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Ngoc-Anh T. Nguyen Mickey L. Wells David C. Cooper 《Drug development and industrial pharmacy》1995,21(14):1671-1682
To identify factors affecting the chemical stability and preservative efficacy of lamivudine oral liquid formulations, an optimization study using a central composite design was performed. In this design, five factors, each at three levels, were investigated: pH (4.5, 5.5, and 73, sucrose (5%, 20%. and 50% w/v), propylene glycol (0% 2%, and 5% w/v), glycerin (4% 8%, and 12% w/v). and EDTA (0.100. 0.175, and 0.250 mg/mL). All formulations contained a constant concentration of lamivudine, parabens, and artificial strawberry and banana flavors. All formulations were evaluated for preservative effectiveness against USP and BP standards and for chemical stability at 30°C and 40°C for three months. All formulations were effective against bacteria and yeasts, but indicated reduced preservative effectiveness against the mold Aspergillus niger. Preservative effectiveness improved with increasing pH (4.5 to 7.5) and to a lesser extent with increasing EDTA concentration (0.100 to 0.250 mg/mL). Increasing glycerin concentration (4% to 12% w/v) slightly decreased preservative effectiveness. Over the concentration ranges tested, no change in preservative effectiveness was noted with concentration changes in sucrose or propylene glycol. The pH was the main factor influencing the chemical stability of the drug and preservatives in this study. Lamivudine chemical stability increased with increasing pH from 4.5 to 7.5. Methyl and propylparaben showed extensive degradation at pH 7.5. 相似文献
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Allen M. Johnson Michael A. Schoenfelder David J. Lebold 《Quality and Reliability Engineering International》1993,9(1):55-62
The Rainbow net simulation technique is applied to modelling the impact of system load and fault handling on the availability of a fault-tolerant multiprocessor architecture. Rainbow nets are described along with the motivation for creating this modelling technique. A Rainbow net fault-handling model is created for the fault-tolerant multiprocessor architecture and the topology is shown to remain constant in size, independent of the number of processor, memory and I/O elements configured in the system. Simulation is performed with a varying load in terms of the number of active jobs the system must support. Results are given showing how the fault-tolerant capability varies with load. Two new metrics for evaluating fault tolerance are introduced; namely full fault-tolerability and partial fault-tolerability. They are based on simple observations in the model. 相似文献