Solubility Enhancement
Latest Whitepaper
Accelerating the Development of Enabled Formulations for Poorly Soluble Drugs using Translational Pharmaceutics®
As the number of poorly soluble compounds continues to increase in the industry development pipeline, conventional formulation strategies may not be sufficient to achieve acceptable levels of solubility. Our expertise in formulation development can help you achieve clinical success, even for the most challenging molecules.
In our latest whitepaper, learn about the benefits of using Quotient Sciences Translational Pharmaceutics® platform of integrated drug substance, drug product and clinical testing activities to improve drug product performance and clinical decision-making, ultimately reducing the time and cost of bringing drugs to market.
Spray drying
One proven method of improving the solubility and bioavailability of your drug candidates is spray drying. The technique involves dissolving the drug in an organic solvent in the presence of a polymer. The resulting solution is then spray dried to form a dispersion (a spray-dried dispersion or SDD).
Quotient Sciences has a proven track record of developing and manufacturing SDDs to overcome poor drug solubility and delivery challenges. We tailor the development of your SDD toward the specific physical and biopharmaceutics properties of each molecule. Over the past several years, we have advanced more than 25 SDD formulations into clinical studies. Using state-of-the-art equipment, including ProCepT spray dryers for up to 1 kg batches and a Niro Mobile Minor spray dryer for batches of 1 to 10 kg, we develop your SDDs using both aqueous and solvent-based processing intended for both oral and inhaled drug delivery. Developed SDDs can be administered either as powder-in-bottle reconstitution prior to dosing or formulated as a powder-in-capsule or tablet presentation.
Particle size reduction
Our experienced team utilizes a suite of particle size reduction processing equipment including mills, nanomills and micronizers depending on your intended final drug product. Your developed products can be presented as a drug in a bottle or can be further formulated as a drug in capsule or tablet formulation.
Lipidic vehicles and complexes
Recent years have seen lipid-based drug delivery systems and complexes become increasingly important tools in the quest to improve the oral bioavailability of poorly soluble drugs. Lipid-based solubility enhancement has developed from the observation that many poorly water-soluble drugs see an improvement in bioavailability when administered with a fat-rich meal; essentially the stimulation of biliary secretion can promote drug solubilization within the GI tract. Lipidic vehicles are designed to mimic this effect by pre-dissolving the drug within an appropriate lipid structure, thus bypassing the need for the poorly soluble, crystalline material to dissolve in situ.
Similarly, cyclodextrin drug-inclusion complexes act to improve aqueous solubility by essentially shielding the hydrophobic drug within an interior cavity of the hydrophilic cyclodextrin, thus enabling the entire complex to drive improved oral bioavailability.
Quotient Sciences has expertise in the development of lipid-based and complex drug delivery vehicles. We can help you screen for a range of lipidic and complexation vehicles including self-emulsifying drug delivery systems, self-microemulsifying drug delivery systems, single oil phases and cyclodextrins. Your formulations are then characterized in vitro, prior to progression into the clinic.
Solubility enhancement
Go further with Quotient Sciences
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Info SheetFormulation Strategies for Poorly Soluble MoleculesWith nearly 30 years of experience, Quotient has established a broad suite of technologies and formulation approaches to address these complex solubility challenges. Our approach allows us to dramatically speed up the optimization of your drug products to improve oral bioavailability.
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Info SheetFormulation Development - Spray DryingWe use a broad range of formulation approaches to address complex solubility and bioavailability challenges, ensuring technology selection is driven by molecule need.
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Case StudiesEndevica Case Study - Peptide Program using Translational PharmaceuticsEndevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Read how they leveraged the Quotient Sciences Translational Pharmaceutics platform for this program.
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Case StudiesEnsysce Biosciences Case StudyRequest a copy of our latest case study with Ensysce Biosciences about how our integrated strategies helped them achieve their regulatory milestones faster for PF614-MPAR, an Extended Release product.