James Polli

Research Interests

Dr. James E. Polli is Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy, as well as Vice-Chair of Pharmaceutical Sciences. He received a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science and a Ph.D. (pharmaceutics) from the University of Michigan. Dr. Polli’s research interest evolves around the performance and pharmaceutical quality of orally administered medicines. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. He has published in the areas of dissolution, drug intestinal permeability, transporter substrate requirements, prodrug design, oral bioavailability, in vitro - in vivo correlation, and bioequivalence. He is a fellow of the American Association of Pharmaceutical Scientists, an Editorial Board member of several journals, an Editor of Pharmaceutical Research, and Vice-Chair of the USP Expert Committee on Biopharmaceutics. He is a licensed pharmacist and teaches professional pharmacy students and graduate students. Dr. Polli frequently advises international and developing agencies on drug product quality standards.

Selected Recent Publications

Balakrishnan, A. and Polli, J.E. (2006): Apical Sodium Dependent Bile Acid Transporter (ASBT, SLC10A2): A Potential Prodrug Target. Mol. Pharmaceutics. 3:223-230.

Seo, P.R., Teksin, Z.S., Kao, J.P.Y., and Polli, J.E. (2006): Lipid composition effect on permeability across PAMPA. Eur. J. Pharm. Sci. 29:259-268.

Chen, I-J, Taneja, R., Yin, D., Seo, P.R., Young, D., MacKerell, A.D., and Polli, J.E. (2006): Chemical substituent effect on pyridine permeability and insight from computational molecular descriptors. Mol. Pharmaceutics. 3:745-755.

Balakrishnan, A., Hussainzada, N., Gonzalez, P., Bermejo, M., Swaan, P.W., and Polli, J.E. (2007): Bias in estimation of transporter kinetic parameters from over-expression systems: interplay of transporter expression level and substrate affinity. J. Pharmacol. Exp. Ther. 320:133-144.

Gonzalez, P.M. and Polli, J.E. (2008): Impact of impurity on kinetic estimates from transport and inhibition studies. J. Pharmacol. Exp. Ther. 326:296-305.

Polli, J.E., Abrahamsson, B.S.I., Yu, L.X., Amidon, G.L., Baldoni, J.M., Cook, J.A., Fackler, P., Hartauer, K., Johnston, G., Krill, S.L., Lipper, R.A., Malick, W.A., Shah, V.P., Sun, D., Winkle, H.N., Wu, Y., and Zhang, H. (2008): Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond. DOI: 10.1208/s12248-008-9040-9. AAPS J. 10: 373-379.

Polli, J.E. (2008): In Vitro Studies Are Sometimes Better than Conventional Human Pharmacokinetic In Vivo Studies in Assessing Bioequivalence of Immediate-release Solid Oral Dosage Forms. DOI: 10.1208/s12248-008-9027-6. AAPS J. 10:289-299.

Chuasuwan,B., Binjesoh, V., Polli, J.E., Zhang, H., Amidon, G.L., Junginger, H.E., Midha, K.K., Shah, V.P., Stavchansky, S., Dressman, J.B., and Barends, D.M. (2008): Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and dicorfenac possium. DOI: 10.1002/jps.21525. J. Pharm. Sci. 98:1206-1219.

Rais, R., Gonzalez, P.M., Zheng, X., Wring, S.A., and Polli, J.E. (2008): Method to screen substrates of apical sodium-dependent bile acid transporter. DOI: 10.1208/s12248-008-9069-9. AAPS J. 10:596-605.

González, P.M., Acharya, C., MacKerell Jr., A.D., and Polli, J.E. (2009): Inhibition Requirements of the human Apical Sodium-dependent Bile acid Transporter (hASBT) using Aminopiperidine Conjugates of glutamyl-Bile Acids. DOI: 10.1007/s11095-009-9877-3. Pharm. Res. 26:1665-1678.

Diao, L., Ekins, S., and Polli, J.E. (2009): Molecular requirements for inhibition of Human Organic Cation/Carnitine Transporter (OCTN2). DOI: 10.1007/s11095-009-9905-3. Pharm. Res. 26:1890-1900.

Selected Previous Publications

Polli, J.E., Bigora, S., Piscitelli, D.A., Straughn, A.B., and Young, D. (1996): “Pavlovian” food effect on the enterohepatic recirculation of piroxicam. Biopharmaceutics & Drug Disposition 17:635-641.

Polli, J.E., Crison, J.R., and Amidon, G.L. (1996): A novel approach to the analysis of in vitro-in vivo relationships. J. Pharm. Sci. 85:753-760.

Polli, J.E., Rekhi, G.S., Augsburger. L.L., and Shah, V.P. (1997): Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J. Pharm. Sci. 86:690-700.

Polli, J.E. and Ginski, M.J. (1998): Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities. Pharm. Res. 15:47-52.

Ginski, M.J., Taneja, R., and Polli, J.E. (1999): Prediction of dissolution-absorption relationships from a continuous dissolution/Caco-2 system. AAPSPharmSci 1(2): [serial on the internet]. June 3, 1999; Approx. size: 76k + 156k in images. Available from: http://www.pharmsci.org/journal.

Shesky, P., Sackett, G., Maher, L., Lentz, K.A., Tolle, S., and Polli, J.E. (1999): Roll compaction granulation of a controlled-release matrix tablet containing HPMC: Effect of process scale-up on robustness of tablets and predicted in vivo performance. Pharm. Tech. 23(suppl.): 6-21.

Lentz, K.A., Hayashi, J., Lucisano, L.J. and Polli, J.E. (2000): Development of a more rapid, reduced serum culture system for Caco-2 monolayers and application to biopharmaceutics classification system. Int. J. Pharm. 200(1): 41-51.

Lentz, K.A., Polli, J.W., Wring, S.A., Humphreys, J.E., and Polli, J.E. (2000): Influence of passive permeability on apparent P-glycoprotein kinetics. Pharm. Res. 17:1456-1460.

Polli, J.E. and McLean A.M. (2001): Novel direct curve comparison metrics for bioequivalence. Pharm. Res. 18:734-741.

Rege, B.D., Yu, L.X., Hussain, A.S., and Polli, J.E. (2001): Effect of common excipients on Caco-2 transport of low permeability drugs. J. Pharm. Sci. 90:1776-1786.

Seo, P.R., Shah, V.P., and Polli, J.E. (2002): Novel metrics to compare dissolution profiles. Pharm. Dev. Technol. 7:223-231.

Rege, B.D., Kao, J.P.Y., and Polli, J.E. (2002): Effects of nonionic surfactants on membrane transporters in Caco-2 cell monolayers. Eur. J. Pharm Sci. 16:237-246.

Tolle-Sander, S., Lentz, K.A., Maeda, D.Y., Coop, A., and Polli, J.E. (2004): Increased acyclovir oral bioavailability via a bile acid conjugate. Mol. Pharm. 1:40-48.

Balakrishnan, A., Rege, B.D., Amidon, G.L., and Polli, J.E. (2004): Surfactant-mediated dissolution: contributions of solubility enhancement and relatively low micelle diffusivity. J. Pharm. Sci. .

Balakrishnan, A. and Polli, J.E. (2006): Apical Sodium Dependent Bile Acid Transporter (ASBT, SLC10A2): A Potential Prodrug Target. Mol. Pharmaceutics. 3:223-230.

Balakrishnan, A., Wring, S.A., Coop, A., and Polli, J.E. (2006): Influence of charge and steric bulk in C-24 region on the interaction of bile acids with human Apical Sodium Dependent Bile Acid Transporter. Mol. Pharmaceutics. 3:282-292.

Seo, P.R., Teksin, Z.S., Kao, J.P.Y., and Polli, J.E. (2006): Lipid composition effect on permeability across PAMPA. Eur. J. Pharm. Sci. 29:259-268.

Khandelwal, A., Bahadduri, P.M., Chang, C., Polli, J.E., Swaan, P.W., and Ekins, S. (2007): Computational models to assign biopharmaceutics drug disposition classification from molecular structure. Pharm. Res. 24:2249-2262.

Benet, L.Z., Amidon, G.L., Barends, D.M., Lennernas, H., Polli, J.E., Shah, V.P., Stavchansky, S.A., and Yu, L.X. (2008): The use of BDDCS in classifying the permeability of marketed drugs. Pharm. Res. 25:483-488.

Gonzalez, P.M. and Polli, J.E. (2008): Impact of impurity on kinetic estimates from transport and inhibition studies. J. Pharmacol. Exp. Ther. 326:296-305.

Polli, J.E. (2008): In Vitro Studies Are Sometimes Better than Conventional Human Pharmacokinetic In Vivo Studies in Assessing Bioequivalence of Immediate-release Solid Oral Dosage Forms.

Acharya, C., Seo, P.R., Polli, J.E., and MacKerell, Jr, A.D. (2008). Computational Model for Predicting Chemical Substituent Effects on Passive Drug Permeability across Parallel Artificial Membranes. DOI: 10.1021/mp800035h. Mol. Pharmaceutics. 5:818–828.

Diao, L., Ekins, S., and Polli, J.E. (2009): Molecular requirements for inhibition of Human Organic Cation/Carnitine Transporter (OCTN2). DOI: 10.1007/s11095-009-9905-3. Pharm. Res. 26:1890-1900.