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High throughput formulation solubility screening
Often, early stage approaches to solubilising a drug substance (for example using DMSO) are 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.
Developed and delivered by Agenda1, we can provide a rational and innovative formulation screening platform, Excipient Solubility Screening. 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 preclinical and clinical use (including pH adjustment, co-solvents, micro-emulsions, SEDDS, oils, lipids and cyclodextrins). With a unique evaluation method it is possible to provide information on the solubility and stability of a drug substance in a wide range of excipients. Agenda 1 can then provide advice on the recommended solubility enhancement approach, which is designed to produce an overview to point to further formulation development steps (e.g. absolute solubility determination and in-use stability).
Benefits of the Excipient Solubility Screening screening platform include:
- Recommendations for formulations designed for maximum drug loading and exposure
- Identification of formulations suitable for either oral or parenteral administration
- Small sample volumes and API masses are required
- Rapid delivery of successful formulations for in vivo investigations
- Supporting stability testing and method development (e.g. HPLC) to match planned study timelines
Identifying excipient options suitable for oral, parenteral or transdermail administration at an early stage brings time-saving and cost benefits to the entire drug development programme.