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Malvern buys NIR chemical imaging firm

By Gregory Roumeliotis , 13-Jul-2006

Malvern Instruments has acquired Spectral Dimensions, a provider of near infrared (NIR) chemical imaging instrumentation and software, seeking products that can enhance pharmaceutical formulation and manufacturing processes.

NIR chemical imaging is emerging as the analytical tool of choice for drug formulation development, analysis and process monitoring of the increasing number of advanced drug delivery systems, making Spectral Dimensions the leader in NIR chemical imaging systems, now receiving 80 per cent of its business from the pharmaceutical market.

The company also provides NIR chemical imaging outsourcing services to at least half of the top 100 pharmaceutical companies who are not yet ready to bring the required machinery in-house.

 

In the past, the main emphasis of quality control in pharmaceuticals has been on the potency and purity of the ingredients in a blend.

 

But this discounts other physical factors, caused by inadequate formulation or process control, such as the size and distribution of the ingredient particles that can also affect the performance of a drug.

 

Standard NIR spectroscopy can measure the constituents and average blending characteristics of a drug product. However, a chemical imaging system offers additional information, including the identities and relative arrangement and sizes of component particles, providing a more complete assessment of the mixture.

 

NIR chemical imaging works by taking a series of images across the known infrared spectrum of a drug sample.

 

This chemical image represents the relative distribution of the active pharmaceutical ingredient (API) and excipients throughout the drug, and the accompanying software then turns the visual into a quantitative picture.

 

Far more than "pretty pictures," chemical images reveal the extent of ingredient blending, particle size distributions, agglomeration of component particles, the presence of polymorphs, and trace contaminants.

 

"Spectral Dimensions' systems are making a significant contribution to improving formulation and manufacturing processes, supporting manufacturers in achieving the goals set out as part of the FDA's Process Analytical Technology (PAT) initiative," Paul Walker, managing director of Malvern Instruments, said.

 

"The addition of chemical imaging technology to our range means that we can extend the support that we provide, adding further value, particularly in the challenging areas of blending and tabletting, and providing synergy with our existing particle characterization systems."

 

Spectral Dimensions will cease trading and the organisation will be integrated into Malvern's US subsidiary.

 

The chemical imaging development and applications teams will continue to operate from the former Spectral Dimensions facility in Maryland.

 

Financial terms of the deal were not disclosed.

 

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