By Allen C Templeton, Stephen R. Byrn, Roy J Haskell, Thomas E. Prisinzano
This authoritative quantity presents a latest view at the newest learn in molecules with optimum drug-like houses. it's a priceless resource to entry present top practices in addition to new examine ideas and methods. Written via best scientists of their fields, the textual content includes fourteen chapters with an underlying subject of early collaborative possibilities among pharmaceutical and discovery sciences. The ebook explores the sensible realities of acting actual pharmaceutical and biopharmaceutical examine within the context of drug discovery with brief timelines and occasional compound availability. Chapters conceal recommendations and strategies to let discovery in addition to predictive ways to set up, comprehend and converse hazards in early improvement. It additionally examines the detection, characterization, and overview of dangers at the reliable country homes of complicated discovery and early improvement applicants, highlighting the hyperlink among stable nation homes and important improvement parameters comparable to solubility and balance. ultimate chapters heart on ideas to enhance molecular solubilization and stop precipitation, with rather emphasis on linking physiochemical homes of molecules to formula choice in preclinical and medical settings.
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Additional info for Discovering and Developing Molecules with Optimal Drug-Like Properties
Considering the significant advancements, projected commercial growth and most importantly, the opportunity to develop breakthrough therapies for unmet medical needs, it is almost inevitable for pharmaceutical and biotech organizations to get heavily involved in the area of enabling delivery technologies (through internal capacity build-up or partnering with external companies) and maximize the potential of their NCEs as well as their existing clinical or commercial candidates. 5 Summary/Concluding Remarks The process of drug discovery and identification of developable NCEs is a multifaceted approach.
Efficacious human doses are usually difficult to predict when NCEs demonstrate significant species differences in their absorption, metabolism and elimination profiles or due to lack of suitable animal models that can demonstrate a PK/PD/efficacy relationship. As a result, it becomes very challenging for technical development functions to develop robust formulation and dosing strategy for early clinical studies. In such instances, it is recommended to proceed faster into the clinic with a simple formulation principle such as powder in bottle, or drink solution in bottle and determine the fate of the molecule sooner rather than later instead of resolving the above issues/liabilities over several years.
Compounds with stronger basicity or acidity may not be good candidates for developing oral nanosuspensions as desired improvement in dissolution and biopharmaceutical performance can be achieved by simply micronization or salt formation. Compounds with basic functional groups when dosed as nanosuspension will most likely dissolve/solubilize in gastric pH of stomach and reprecipitate under intestinal pH conditions with a completely different particle size distribution. Similarly, acidic compounds will dissolve readily under intestinal pH conditions and may not benefit significantly from nanosized formulation.