2024

  1. Patel, D. S.; Méndez, R.; Romañach, R. J. Cleaning of Direct Compression Continuous Manufacturing Equipment through Displacement of API Residues by Excipients. Int. J. Pharm. 2024, 652 (January). https://doi.org/10.1016/j.ijpharm.2024.123849

2023

  1. Movilla-Meza, N. A.; Sierra-Vega, N. O.; Alvarado-Hernández, B. B.; Méndez, R.; Romañach, R. J. The Use of a Closed Feed Frame for the Development of Near-Infrared Spectroscopic Calibration Model to Determine Drug Concentration. Pharm. Res. 2023https://doi.org/10.1007/S11095-023-03601-1
  2. Echeverría-Altamar, K.; Alvarado-Hernandez, B. B.; Resto-Irizarry, P.; Romañach, R. J. Identification of Four Similar Cell Culture Media According to Their Glucose, Glutamine, and Pyruvate Content by Handheld Raman Spectroscopy. Pharm. Res. 2023, 40 (12), 2859–2871. https://doi.org/10.1007/s11095-023-03584-z
  3. Rangel-Gil, R. S.;  Sierra-Vega, N. O.;  Romañach, R. J.; Méndez, R., Assessment of blend uniformity in a stream sampler device using Raman spectroscopy. Int. J. Pharm. 2023, 639, 122934. https://doi.org/10.1016/j.ijpharm.2023.122934
  4. Romañach, R. J.;  Stelzer, T.;  Sanchez, E.; Muzzio, F., Advanced pharmaceutical manufacturing: A functional definition. Journal of Advanced Manufacturing and Processing 2023,5 (2), e10150. https://doi.org/10.1002/amp2.10150
  5. Romañach , R. J. (2023). Moving to Manufacturing – Lessons Learned in A Career in Process Analytical Technology. In A. S. Narang & A. Dubey (Eds.), Continuous Pharmaceutical Processing and Process Analytical Technology (1st ed., pp. 494). Boca Raton: Taylor & Francis Group. https://doi.org/10.1201/9781003149835

2022

  1. Puche, J.; Romañach, R.; Sierra Vega, N.; Méndez, R. In Differentiating analytical error from sampling errors in PAT methods through variographic analysis, World Conference on Sampling and Blending 10, Kristiansand, Norway, May 27, 2022, Esbensen, K. H., Ed. IMPublicationsOpen: Kristiansand, Norway, 2022; pp 99-110
  2. Metta N, Yohannes B, Kotamarthy L, Ramachandran R, Romañach RJ, Cuitiño AM. Chapter 5 – Continuous dry granulation. In: Muzzio FJ, Oka S, editors. How to Design and Implement Powder-To-Tablet Continuous Manufacturing Systems: Academic Press; 2022. p. 93-118.
  3. Fontalvo-Lascano MA, Alvarado-Hernández BB, Conde C, Sánchez EJ, Méndez-Piñero MI, Romañach RJ. Development and Application of a Business Case Model for a Stream Sampler in the Pharmaceutical Industry. J Pharm Innov. 2022
  4. Sierra-Vega N, González-Rosario R, Rangel-Gil R, Romañach R, Méndez R. Quantitative analysis of blend uniformity within a Three-Chamber feed frame using simultaneously Raman and Near-Infrared spectroscopy. International Journal of Pharmaceutics. 2022 February; 613:121417. https://doi.org/10.1016/j.ijpharm.2021.121417
  5. Sánchez-Paternina A, Martínez-Cartagena P, Li J, Scicolone J, Singh R, Lugo Y, Romañach R, Muzzio F, Román-Ospino A. Residence time distribution as a traceability method for lot changes in a pharmaceutical continuous manufacturing system. International Journal of Pharmaceutics. 2022 January; 611:121313-. doi: 10.1016/j.ijpharm.2021.121313.

2021

  1. Romañach, R. J., Sampling in pharmaceutical manufacturing: a critical business case element. Spectroscopy Europe 2021, 33 (7), 67-69.
  2. De la Rosa, M. V. G.; Báez, J. P. F.; Romañach, R. J.; López-Mejías, V.; Stelzer, T., Real-time concentration monitoring using a compact composite sensor array for in situ quality control of aqueous formulations. J. Pharm. Biomed. Anal. 2021, 206, 114386.
  3. Sierra-Vega N, Karry K, Romañach R, Méndez R. Monitoring of high-load dose formulations based on co-processed and non co-processed excipients. International Journal of Pharmaceutics. 2021 September; 606:120910-. doi: 10.1016/j.ijpharm.2021.120910.
  4. Esbensen, K. H.; Romañach, R. J., A Framework for Representative Sampling for NIR Analysis–Theory of Sampling (TOS). Handbook of Near-Infrared Analysis 2021, 415.
  5. Romañach, R.; Joubert Castro, A.; Esbensen, K., WHAT are sampling errors—and WHAT can we do about them? Part 1. Spectroscopy Europe 2021, 33 (2), 7.
  6. Alvarado-Hernandez, B.; Fontalvo, M. A.; Valentin Roman, N.; Mendez Roman, R.; Mendez, M. I.; De Hoyos Ruperto, M.; Romañach, R. J., Advanced Manufacturing and Process Analytical Technology for Competitiveness and Resilience in Pharmaceutical Manufacturing. American Pharmaceutical Review 2021, 24 (3), 3.
  7. Martínez-Cartagena, P. A.; Sierra-Vega, N. O.; Alvarado-Hernández, B. B.; Méndez, R.; Romañach, R. J., An innovative sampling interface for monitoring flowing pharmaceutical powder mixtures. J. Pharm. Biomed. Anal. 2021, 194, 113785.
  8. Aldama, J.; Shi, Z.; Ortega-Zúñiga, C.; Romañach, R. J.; Lysenko, S., Fractal and Polarization Properties of Light Scattering Using Microcrystalline Pharmaceutical Aggregates. Appl. Spectrosc. 2021, 75 (1), 94-106

2020

  1. Fontalvo, M. A.; Méndez-Piñero, M. I.; Romañach, R. J. In Design and Development of a Cost Model for the Implementation of Process Analytical Technology in the Pharmaceutical Industry, 9th Annual World Conference of the Society for Industrial and Systems Engineering, September 17-18, 2020; Society for Industrial and Systems Engineering (SISE): 2020; p 6.
  2. Fontalvo-Lascano, M. A.; Méndez-Piñero, M. I.; Romañach, R. J. In Development of a Business Case Model for Process Analytical Technology Implementation in the Pharmaceutical Industry, Proceedings of the 5th NA International Conference on Industrial Engineering and Operations Management, Detroit, Michigan, August 10-14, 2020; IEOM Society International: Detroit, Michigan, 2020; pp 1144 – 1152.
  3. Sierra-Vega N, Romañach R, Méndez R. Real-time quantification of low-dose cohesive formulations within a sampling interface for flowing powders. International Journal of Pharmaceutics. 2020 October; 588:119726-. doi: 10.1016/j.ijpharm.2020.119726.
  4. Cárdenas, V.; Rosas, J. G.; Pinzón, C.; Romañach, R. J., Statistical Methods in Quality by Design and Process Analytical Technologies for Continuous Processes to Enable Real-Time Release. In Continuous Pharmaceutical Processing, Nagy, Z. K.; El Hagrasy, A.; Litster, J., Eds. Springer International Publishing: Cham, 2020; pp 361-393.
  5. Sierra-Vega NO, Martínez-Cartagena PA, Alvarado-Hernández BB, Romañach RJ, Méndez R. In-line monitoring of low drug concentration of flowing powders in a new sampler device. Int J Pharm. 2020 Jun 15;583:119358. doi: 10.1016/j.ijpharm.2020.119358.
  6. Alvarado-Hernández B, Scicolone J, Ortega-Zuniga C, Román-Ospino A, Colón-Lugo Y, Aymat E, Sánchez E, Muzzio F, Romañach R. Method transfer of a near-infrared spectroscopic method for blend uniformity in a poorly flowing and hygroscopic blend. Journal of Pharmaceutical and Biomedical Analysis. 2020 February; 180:113054-. doi: 10.1016/j.jpba.2019.113054.
  7. Cárdenas V, Rosas J, Pinzón C, Romañach R. Statistical Methods in Quality by Design and Process Analytical Technologies for Continuous Processes to Enable Real-Time Release. In: AAPS Advances in the Pharmaceutical Sciences Series [Internet] Cham: Springer International Publishing; 2020. Chapter Chapter 10; 361-393p. Available from: http://link.springer.com/10.1007/978-3-030-41524-2_10.
  8. Alvarado-Hernández B, Sierra-Vega N, Martínez-Cartagena P, Hormaza M, Méndez R, Romañach R. A sampling system for flowing powders based on the theory of sampling. International Journal of Pharmaceutics. 2020 January; 574:118874-. doi: 10.1016/j.ijpharm.2019.118874.
  9. Fontalvo-Lascano, M. A.; Méndez-Piñero, M.; Romañach, R. J., The Business Case for Process Analytical Technology (PAT)-A Starting Point. American Pharmaceutical Review 2020, 23 (1), 54-56.

2019

  1. Romañach RJ, Mendez, Rafael inventors; University of Puerto Rico, assignee. Stream sampler—mass reduction system for flowing powders patent 10520400. Application date: September 19, 2018. Issue date: 2019 December 31, 2019.
  2. Sierra-Vega N, Romañach R, Méndez R. Feed frame: The last processing step before the tablet compaction in pharmaceutical manufacturing. International Journal of Pharmaceutics. 2019 December; 572:118728-. doi: 10.1016/j.ijpharm.2019.118728.
  3. Romañach, R. J.; Lugo, J. E.; Morales-Velez, A.; Córdova, U. M.; Hughes, K. S. In HSI Conference: Proceedings: Accelerating the Impact of HSI STEM Education and Research on Innovation Ecosystems, HSI Conference: Accelerating the Impact of HSI STEM Education and Research on Innovation Ecosystems, Mayaguez 10/30/2019; Romañach, R. J., Ed. Mayaguez 2018; p 34.
  4. Romañach, R. J. In A Four Level View of Industry-University Collaboration, HSI Conference: Accelerating the Impact of HSI STEM Education and Research on Innovation Ecosystems, Mayaguez, Puerto Rico, 10/30/2019; Romañach, R. J., Ed. Mayaguez, Puerto Rico, 2019; p 34.
  5. Romañach, R. J.; Méndez, R.; Esbensen, K. H., Application of TOS principles for real-time monitoring of pharmaceutical powder blends by Near Infrared Spectroscopy. Spectroscopy Europe 2019, 31 (5), 24-29.
  6. Razuc M, Grafia A, Gallo L, Ramírez-Rigo M, Romañach R. Near-infrared spectroscopic applications in pharmaceutical particle technology. Drug Development and Industrial Pharmacy. 2019 July; 45(10):1565-1589. doi: 10.1080/03639045.2019.1641510.
  7. Martínez-Cartagena, P. A.; Alvarado-Hernández, B. B.; Sierra-Vega, N. O.; Méndez, R.; Esbensen, K. H.; Romañach, R. J. In Design and Pilot Studies OF TOS-Compliant Sampling Interface for Process Analytical Technology (PAT) Analysis of Pharmaceutical Flowing Powders Mixtures, WCSB9 9th World Conference on Sampling and Blending Beijing, China, May 6-9, 2019; Beijing, China, 2019; pp 728-736.
  8. Romañach, R. J., An Exercise for Understanding the Effect of Resolution on Near Infrared Spectra. American Pharmaceutical Review 2019, 22 (2), 56-58.
  9. Sánchez-Paternina A, Sierra-Vega N, Cárdenas V, Méndez R, Esbensen K, Romañach R. Variographic analysis: A new methodology for quality assurance of pharmaceutical blending processes. Computers & Chemical Engineering. 2019 May; 124:109-123. doi: 10.1016/j.compchemeng.2019.02.010.
  10. Sierra-Vega N, Román-Ospino A, Scicolone J, Muzzio F, Romañach R, Méndez R. Assessment of blend uniformity in a continuous tablet manufacturing process. International Journal of Pharmaceutics. 2019 April; 560:322-333. doi: 10.1016/j.ijpharm.2019.01.073.
  11. Ortega-Zúñiga C, la Rosa C, Román-Ospino A, Serrano-Vargas A, Romañach R, Méndez R. Development of near infrared spectroscopic calibration models for in-line determination of low drug concentration, bulk density, and relative specific void volume within a feed frame. Journal of Pharmaceutical and Biomedical Analysis. 2019 February; 164:211-222. doi: 10.1016/j.jpba.2018.10.046.

2018

  1. Fontalvo-Gomez, M.; Johnson-Restrepo, B.; Stelzer, T.; Romañach, R. J., Process Analytical Chemistry, and non-Destructive Analytical Methods – The Green Chemistry Approach for Reaction Monitoring, Control, and Analysis. In Handbook of Green Chemistry: Vol 12 – Green Chemical Engineering, Lapkin, A., Ed. Wiley: 2018; Vol. 12, pp 259-287.
  2. Cárdenas, V.; Romañach, R. J., Determining the number of significant figures for reporting NIR results. NIR news 2018, 29 (4), 15-17.
  3. Esbensen, K. H.; Romañach, R. J.; Román-Ospino, A. D., Chapter 4 – Theory of Sampling (TOS): A Necessary and Sufficient Guarantee for Reliable Multivariate Data Analysis in Pharmaceutical Manufacturing A2 – Ferreira, Ana Patricia. In Multivariate Analysis in the Pharmaceutical Industry, Menezes, J. C.; Tobyn, M., Eds. Academic Press: 2018; pp 53-91.
  4. Sierra-Vega N, Sánchez-Paternina A, Maldonado N, Cárdenas V, Romañach R, Méndez R. In-line monitoring of the powder flow behavior and drug content in a Fette 3090 feed frame at different operating conditions using Near Infrared spectroscopy. Journal of Pharmaceutical and Biomedical Analysis. 2018 May; 154:384-396. https://doi.org/10.1016/j.jpba.2018.03.017
  5. Romañach, R. J.; Sanchez-Paternina, A.; Esbensen, K. H., Variographic Analysis of 1-D lots in Pharmaceutical Manufacturing (Powder Mixing). American Pharmaceutical Review 2018, 21 (1), 22-26.
  6. Vargas, J. M.; Nielsen, S.; Cárdenas, V.; Gonzalez, A.; Aymat, E. Y.; Almodovar, E.; Classe, G.; Colón, Y.; Sanchez, E.; Romañach, R. J., Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. Int. J. Pharm. 2018, 538 (1–2), 167-178.

2017

  1. Hausner, D. B.; Romañach, R. J., Progress Towards Advanced Pharmaceutical Manufacturing. American Pharmaceutical Review 2017, 20 (July-August), 54-57.
  2. Romañach, R. J. In Theory of Sampling – From Missing Link to Key Enabler for Process Analytical Technology (PAT), 8th World Conference on Sampling and Blending, Perth, Australia, May 9- 11, 2017; Australian Institute of Mining and Metallurgy: Perth, Australia, 2017; pp 63-68.
  3. Pinzon de la Rosa, C.; Rodriguez, V.; Hormaza, M. L.; Romañach, R. J. In TOS MEETS THE NSF I-CORPS™ PROGRAM, 8th World Conference on Sampling and Blending, Perth, Australia, Australian Institute of Mining and Metallurgy: Perth, Australia, 2017; pp 351-354.
  4. Vargas, J. M.; Roman-Ospino, A. D.; Sanchez, E.; Romañach, R. J., Evaluation of Analytical and Sampling Errors in the Prediction of the Active Pharmaceutical Ingredient Concentration in Blends from a Continuous Manufacturing Process. J Pharm Innov 2017, 12 (2), 155–167.
  5. Ortega-Zuñiga, C.; Reyes-Maldonado, K.; Méndez, R.; Romañach, R. J., Study of near-infrared chemometric models with low heterogeneity films: The role of optical sampling and spectral preprocessing on partial least squares errors. J. Near Infrared Spectrosc. 2017, 25 (2), 103-115.
  6. 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.

2016

  1. 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.
  2. Romañach, R. J.; Esbensen, K. H., Theory of Sampling (TOS) – for Development of Spectroscopic Calibration Models American Pharmaceutical Review 2016, 19 (6), 138-139.
  3. 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.
  4. 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.
  5. Romañach, R. J., Independence and Dependence in Calibration: A Discussion of FDA and EMA Guidelines. American Pharmaceutical Review 2016, 19 (4), 46-49.
  6. 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.
  7. 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.
  8. 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.
  9. Romañach, R., Near-infrared spectroscopy: from feasibility to implementation in the pharmaceutical industry. NIR news 2016, 27 (1), 33-38.
  10. 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.
  11. 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.
  12. 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
  13. 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.

2015

  1. Singh, R.; Román-Ospino, A. D.; Romañach, R. J.; Ierapetritou, M.; Ramachandran, R., Real-time monitoring of powder blends bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process. International Journal of Pharmaceutics 2015, 495 (1), 612-625.
  2. Florian-Algarin M, Méndez R. Effect of material properties and design parameters on the final blend uniformity using experimental and simulation results. Powder Technology. 2015 May; 276:156-165. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0032591015001345 DOI: 10.1016/j.powtec.2015.02.024
  3. Cullen, P. J.; Romañach, R. J.; Abatzoglou, N.; Rielly, C. D., Pharmaceutical Blending and Mixing. John Wiley & Sons, Ltd: 2015; p 512.
  4. Mateo-Ortiz D, Méndez R. Relationship between residence time distribution and forces applied by paddles on powder attrition during the die filling process. Powder Technology. 2015 July; 278:111-117. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0032591015002107 DOI:10.1016/j.powtec.2015.03.015
  5. Osorio, J. G.; Vanarase, A. U.; Romañach, R. J.; Muzzio, F. J., Continuous Powder Mixing. In Pharmaceutical Blending and Mixing, John Wiley & Sons, Ltd: 2015; pp 101-127.
  6. Romañach, R. J., Sampling and Determination of Adequacy of Mixing. In Pharmaceutical Blending and Mixing, John Wiley & Sons, Ltd: 2015; pp 57-78.
  7. Alcala, M.; Martinez, L.; Esquerdo, R.; Hausner, D.; Romañach, R. J., Continuous Manufacturing, Near Infrared Spectroscopy, and Process Knowledge. American Pharmaceutical Review 2015, 18 (5), 59-63.
  8. Esbensen, K.; Romañach, R. In Proper sampling, total measurement uncertainty, variographic analysis & fit-for-purpose acceptance levels for pharmaceutical mixing monitoring, TOS Forum, 2015; pp 25-30.
  9. Sánchez-Paternina, A.; Román-Ospino, A.; Ortega-Zuñiga, C.; Alvarado, B.; Esbensen, K.; Romañach, R. In When “homogeneity” is expected—Theory of Sampling in pharmaceutical manufacturing, TOS Forum, 2015; pp 67-70.
  10. Diaz-Candelas, C. C.; Morales-Payan, J. P.; Romanach, R.; Kolterman, D. A.; Garrastazu, S. M., Tahiti Lime Postharvest and Non-Destructive Assessment of Essential Oils by NIR Spectroscopy. In Xii International Citrus Congress – International Society of Citriculture, Sabater Munoz, B.; Moreno, P.; Pena, L.; Navarro, L., Eds. 2015; Vol. 1065, pp 1463-1469.
  11. Florian-Algarin M, Méndez R. Blend uniformity and powder phenomena inside the continuous tumble mixer using DEM simulations. AIChE Journal. 2015 March; 61(3):792-801. Available from: https://onlinelibrary.wiley.com/doi/10.1002/aic.14694 DOI: 10.1002/aic.14694
  12. Roman-Ospino, A.; Ortega-Zuñiga, C.; Sanchez-Paternina, A.; Ortiz, S.; Esbensen, K.; Romañach, R. In Estimating total sampling error for near-infrared spectroscopic analysis of pharmaceutical blends—theory of sampling to the rescue, TOS Forum, 2015; pp 71-75
  13. Romañach, R. J.; Esbensen, K. H., Sampling in pharmaceutical manufacturing – Many opportunities to improve today’s practice through the Theory of Sampling (TOS). TOS Forum 2015, 4, 5-9.

2014

  1. Mateo-Ortiz D, Muzzio F, Méndez R. Particle size segregation promoted by powder flow in confined space: The die filling process case. Powder Technology. 2014 August; 262:215-222. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0032591014003295 DOI: 10.1016/j.powtec.2014.04.023
  2. Zhang, J.; Ying, Y.; Pielecha-Safira, B.; Bilgili, E.; Ramachandran, R.; Romanach, R.; Dave, R. N.; Iqbal, Z., Raman spectroscopy for in-line and off-line quantification of poorly soluble drugs in strip films. International Journal of Pharmaceutics 2014, 475 (1-2), 428-437
  3. Romañach, R. J.; Hernández Torres, E.; Roman Ospino, A.; Pastrana, I.; Semidei, F., NIR and Raman Spectroscopic Measurements to Train the Next Generation of PAT Scientists. American Pharmaceutical Review 2014, 17 (6), 82-87.
  4. Colón, Y. M.; Florian, M. A.; Acevedo, D.; Mendez, R.; Romanach, R. J., Near Infrared Method Development for a Continuous Manufacturing Blending Process. J Pharm Innov 2014, 9 (4), 291-301.
  5. Mateo-Ortiz, D.; Colon, Y.; Romanach, R. J.; Mendez, R., Analysis of powder phenomena inside a Fette 3090 feed frame using in-line NIR spectroscopy. J Pharm Biomed Anal 2014, 100, 40-49.
  6. Romañach, R., IDRC-17—Opening our minds to our legacy and new ideas. NIR news 2014, 25 (6), 19-21.
  7. Prats-Montalbán, J.; Jerez-Rozo, J.; Romañach, R.; Ferrer, A., Multivariate image analysis and near infrared chemical imaging for characterisation of micro-mixing in polymeric thin films. NIR news 2014, 25 (6), 4-7.
  8. Romañach, R., IDRC-17 (Chambersburg), 2–8 August 2014. NIR news 2014, 25 (4), 23-25.
  9. Cebeci-Maltaş, D.; McCann, R.; Wang, P.; Pinal, R.; Romañach, R.; Ben-Amotz, D., Pharmaceutical Application of Fast Raman Hyperspectral Imaging with Compressive Detection Strategy. J Pharm Innov 2014, 9 (1), 1-4.

2013

  1. Fontalvo-Gomez, M.; Colucci, J. A.; Velez, N.; Romanach, R. J., In-Line Near-Infrared (NIR) and Raman Spectroscopy Coupled with Principal Component Analysis (PCA) for In Situ Evaluation of the Transesterification Reaction. Applied spectroscopy 2013, 67 (10), 1142-1149.
  2. Boada-Lopez, J.; DeJesus-Maldonado, I.; Jerez, J.; Romañach, R.; Diffoot-Carlo, N.; Sundaram, P., Collagen abundance in mechanically stimulated osteoblast cultures using near-infrared microscopy. Journal of Biomechanics 2013, 46 (14), 2442-2450
  3. Susarla, R.; Sievens-Figueroa, L.; Bhakay, A.; Shen, Y. Y.; Jerez-Rozo, J. I.; Engen, W.; Khusid, B.; Bilgili, E.; Romanach, R. J.; Morris, K. R.; Michniak-Kohn, B.; Dave, R. N., Fast drying of biocompatible polymer films loaded with poorly water-soluble drug nanoparticles via low temperature forced convection. International Journal of Pharmaceutics 2013, 455 (1-2), 93-103.
  4. Beck, C.; Sievens-Figueroa, L.; Gartner, K.; Jerez-Rozo, J. I.; Romanach, R. J.; Bilgili, E.; Dave, R. N., Effects of stabilizers on particle redispersion and dissolution from polymer strip films containing liquid antisolvent precipitated griseofulvin particles. Powder Technology 2013, 236, 37-51.

2012

  1. Mendez R, Velazquez C, Muzzio F. Effect of feed frame design and operating parameters on powder attrition, particle breakage, and powder properties. Powder Technology. 2012 October; 229:253-260. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0032591012004548 DOI:10.1016/j.powtec.2012.06.045
  2. Alcalà, M., Blanco, M., Menezes, J. C., Felizardo, P. M., Garrido, A., Pérez, D., Zamora, E., Pasquini, C. and Romañach, R. J. 2012. Near-Infrared Spectroscopy in Laboratory and Process Analysis. Encyclopedia of Analytical Chemistry. Online ISBN: 9780470027318. DOI: 10.1002/9780470027318.a9361
  3. Court, K. A.; Jerez, J.; Romañach, R. J.; Torres-Lugo, M., Particle Encapsulation in Cross-linked Hydrogel Networks: Particle Distribution Optimization. Journal of Materials Science and Engineering 2012, B2 (10), 539- 550.
  4. R.J. Romañach, Group Profile: Analytical & Pharmaceutical Group: University of Puerto Rico, NIR News, 2012, 23(6), 18 – 21, doi:10255/nirn.1325.
  5. Acevedo, D.; Muliadi, A.; Giridhar, A.; Litster, J. D.; Romanach, R. J., Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy. AAPS PharmSciTech 2012, 13 (3), 1005-1012.
  6. Prats-Montalban, J. M.; Jerez-Rozo, J. I.; Romanach, R. J.; Ferrer, A., MIA and NIR Chemical Imaging for pharmaceutical product characterization. Chemometrics and Intelligent Laboratory Systems 2012, 117, 240-249
  7. Sievens-Figueroa, L.; Bhakay, A.; Jerez-Rozo, J. I.; Pandya, N.; Romanach, R. J.; Michniak-Kohn, B.; Iqbal, Z.; Bilgili, E.; Dave, R. N., Preparation and characterization of hydroxypropyl methyl cellulose films containing stable BCS Class II drug nanoparticles for pharmaceutical applications. International Journal of Pharmaceutics 2012, 423 (2), 496-508.
  8. Mendez R, Muzzio F, Velazquez C. Powder hydrophobicity and flow properties: Effect of feed frame design and operating parameters. AIChE Journal. 2012 March; 58(3):697-706. Available from: https://onlinelibrary.wiley.com/doi/10.1002/aic.12639 DOI: 10.1002/aic.12639

2011

  1. Jerez-Rozo, J. I.; Zarow, A.; Zhou, B.; Pinal, R.; Iqbal, Z.; Romañach, R. J., Complementary Near-Infrared and Raman Chemical Imaging of Pharmaceutical Thin Films. Journal of pharmaceutical sciences 2011, 100 (11), 4888-4895.
  2. Ropero, J.; Colón Y.; Johnson-Restrepo B., Romañach R. J., Near infrared chemical imaging slope as a new method to study tablet compaction and tablet relaxation.  Applied Spectroscopy, 2011, 65(4), 459 – 465.

2010

  1. Pingali K, Mendez R, Lewis D, Michniak-Kohn B, Cuitiño A, Muzzio F. Evaluation of strain-induced hydrophobicity of pharmaceutical blends and its effect on drug release rate under multiple compression conditions. Drug Development and Industrial Pharmacy. 2010 October 13; 37(4):428-435. Available from: http://www.tandfonline.com/doi/full/10.3109/03639045.2010.521160 DOI: 10.3109/03639045.2010.521160
  2. Vanarase, A. U.; Alcalà, M.; Jerez Rozo, J. I.; Muzzio, F. J.; Romañach, R. J., Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy. Chemical Engineering Science 2010, 65 (21), 5728-5733.
  3. Beach L.; Ropero J.; Mujumdar A.; Alcalà M.; Romañach R J.; Davé, R.N. Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part II: Quantification of Enhanced Flow Properties of Surface Modified Active Pharmaceutical Ingredients. J Pharm Innov, 2010, 5(1-2), 1 -13.
  4. Mendez R, Muzzio F, Velazquez C. Study of the effects of feed frames on powder blend properties during the filling of tablet press dies. Powder Technology. 2010; 200(3):105-116. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0032591010000847 DOI: 10.1016/j.powtec.2010.02.010

2009

  1. Ropero, J.; Beach, L.; Alcala, M.; Rentas, R.; Dave, R. N.; Romanach, R. J., Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part I: Development of the Methodology. J Pharm Innov 2009, 4 (4), 187-197.
  2. Alcalà M.; Ropero J.; Vázquez R.; Romañach, R.J.  Deconvolution Of Chemical And Physical Information From Intact Tablets NIR Spectra. Two- And Three-Way Multivariate Calibration Strategies for Drug Quantitation, Journal of Pharmaceutical Sciences, 2009, 98(8), 2747 – 2758.

2008

  1. Mercado, J.; Alcalà, M.; Karry, K.; Ríos-Steiner, J.; Romañach, R., Design and In-line Raman Spectroscopic Monitoring of a Protein Batch Crystallization Process. J Pharm Innov 2008, 3 (4), 271-279.
  2. Alcalà M.; León J.; Ropero J.; Blanco M.; Romañach R.J.  Analysis of low content drug tablets by transmission near-infrared spectroscopy:  Selection of calibration ranges according to multivariate detection and quantitation limits of PLS models”, Journal of Pharmaceutical Sciences, 2008, 97(12), 5318-5327.
  3. R.J. Romañach, “PAT – A Team Effort”, Pharmaceutical Technology Europe, 2008, 20(10), 44 – 46
  4. M.T. Carvajal, C. Velázquez, M. Alcalà, and R.J. Romañach, “The Time for Process Understanding”, Pharmaceutical Technology Europe, 2008, 20(5), 26 – 31.

2007

  1. R.J. Romañach, “Research initiatives to support science-based pharmaceutical manufacturing”, Pharmaceutical Technology Europe”, 2007, 19(10), 47 – 51.
  2. Barajas, M. J.; Cassiani, A. R.; Vargas, W.; Conde, C.; Ropero, J.; Figueroa, J.; Romanach, R. J., Near-infrared spectroscopic method for real-time monitoring of pharmaceutical powders during voiding. Applied spectroscopy 2007, 61 (5), 490-6.
  3. C. Aguirre-Mendez and R. Romañach, “A Raman spectroscopic method to monitor magnesium stearate in blends and tablets”, Pharm. Technol. Asia Pacific, 2007, 1(1), 9–15, and Pharm. Technol. Europe, 19(9), 53-61.

2006

  1. P.  Hernández, S. Romero-Torres, D. Radspinner, N. Rodríguez-Hornedo, J.J. Dougherty, and R.J. Romañach, The Real Challenge is Moving to a PAT System – IFPAC/INDUNIV PAT Summit, Journal of Process Analytical Technology, 2006, 3(6), 20-23.
  2. R.J. Romañach, “An Exciting Time for Pharmaceutical Process Research and Improvement”, Conference Proceedings 4to Congreso y Exposición Tecnología Farmacéutica, October 2006, Buenos Aires, Argentina.
  3. K. Karry, J. Figueroa, R. Rentas, D. Ely, M. Teresa Carvajal, and R.J. Romañach, “Towards a 360º View of Blend Uniformity”, Conference Proceedings 4to Congreso y Exposición Tecnología Farmacéutica, October 2006, Buenos Aires, Argentina.
  4. R. Parrilla, M. Vega, M. Pabón, and R.J. Romañach, “Innovation Within the PAT Context”, Journal of Process Analytical Technology. 2006, 3(4), 25-28.
  5. Meza, C. P.; Santos, M. A.; Romanach, R. J., Quantitation of drug content in a low dosage formulation by transmission near-infrared spectroscopy. AAPS PharmSciTech 2006, 7 (1), E29.
  6. R.J. Romañach, “Presenting PAT to Non-PAT Experts”, Journal of Process Analytical Technology, 2006, 3(1), 22 – 25.
  7. J. Colón Soto, C. Peroza Meza, W. Caraballo, C. Conde, T. Li, K. R. Morris, and R. J. Romañach, “On-Line Non-Destructive Determination of Drug Content in Moving Tablets Using Near Infrared Spectroscopy”, Journal of Process Analytical Technology, 2005, 2(5), 8 -15.

2005

  1. G. Cook, T. Navedo, P. Pérez, M. Hormaza, R. Cooley, and R.J. Romañach, “PAT from A to Z – News from Induniv Forum for Innovation Meeting”, Journal of Process Analytical Technology, 2005, 2(3), 21 – 23.
  2. R.J. Romañach, “News from the PRPQA Meeting: Progress in PAT and Pharmaceutical Quality for the 21st Century”, Journal of Process Analytical Technology, 2005, 2(2), 21 – 22. (http://www.patjournal.com).
  3. L. Morales-Cruz, R Tremont, R. Martínez, R. Romañach, and C. R. Cabrera*, “Atomic Force Measurements of 16-mercaptohexadecanoic Acid and its Salt with CH3, OH, and CONHCH3 Functionalized Self-assembled Monolayers”, Applied Surface Science, 2005, 241(3-4), 371-383.

2004

  1. R.J. Romañach, “Pharmaceutical Analytical Chemistry: Bringing the Pharmaceutical Industry to the Classroom”, Journal of Process Analytical Technology, 2004, 1(2), 19 – 23.
  2. R.J. Romañach, “Is PAT the Beginning of a Revolution in Pharmaceutical Manufacturing? – A Personal Interpretation of the PAT Initiative”, Journal of Process Analytical Technology, 2004, 1(1), 10 – 12.

2003

  1. L. Saliceti-Piazza, R. Buxeda, and R. Romañach, “The Industrial Biotechnology Learning Centre (IBLC): an industry-academia training model in response to strategic high-tech economic development”, Proceedings of 7 th Baltic Region Seminar on Engineering Education, St. Petersburg, Russia, September 4 -6, 2003.
  2. R.J. Romañach and M.A. Santos, “Content Uniformity Testing with Near Infrared Spectroscopy”, American Pharmaceutical Review, 2003, 6(2), 62 – 67.

2002

  1. R. Buxeda, L. Saliceti, R. Romañach, C. Ríos Velázquez, J. Gill, J.I. Vélez Arocho, D. Rámirez and A. Ruiz, “The Incorporation of Biotechnology into the Higher Education System to Contribute to a Knowledge-Based Economy”, Dimensión, 2002. 16(2), 13 – 16.
  2. Popo, M.; Romero-Torres, S.; Conde, C.; Romañach, R. J., Blend uniformity analysis using stream sampling and near-infrared spectroscopy. AAPS PharmSciTech 2002, 3 (3), E24.

2001

  1. J.L. Ramirez, M.K. Bellamy, and R.J. Romañach, “A novel method for Analyzing Thick Tablets by Near Infrared Spectroscopy”, AAPS PharmSciTech 2001; 2 (3) article 11 (http://www.pharmscitech.com).