in 60 patients. Using the 95th percentile range of 42 healthy volunteers the sensitivity for the detection of DVT was: 37% for TAT, 95% for TDP, 92% for FbDP and 90% for FgDP. Specificity was: 88% for TAT, 16% for TDP, 20% for FbDP and 25% for FgDP.We conclude that these assays are of little value in the diagnosis of DVT in outpatients.


Author(s):  
P. Yu. Mylnikov ◽  
Yu. Tranova ◽  
A. V. Shchulkin ◽  
E. N. Yakusheva

Relevance. BCRP is an efflux transporter protein that plays an important role in the pharmacokinetics of a wide range of drugs. The BCRP activity in vitro experiments is assessed by the transport of transporter protein substrates (methotrexate, etc.) across the bilipid membrane of cells overexpressingBCRP, for example, Caco-2 cells. The aim is to develop and validate a method for the quantitative determination of the BCRP substrate, methotrexate, in the transport medium of Caco-2 cells by HPLC-MS/MS. Methods. The work was performed on an Ultimate 3000 HPLC chromatograph (ThermoFisher, USA) with a TSQ Fortis tandem mass-selective detector (ThermoFisher, USA). The conditions of chromatographic analysis were as follows: column UCT Selectra C18 4.6 mm * 100 mm 5um, 100A, Selectra C18 Guard Cartridges SLC-18GDC46-5UM, separation temperature 35 °С, flow rate 0.3 ml/min, injected sample volume - 2 μl, analysis time - 10 min. Used a gradient elution: the ratio of the solution of 0.1 % formic acid and acetonitrile was at 0 min 75 and 25 %; 0.4 min 60 and 40 %; 6 minutes 20 and 80 %; 8 minutes 75 and 25 %. Under these conditions, the retention time of methotrexate is 3.11 minutes. Detection conditions: methotrexate - positive ionization mode, 455.15 m / z → 308.125 m / z, collision energy 22.99 V, source fragmentation 5, CID gas pressure 2 mTorr. The extraction of methotrexate from the transport medium (Hanks solution with 25 mM Hepes and 1% dimethyl sulfoxide) after incubation with Caco-2 cells for 3 h was carried out with a mixture of methanol + water in a ratio of 1: 1. Results. The developed method was validated according to the following parameters: selectivity, linearity, accuracy, precision, limit of quantitative determination, sample transfer, sample stability. The confirmed analytical range of the method was 60 -10,000 nmol / L in the transport medium. Conclusions: a method for the quantitative determination of methotrexate in the transport medium of Caco-2 cells by HPLC-MS / MS was developed and validated.


2012 ◽  
Vol 81 (3) ◽  
pp. 498-505 ◽  
Author(s):  
E. Allard-Vannier ◽  
S. Cohen-Jonathan ◽  
J. Gautier ◽  
K. Hervé-Aubert ◽  
E. Munnier ◽  
...  

2009 ◽  
Vol 7 (4) ◽  
pp. 721-730 ◽  
Author(s):  
Lachezar Radev ◽  
Maria Fernandes ◽  
Isabel Salvado ◽  
Daniela Kovacheva

AbstractIn this work we present our experimental results on synthesis, structure evolution and in vitro bioactivity assessment of new gelatin/silicocarnotite hybrid materials. The hybrids were obtained by diluting gelatin (G) and silicocarnotite (S) ceramic powder with G:S ratios of 75:25 and 25:75 wt.% in hot (40°C) water. The hybrids were characterized using XRD, FTIR, SEM/EDS and XPS. FTIR depicts that the “red shift” of amide I and COO− could be attributed to the fact that the gelatin prefers to chelate Ca2+ from S. The growth of calcium phosphates on the surface of the hybrids synthesized and then immersed in 1.5 SBF for 3 days was studied by using of FTIR, XRD and SEM/EDS. According to FTIR results, after an immersion of 3 days, A and B-type CO3HA can be observed on the surface. XRD results indicate the presence of hydroxyapatite with well defined crystallinity. SEM/EDS of the precipitated layers show the presence of CO3HA and amorphous calcium phosphate on the surface of samples with different G/S content when immersed in 1.5 SBF. XPS of the G/S hybrid with 25:75 wt.% proved the presence of Ca-deficient hydroxyapatite after an in vitro test for 3 days.


2009 ◽  
Vol 366 (1-2) ◽  
pp. 111-116 ◽  
Author(s):  
Simon Gaisford ◽  
Anthony E. Beezer ◽  
Alistair H. Bishop ◽  
Michael Walker ◽  
David Parsons

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