At HyCON, we offer comprehensive preformulation solutions designed to assess developability of preclinical stage molecules. Our expertise focuses on addressing key challenges such as solubility, stability and bioavailability, ensuring that these molecules are optimally prepared for progression to toxicity studies.
Our scientists possess deep expertise in the core scientific disciplines of Formulation, Solid State, and Analytical Development. Leveraging cross-functional expertise, they provide end-to-end support for preclinical molecules, focusing on the following activities.
Our laboratory is well-equipped to profile the lead molecules coming of drug discovery and assess developability. We conduct thorough physico-chemical characterisation of the molecule for;
Thorough profiling of molecule at discovery stage with small amount of material helps scientists to assess developability of the molecules coming out of drug discovery research and guide project teams for lead molecule selection for toxicity studies. The profiling data also helps scientists to understand developability risks of the molecule and devise appropriate development strategies to resolve and enable them for toxicity studies. Some of the lead molecules at preclinical stage may have stability or solubility challenges risking them to progress to toxicity studies. We offer solid state and formulation solutions to fix these issues early and enable molecules to progress further.
We provide solid state solutions for molecules which are amorphous in nature or having sub-optimal crystalline properties like low crystallinity, polymorphism, low melting point, instability etc. which pose significant risk for successful clinical development. In addition, appropriate solid form selection can help with oral bioavailability enhancement, slow-release profile by injectable route with hydrophobic salts etc. We utilize our deep expertise in solid state assessment of the molecule and extrapolating those properties to clinical and commercial development to devise appropriate solutions and fix them early in the development stage. Our offerings include;
Molecules with optimal solid-state properties can progress through development stages smoothly and it is critical to fix them early in development stage to avoid significant delays in late phase development. In addition, using the same solid form in the preclinical and clinical phases will avoid surprises.
We provide novel formulation solutions for molecules intended for oral delivery and are insoluble in nature classified as BCS class II or IV categories, exhibiting poor bioavailability in preclinical species,. We can also support BCS class III molecule to enhance their absorption using permeability enhancers. For parenteral delivery, we offer novel solutions to achieve slow-release profile of a molecule as long-acting injectable formulation. We utilize our deep expertise in drug delivery technologies and apply them to molecules to achieve desired in vivo performance. All the technologies developed at this stage would be ensured for successful scaleup and clinical development. Our offerings include;
Molecules with right drug delivery technology selected at preclinical stage can overcome challenges timely to complete preclinical studies in time. In addition, they can progress to clinic faster with well devised formulation approach utilising similar formulation principles for preclinical and clinical stages and a solution provider capable of offering end to end formulation solutions.
At HyCON Labs, our commitment to advancing medicine extends beyond providing service to our customers. We strive to advance medicines to patients through novel, tailored solutions with excellence in execution.
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