Pharmaceutical Excipients

Graphical abstract from “Anomalous behavior of mannitol hemihydrate: Implications on sucrose crystallization in colyophilized systems.” published in Int. J. Pharm., 587, 119629 (2020).
Reprinted from Thakral, Seema, Jayesh Sonje, and Raj Suryanarayanan. "Anomalous behavior of mannitol hemihydrate: Implications on sucrose crystallization in colyophilized systems." International journal of pharmaceutics 587 (2020): 119629. Copyright (2020), with permission from Elsevier
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).
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).
2022R. Lalge, N. Kaur, N.K. Duggirala, R. Suryanarayanan, Dual functionality of bile acid: Physical stabilization of drugs in the amorphous form and solubility enhancement in solution. Mol Pharm, 19(7), 2595-2606 (2022).
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).
2021N.K. Duggirala, J. Sonje, X. Yuan, E. Shalaev, R. Suryanarayanan, Phase behavior of Poloxamer 188 in frozen aqueous solutions – Influence of processing conditions and cosolutes. Int J Pharm, 609: 121145 (2021)
2021S. Thakral, J. Sonje, B. Munjal, R. Suryanarayanan, Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations. Adv Drug Deliv Rev, 173:1-19 (2021).
2021N. Kaur, R. Suryanarayanan, Investigating the influence of excipients on the stability of levothyroxine sodium pentahydrate. Mol Pharm, 18(7), 2683-2693 (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).
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).
2020A. Sahoo, R. Suryanarayanan, R.A. Siegel, Stabilization of amorphous drugs by polymers: The role of overlap concentration (C*). Mol Pharm, 17(11), 4401-4406 (2020)
2020K. K. Amponsah-Efah, C. Glorieux, J. Thoen, R. Suryanarayanan, Effect of glycerol on the order of the mesophase transitions of super-cooled itraconazole. J Mol Liquids, 114222 (2020).
2020S. Thakral, J. Sonje, R. Suryanarayanan, Anomalous behavior of mannitol hemihydrate: Implications on sucrose crystallization in colyophilized systems. Int J Pharm, 587: 119629 (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).
2019A. Sahoo, N.S.K. Kumar, R. Suryanarayanan, Crosslinking: An avenue to develop stable amorphous solid dispersion with high drug loading and tailored physical stability. J Control Release, 311-312, 212-224 (2019).
2019S. Koranne, J.F. Krzyzaniak, S. Luthra, K.K. Arora, R. Suryanarayanan, Role of conformer and excipient properties on the solid-state stability of theophylline cocrystals. Cryst Growth Des, 19(2), 868-875 (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).
2019R. Tanaka, N.K. Duggirala, Y. Hattori, M. Otsuka, R. Suryanarayanan, Formation of Indomethacin-Saccharin Cocrystals during Wet Granulation: Role of Polymeric Excipients. Mol Pharm, 17(1):274-283 (2019).
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).
2018M. H. Fung, R. Suryanarayanan, Effect of organic acids on molecular mobility, physical stability and dissolution of ternary ketoconazole spray dried dispersions. Mol Pharm, 16(1), 41-48 (2018).
2018M.H. Fung, M. DeVault, K.T. Kuwata, R. Suryanarayanan, Drug-excipient interactions: effect on molecular mobility and physical stability of ketoconazole-organic acid coamorphous systems. Mol Pharm, 15(3), 1052-1061 (2018).
2018K. Berzins, R. Suryanarayanan, Compression-induced crystallization in sucrose-polyvinylpyrrolidone amorphous solid dispersions. Cryst Growth Des, 18(2), 839-848 (2018).
2018S. Thakral, S. Koranne, R. Suryanarayanan, Intra-vial heterogeneity in physical form of mannitol in colyophilized binary systems. Pharm Res, 35(11), 214 (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).
2017S. Mohapatra, S. Samanta, K. Kothari, P. Mistry, R. Suryanarayanan. Effect of polymer molecular weight on the crystallization behavior of indomethacin amorphous solid dispersions. Cryst Growth Des, 17(6), 3142-3150 (2017).
2017N.K. Duggirala, A. Vyas, J.F. Krzyzaniak, K.K. Arora, R. Suryanarayanan, Mechanistic insight into caffeine-oxalic cocrystal dissociation in formulations: Role of excipients. Mol Pharm, 14(11), 3879-3887 (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).
2015K. Kothari, V. Ragoonanan, R. Suryanarayanan, The role of drug-polymer hydrogen bonding interactions on the molecular mobility and physical stability of nifedipine solid dispersions. Mol Pharm, 12(1), 162-170 (2015).
2015K. Kothari, V. Ragoonanan, R. Suryanarayanan, The role of polymer concentration on the molecular mobility and physical stability of nifedipine solid dispersions. Mol Pharm, 12(5), 1477-1484 (2015).
2015P. Mistry, S. Mohapatra, T. Gopinath, F.G. Vogt, R. Suryanarayanan, Role of the strength of drug-polymer interactions on the molecular mobility and crystallization inhibition in ketoconazole solid dispersions. Mol Pharm, 12(9), 3339-3350 (2015). Recipient of 2016 AAPS PPB Outstanding Manuscript award.
2015N.K. Thakral, H. Yamada, G.A. Stephenson, R. Suryanarayanan, Spatial distribution of trehalose dihydrate crystallization in tablets by X-ray diffractometry. Mol Pharm, 12(10), 3766-3775 (2015).
2014S. Bhattacharya., S.P. Bhardwaj, R. Suryanarayanan, Molecular motions in sucrose-PVP and sucrose-sorbitol dispersions-II: implications of annealing on secondary relaxations. Pharm Res, 31(10), 2822-2828 (2014).
2014R. Govindarajan, M. Landis, B. Hancock, L.A. Gatlin, R. Suryanarayanan, E.Y. Shalaev, Surface acidity and solid-state compatibility of excipients with an acid-sensitive API: case study of atorvastatin calcium. AAPS PharmSciTech, 16(2), 1-10 (2014).
2014R. Govindarajan, M. Landis, B. Hancock, L. Gatlin, R. Suryanarayanan, E. Shalaev, Surface acidity and solid-state compatibility of excipients with an acid-sensitive API: Case study of atorvastatin calcium. AAPS PharmSciTech, 16(2), 354-363 (2014).
2013S. Bhardwaj, R. Suryanarayanan, Molecular mobility as a predictor of the water sorption by annealed amorphous trehalose. Pharm Res, 30(3), 714-720 (2013).
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).
2012S. Bhardwaj, R. Suryanarayanan, Use of dielectric spectroscopy to monitor molecular mobility in glassy and supercooled trehalose. J Phys Chem, 116(38), 11728-11736 (2012).
2012S. Bhardwaj, R. Suryanarayanan, Molecular mobility as an effective predictor of the physical stability of amorphous trehalose. Mol Pharm, 9(11), 3209-3217 (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).
2011S. Bhattacharya, R. Suryanarayanan, Molecular motions in sucrose-PVP and sucrose-sorbitol dispersions: I. Implications of global and local mobility on stability. Pharm Res, 28(9), 2191-2203 (2011).
2011S.P. Bhardwaj, R. Suryanarayanan, Subtraction of DC conductivity and annealing – Approaches to identify Johari-Goldstein relaxation in amorphous trehalose. Mol Pharm, 8(4), 1416-1422 (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).
2011A.M. Kaushal, V. R. Vangala, R. Suryanarayanan, Unusual effect of water vapor pressure on dehydration of dibasic calcium phosphate dihydrate. J Pharm Sci, 100(4), 1456-1466 (2011).

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