portico

Chemistry Department


Rodolfo J. Romañach Professor


phone: (787) 832-4040 ext. 2604
fax: (787) 265-3849
email: rodolfoj.romanac@upr.edu
office: Q-021
website:  https://sites.google.com/site/analyticalpharmaceuticalgroup/home

Group Members:

Education

Ph.D. University of Georgia, 1986

Teaching Interests

QUIM 5205 (taught every three semesters) - This course discusses the use of analytical chemistry in service to pharmaceutical development and manufacturing. A number of lectures have been developed to present drug development and research, cGMP’s, pharmaceutical manufacturing, HPLC assay development and validation, dissolution testing, polymorphism, polarized light microscopy, mid and near infrared spectroscopy, and the use of these analytical methods to understand pharmaceutical materials. This course has been taught six (6) times to 95 undergraduate and graduate students from the chemistry, chemical engineering, and industrial biotechnology programs. This course does not have a text book, instead a number of journal articles and “primary” reference materials are used. The course prerequisites are: completion of QUIM 3055 or QUIM 3065, and QUIM 3450 or QUIM 3072, and QUIM 4041 or authorization of the Director of the Department.

QUIM 3055 (Analytical Chemistry)- this is a fast paced course that includes quantitative chemical analysis and instrumental analysis taught to chemical engineering and industrial biotechnology. The course is taught with special emphasis on Process Analytical Technology (PAT), and from the point of view of chemical engineering and industrial biotechnology.

QUIM 8995 - Solid State Vibrational Spectroscopy - Analysis of Solids through diffuse reflectance near infrared spectroscopy and chemical imaging as well as Raman Spectroscopy.

QUIM 6835 - Chemometrics - Application of statistics, mathematics and development of strategies to design experiments that provide the information need to understand, analyze and improve chemical and pharmaceutical processes.

Research Interests

Most analytical labs are situated a couple of blocks away from the manufacturing site that they service. Laboratories analyze representative samples after the manufacturing process is completed.  The analytical methods carried out by chemists indicate whether the product was manufactured according to the desired specifications.  However, analytical chemistry can be even more productive. The critical process parameters and conditions could be monitored as the process occurs, and this information could be used by chemical engineers to control the process and assure that all products meet the desired information. This real time information could also be used to improve the process. The analytical lab can be embedded within a manufacturing plant, providing real time information to improve the process. This new approach to Quality Assurance and higher efficiency manufacturing processes is what FDA has termed Process Analytical Technology.

Future manufacturing should not occur with the traditional Quality Assurance (QA) programs where products are evaluated after the fact; once the manufacturing process is completed. Quality Assurance should consist of sensors or instruments to monitor and control manufacturing following the process analytical chemistry concept pioneered by Callis and Kowalski at the Center for Process Analytical Chemistry.  In this manner, QA is not an additional cost of manufacturing, but a means for continuous improvement in manufacturing, and an element to increase manufacturing competitiveness.

The efforts in Process Analytical Technology are carried out in collaboration with the the NSF Engineering Center for Structured Organic Particulate Systems (http://www.ercforsops.rutgers.edu/), where Dr. Romañach is part of the Leadership Team in the Engineering Research Center for Structured Organic Particulate Systems (http://ercforsops.org) an NSF-sponsored Engineering Research Center (ERC), in collaboration with Rutgers University, Purdue University and New Jersey Institute of Technology.  Dr. Romañach leads the Sensing and the Material Properties and Sensing Working Group, for monitoring continuous pharmaceutical processes in the ERC, in efforts that involve researchers from the four universities.   This NSF funded center groups together over 30 faculty members from the four institutions and will be receiving over $50 million from NSF and industrial partners over a 10-year period with the objective of transforming pharmaceutical manufacturing by advancing its scientific foundation and achieving optimal design with advanced functionality.

Our group also collaborates with two emerging companies located in Puerto Rico and which are dedicated to providing service to those companies engages in Process Analytical Technology, Quality by Design, and Real Time Release efforts.

Dr. Romañach is also Adjunct Professor of Industrial and Physical Pharmacy at Purdue University. He co-edited book Pharmaceutical Blending and Mixing recently published by Wiley with Professor P.J. Cullen from the University of South Wales, Professor Nicolas Abatzoglou from the Université of Sherbooke, and Professor Chris D. Rielly from Londborough University.

Recent Publications

  1. Colón, Y. M.; Vargas, J.; Sánchez, E.; Navarro, G.; Romañach, R. J., Assessment of Robustness for a Near-Infrared Concentration Model for Real-Time Release Testing in a Continuous Manufacturing Process. J Pharm Innov 2017, 12 (1), 14-25.
  2. Cárdenas, V.; Roman Ospino, A.; Romañach, R. J., Recent Advances in Obtaining Process Information from Near Infrared Spectra. American Pharmaceutical Review 2016, 19 (7), 22-25.
  3. Romañach , R. J.; Esbensen, K. H., Theoy of Sampling (TOS) - for Development of Spectroscopic Calibration Models American Pharmaceutical Review 2016, 19 (6), 138-139.
  4. Román-Ospino, A. D.; Singh, R.; Ierapetritou, M.; Ramachandran, R.; Méndez, R.; Ortega-Zuñiga, C.; Muzzio, F. J.; Romañach, R. J., Near infrared spectroscopic calibration models for real time monitoring of powder density. International Journal of Pharmaceutics 2016, 512 (1), 61-74.
  5. Banquet-Terán, J.; Johnson-Restrepo, B.; Hernández-Morelo, A.; Ropero, J.; Fontalvo-Gomez, M.; Romañach, R. J., Linear and Nonlinear Calibration Methods for Predicting Mechanical Properties of Polypropylene Pellets Using Raman Spectroscopy. Appl. Spectrosc. 2016, 70 (7), 1118-1127.
  6. Romañach, R. J., Independence and Dependence in Calibration: A Discussion of FDA and EMA Guidelines. American Pharmaceutical Review 2016, 19 (4), 46-49.
  7. Hernández, E.; Pawar, P.; Rodriguez, S.; Lysenko, S.; Muzzio, F. J.; Romañach, R. J., Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra. Appl. Spectrosc. 2016, 70 (3), 455-466.
  8. Osorio, J. G.; Hernández, E.; Romañach, R. J.; Muzzio, F. J., Characterization of resonant acoustic mixing using near-infrared chemical imaging. Powder Technology 2016, 297, 349-356.
  9. Sánchez-Paternina, A.; Román-Ospino, A. D.; Martínez, M.; Mercado, J.; Alonso, C.; Romañach, R. J., Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures. J. Pharm. Biomed. Anal. 2016, 123, 120-127.
  10. Romañach, R., Near infrared spectroscopy: from feasibility to implementation in the pharmaceutical industry. NIR news 2016, 27 (1), 33-38.
  11. Esbensen, K. H.; Román-Ospino, A. D.; Sanchez, A.; Romañach, R. J., Adequacy and verifiability of pharmaceutical mixtures and dose units by variographic analysis (Theory of Sampling) – A call for a regulatory paradigm shift. Int. J. Pharm. 2016, 499 (1–2), 156-174.
  12. Hernandez, E.; Pawar, P.; Keyvan, G.; Wang, Y.; Velez, N.; Callegari, G.; Cuitino, A.; Michniak-Kohn, B.; Muzzio, F. J.; Romañach, R. J., Prediction of dissolution profiles by non-destructive near infrared spectroscopy in tablets subjected to different levels of strain. Journal of Pharmaceutical and Biomedical Analysis 2016, 117, 568-576.
  13. Romañach, R.; Román-Ospino, A.; Alcalà, M., A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products. In Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture, Ierapetritou, M. G.; Ramachandran, R., Eds. Springer New York: 2016; pp 133-158
  14. Palma, F.; Michniak-Kohn, B.; Pérez-Correa, J. R.; Hernandez, E.; Romañach, R. J.; Valenzuela, L. M., Near-infrared chemical imaging and its correlation with the mechanical properties of chitosan–gelatin edible films. Carbohydrate Polymers 2016, 136, 409-417.