By providing robust information on how formulations are working in vivo through the non-invasive imaging technique of gamma scintigraphy, you can uncover the reasons for clinical failure.
Alternatively, increase your chance of success first time by implementing these strategies early.
Gamma scintigraphy is a nuclear imaging technique that allows non-invasive in vivo assessment of dosage form behaviour. It can be applied to most routes of drug delivery including oral, nasal, pulmonary and ophthalmic.
Achieve real-time monitoring of dosage form behaviour by including a suitable radiolabel.
Combine scintigraphy with PK to give insight into how absorption is affected by dosage form transit and residence.
Scintigraphy studies can be carried out in healthy volunteers or patient groups with a cohort size from as few as 6 individuals to show that:
The drug is actually being released
The drug is delivered at the right physiological location
The drug is being released at the right time
These indicators are valuable tools to begin to understand the reasons behind failure in the clinic.
We believe that no in vitro test can replace the human body as a formulation screening tool and scintigraphy allows us to do this in a quick and cost effective way.
A Solution to the Problem
BDD also thrives on dealing with challenging formulation issues and has a wealth of experience in various routes of drug delivery.
Using the valuable data gained from a simple scintigraphic/PK study, DDi scientists will improve on the formulation and deliver a dosage form that will have a significantly higher chance of clinical success.
Back into the Clinic
With heightened confidence, you can place the improved product back into your clinical trial. We can further assist by providing small scale GMP manufacture of IMPs for these trials.
Reduce Risk of Clinical Failure
Utilise clinical gamma scintigraphy even before embarking on Phase I/II studies to:
Screen a panel of formulations prior to choosing which one to take forward into clinical trials
Establish accurate delivery profiles for controlled and targeted release systems
Demonstrate superiority over marketed competitor products
Early stage clinical formulation screening is exceptionally advantageous in terms of providing valuable data for critical decision making.