Evotec's early and preclinical formulation team can provide valuable assistance in developing "phase-appropriate" formulations tailored to the specific properties of your compound. With our unique "phase-dependent approach," we are committed to finding the optimal combination of composition and dosage form, offering comprehensive support throughout the entire drug development process. Backed by decades of expertise in the field, we offer flexible partnership options, allowing you to choose the phases that best align with your specific needs. 

One of the key challenges in drug discovery and development is poor solubility and low bioavailability. It has been reported that a significant percentage of compounds currently under development, up to 75%, suffer from poor water solubility. This number even reaches 90% for new chemical entities. These solubility issues are of great concern as they can hinder the progress of compound development, leading to project delays and increased overall costs. Therefore, it is crucial to address and understand bioavailability challenges early on by employing "phase-appropriate" formulation strategies. 

At Evotec, we possess an integrated knowledge base encompassing developability liability understanding. Our multidisciplinary experts bridge the gap between the physical properties of the compound, in vivo performance, and in silico modeling. By leveraging this expertise, we can predict and implement the best strategies for your compound, ensuring its successful development. 

Evotec possesses extensive expertise in formulation and excels in expediting formulation development from the discovery phase to clinical trials. Our capabilities encompass early formulation assessment, as well as comprehensive support for Chemistry, Manufacturing, and Control (CMC), including drug substance and drug product development, and Good Manufacturing Practice (GMP) manufacturing for Phase I to III clinical development programs.

Our approach is characterized by speed, cost-effectiveness, and flexibility, all while consistently prioritizing project requirements at every stage of development. The early formulation group at Evotec is well-equipped to address your formulation challenges during drug discovery. We excel in developing optimal strategies for pharmacokinetic (PK) and toxicology (Tox) studies, and we provide invaluable support in selecting the most suitable technology for the clinical phase, even when working with small compound quantities.

Our preclinical formulation scientists form a dedicated and responsive team with profound expertise across a broad range of formulation capabilities, technologies, and approaches, from straightforward solutions to more intricate, bio-enhanced methods.

They collaborate closely with experts in Material Science, Drug Metabolism and Pharmacokinetics (DMPK), and toxicology, synergistically designing effective formulation screening programs to swiftly overcome any formulation-related obstacles.

Overall, Evotec's formulation services are designed to meet your needs with precision, delivering rapid solutions and ensuring seamless progress in your project.

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We offer a diverse range of formulation and drug delivery strategies to address issues such as low drug exposure and potential stability concerns related to the active pharmaceutical ingredient (API). Our primary objective is to provide the most suitable vehicle for conducting in vivo studies. We support both oral and parenteral routes of administration, including intravenous (IV), subcutaneous (SC), dermal/transdermal, intra-ocular, and intraperitoneal (IP) routes. With our screening platform, we ensure a swift turnaround time and a specialized formulation approach to maximize exposure potential while optimizing the quantity of the compound required.

Our team of experienced professionals excels at recommending the optimal vehicles based on their ability to overcome solubility and tolerability challenges observed in in vivo preclinical studies. These recommendations are tailored to align with the specific study requirements, including the dosing volume and frequency of administration. We strive to enhance the clarity and precision of our formulations, ensuring they align with the study objectives and enable efficient and effective evaluations.

Overall, our comprehensive offerings and expertise empower our customers to make informed decisions regarding vehicle selection, facilitating successful preclinical investigations.

• Compendial in vitro dissolution testing (USP I and II) 
• Dynamic dissolution testing using pHysio-stat^® automated system (predictive dissolution testing) 
• Precipitation studies in simulated gastro-intestinal fluids and plasma from different animal species  
• In vitro lipolysis tests 
• Hemolytical potential  
• Franz cell studies  
• Stability assessment of developed prototypes  
• Accelerated stability testing

• pH solubility profile in bio-relevant media 
• pKa, Log P/ Log D - in collaboration with the DMPK group
• Solubility/ Stability in pharmaceutical solvents/ excipients  
• Permeability measurements  - in collaboration with the DMPK group and Cyprotex
• Physico-chemical characterization techniques such as SEM, polarized light microscopy, PSD, GVS, TGA, XRPD and mDSC  techniques – These techniques as well as additional characterization equipment are also available in our Material Science group

• Design of well tolerated preclinical dose-vehicles in support of PK/ PD and toxicological investigations  
• Micronisation (ball/air jet milling) 
• Nanosuspensions  (nanomilling)
• Amorphous solid dispersions by spray drying, hot melt extrusion, drug layering via Fluidized bed technology
• Emulsions (standard emulsions and SMEDDs/ SEDDs) 
• Lyophilisation 
• Liposomes  
• Film coating (pellets, tablets, capsules) and drug layering (size 9h to 00) 
• Microparticles (controlled/ sustained release) 
• Our team works on formulations planned for any route of administration (oral, pulmonary, dermal/transdermal, intra-ocular, parental)
• Formulation development and GMP manufacturing are available at our Verona site

• Proven experience in effective use of formulation approaches under GLP requirements also for non-conventional technologies 
• Analytical and bioanalytical support integrated in the service including stability study under GLP 
• Superior knowledge of excipient tolerability to design well tolerated and to administer complex vehicles based on species, route of administration and dose requirement for toxicology assessment