IntraSOLV® - Stabilised amorphous solid solutions
Non-IP based, fee for service, formulations with proven market potential
We have taken a large number of amorphous formulations to clinical trials with great success. Pharmaterials has a wealth of experience in formulation development of amorphous solid dispersions using public domain systems, all adapted to meet your needs by our experienced formulation team.
We have experience of formulation and technology transfer to GMP for many actives using this technology.
We will:
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use small scale rapid methods to design the formulation with minimal API usage. Optionally using a rapid screening method which explores numerous carriers and surfactants in combination on an automated 96 well plate platform (reading with Raman and X-ray diffraction).
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Optimise the formulation using our wealth of experience and world class physical testing facilities
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Use our leading scientific knowledge of characterisation of amorphous materials.
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Use tried and tested scale up options leading to GMP spray drying for product manufacture.
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Use rapid and reliable excipient compatibility testing
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Formulate into either hard gelatin capsules or tablets
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Produce viable rapid release stable dosage forms for your active
Case Study
The Problem:
A mid-sized pharmaceutical company had selected their lead compound from the drug discovery phase, which was an orally active cell cycle inhibitor. The drug was presented in a non-ionisable, highly crystalline state, which led to poor dissolution characteristics and low absorption. Initial studies had shown a significant improvement when using a nano-suspension formulation, but the overall % plasma concentrations did not reach the desired levels. Previous attempts to formulate an amorphous solid solution were unsuccessful due to the inherant physcial instability of the amorphous state, which led to rapid recrystallisation upon storage and a decrease in product efficacy.
The Answer:
Using our formulation screening platform, we were able to carefully choose the optimal formulation to enhance bioavailability and produce a stable product.
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