BackgroundA fixed-dose combination (FDC) of amlodipine and losartan has been used to reduce blood pressure in patients whose hypertension is not sufficiently controlled with either drug alone. The aim of this study was to evaluate the pharmacokinetic (PK) characteristics and tolerability of an FDC of 6.94 mg amlodipine besylate (5 mg as amlodipine)/50 mg losartan potassium compared to an FDC of 5 mg amlodipine camsylate/50 mg losartan potassium in healthy subjects.Subjects and methodsA randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted on 46 healthy male subjects. Blood concentrations were measured by liquid chromatography–tandem mass spectrometry. Blood samples were collected up to 144 hours post dose for each period. PK parameters were calculated in each treatment group using a noncompartmental method. The 90% confidence intervals (CIs) of the geometric mean ratios of the two treatments for the maximum plasma concentration (Cmax) and the area under the concentration curve from time zero to the last quantifiable time point (AUC0–t) were estimated. Tolerability assessments were performed for all subjects who received the drug at least once.ResultsThe PK profiles of the two treatments were similar. For amlodipine, the geometric mean ratios (90% CIs) of amlodipine besylate to amlodipine camsylate for the Cmax and AUC0–t were 0.98 (0.94−1.01) and 0.97 (0.93−1.01), respectively. The corresponding values for losartan were 0.91 (0.81−1.02) and 1.05 (0.98−1.12), respectively. The incidence of adverse events was not significantly different between the two treatments, and both were well tolerated.ConclusionAn FDC of 6.94 mg amlodipine besylate (5 mg as amlodipine)/50 mg losartan potassium produced similar results to an FDC of 5 mg amlodipine camsylate/50 mg losartan potassium treatment with respect to the PK parameters of amlodipine and losartan based on Cmax and AUC0–t values. The amlodipine besylate/losartan potassium combination was well tolerated by healthy male subjects.

For usage of glass fertilizer, physical and dissolution properties were investigated according to variation of the SiO2 and K2O contents in silicate glasses. In glass forming region, K2O/P2O5 0-0.24, SiO2/(SiO2+P2O5) 0-0.29 and CaO/P2O5 0-1.00 were fabricated as clear glass in K2O-CaO-SiO2-P2O5 glass system. The glass transition temperature (Tg) and softening temperature (Ts) were gradually shifted to the higher temperature range according to increase of SiO2 contents. The K2O contents, which could cause the structure change from network structure to polymeric chain structure, have direct proportion with the thermal expansion coefficient and inverse proportion with Tg and Ts. The change of the K2O/P2O5 ratio was a main factor to control chemical durability and physical properties such as density and hardness. In the abnormal glass properties such as fast dissolution in aqueous solution, it was presented that the glass can be a good candidate for agriculture fertilizer.

For the application of environment conscious glass-fertilizer, K2O-CaO-P2O5 glasses were fabricated by melt-quenching process, and the dissolution properties of these glasses were investigated using pH meter and ICP analyzer. Additionally, the fertilizer effects on rice culture were evaluated. The pH values depended on the glass compositions, and the ICP analysis confirmed that the dissolution amount was inversely proportional to the change of the K2O/P2O5 ratio, which was a main factor in controlling chemical durability, and which could be controlled by mother glass composition. The results of their application to rice plants indicated that the growth and quantity were similar to those used in chemical fertilizer. Therefore, the phosphate glasses are expected to provide the slow-releasing nutrient fertilizers that are easy to produce, environmentally safe, and widely applicable.

H 3 PO 4 (85% aqueous solution) was used as a proton donor. All the chemicals were used as received. The whole synthetic process is shown in Fig. 2. The total molar ratio of ethanol/Si was fixed 3427 J ournal

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