Frozen & Freeze Dried Systems

Graphical abstract from “Characterization of phosphate buffered saline (PBS) in frozen state and after freeze-drying.” published in Pharm. Res., 36(7), 98 (2019)
Reprinted by permission from Springer nature: Thorat, Alpana A., and Raj Suryanarayanan. "Characterization of phosphate buffered saline (PBS) in frozen state and after freeze-drying."
Publication YearCitation
2023D. Yong, J. Li, W. Xu, A. Cote, A. Lay-Fortenbery, R. Suryanarayanan, and Yongchao Su. Solid-State NMR Spectroscopy to Probe State and Phase Transitions in Frozen Solutions. Mol. Pharm, 20: 6380-6390 (2023).
2023J. Li, J. Sonje, R. Suryanarayanan. Role of Poloxamer 188 in preventing ice-surface-induced protein destabilization during freeze–thawing. Mol. Pharm, 20: 4587-4596 (2023).
2023D. Heger, R. Govindarajan, E. Lu, S. Ewing, A. Lay-Fortenbery, X. Yuan, L. Veselý, E. Munson, L. Gatlin, B. Hancock, R. Suryanarayanan. Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals. InPrinciples and Practices of Lyophilization in Product Development and Manufacturing 2023 Apr 25 (pp. 39-61). Cham: Springer International Publishing.
2023J. Sonje, S. Thakral, S. Krueger, R. Suryanarayanan. Enabling Efficient Design of Biological Formulations Through Advanced Characterization. Pharm Res, 40: 1459-1477 (2023).
2022S. Thakral, J. Sonje, B. Munjal, B. Bhatnagar, R. Suryanarayanan, Mannitol as an excipient for lyophilized injectable formulations. J Pharm Sci, in Press, Corrected Proof (2022).
2022J. Sonje, S. Thakral, B. Mayhugh, G. Sacha, S. Nail, J. Srinivasan, R. Suryanarayanan, Mannitol hemihydrate in lyophilized protein formulations: Impact of its dehydration during storage on sucrose crystallinity and protein stability. Int J Pharm, 624: 121974 (2022).
2022J. Sonje, C.F. Chisholm, R. Suryanarayanan, Frozen storage of proteins: Use of mannitol to generate a homogenous freeze-concentrate. Int J Pharm, 630: 121995 (2022).
2022A. Ukidve, K.B. Rembert, R. Vanipenta, P. Dorion, P. Lafarguette, T. McCoy, A. Saluja, R. Suryanarayanan, S. Patke, Succinate buffer in biologics products: Real-world formulation considerations, processing risks and mitigation strategies. J Pharm Sci, In Press, Corrected Proof (2022).
2022B. Munjal, S.M. Patel, R. Suryanarayanan, Role of arginine salts in preventing freezing-induced increase in subvisible particles in protein formulations. Int J Pharm, 619: 121694 (2022).
2021C. Staley, H. Halaweish, C. Graiziger, M. J. Hamilton, A. J. Kabege, A. L. Galdys, B. P. Vaughn, K. Vantanasiri, R. Suryanarayanan, M. J. Sadowsky, A. Khoruts, Lower endoscopic delivery of freeze-dried intestinal microbiota results in more rapid and efficient engraftment than oral administration, Sci Rep, 11(1), 4519 (2021).
2021S.S. Kulkarni, S.M. Patel, R. Suryanarayanan, J.V. Rinella Jr., R.H. Bogner, Key factors governing the reconstitution time of high concentration lyophilized protein formulations. Eur J Pharm Biopharm, 165: 361-373 (2021).
2020A. A. Thorat, B. Munjal, T.W. Geders, R. Suryanarayanan, Freezing-induced protein aggregation - Role of pH shift and potential mitigation strategies, J Control Release, 323, 591-599 (2020).
2020S. Thakral, S. Sonje, R. Suryanarayanan, Anomalous behavior of mannitol hemihydrate: Implications on sucrose crystallization in co-lyophilized systems. Int J Pharm, 587, 119629 (2020).
2020J. Sonje, S. Thakral, R. Suryanarayanan, t-Butanol enables dual functionality of mannitol: A cryoprotectant in frozen systems and bulking agent in freeze-dried formulations, Mol Pharm, 17(8), 3075-3086 (2020).
2020B.S. Bhatnagar, J. Sonje, E. Shalaev, S.W.H. Martin, D.L. Teagarden, R. Suryanarayanan, A refined phase diagram of the tert-butanol-water system and implications on lyophilization process optimization of pharmaceuticals, Phys Chem Chem Phys, 22(3), 1583-1590 (2020).
2020J.R. Snell, N.K. Kumar, R. Suryanarayanan, T.W. Randolph, Nanobubbles in reconstituted lyophilized formulations: Interaction with proteins and mechanism of formation, J Pharm Sci, 109(1):284-292 (2020).
2019S. Jena, N.S.K. Kumar, A. Aksan, R. Suryanarayanan, Stability of lyophilized albumin formulations: Role of excipient crystallinity and molecular mobility, Int J Pharm, 569:118568 (2019).
2019A.A. Thorat, R. Suryanarayanan, Characterization of phosphate buffered saline (PBS) in frozen state and after freeze-drying, Pharm Res, 36(7), 98 (2019).
2018S. Thakral, S. Koranne, R. Suryanarayanan, Intra-vial heterogeneity in physical form of mannitol in colyophilized binary systems, Pharm Res, 35(11), 214 (2018).
2018S.S. Kulkarni, R. Suryanarayanan, J.V. Rinella Jr., R.H. Bogner, Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations, Eur J Biopharm, 130, 70-81 (2018).
2018S. Thakral, A. Wolf, G.J. Beilman, R. Suryanarayanan, Development and in vivo evaluation of a novel lyophilized formulation for the treatment of hemorrhagic shock, Int J Pharm, 537(1-2), 162-171 (2018).
2018S. Koranne, S. Thakral, R. Suryanarayanan. Effect of Formulation and Process Parameters on the Disproportionation of Indomethacin Sodium in Buffered Lyophilized Formulations, Pharm Res, 35(1), 21 (2018).
2017S. Jena, J. Horn, R. Suryanarayanan, W. Friess, A. Aksan, Effects of excipient interactions on the state of the freeze-concentrate and protein stability, Pharm Res, 34(4), 462-478 (2017).
2016S. Jena, R. Suryanarayanan, A. Aksan, Mutual influence of mannitol and trehalose on crystallization behavior in frozen solutions, Pharm Res, 33(6), 1413-1425 (2016).
2015S. Thakral, R. Suryanarayanan, Salt formation during freeze-drying – an approach to enhance indomethacin dissolution. Pharm Res, 32(11), 3722-3731 (2015). Recipient of 2016 AAPS PPB Outstanding Manuscript award.
2014V. Ragoonanan, R. Suryanarayanan, Ultrasonication as a potential tool to predict solute crystallization in freeze-concentrates. Pharm Res, 31(6), 1512-1524 (2014).
2013M. Mehta, S. Bhardwaj, R. Suryanarayanan, Controlling the physical form of mannitol in freeze-dried systems. Eur J Pharm Biopharm, 85(2), 207-213 (2013).
2012P. Sundaramurthi, R. Suryanarayanan, Calorimetry and complimentary techniques to characterize frozen and freeze-dried systems. Adv Drug Del Rev, 63(13), 1118-1159 (2012).
2012P. Sundaramurthi, M. Burcusa, R. Suryanarayanan, Physical characterization of pentamidine isethionate during freeze-drying - Relevance to development of stable lyophilized product. J Pharm Sci, 101(5), 1732-1743 (2012).
2011B.S. Bhatnagar, S.W.H. Martin, T.S. Hodge, T.K. Das, L. Joseph, D.L. Teagarden, E.Y. Shalaev, R. Suryanarayanan, Investigation of PEG crystallization in frozen and freeze-dried PEGylated recombinant human growth hormone-sucrose systems - Implications on storage stability. J Pharm Sci, 100(8), 3062-3075 (2011).
2011P. Sundaramurthi, R. Suryanarayanan, Effect of crystallizing and non-crystallizing cosolutes on succinate buffer crystallization and the consequent pH shift in frozen solutions. Pharm Res, 28(2), 374-385 (2011).
2011P. Sundaramurthi, R. Suryanarayanan, Predicting the crystallization propensity of carboxylic acid buffers in frozen systems – Relevance to freeze drying. J Pharm Sci, 100(4), 1288-1293 (2011).
2011P. Sundaramurthi, R. Suryanarayanan, Thermophysical properties of carboxylic and amino acid buffers at subzero temperatures: Relevance to frozen state stabilization. J Phys Chem B, 115(21), 7154-7164 (2011).

Previous publications can be found on Professor Sury's Google Scholar page at this link.