Gilead’s Captisol-enabled Remdesivir Approved for Use in Renally Impaired Patients
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Publications

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Suma, G., O’Neill, E., Rodriguez, L., Champ, R., Phillips, M., Nouraldeen, A., Wendt, M., G.E. Wilson, A., Krame, J.; In vivo toxicology of excipients commonly employed in drug discovery in rats. Submitted to Journal of Pharmacological and Toxicological Methods, 2013

McCue, S., Salapatek, A. M., Patel, D., D'Angelo, P., Pipkin, J.D., Zimmerer, R.; Complexed Steroid (CDX-947) and in Combination with Antihistamine (CDX-313) Provide Improved Efficacy and Onset of Action in Patients with Allergic Rhinitis in Two Environmental Exposure Chamber (EEC) Studies. For submission to Annals of Allergy, Asthma and Immunology, 2010

Uehata, K., Anno, T., Hayashida, K., Motoyama, K., Hirayama, F., Ono, N., Pipkin, J.D., Uekama, K., Arima, H.; Effect of Sulfobutyl ether-β-cyclodextrin on Bioavailability of Insulin Glargine and Blood Glucose Level after Subcutaneous Injection to Rats. submitted to International Journal of Pharmaceutics, 2010

Samra, H.S., He, F., Bhambhani, A., Pipkin, J.D., Zimmerer, R.O., Joshi, S.B., Middaugh, C.R.; The Effects of Substituted Cyclodextrins on the Colloidal and Conformational Stability of Selected Proteins. J. Pharm. Sci., 99(6), 2800-2818, 2010

Mosher, G.L., and Pipkin, J.D.; 'Sulfobutylether β-Cyclodextrin' Excipient Monograph, in Handbook of Pharmaceutical Excipients, Sixth Edition, edited by R.C. Rowe, .J. Sheskey and M.E. Quinn, The Pharmaceutical Press and the American Pharmacists Association, Royal Pharmaceutical Society of Great Britain, London, 2009.

Zimmerer, R.O., Pipkin, J.D., Salapatek, A.M., D'Angelo, P., Bates, M., Patel, P., Patel, D.; Captisol-Enabled® Budesonide + Azelastine HCl Nasal Spray Significantly Reduces Total Symptoms Scores (TSS) Compared to Placebo in Ragweed Allergic Patients in an Environmental Exposure Chamber (EEC) Model. Respiratory Drug Delivery Europe 2009 Proceedings, Virginia Commonwealth University Publisher, 2009

Ono, N., Pipkin, J.D.; Relative Precipitation Potential of Current Injectable Azole Antifungal Products Containing Cyclodextrins. Online Poster - American Pharmaceutical Review, June 2009 – June 2010

Stella, V.J., He, Q.; Cyclodextrins. Toxicol Pathol. 2008, 36(1), 30-42, 2008

Ono, N., Rytting, J.H., Pipkin, J.D.; Captisol-Enabled® Testosterone: Sulfobutylether -Cyclodextrins Provide for Concentrated Ready-Made Solutions. Proc. 14th Int. Cyclodextrins Symposium, 161-164 (2008)

Zimmerer, R.O.; Pipkin, J.D.; Captisol-Enabled® Budesonide Nasal Spray Significantly Reduces Total Nasal and Non-Nasal Symptoms Scores Compared to Rhinocort Aqua® and Placebo in Ragweed Allergic Patients in an Environmental Exposure Chamber Model. Respiratory Drug Delivery, pp.501-504, 2008

Ono, N.; Thompson, D.O.; Recent Approval Situation of Sulfobuthylether -Cyclodextrine in Pharmaceutical Formulation. Representative Book Chapters: Nano-material Cyclodextrins, Chapter IV-4. 2005 

Smyth, H.D.C.; Garmise, R.J.; Cooney, D.J.; Zimmerer, R.O.; Pipkin, J.D.; Hickey, A.J.; Influence of Physical Form of Captisol(R) Particles on Performance as a Dry Powder Aerosol Carrier. Respiratory Drug Delivery IX, 809-811, 2004

Smyth, H.D.C.; Cooney, D.J.; Garmise, R.J.; Zimmerer, R.O.; Pipkin, J.D; Hickey, A.J.; Dynamic Electrostatic Charge Determinations of Dry Powder Blends for Inhalation: Correlations with Dispersion Performance. Respiratory Drug Delivery IX, 805-807, 2004 

Contreras, L.G.; Cooney, D.J.; Smyth, H.D.C.; Zimmerer, R.O.; Pipkin, J.D.; Hickey, A.J.; Evaluation of Cyclodextrin-Rifampicin Solutions in Calu-3 Monolayer Cell Culture System. Respiratory Drug Delivery IX, 797-800, 2004 

Zimmerer, R.O.; Pipkin, J.D.; Somaraju, S.; Suman, J.D.; Su, G.; Dalby, R.N.; In Vitro Characterization of a Captisol-Enabled(R) Budesonide Inhalation Solution in Ultrasonic and Air-Jet Nebulizers. Respiratory Drug Delivery IX, 461-464, 2004 

Lockwood, S.F.; O'Malley, S.; Mosher, G.L.; Improved Aqueous Solubility of Crystalline Astaxanthin (3,3'-dihydroxy-?, -carotene-4,4'-dione) by Captisol® (Sulfobutyl Ether -Cyclodextrin). Journal of Pharmaceutical Sciences, 92(4), 922-926, 2003

Johnson, K.T.; Mosher, G.L.; Development and Qualification of a Fluorescence Method for the Determination of Sulfobutylether-7--Cyclodextrin Delivered In an Aerosol Inhalation Safety Study. AAPSPharmSci, 3(3), 2001

Mosher, G.L.; Fulk, C.; Co-Solvent Effects on Tte Rate and Extent of Solubilization of Drugs by Captisol® Brand of Sulfobutyl Ether -Cyclodextrin. AAPSPharmSc,, 3(3), 2001

Fulk, C.; Ghate, S.; Mosher, G.; Thompson, D.; Preparation of the Ammonium Salt of Sulfobutyl Ether -cyclodextrin (Captisol®) for Use in Controlled Release Formulations. Proceed. Int'l Symp. Control. Rel. Bioact. Mater. on CD-ROM, (27), Controlled Release Society; Mira Publishing, St. Louis, MO; 654-655, 2000 

Mosher, G.; Thompson, D.; Complexation and Cyclodextrins. Encyclopedia of Pharmaceutical Technology, James Swarbrick & James Boylan; Volume 19(Supplement 2), 49-88, 2000 

Dollo, G.; Thompson, D. O.; Le Corre, P.; Chevanne, F.; and Le Verge, R.; Inclusion Complexation of Amide-Typed Local Anesthetics With Beta-Cyclodextrin and Its Derivatives. III. Biopharmaceutics of Bupivacaine-SBE7-Beta CD Complex Following Percutaneous Sciatic Nerve Administration in Rabbits. Int. J. Pharm, 164(1-2), 11-19, 1998

Totterman, A.M.; Schipper N.G.M.; Thompson D.O.; Mannermaa J.P.; Kaukonen A.M.; Intestinal Safety of Water-Soluble Beta-Cyclodextrins in Paediatric Oral Solutions of Spironolactone: Effects on Human Intestinal Epithelial Caco-2 Cells. J. Pharm. Pharmacol. 49(1), 43-48, 1997 

Luna, E. A.; Bornancini, E. R. N.; Thompson, D. O.; Rajewski, R. A.; Stella, V. J.; Fractionation and Characterization of 4-Sulfobutyl Ether Derivatives of Cyclomaltoheptaose (-Cyclodextrin). Carbohydr. Res. 299, 103-110, 1997

Luna, E. A.; Vander Velde, D. G.; Tait, R. J.; Thompson, D. O.; Rajewski, R. A.; Stella, V. J.; Isolation and Characterization by NMR Spectroscopy of Three Monosubstituted 4-Sulfobutyl Ether Derivatives of Cyclomaltoheptaose (-Cyclodextrin). Carbohydr. Res. 299, 111-118, 1997

Thompson D.O.; Cyclodextrins-Enabling Excipients: Their Present and Future Use in Pharmaceuticals. Critical Reviews in Therapeutic Drug Carrier Systems, 14(1), 1-104, 1997

Luna, E. A.; Bornancini, E. R. N.; Tait, R. J.; Thompson, D. O.; Stobaugh, J. F.; Rajewski, R. A.; Stella, V. J.; Evaluation of the Utility of Capillary Electrophoresis for the Analysis of Sulfobutyl Ether Beta-Cyclodextrin Mixtures. J. Pharm. Biomed. Anal. 15(1), 63-71, 1996

Luna, E. A.; Trewyn, R. M.; Bornancini, E. R.; Thompson, D. O.; Rajewski, R. A.; Stella, V. J.; An HPLC Method for the Analysis of Sulfobutyl Ether -Cyclodextrins. Pharm. Res. 13(9), S-17, 1996

Shiotani, K.; Uehata, K.; Irie, T.; Uekama, K.; Thompson, D. O.; Stella, V. J.; Differential Effects of Sulfate and Sulfobutyl Either of -Cyclodextrin on Erythrocyte Membranes in Vitro. Pharm. Res. 12(1), 78-84, 1995 

Järvinen, T.; Järvinen, K.; Urtti, A.; Thompson, D.; Stella, V. J.; Sulfobutyl Ether -Cyclodextrin (SBE-? -CD) in Eyedroppers Improves the Tolerability of a Topically Applied Pilocarpine Prodrug in Rabbits. J. Ocular Pharmacology and Therapeutics, 11(2), 95-106, 1995

Rajewski, R. A.; Traiger, G.; Bresnahan, J.; Jaberaboansari, P.; Stella, V. J.; Thompson, D. O.; Preliminary Safety Evaluation of Parenterally Administered Sulfoalkyl Ether -Cyclodextrin Derivatives. J. Pharm. Sci. 84(8), 927-932, 1995

Stella, V. J.; Lee, H. K.; Thompson, D. O.; The Effect of SBE4--CD on I.M. Prednisolone Pharmacokinetics and Tissue Damage in Rabbits: Comparison to a Co-Solvent Solution and a Water-Soluble Prodrug. Int. J. Pharm. 120(2), 197-204, 1995

Stella, V. J.; Lee, H. K.; Thompson, D. O.; The Effect of SBE4--CD on I.V. Methylprednisolone Pharmacokinetics in Rats: Comparison to a Co-Solvent Solution and Two Water-Soluble Prodrugs. Int. J. Pharm. 120(2), 189-95, 1995

Shiotani, K.; Uehata, K.; Ninomiya, K.; Irie, T.; Uekama, K.; Thompson, D. O.; Stella, V. J.; Different Mode Of Interaction Of Chlorpromazine With Sulphated And Sulfphoalkylated Cyclodextrins And Effects On Erythrocyte Membranes. Proc. Int. Symp. Cyclodextrins, 7th; Ed. Tetsuo Osa; Pub. Business Center for Academic Societies Japan, Tokyo, 192-195, 1994

Järvinen, K.; Järvinen, T.; Thompson, D. O.; Stella, V. J.; The Effect of a Modified -Cyclodextrin, SBE4--CD, on the Aqueous Stability and Ocular Absorption of Pilocarpine. Curr. Eye Res.; 13, 897-905, 1994

Tait, R. J.; Skanchy, D. J.; Thompson, D. O.; Chetwyn, N. C.; Dunshee, D. A.; Rajewski, R. A.; Stella, V. J.; Stobaugh, J. F.; Characterization of Sulfoalkyl Ether Derivatives of Beta-Cyclodextrin by Capillary Electrophoresis With Indirect UV Detection. J. Pharm. Biomed. Anal. 10(9), 615-22, 1992