High throughput GRAS excipient solubility screening

Early stage approaches to solubilising a drug substance (for example using DMSO) are often not appropriate for a dose formulation that needs to be suitable for pre-clinical and clinical studies. Identification of a formulation approach designed to maximise drug loading and exposure is a prerequisite. Identifying options suitable for oral, parenteral or transdermal administration at an early stage brings time-saving and cost benefits to the entire programme.

Excipient solubility screening is a useful way of obtaining a large amount of information outside of in silico studies. The foundation of Excipient Solubility Screening is its utilisation of a proprietary preformulation matrix, comprising a wide variety of combinations of liquid-based GRAS/IIG formulation excipients approved for pre-clinical and clinical use (including pH adjustment, co-solvents, micro-emulsions, SEDDS, oils, lipids and cyclodextrins).

With our unique evaluation method it is possible to provide information on the solubility and stability of a drug substance in a wide range of excipients. We can then provide advice on the recommended solubility enhancement approach, which is designed to produce an overview to point to further formulation development steps, for example absolute solubility determination and in-use stability.

With our unique evaluation method it is possible to provide information on the solubility and stability of a drug substance in a wide range of excipients. We can then provide advice on the recommended solubility enhancement approach, which is designed to produce an overview to point to further formulation development steps, for example absolute solubility determination and in-use stability.

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