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The founders of NiRACLE believe Process Analytical Technology (PAT) and Quality by Design (QbD) represent the future of the pharmaceutical industry. As a knowledge-based company, NiRACLE will serve clients in these areas. As implied by its name and logo, NiRACLE is specialized in Near Infrared (NIR) technologies including the conventional NIR and NIR chemical imaging. NiRACLE is also specialized in multivariate data analysis and modeling. The combination of both forms a powerful tool that is badly needed in pharmaceutical research and development.

Although NIR and multivariate data analysis are becoming popular in the pharmaceutical industry, along with PAT and QbD, the sciences behind them are not well publicized and understood. This is due to them not having been part of the core curriculum of chemistry professionals for a long time.

METHOD DEVELOPMENT
NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and are intended for supporting early stage formulation development and late stage commercial production scale up. GMP NIR methods are for tablet content uniformity testing and can be used for supporting NDA/ANDA filings. NiRACLE also assists clients in developing real-time process monitoring methods for various unit operations including blending, film coating and granulation. The services also include experimental design, method validation and method transfer.
PROCESS VALIDATION
NiRACLE is specialized in multivariate data analysis, which plays a critical role in today’s process validation. NiRACLE works with clients in selecting suitable process monitoring methods and designing a comprehensive sampling plan. NiRACLE’s technology allows for the fast analysis of thousands of process related samples for mapping the manufacturing processes. Our services are extremely cost-effective and the results will give clients a much better understanding of their manufacturing processes and products.
PHARMACEUTICAL PRODUCT/PROCESS TROUBLESHOOTING
Using NIR chemical imaging and multivariate data analysis tools, NiRACLE can assist clients in troubleshooting product and process related problems. Examples include content uniformity related failures, dissolution problems, polymorph conversions during manufacturing and stability studies, drug release related issues for prolonged release formulations, and problems related to fluid-bed wet granulation processes.
RAW MATERIAL IDENTIFICATION BY NIR
NiRACLE can help clients in developing a NIR-based raw material identification system to replace the conventional wet chemistry methods. This approach is cost effective, fully GMP compliant, and accepted by the regulatory agencies.
USER TRAINING
NiRACLE provides training in basic and advanced NIR/NIR chemical imaging related method development, which include proper use of instruments, experiment design and multivariate modeling. NiRACLE’s experts conduct the trainings through class-room presentations and real-life project related practices alike.

Case Studies

Tablet Content Uniformity
We have used a proven process to develop NIR assay methods for our clients for the determination of active pharmaceutical ingredient(s) in tablet dosage forms
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Process Validation
We have developed a proprietary multivariate modeling method that is named Supervised Principal Component Analysis (SPCA).........
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NIR in Formulation Development
NIR-SPCA method can also be used for speeding up the formulation development process.....
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PAT
Monitor blend uniformity in real time using our SPCA method to analyze the NIR blending data.
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Chemical Imaging
NIR chemical imaging as powerful tool to study the drug release mechanism of the matrix tablets
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