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Non-invasive diffusion tracking in pharmacokinetics
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Lein Applied Diagnostics is seeking partners to utilise a novel technology for making non-invasive pharmacokinetics (PK)
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measurements both in vivo and in vitro.Funding available until: Name of organisation: Executive summary:
Lein Applied Diagnostics is seeking partners to utilise a novel
technology for making non-invasive pharmacokinetics (PK)
measurements both in vivo and in vitro. This technology has
been proven to be able to track pharmaceuticals in the anterior
chamber of the eye and is now being extended to measure
distribution through skin and through artificial constructs in vitro.
Scientific background:
Lein Applied Diagnostics has developed a novel optical technique for
making non-invasive measurements on many biological and industrial
materials (1). The technique combines confocal technology with
fluorescence approaches to build up a map of the level of, and distribution
of, a compound within simple tissue constructs and materials in areas
such as ophthalmology, and tissue engineering.
Working with Durham University we have successfully developed the
technology as a proof of concept device that is able to accurately and
reproducibly measure the level of, and distribution of, pharmaceuticals
within the anterior chambers of excised porcine eyes with high spatial discrimination (2).
One of the devices strengths is the speed of data collection that enables real-time tracking of
the diffusion of the compound of interest. This work is now being built upon by extending the
technology to make measurements to assess the motility of the compound/material of interest
through the skin and on other test samples, for example tissue constructs in vitro.
Current state of the art:
Current methods for PK measurements in vivo are invasive. For ophthalmology, there are no
effective techniques to make non-invasive measurements of the diffusion of pharmaceutical
drugs in the eye. As a result, it is necessary to physically remove fluid or material from the area
of interest in order to evaluate the location and concentration of the compound under
investigation. This requires the invasive use of a needle or other such device and can often
require the sacrifice of the animal (3). In addition, in order to assess the kinetics of the
compound over time, it may be necessary to perform parallel tests on several animals at
multiple time-points, with animal sacrifice at each time-point. As mice and rats are not
recommended for ocular studies these trials tend to be performed on rabbits, beagles and
non-human primates. Invasive approaches are also currently employed for the in vivo PK
measurement of topically applied creams and drugs (4, 5). The non-invasive nature of Lein’s
technology offers significant advantages, both in vivo and in vitro, by enabling real time
measurements without affecting the physical process.
What could your solution:
With minor adaptations the current technology may be used to measure a wide range of
be used for?
compounds of interest in diverse applications:
In vitro assessment of the diffusion of pharmaceutical drugs, non-pharmaceutical chemicals and household and cosmetic products through eye and skin models to determine PK prior to animal studies.
Non-invasive in vivo assessment of PK.
Assessing the motility of fluorescently labelled tumoroids in vitro through biomimetic tissue constructs.
Need for collaboration:
Lein has many years of experience in the development of optical instruments for the
measurement of biological systems. However, our knowledge of industry (pharmaceutical,
chemical and consumer product) requirements is limited, so we are seeking input from
industry experts to make our devices viable for everyday use in these applications.
We are therefore seeking collaborations with companies who wish to have the means of
assessing the in vitro and in vivo kinetics of their products and are keen to partner on the
development of such measurement devices. Lein can provide the technical know-how; our
requirement is for partners who have specific measurement needs who can guide us in
ensuring that the device performs the measurements that are most needed, to the resolution
Type of company looking: to collaborate with Information on IP:
Lein has filed a total of nine patents to protect its novel confocal technology. Of these,
seven have been granted and a further two are working their way through the approval process. These patents cover the measurement technique, the alignment to the item under test to ensure consistent results and the engineering that goes into making the device effective. The patents have been structured in such a way that they reinforce each other leading to a protective "patent thicket".
3Rs impact assessment:
Early identification and removal of chemicals (pharmaceutical and non-pharmaceutical) with
inappropriate PK from the development pathway will reduce the number of substances
entering the subsequent cascade of studies in animals which are required before these
substances can be used in humans, and so will substantially reduce animal use. The current
device provides an enabling, in vitro screening platform to achieve this.
Where animal studies are required, the ability to assess diffusion characteristics longitudinally
and non-invasively will reduce the overall number of animals required per study (each animal
acts as its own control) and improve animal welfare. Reducing stress in the test animals will
improve the reproducibility and quality of the data generated, thus maximising the volume of
data that can be obtained from each animal and further reducing the number of animals
References:
Hearn A., Taylor R., Holley R., Wilson T. (2008). “A novel confocal system to provide high precision noncontact measurements of optical media applied to the human eye.” Biomedical Optics, OSA Technical Digest (CD), Optical Society of America.
Buttenschön K. K.; Girkin J. M., Daly D. J. (2012). “Tracking ophthalmic drugs in the eye using confocal fluorescence microscopy.” SPIE Proceedings Vol. 8214 Advanced Biomedical and Clinical Diagnostic Systems X
Bucolo C., Melilli B., Piazza C., Zurria M., Drago F. (2011). “Ocular pharmacokinetics profile of different indomethacin topical formulations.” J. Ocul Pharmacol Ther. 2011 Dec; 27(6):571-6
Escobar-Chavez, J. J., V. Merino-Sanjuan, et al. (2008). "The tape-stripping technique as a method for drug quantification in skin." J Pharm Pharm Sci 11(1): 104-130.
Schnetz, E. and M. Fartasch (2001). "Microdialysis for the evaluation of penetration through the human skin barrier - a promising tool for future research?" Eur J Pharm Sci 12(3): 165-174.
Keywords:
Pharmacokinetics, confocal, fluorometer, spectroscopy, tissue engineering
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Sober Talk Article for July 2009 Energy Drinks Carry Unexpected Risks By; Kathleen M. Blair, LCSW-R Energy drinks have been integrated into our culture since the 1990’s. An energy drink is defined as any beverage that contains legal stimulants and/or vitamins, added for the specific purpose of giving the consumer a short-term boost of energy. Many people do not realize that these popular drink
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industry experts to make our devices viable for everyday use in these applications.
We are therefore seeking collaborations with companies who wish to have the means of
assessing the in vitro and in vivo kinetics of their products and are keen to partner on the
development of such measurement devices. Lein can provide the technical know-how; our
requirement is for partners who have specific measurement needs who can guide us in
ensuring that the device performs the measurements that are most needed, to the resolution
Type of company looking: 
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Copyright 2013 NC3Rs, All rights reserved