SPEED

Click on image to enlarge

Rapid Solutions For Tox Testing

Objectives

a) Our Speed Service swiftly develops the best delivery strategy to maximize the exposure of animals to a poorly soluble compound in tox testing. It helps you understand the safety margin of your compound and minimizes the risk of having to repeat tox trials due to insufficient exposure in man. This knowledge is vital

b) Minimize the interference from excipients whilst making the administration form easy and straightforward to use.  The test species that will be studied also needs to be factored in  

c) Supply materials that use the best strategy for rapid in vivo evaluation. This enables you to progress your compound through pre-clinical testing without delay

Background

Formal tox testing is on the Critical Path. Any delay during this stage, such as insufficient exposure or a hold up in the supplies for testing, will stall the entry of your compound into man. This time pressure means expensive tox trials are frequently started before the issue of exposure is adequately addressed.

Poor solubility presents distinct delivery challenges during tox testing. Compounds with a high target specificity but low toxicity profile can be particularly problematic. This is because extremely high levels of the compound have to be systemically exposed. After oral administration, traditional formulations are frequently unsuitable for tox testing due to insufficient exposure. After intravenous administration, the problems are more obvious. Insoluble compounds can crash out in vivo causing local thrombophlebitis or capillary blockage.

Strategy

Some insoluble compounds are orally bioavailable from a simple suspension even at high dose. In these situations, you will not need this service. Speed will help if you cannot observe the toxicity of your compound and have to increase exposure levels to observe tox effects. It offers focused strategies designed to address the technical issues of exposing challenging insoluble compounds orally and intravenously within a very short time frame. We’ve developed a broad selection of pioneering strategies specifically designed for use in tox for both acute and chronic testing. These approaches minimize, or where possible eliminate, vehicles and excipients that interfere with the testing.

The knowledge Speed provides you with may also serve as a basis for the further development of your compound. Should you require a dedicated solution, it can be tailored to meet your needs of tox without any unnecessary activities.

Speed is offered as fee for service.  

Equipment

• Pragmatic and streamlined methodology to identify promising strategies fast
• Extensive palette of equipment for preparing both small and intermediate scale supplies
• Specialist techniques for detecting delivery approaches resistant to precipitation

Technologies

For oral administration, we employ the complete range of solubilized, crystalline and amorphous delivery approaches. The selection of the most appropriate approach is dependent upon the nature of the compound, particularly its potency. Solubilized forms may be useful on occasions but only in situations where the excipients do not interfere with the tox read out. Generally, a crystalline form is preferred but typically crystalline forms may not give a high enough expose for tox testing. Hence, amorphous forms can often be employed successfully in this service as limited duration of physical stability is required.

Time Frame

• Lead swiftly identified within 3 weeks
• Report and Supply within 7 weeks
• Frequent communication on progress and results

You Need Speed If…

• You observe a plateauing or variability of exposure at higher dosing levels
• You think you don’t have enough time to solve your limited exposure
• You observe promising pharmacology but cannot observe toxicity of your poorly soluble compound
• Your dosing is limited by low drug load and/or excipients causing tox
• Your exposure is erratic and unpredictable

Request a quote