Cobalt Light Systems Ltd

Harwell, United Kingdom

Cobalt Light Systems Ltd

Harwell, United Kingdom
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McGoverin C.M.,MacDiarmid Institute for Advanced Materials and Nanotechnology | McGoverin C.M.,Stellenbosch University | Hargreaves M.D.,Cobalt Light Systems Ltd | Matousek P.,Central Laser Facility | Gordon K.C.,MacDiarmid Institute for Advanced Materials and Nanotechnology
Journal of Raman Spectroscopy | Year: 2012

The quantification of polymorphs in dosage forms is important in the pharmaceutical industry. Conventional Raman spectroscopy of solid-state pharmaceuticals may be used for this, but it has some limitations such as sub-sampling and fluorescence. These problems can be mitigated through the use of transmission Raman spectroscopy (TRS). The efficacy of TRS measurements for the prediction of polymorph content was evaluated using a ranitidine hydrochloride test system. Four groups of ranitidine hydrochloride-based samples were prepared: three containing form I and II ranitidine hydrochloride and microcrystalline cellulose (spanning the ranges 0-10%, 90-100% and 0-100% form I fraction of total ranitidine hydrochloride), and a fourth group comprising form I ranitidine hydrochloride (0-10%) spiked commercial formulation. Transmission and conventional Raman spectroscopic measurements were recorded from both capsules and tablets of the four sample groups. Prediction models for polymorph and total ranitidine hydrochloride content were more accurate for the tablet than for the capsule systems. TRS was found to be superior to conventional backscattering Raman spectroscopy in the prediction of polymorph and total ranitidine hydrochloride content. The prediction model calculated for form I content across the 0-100% range was appropriate for process control [ratio of prediction to deviation (RPD) equal to 14.62 and 7.42 for tablets and capsules, respectively]. The 10% range calibrations for both form I and total ranitidine hydrochloride content were sufficient for screening (RPDs greater than 2.6). TRS is an effective tool for polymorph process control within the pharmaceutical industry. Copyright © 2011 John Wiley & Sons, Ltd.


Bloomfield M.,Cobalt Light Systems Ltd | Andrews D.,Cobalt Light Systems Ltd | Loeffen P.,Cobalt Light Systems Ltd | Tombling C.,Cobalt Light Systems Ltd | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2013

A new approach to verification of incoming raw materials through packaging in pharmaceutical manufacturing is proposed and demonstrated. The method is based around Spatially Offset Raman Spectroscopy (SORS) and permits a rapid chemical identity analysis of incoming materials to satisfy regulatory requirements but without the need to open the packaging. This dramatically increases the throughput of incoming raw materials into the pharmaceutical manufacturing chain and eliminates the need for a chemically safe sampling environment required for invasive inspection methods. Since the inspection is non-invasive the safety of the operators is ensured and the integrity of inspected material is not compromised by preventing exposure to the ambient atmosphere and cross contamination. The experiments presented here demonstrate the ability to accurately identify common pharmaceutical materials, typically in under 10. s acquisition time, through a range of frequently used packaging, including translucent plastic and paper sacks and coloured glass bottles, which can be challenging for conventional Raman spectroscopy as well as other optical spectroscopy methods. With the exception of metallic containers and cardboard drums all the tested packaging materials proved to be amenable to this technique. This demonstrates the viability of this new rapid verification method for non-invasive materials identification in pharmaceutical manufacture. © 2012 Elsevier B.V.


Hargreaves M.D.,Cobalt Light Systems Ltd | Macleod N.A.,Rutherford Appleton Laboratory | Smith M.R.,Pfizer | Andrews D.,Cobalt Light Systems Ltd | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2011

A detailed characterisation of the performance of transmission Raman spectroscopy was performed from the standpoint of rapid quantitative analysis of pharmaceutical capsules using production relevant formulations comprising of active pharmaceutical ingredient (API) and 3 common pharmaceutical excipients. This research builds on our earlier studies that identified the unique benefits of transmission Raman spectroscopy compared to conventional Raman spectroscopy. These include the ability to provide bulk information of the content of capsules, thus avoiding the sub-sampling problem, and the suppression of interference from the capsule shell. This study demonstrates, for the first time, the technique's insensitivity to the amount of material held within the capsules. Different capsules sizes with different overall fill weights (100-400. mg) and capsule shell colours were assayed with a single calibration model developed using only one weight and size sample set (100. mg) to a relative error of typically <3%. The relative root mean square error of prediction of the concentration of API for the main sample set (nominal content 75%, w/w) was 1.5% with a 5. s acquisition time. Models built using the same calibration set also predicted the 3 low level excipients with relative errors of 5-15%. The quantity of API was also predicted (with a relative error within ∼3%) using the same model for capsules prepared with different generations of API (i.e. API manufactured via different processes). The study provides further foundation blocks for the establishment of this emerging technique as a routine pharmaceutical analysis tool, capitalising on the inherently high chemical specificity of Raman spectroscopy and the non-invasive nature of the measurement. Ultimately, this technique has significant promise as a Process Analytical Technology (PAT) tool for online production application. © 2010.


Aina A.,University of Nottingham | Hargreaves M.D.,Cobalt Light Systems Ltd | Matousek P.,Rutherford Appleton Laboratory | Burley J.C.,University of Nottingham
Analyst | Year: 2010

We present the first quantitative study of polymorphic content in a model pharmaceutical formulation using transmission Raman spectroscopy (TRS), and compare the results obtained with those from traditional backscattering geometry. The transmission method is shown to provide a true bulk measurement of the composition, being unaffected by systematic or stochastic sub-sampling issues that can plague traditional backscattering geometries. The accuracy of the quantification of the polymorphs using TRS was shown to surpass considerably that achieved using conventional backscattering mode. For a model-free fit, the TRS method yielded R2 of 0.996 compared to the backscattering value of 0.802; for a partial least squares fit with a single component the TRS method accounted for 98.09% of the variance in the data and yielded an R2 of 0.985, compared to 89.65% of the variance and R2 of 0.804 for the backscattering method. © 2010 The Royal Society of Chemistry.


Buckley K.,Rutherford Appleton Laboratory | Buckley K.,University College London | Matousek P.,Rutherford Appleton Laboratory | Matousek P.,University College London | Matousek P.,Cobalt Light Systems Ltd.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2011

This article reviews recent advances in transmission Raman spectroscopy and its applications, from the perspective of pharmaceutical analysis. The emerging concepts enable rapid non-invasive volumetric analysis of pharmaceutical formulations and could lead to many important applications in pharmaceutical settings, including quantitative bulk analysis of intact pharmaceutical tablets and capsules in quality and process control. © 2010.


Buckley K.,Rutherford Appleton Laboratory | Buckley K.,University College London | Matousek P.,Rutherford Appleton Laboratory | Matousek P.,University College London | Matousek P.,Cobalt Light Systems Ltd.
Analyst | Year: 2011

Raman spectroscopy has recently seen major advances in the area of deep non-invasive characterisation of diffusely scattering samples; this progress is underpinned by the emergence of spatially offset Raman spectroscopy and associated renaissance of transmission Raman spectroscopy permitting the characterisation of diffusely scattering samples at depths not accessible by conventional Raman spectroscopy. Examples of emerging research activities include non-invasive diagnosis of bone disease and cancer, rapid quality control of pharmaceutical formulations and security screening of explosives and counterfeit drugs through unopened translucent bottles. This article reviews this field focusing on recent developments with high societal relevance. © The Royal Society of Chemistry 2011.


Grant
Agency: European Commission | Branch: H2020 | Program: SME-1 | Phase: NMP-25-2014-1 | Award Amount: 71.43K | Year: 2015

The objective of the overall innovation project is to develop a novel instrument to measure and control pharmaceutical drug potency during manufacture at sub-second analysis speeds. This will significantly reduce the cost of quality testing, reduce the dosage variability that a patient receives, reduce production waste and solvent disposal and address challenging new regulatory testing guidelines. Pharmaceutical companies, in response to regulators (such as the US FDA) setting direction and guidance, need to better understand and control their processes. Real-time release testing (RTRT) and Quality by Design (QbD) are promoted by regulators as their vision of where quality must go; pharmacopeia guidance supports that vision. Cobalt has developed a successful, patented, high speed quantitative analysis technology called transmission Raman spectroscopy (TRS), which measures drug potency of intact tablets and capsules. When used during production (on-line) in combination with an automated physical tablet testing system, TRS will enable immediate release of drug product without off-line analysis in a quality control (QC) laboratory.


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Smart - Development of Prototype | Award Amount: 180.11K | Year: 2012

In this project, a prototype is developed that leads to a novel product for screening liquids in sealed containers at airports, to detect and identify liquid explosives. The prototype is based on a proprietary technology called SORS, which was recently developed at the Rutherford Appleton Laboratory. The project builds on the work funded under the Innovative Research Call for Weapons & Explosives (2010) organised by the Home Office, which demonstrated the proof of concept with a basic SORS prototype. There is currently a well-defined market need for new devices to screen liquids in sealed containers as the EU has set a date of April 2013 to relax the ban on carrying liquids in cabin baggage. By that date, airport operators will be required to equip with new technology to screen for liquid explosives as passengers will be allowed to carry unrestricted volumes on board; the accessible market for new devices is estimated at >£100 million over 5 years. Existing X-ray devices can be modified to screen liquids but do so with unacceptably high false alarm rates (FAR). Consequently, alarm resolution devices are required which can reliably screen sealed containers with a low FAR; unfortunately, devices currently available have a FAR of about 10-20%. The output of this project will be a system with a very high detection capability and an ultra-low FAR of 1-2% for common non-metallic containers. This is highly desirable for airports since false alarms have a high associated cost in resources and reduced passenger throughput. The device will be demonstrated to exceed required EU and US standards for liquid explosive detection systems and will be manufactured in the UK. As such this project has clear social and civilian-safety benefits as well as a high economic return . The project will cost £400,248 over 14 months. This is a time-bound opportunity due to the fixed 2013 date for lifting the liquids ban and so two duplicate prototypes are built to compress the timescale.


Trademark
Cobalt Light Systems Ltd | Date: 2015-04-10

Apparatus and instruments for analysing, measuring and detecting explosives, hazardous chemicals, illegal substances and other substances through sealed or opaque containers; infrared detection apparatus; ultraviolet detection apparatus; apparatus for detecting Raman scattering; apparatus and instruments for the purpose of detecting explosive materials; apparatus and instruments for the purpose of detecting hazardous materials; apparatus and instruments for the purpose of detecting counterfeit materials; apparatus and instruments for the purpose of counterfeit detection; apparatus and instruments for material identity verification; apparatus and instruments for the purpose of detecting narcotics; apparatus and instruments for the purpose of counter narcotics drug screening; apparatus and instruments for the purpose of mail screening; apparatus and instruments for the purpose of ethanol and alcohol screening; spectrum analyzers for use outside laboratories other than for medical use; spectroscopy analyzers for use outside laboratories other than for medical use; lasers for scientific use; laser measuring systems; infrared sensors; infrared scanners; Raman spectroscopy scanners.


Patent
COBALT LIGHT SYSTEMS Ltd | Date: 2016-07-01

Apparatus for carrying out spatially offset Raman spectroscopy (SORS) is described. The apparatus comprises a rotatable prism arranged such that a spatial offset between an entry region and a collection region at a sample is dependent upon an angle of rotation of the prism.

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