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the compound supply and screening functions in the overall compound processing cycle. More important, there has been little data published on the best storage conditions or on the stability pro les of large, diverse pharmaceutical compound screening collections. While the breadth of compound classes, functionality, and physiochemical properties associated with such a diverse set of compounds makes setting any one standard an arduous process, the proper design and use of the storage facility along with wellestablished expiration limits or expiry dates for compound retention is essential to extending the life and value of the compound supply and to ensuring the robustness and reliability of the biological screening data. Recently there has been increased activity in this area resulting in several publications7 12 and more than a dozen conference reports in the last three years13 27 compared to pre-2000 period.28 30 Some of the interest here may be due to HTS maturing to become an integral part of most drug discovery programs, and some may be due to the recognition that the ef ciency of discovering a novel drug is largely dependant on the quality and quali cation of the biological screening compound collection (i.e., size, chemical diversity, purity, and stability). Some of the issues associated with long-term soluble compound storage are addressed in Figure 13.3. While sparse and far from complete, we will summarize major ndings from the authors laboratories, as well as those presented at recent combinatorial and high-throughput screening conferences. This will include a discussion of the factors in uencing compound
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Instrumental Limitations TIME
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Figure 13.3. Environmental factors that can lead to compound degradation.
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organic compound stability in large, diverse pharmaceutical
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stability, such as atmosphere, humidity, temperature, container materials, storage format, and storage time.We will conclude by outlining future directions in this area. However, because of the relatively new interest in the stability of large, diverse compound screening collections, the reader is cautioned that much of the work published in this chapter is yet unpublished in peer review journals. Therefore the conclusions drawn on the part of the authors are preliminary and should be validated in subsequent experiments and laboratories. Finally, while studies on the stability of individual drugs in speci c formulations at preclinical and clinical stages have been documented extensively as required by the Food and Drug Administration (FDA) for drug approval,31 34 these studies are not directly applicable to repository compounds and will not be included in this review. It is suggested that the reader consult these references for more information.
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Compound loss related to the liquid storage of organic libraries for biological screening may result from a variety of processes such as precipitation, absorption, and decomposition, as well as the structural characteristics of compounds that determine reactivity, solubility, and absorption. However, the presence of other components in the sample such as salts, impurities, or excess acids and bases can also result in the increased reactivity or accelerated degradation for the compound of interest, while environmental factors, such as temperature, humidity, atmosphere and light and operational and processes parameters (e.g., storage time, storage format of solid state vs. DMSO solution), storage container type, sealing, and processes such as repeated freeze/thaw may also affect compound stability. In this chapter we address many of the confounding factors that may compromise compound integrity following long-term solution storage. The chapter is divided to show the various environmental, container, and process conditions that in uence compound behavior in solution (i.e., DMSO). The data presented were obtained from a variety of sources and include ndings from a number of recent conference proceedings as well as work conducted in the authors laboratories. However, the results we discuss should not be considered conclusive or a comprehensive as our access to corporate repository collections, storage systems and processing procedures was limited. We hope, however, that the results we present will provide useful guidance to readers developing, maintaining, or screening large diverse collections of pharmaceutical compounds.
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