Terahertz pulsed spectroscopy (TPS) and terahertz pulsed imaging (TPI) are two novel techniques for the physical characterization of pharmaceutical drug materials & final solid dosage forms.
The Pharmaceutical Technologies facility is based around the TPS Spectra 3000 from TeraView. The TPS 3000 is the world’s first commercial terahertz spectrometer capable of performing both transmission and attenuated total reflection (ATR) measurements. The TPS Spectra 3000 yields superior analytical performance – all while operating under ambient conditions. TPS Spectra 3000’s modular sample compartment accepts standard IR sampling accessories for transmission measurements. ATR modules provide non-destructive measurements of solids, suspensions, slurries pastes and gels. ATR measurements are obtained from as little as 1 mg of solid sample. TPS Spectra 3000 offers enhanced flexibility to investigate intermolecular hydrogen-bonding vibrations, crystalline structure lattice vibrations or low-frequency internal vibrations without concern for thermal effects.
The facility (which is funded by the East Midlands Development Agency and De Montfort University's HEIF) is available to all East Midlands companies via demonstration workshops which are aimed at creating opportunities for process and product development and quality control. Please see the Applications Section and Document Library for example pharmaceutical and biological uses of this instrument.
For more information, or to book a place on the demonstrator workshops, contact Geoff Smith +44 116 250 6298gsmith02@dmu.ac.uk or download the forms from thes links (Booking Form; Invitation and Agenda)
Applications
Drug Polymorphism TPS can be used to characterize crystalline properties of drugs and excipients. Different polymorphic forms of a drug can be readily distinguished and quantified, ensuring product quality by maintaining the correct bioavailability of the formulation. Having the wrong polymorph in a formulation can dramatically alter the solubility and hence efficacy of the drug.
Pharmaceutical Co-crystals These are drugs that have been crystallized with another compound/chemical embedded intimately within the crystal structure. The result is a sold with greater solubility than the pure drug crystal and hence higher therapeutic activity. Many new drugs are poorly soluble and co-crystals are being research intensively as a potential means of improving drug activity. Screening of potential co-crystals is time consuming. Owing to the particular sensitivity of TPS to intermolecular interactions, terahertz therefore offers a potential rapid screening of co-crystal formations.
In-Process Monitoring The pharmaceutical industry is increasing looking at a variety of in-process analytical technologies. TPI and time of flight TPS offers the opportunity of monitoring specific chemical formation processes, such as the batch crystallization of drugs & wet granulation of powders prior to tabletting.
Tablet Coating TPI greatly improves quality control in production and speeds up the development of new coating formulations and processes. Because the tablets are not destroyed during analysis, further tests can be carried out after TPI using the same samples. This approach provides a tool for the detection of problems with coating processes in a very early stage of formulation development.
Solid Dispersions These are mixtures of drug and polymers to form solid particles with high solubility. The distribution and form of the drug within these matrices is critical to their performance as drug delivery systems. TPI can provide imaging of the matrix to identify and control quality parameters related to the functionality of these materials.
Transdermal Drug delivery The skin provides for a convenient route for delivering drugs. However, the top layer of the skin, the stratum corneum, presents a significant barrier to drug delivery. TPI provides a convenient imaging tool for investigating the hydration and thickness of the stratum corneum, which are two of the most significant features defining the barrier function. In addition TPI can be used to image the disintegration of subcutaneous implants, and provide for models of drug dissolution in real time. Again this is essential knowledge for drug development companies in these efforts to use solid dispersions in drug delivery applications.
Dental TPI provides a convenient approach to the imaging of enamel thickness, the measurement of demineralization of imaging of early stage caries, which is either not-possible of difficult to achieve with X-Ray, which is also ionizing and hazardous. TPI is non-ionising and safe.
Oncology In working with the Leicestershire Hospitals trust a number of medical applications will be developed. One potential application is the use of TPI for a non-invasive imaging of sub-surface skin and mouth tumors. ‘Hot-spots’, below the skin surface, can highlight the progression of the tumor and help define intervention and treatment strategies.
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