Formulation screening for poorly soluble drugs
We have many years of experience in the formulation of poorly soluble and poorly bioavailable drugs.
We will explore a range of options to give the best possible, fit for purpose and cost effective outcome. Firstly we will explore salt form and co-crystal formation to enhance solubility, then micronisation. If these meet requirements then we can take you fast to clinic using powder in capsule fill with our Xcelodose.
If further work is required we can rapidly (within just a few weeks) explore a range of formulation options to see which will best suit your needs. Our MacroSOLV screen is a fee for service approach to optimise co-solvent, solubilisation, complexation and lipidic formulation options. Based on the skill and experience of Pharmaterials staff we can screen different formulation approaches rapidly and with minimal API requirements. With many examples of successful outcomes from our MacroSOLV formulations having shown excellent bioavailability and having been through technology transfer, we are confident that we can help you.
The technologies screened include:
- Suspension / Nanosuspension (Oral)
- Co-solvent Systems (Oral, Parenteral)
- Cyclodextrins (Oral, Parenteral, Topical)
- Oily liquids (Oral, Parenteral, Topical)
- Emulsions (Oral, Parenteral, Topical)
- Microemulsions (Oral, Topical)
- Mixed micelles (Parenteral)
Additionally we will explore amorphous dispersion formulation options and microfluidised formulations.
Amorphous dispersions can be made stable and can be processed into capsules or tablets. We manufacture such formulations using our GMP spray drier after suitable lab development and physico-chemical testing.
Microfluidised formulations reduce particle size to a micron or less and greatly enhance the dissolution rate of poorly soluble APIs. The wet size reduction with stabilising surfactant can yield nanoparticles which can be spray dried and further processed into capsules or tablets with excellent dissolution and bioavailability.
The products can all be made in our GMP manufacturing facility.
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