Pre-clinical formulation

Integrated CMC API capabilities Material sciences Analytical development and Quality Control Pre-clinical formulation DP Development & Manufacturing Integrated inhalation

Addressing your complex formulation issues fast from an early stage

Evotec’s pre –clinical formulation team can assist you in developing "phase-appropriate" formulations tailored to your compound properties.

Poor solubility/ low bioavailability are significant issues during drug development. It is reported that up to 75% of compounds currently under development are poorly water-soluble, with this figure rising to 90% for new chemical entities. This is of concern because solubility issues can compromise the developability of compounds, resulting in project delays and ultimately increase the overall cost of a project. Therefore, it is important to understand and address bioavailability issues early with "phase-appropriate" formulation strategies. 

A fast, cost effective and flexible approach in each stage of development focusing in meeting the project needs:
  • Evotec has considerable expertise in formulation and can expedite early phase formulation development from discovery to clinic
  • Evotec’s early formulation team can tackle your formulation problems fast, in support of pre-clinical testing using small amounts of compound
  • This dedicated and responsive team of pre-clinical formulation scientists has an in-depth knowledge of a wide range of formulation capabilities and expertise to support your project, ranging from simple to complex, bio-enhanced approaches
  • The team works in synergy with Material Science/ DMPK investigators and toxicologists to design an effective formulation screening programme that can quickly solve your formulation problems 

How do we work with your team?

We work with your team using 4 very simple steps to improve the outcome of your pre-clinical studies:

Review
Design
Develop
Supply
Our team of experts will review all relevant information related to your compounds
After reviewing the available information, the team will design a formulation screening programme including bio-enhanced strategies
A range of pre-formulation and formulation studies will then be executed in a fast and flexible approach using limited amounts of your compound 
We supply formulations for GLP and non-GLP studies and can design/ perform your in-life studies
We will you provide with the consultative input to enable you to make the best decision
Our team of material scientists and DMPK/ toxicology experts combined with powerful in silico models will assist us with the study design
The formulation will be tested in vitro to ensure the best outcome during in-life studies
Stability and scalability trials included
Review Our team of experts will review all relevant information related to your compounds
Design After reviewing the available information, the team will design a formulation screening programme including bio-enhanced strategies
Develop A range of pre-formulation and formulation studies will then be executed in a fast and flexible approach using limited amounts of your compound 
Supply We supply formulations for GLP and non-GLP studies and can design/ perform your in-life studies
Review We will you provide with the consultative input to enable you to make the best decision
Design Our team of material scientists and DMPK/ toxicology experts combined with powerful in silico models will assist us with the study design
Develop The formulation will be tested in vitro to ensure the best outcome during in-life studies
Supply Stability and scalability trials included

Our capabilities

Analytical support
  • 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 
Pre-formulation
  • pH solubility profile in bio-relevant media
  • pKa, Log P/ Log D
  • Solubility/ Stability in pharmaceutical solvents/ excipients 
  • Permeability measurements 
  • Characterisation techniques such as SEM, light and polarised microscopy, PSD, GVS, TGA, XRPD and mDSC
Formulation
  • Design of well tolerated pre-clinical dose-vehicles in support of PK/ PD and toxicological investigations 
  • Micronisation (ball/ air jet milling)
  • Nano-suspension
  • Amorphous solid dispersions by spray drying, hot melt extrusion, drug layering and emulsification approaches
  • Emulsion development (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)

Supply for GLP studies
  • 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

Contact us

Evotec

Business Development

T +44.(0)1235.86 15 61 F +44.(0)1235.86 31 39 Get in touch with our experts vCard
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