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PAT & QbD Solutions

Case Studies

Tablet Content Uniformitytd>
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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Introduction

Previously known as Nirvation, NiRACLE, LLC was founded in 2009 by Dr. Weiyong Li who has more than 20 years of experience in formulation an PAT technology, especially using Near Infrared as tool. After partnering with more scientific and business talents, Nirvation became NiRACLE in 2011.

NiRACLE has a wide range of experience in pre-formulation and formulation development. We have pioneered “Supervised Principle Component” (SPC) technology (US Patent No. 2011 / 0216313 A1). Our services include but not limited to:

  • Late-stage pharmaceutical product development including characterization, control of fluid-bed wet granulation process, establishment of correlations between formulation/process parameters and product quality attributes
  • Development and implementation of multivariate data analysis approach to help define the quality-by-design process control strategies in formulation development and pharmaceutical manufacturing
  • Study of drug release mechanism from matrix based prolonged release tablets to help expand formulation development capability of the department
  • Online NIR probe for monitor pharmaceutical blend uniformity
  • Development of a novel approach for creation of NIR calibration models that can be implemented in early and late stage tablet formulation development for assessment of content uniformity
  • Implementation of NIR methods for commerical products to reduce testing cost and improve quality
  • Training of lab chemists in NIR, NIR chemical imaging and multivariate modeling

NiRACLE maintains strict confidentiality to our client’s product R&D programs. Our capability will increase the probability of achieving your next key milestones (new drug product approving). We understand exactly what your need and requirements are.  Our scientists are motive to provide you highest levels of scientific expertise. Together as a team, we work closely with our client to demonstrate high quality and best possible results, project by project, client by client.

Our Vision

Improve human health by promoting new pharmaceutical technology and designing new medicine products

Our Mission

Provide outstanding drug discovery and development services to today and tomorrow's pharmaceutical and life science industry

Our Values

  • Trust- We build honestly, respect, fairness and trust in relationships with our clients.
  • Scientific Excellence- We work hard to discover world leading finance and technology.
  • Innovation- We believe only innovation will drive our technology and expertise to the next level.
  • Teamwork - From scientists inside NiRACLE to our clients and partners, together we will achieve our goal: to make new medicine possible.

Our Service


       
Method Development   Process Validation   Troubleshooting   Material Identification   User Training
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 designing a comprehensive sampling plan.   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.   Using NIR chemical imaging and multivariate data analysis tools, NiRACLE can assist clients in troubleshooting product and process related problems.   NiRACLE can help clients in developing a NIR-based raw material identification system to replace the conventional wet chemistry methods.   NiRACLE provides training in basic and advanced NIR/NIR chemical imaging related method development, which include proper use of instruments, experiment design and multivation...
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