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Extractables and Leachables Testing
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Pre-Clinical Formulation Development

Investigating the Options

At this stage, a pre-clinical formulation strategy will have been developed. Often this will be a simple solution for parenteral delivery, though it can also mean a powder blend, or suspension, possibly for a capsule delivery route. We can support by helping make up various formulation options and assessing them for chemical and physical stability, solubility, dissolution and permeability. If the work goes well, the team can move quickly to PRE-CLINICAL DOSE FORMULATION OPTIMISATION. If the work stalls, there are other ways we can support. In particular we have a range of drug-excipient compatibility testing options, including TGA, DSC and HPLC, as well as our Excipient Solubility Screening techniques which can yield valuable information about drug excipient compatibility.

Problem solving at this stage:

Changing the physical form: Often additional pre-formulation sample preparation/optimisation work is required, which could include crystallisation, spray or freeze drying, milling or micronization services. Most of this work we carry out on site, and some via approved sub-contractors, with the materials being returned to Agenda1 for analysis.

Solubility Enhancement: Our proprietary formulation solubility screen can be used to provide a fast and efficient route to investigate and solve many pre-clinical formulation challenges.

Physical Preparation: In addition to problem solving, we also offer API processing services such as micronizing or blending to prepare samples for further development. We can carry out such work on site with characterisation analysis, before forwarding samples to your developmental partners for use or further processing to the finalised form. Again we can support with small volume spray and freeze drying and a range of milling/micronisation approaches.