The imperative

Often, early stage approaches to solubilizing a drug product (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 maximum drug loading and exposure is a prerequisite. Identifying options suitable for oral or parenteral administration at an early stage brings time-saving and cost benefits to the entire program.

The solution

Developed by Synectix Pharmaceutical Solutions Ltd and delivered by Agenda 1, we can provide a rational and innovative formulation screening platform, SOLENT™ (SOLubility ENhancement Technology). The foundation of SOLENT™ is its utilisation of a proprietary preformulation matrix, comprising a wide variety of combinations of liquid-based GRAS 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 product 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 analysis steps.

Benefits of the SOLENT™ 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 required.
• Rapid delivery of successful formulations for in vivo investigations.
• Supporting stability testing to match planned study timelines