2024
- 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
- 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. 2023. https://doi.org/10.1007/S11095-023-03601-1
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
- 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
- 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
- Romañach, R. J., Sampling in pharmaceutical manufacturing: a critical business case element. Spectroscopy Europe 2021, 33 (7), 67-69.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Romañach, R. J., An Exercise for Understanding the Effect of Resolution on Near Infrared Spectra. American Pharmaceutical Review 2019, 22 (2), 56-58.
- 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.
- 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.
- 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
- 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.
- Cárdenas, V.; Romañach, R. J., Determining the number of significant figures for reporting NIR results. NIR news 2018, 29 (4), 15-17.
- 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.
- 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
- 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.
- 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
- Hausner, D. B.; Romañach, R. J., Progress Towards Advanced Pharmaceutical Manufacturing. American Pharmaceutical Review 2017, 20 (July-August), 54-57.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- Romañach, R. J.; Esbensen, K. H., Theory of Sampling (TOS) – for Development of Spectroscopic Calibration Models American Pharmaceutical Review 2016, 19 (6), 138-139.
- 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.
- 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.
- Romañach, R. J., Independence and Dependence in Calibration: A Discussion of FDA and EMA Guidelines. American Pharmaceutical Review 2016, 19 (4), 46-49.
- 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.
- 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.
- 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.
- Romañach, R., Near-infrared spectroscopy: from feasibility to implementation in the pharmaceutical industry. NIR news 2016, 27 (1), 33-38.
- 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.
- 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.
- 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
- 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
- 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.
- 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
- Cullen, P. J.; Romañach, R. J.; Abatzoglou, N.; Rielly, C. D., Pharmaceutical Blending and Mixing. John Wiley & Sons, Ltd: 2015; p 512.
- 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
- 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.
- Romañach, R. J., Sampling and Determination of Adequacy of Mixing. In Pharmaceutical Blending and Mixing, John Wiley & Sons, Ltd: 2015; pp 57-78.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- Romañach, R., IDRC-17—Opening our minds to our legacy and new ideas. NIR news 2014, 25 (6), 19-21.
- 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.
- Romañach, R., IDRC-17 (Chambersburg), 2–8 August 2014. NIR news 2014, 25 (4), 23-25.
- 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
- 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.
- 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
- 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.
- 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
- 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
- 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
- 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.
- R.J. Romañach, Group Profile: Analytical & Pharmaceutical Group: University of Puerto Rico, NIR News, 2012, 23(6), 18 – 21, doi:10255/nirn.1325.
- 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.
- 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
- 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.
- 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
- 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.
- 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
- 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
- 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.
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- R.J. Romañach, “PAT – A Team Effort”, Pharmaceutical Technology Europe, 2008, 20(10), 44 – 46
- 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
- R.J. Romañach, “Research initiatives to support science-based pharmaceutical manufacturing”, Pharmaceutical Technology Europe”, 2007, 19(10), 47 – 51.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- R.J. Romañach, “Presenting PAT to Non-PAT Experts”, Journal of Process Analytical Technology, 2006, 3(1), 22 – 25.
- 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
- 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.
- 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).
- 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
- R.J. Romañach, “Pharmaceutical Analytical Chemistry: Bringing the Pharmaceutical Industry to the Classroom”, Journal of Process Analytical Technology, 2004, 1(2), 19 – 23.
- 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
- 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.
- R.J. Romañach and M.A. Santos, “Content Uniformity Testing with Near Infrared Spectroscopy”, American Pharmaceutical Review, 2003, 6(2), 62 – 67.
2002
- 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.
- 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
- 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).