1. Customizing the Content: The placeholders in this poster are formatted for you. Type in the placeholders to add text, or click an icon to add a table, chart, SmartArt graphic, picture or multimedia file. To add or remove bullet points from text, just click the Bullets button on the Home tab. If you need more placeholders for titles, content or body text, just make a copy of what you need and drag it into place. PowerPoint’s Smart Guides will help you align it with everything else. www.ercforsops.org Customizing the Content: In the section titled “Research Relation to ERC” delete any check- box that does not apply to your research. Customizing the Content: Consider using tables instead of text boxes to organize information and create interesting presentation poster layouts with side-by-side columns of text and graphics. In a table, as on a spreadsheet, you work with rows and columns of cells. You can add and remove rows, merge and split table cells, change row height and column width, align the contents of table cells, apply pre-defined table styles NSF Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) GOALS AND DELIVERABLES Project Goals: Develop a non-destructive method for dissolution using NIR spectroscopy Build a calibration model to predict dissolution Deliverables: Provide a reliable non-destructive method to predict drug release in one minute DESCRIPTION The dissolution test is required in the development, registration, approval and quality control of a solid oral dosage form except where the label says that they are to be chewed. The dissolution test is required by over 500 tablet and capsule products described in the United States Pharmacopeia (USP). The dissolution test is the only test performed in manufacturing with the objective of monitoring whether the product will perform adequately throughout its shelf life. The dissolution test is performed in USP dissolution apparatus suitable for the analysis. The method is not suitable for predicting in vivo, but is used for batch-to-batch comparisons. The purpose of this assessment is to use NIR spectroscopy (diffuse reflectance ) in combination with multivariate data analysis to predict dissolution properties of the samples in real time. A set of acetaminophen tablets with different shear levels are being studied. All the spectra were pretreated with a baseline correction to maintain the effects of scattering related to tablet physical properties. METHOD DEVELOPMENT RESULTS RESEARCH RELATION TO ERC APAP Tablet Description Mixing Tableting Shearing NIR Spectroscopy Dissolution Test Instrument ResponseReference Values Multivariate Data Analysis (PCA, PLS-2) Presenter(S): Eduardo Hernandez, UPRM Research Participants: Pallavi Pawar (Rutgers University), Yifan Wang (Rutgers University),Natasha Velez (UPRM), Goldshid Keyvan (Rutgers University), Fernando Muzzio (Rutgers University), Rodolfo Romanach (UPRM), Alberto Cuitino (Rutgers University) Prediction of Dissolution Profiles by Non-Destructive Near Infrared Spectroscopy in Tablets Subjected to Different Levels of Strain Absorbance on NIR spectra decrease as shear increases. Drug release decrease as shear increase. PCA model projection of test set for NIR spectra PLS-2 calibration model prediction of dissolution of test set (NIR) vs Dissolution Test (USP Apparatus II) Comparison between dissolution profiles (USP Apparatus II) with the predicted profiles (NIR calibration model) using PCA. Impact on Testbed (s) Non destructive fast prediction of dissolution at the end of the continuous process. Conclusions 1.PLS regression can be used to predict the dissolution of the tablets at X time 2.Test Set prediction are highly correlated with the reference method values. Model capable to discriminate variation in manufacturing conditions Future Work 1.Compare Diffuse Reflectance NIR and Transmittance NIR spectroscopic methods as techniques to predict dissolution References 1.Kukura, J.; Baxter, J. L.; Muzzio, F. J., Shear distribution and variability in the USP Apparatus 2 under turbulent conditions. International journal of pharmaceutics 2004, 279 (1-2), 9-17. 2.S.H. Tabasi, V. Moolchandani, R. Fahmy and S.W. Hoag, "Sustained Release Dosage Forms Dissolution Behavior Prediction: A Study of Matrix Tablets Using NIR Spectroscopy", Int. J. Pharm. 382, 1 (2009) Correlation coefficient between NIR prediction and USP Apparatus II Model Evaluation Results