Preclinical Formulation Screening
In the drug discovery process, formulation plays a crucial role in assessing the biological characteristics of molecules. Increasing the exposure of the test compound in studies in vivo is one of the main goals of early animal experiments. Choosing a suitable preclinical formulation not only optimizes in vivo PK exposure, but also promotes the optimization, selection, and development evaluation of compounds to provide data support for the design and development of clinical formulations
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Overview
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Assays
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Study Strategies
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Experience
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FAQs
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Related Resources
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Related Services
Overview
For the test compounds in the early screening stage, the unsatisfactory physical and chemical properties, the insufficient compound amount, and the tight time are commonly encountered. To deal with these challenges, the WuXi AppTec DMPK established a team for preclinical formulation screening for PK studies, pharmacodynamic, and toxicological studies. The team has more than ten years of experience and can perform rapid formulation screening and preparation services for large and small animal experiments. They also provide more than nearly 1,000 arms of formulations for preclinical animal experiments every week. They can use limited (milligram) compounds to offer a suitable formulation for preclinical animal experiments within 24 hours
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Assays
The formulation team provides formulation screening and formulation services for pharmacokinetic studies from the screening stage to the IND application stage. It provides formulation screening services for pharmacodynamic tests and preclinical toxicological experiments. The team can select suitable excipients to dissolve the compound to tackle the solubility issue according to the physical and chemical properties of each specific drug substance (such as dissociation constant pKa, lipophilicity, aqueous solubility). The most suitable formulation for a drug substance is selected by in vitro solubility assessment, homogeneity, and particle size analysis. Further screening is performed from eligible candidates to ensure the formulation with better in vivo bioavailability or good achievement of experimental objectives.
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Study Strategies
The formulation team can select vehicles that meet the requirements of the PK study within one working day. In formulation screening, solubilization technology (such as pH adjustment and cosolvent) is a commonly used technical means. For some poorly soluble compounds, a cosolvent plus surfactant or complexing agent plus pH adjustment are typically used in combination. In addition, the DMPK formulation team can customize the formulation screening strategy according to differentiated project needs
Common methods for preclinical formulation screening
Experience
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12+
Years of experience in preclinical vehicle screening
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1000+
Bottles per week of formulation screening and preparation
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10000+
Vehicle safety database
FAQs
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What methods are used in preclinical formulation screening?
Cosolvent, surfactant, pH adjustment, particle size reduction; solid dispersion and so on.
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How can preclinical formulation screening optimize drug development?
Optimize the exposure to enable the in vivo profiling; Provide the insight for formulation design and development in the preclinical late stage; Facilitate compound design and developability assessment
Related Resources
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Formulation Development Strategy: Preclinical PK, PD, and TK Considerations
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Enhancing the Bioavailability of Poorly Soluble Compounds: Strategies for Formulation Optimization in Preclinical Studies
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