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It’s Collective

Knowledge, Analytics,

Formulation, and Modeling

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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Publications

1. Bagchi, S. Li, W. Plakogiannis, F. “Optimization and prediction of drug release from matrix tablets using response surface methodology and near infrared chemical imaging”. Pharm. Dev. Tech. (2011) 1-9.

2. Li, W. Woldu, A. Araba, L. Winstead, D. “Determination of swelling and release mechanisms from matrix tablets consisting of HPMC and high dose water soluble drug by near infrared chemical imaging” J. Pharm. Sci. 99 (2010) 3081 – 3088.

3. Li, W. Bagnol, L. Berman, M. Chiarella, R. A. Gerber, M. “Application of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principle component analysis” Int. J. Pharm. 380 (2009) 49-54.

4. Bashai-Woldu, A. Li, W. Winstead, D. “Monitoring of pseudo-polymorphic conversion of a solvate API during a solvent or aqueous based fluid bed granulation by near infrared spectroscopy” Pharm. Tech. Eur. 20 (2008) 48-55.

5. Li, W. Bashai-Woldu, A. Kelly, R. Bruce, R. Rasmussen, H. Cunningham, J. Winstead, D. “Measurement of drug agglomerates in powder blending simulation samples by near infrared chemical imaging”. Int. J. Pharm. 350 (2008) 369-73.

6. Li, W. Cunningham, J. Rasmussen, HT. Winstead, D. “A qualitative method for monitoring of nucleation and granule growth in fluid bed wet granulation by reflectance near-infrared spectroscopy”. J Pharm Sci. 96 (2007) 3470-3477.

7. Li, W. Bashai-Woldu, A. Ballard, J. Johnson MC. Agresta, M. Rasmussen, HT. Hu, S. Cunningham, J. Winstead, D. “Applications of NIR in early stage formulation development. Part I. Semi-quantitative blend uniformity and content uniformity analyses by reflectance NIR without calibration models”. Int. J. Pharm. 340 (2007) 97-103.

8. Li, W. Johnson, MC. Bruce, R. Rasmussen, HT. Worosila, GD. “The effect of beam size on real-time determination of powder blend homogeneity by an online near infrared sensor”. J. Pharm. Biomed. Anal. 43 (2007) 711-717.

9. Li, W. Johnson, MC. Bruce, R. Ulrich, S. Rasmussen, HT. Worosila, GD. “Mass-balanced blending uniformity assessment of pharmaceutical powder blends by at-line near-infrared spectroscopy with a fiber-optic probe”. Int. J. Pharm. 326 (2006) 182-185.

10.Li, W. Worosila, G. Wang, W. Mascaro, T. “Determination of polymorph conversion of an active pharmaceutical ingredient in wet granulation using NIR calibration models generated from the premix blends”, J. Pharm. Sci. 94 (2005) 2800-2806

11.Li, W. Worosila, G. “Quantitation of Active Pharmaceutical Ingredients and Excipients in Powder Blends Using Designed Multivariate Calibration Models by Near Infrared Spectroscopy”, Int. J. Pharm. 295 (2005) 213-219.

12.Wang, X. Li, W. Rasmussen, H.T. “Orthogonal Method Development Using Hydrophilic Interaction Chromatography and Reversed Phase HPLC for the Determination of Pharmaceuticals and Impurities”, J. Chromatogr. A. 1083 (2005) 58-62.

13.Styslo-Zalasik, M. Li, W. “Determination of topiramate and its degradation product in liquid oral solutions by high performance liquid chromatography with a chemiluminescent nitrogen detector”, J. Pharm. Biomed. Anal. 37 (2005) 529-534.

14.Li, W. Nadig, D. Rasmussen, H. T. Patel, K. Shah, T. “Sample Preparation Optimization for Assay of Active Pharmaceutical Ingredients in Transdermal Drug Delivery System Using Experimental Designs”, J. Pharm. Biomed. Anal. 37 (2005) 493-498.

15.Li, W. “Trace analysis of residual methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate in pharmaceuticals by capillary gas chromatography with flame-ionization detection”, J. Chromatogr. A. 1046 (2004) 297-301.

16.Li, W. Rasmussen, H. T. “A Strategy for Developing and Optimizing HPLC Methods in Pharmaceutical Development Using Computer-Assisted Screening and Plackett-Burman Experimental Design”, J. Chromatogr. A. 1016 (2003) 165-180.

Our Services


       
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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