An oral formulation development leader for complex dosage forms
When it comes to oral formulation development, Evonik has been providing pharmaceutical companies with advanced functional solutions for more than 60 years. Today, we lead the market for the oral formulation development of complex dosage forms including monolithics and multiparticulates for use with small molecules and other drug substances. In addition to our experience with highly potent APIs and controlled substances, we have strong competencies in the development of drug products across areas including:
- personalized medicines and 3D printing,
- solubility and bioavailability enhancement,
- pediatric and geriatric medicines,
- microbiome delivery,
- and the oral delivery of biologics.
Whether you are seeking a partner to support your journey from discovery through to the commercial launch of the finished drug product, or you require solutions for a specific project stage, our global team of oral formulation development experts is ready to help.
Oral formulation development services for pre-clinical projects
Our large worldwide network of fully equipped laboratories for oral formulation development may support and accelerate your entry into human clinical studies and pathway to regulatory filings and commercial launch. Evonik takes a Quality by Design (QbD) approach to oral formulation development, bringing together a complementary mix of core competencies across functional polymers, process development, analytical method development, clinical manufacturing, scale-up and transfer. These QbD principles are applied from the first pre-formulation steps to reduce risk and streamline your entry into clinical trials. A range of pre-formulation services are offered to customers, including fast-track feasibility studies, the rapid evaluation of polymer options, initial stability studies and a review of various drug delivery technologies that can enhance product performance. We also provide predictive formulation screening services to identify and select the best process, excipient, and solubility and stability solutions for your drug substance.
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Oral formulation development services for the clinical and commercial stage
Regardless of if you are seeking to formulate or reformulate your drug substance, we can provide you project teams that has the right drug delivery, process technology and application expertise to address your specific oral formulation development requirements. In addition to selecting the right combination of EUDRAGIT® polymers and drug delivery technologies to match your target release profile, we will tailor each formulation to optimize solubility, bioavailability and permeability; develop and validate the methods to ensure consistent levels of quality and efficacy during scale-up; and maximize rates of patient acceptability. We also routinely help customers to boost drug performance, protect highly sensitive APIs from light, moisture or oxygen to maximize product shelf life and release kinetics, and co-ordinate the development and validation of your analytical methods. In parallel, prototypes can be rapidly manufactured and supplied for pharmacokinetic studies and stability studies while our cGMP clinical manufacturing capabilities can support your batch requirements for phase I to IIA human clinical studies.
Analytical services to support oral formulation development
We also boast an exhaustive array of analytical capabilities including dissolution testing, particle size analysis, molecular weight determination, surface charge, viscosity, drug elution and purity, thermal property analysis, osmolality, titration, cell biology and protein analysis. Additional in-house capabilities for biopharmaceutical testing include toxicity, cell adhesion, cell uptake and permeation.
Additional areas of project support for oral formulation development
A full range of particle manufacturing technologies are available for the formulation screening, including:
- high shear mixing
- solvent displacement
- high pressure homogenization
- spray drying
- fluidized bed coating
In parallel with our oral formulation development services, we also provide customers with the opportunity to leverage our expertise to support their production, technology transfer and regulatory requirements. This includes the availability of our local teams of oral formulation development and application specialists to travel to your locations to provide on-site production support and troubleshooting, a review of potential CMOs for clinical and commercial scale-up and associated technology transfer to the preferred production site.