PUBLICATIONS / 2026-11-14

A record of inquiry.

100 published journal articles and 2 book chapters. Includes online-first articles assigned to future journal issues. Years follow the maintained bibliography.

2027

The photostability of ketamine products: part ii impact of light exposure and storage on multi-use ketamine parenteral products

H. Wang, G. Zou, Y. Liang, J. Gu, R. Lupitskyy, X. Dong, M. Essandoh, D. Shakleya, X. Xu, D. Keire, P. Faustino

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2026.127544

2026

A multi-platform characterization of aggregation in morpholino oligonucleotide drug products: From soluble aggregates to subvisible particles

X. Dong, H. Qu, M. Shih, X. Xu, P. Faustino, G. Tian, M. Ashraf, M. Korang-Yeboah

Journal of Pharmaceutical Sciences · DOI: 10.1016/j.xphs.2026.104588

2026

Process-dependent N-nitroso-ketamine formation during ketamine active pharmaceutical ingredient manufacturing: part I impact of process design, solvent selection, and activated carbon

G. Zou, H. Wang, R. Lupitskyy, J. Gu, D. Johnson, D. Shakleya, X. Xu, P. Faustino

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2026.127183

2026

Simultaneous quantification of D-penicillamine, D-penicillamine disulfide, and L-cysteine-D-penicillamine disulfide in human plasma: optimization of sample preparation and mass spectrometry procedures to support bioequivalence studies

J. Gu, S. Li, G. Zou, N. Tampal, L. Xia, M. Kaur, D.S. Oh, X. Xu, P.J. Faustino, D.A. Keire, D. Shakleya

Bioanalysis · DOI: 10.1080/17576180.2026.2690263

2026

In vitro release testing of levonorgestrel intrauterine systems: Correlation of accelerated release rates in organic/aqueous release media to Hansen Solubility Parameters

R.U. Zaman, C. Johnson, W. Smith, Y. Wang, Z. Zhong, F. Zhang, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2026.126786

2026

Minimizing in Source Fragmentation for Mass Spectrometry Based NDSRI Analytical Procedures: A Case Study of Nitroso-bumetanide

J. Zhang, M. Shih, J. Yang, D.A. Keire, X. Xu, P.J. Faustino

The AAPS Journal · DOI: 10.1208/s12248-026-01230-1

2026

Mastering particle size analysis: lessons, challenges, and future directions from the FDA–CRCG workshop

X. Xu, W.C. Smith, J.E. Polli, C.L. Plavchak, B. Qin, Y. Wang, N. Holtgrewe, S.G. Raney, A. O’Reilly Beringhs, Y.B. Yu, M. Taraban, V. Krishnan, A. Schwendeman, D.C. Hammell, J.D. Clogston, A.F. Rawle, J. Grmaš, Y. Ayoub, B. Domnic, R.S. Reddy, J. Duncan, M. McGann, J. Bodycomb, C.C.L. Schuurmans, M. Hermes, J.G. Mehtala, P. Roy, K. Lance, C. Britten, K. Park, D. Beach, M. Elmer, K.B. Rodenhausen, Z. Xu, H. Qu, K.W. Wu, M. Korang-Yeboah, Y. Zou, J. Li, A.H. Abuznait, C. Quinn, A. Ethier, K. Ip, D. Dhamecha, Q. Li, D. Zhu, R. Valapil

AAPS Open · DOI: 10.1186/s41120-026-00148-4

2026

In Vitro Permeation Testing of Sunscreens using Reconstructed Human Skin versus Human Cadaver Skin Models

K.R. Roy, A. Wanasathop, L. Xu, J. Wang, S.G. Coelho, S.A. Adah, T.M. Michele, P.J. Faustino, M. Ashraf, X. Xu, Y. Yang

AAPS PharmSciTech · DOI: 10.1208/s12249-026-03343-4

2026

Advanced control of continuous pharmaceutical manufacturing processes: A case study on the application of artificial neural network for predictive control of a CDC line

J. Zhao, G. Tian, W. Yang, D. Jayanti, A. Koolivand, X. Xu

Computers & Chemical Engineering · DOI: 10.1016/j.compchemeng.2026.109560

2025

The impact of product quality attributes on in vivo performance of bupivacaine multivesicular liposomes

Z. Xia, Y. Liu, Z. Lu, J. Gan, M. Yu, K. Olsen, Y. Wang, X. Xu, S. Schwendeman, A. Schwendeman

Drug Delivery and Translational Research · DOI: 10.1007/s13346-025-01806-y

2025

Understanding the impact of accelerated release testing conditions on physicochemical properties and drug release mechanisms from etonogestrel implants based on ethylene vinyl acetate

A. Ren, Z. Zhong, M. Magaw, Y. Wang, B. Qin, W. Smith, X. Xu, T. Listro, F. Zhang

European Journal of Pharmaceutics and Biopharmaceutics · DOI: 10.1016/j.ejpb.2025.114805

2025

Impact of polymer source variations on hydrogel structure and product performance in dexamethasone-loaded ophthalmic inserts

M.A. VandenBerg, R.U. Zaman, C.L. Plavchak, W.C. Smith, H.B. Nejad, A.O.R. Beringhs, Y. Wang, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2025.125959

2025

Characterization of the Repeat Unit Sequence of Poly(lactide-co-glycolide)

L. Kuehster, M. Bingham, J. Dai, Y.K. Jhon, Y. Wang, B. Qin, W.C. Smith, X. Xu, F. Zhang, N.A. Lynd

Macromolecules · DOI: 10.1021/acs.macromol.4c02895

2025

Learning from the future: towards continuous manufacturing of nanomaterials

M.A. VandenBerg, X. Dong, W.C. Smith, G. Tian, O. Stephens, T.F. O’Connor, X. Xu

AAPS Open · DOI: 10.1186/s41120-025-00111-9

2025

Utilization of AF4 for characterizing complex nanomaterial drug products: Reexamining sample recovery and its impact on particle size distribution as a quality attribute

C.L. Plavchak, J. Liu, Y. Wang, X. Xu, P.J. Faustino, H. Qu, W.C. Smith

Journal of Chromatography A · DOI: 10.1016/j.chroma.2025.465703

2025

Advanced Manufacturing, Modeling And Analytical Tools In Injectable Products

H. Stamato, M. Korang-Yeboah, J. Rangineni, X. Xu, R. Bogner

Pharmaceutical Research · DOI: 10.1007/s11095-025-03815-5

2025

Nasal absorption of oxycodone predicted using a novel computational fluid dynamics-physiologically based pharmacokinetic model

R.L. Walenga, A.H. Babiskin, H.J. Boyce, X. Feng, A. Zidan, N.S. Kamal, X. Xu, M.J. Kim, L. Zhao

Journal of Controlled Release · DOI: 10.1016/j.jconrel.2024.12.049

2025

Reverse engineering of Onivyde® – Irinotecan liposome injection

J. Gan, V. Juang, K. Wang, Z. Xia, R. Ackermann, M. Yu, K.H. Dorsey, W. Lin, X. Wang, Y. Wang, J. Liang, J. Zheng, X. Xu, J.H. Park, A. Schwendeman

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2024.125000

2025

Manufacture, characterization, and elucidation of drug release mechanisms of etonogestrel implants based on ethylene vinyl acetate

A. Ren, Z. Zhong, Y. Wang, B. Qin, W. Smith, X. Xu, T. Listro, F. Zhang

Journal of Pharmaceutical Sciences · DOI: 10.1016/j.xphs.2024.08.015

2024

Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure

J. Zhang, R. Raghavachari, D.C. Kirkpatrick, D.A. Keire, X. Xu, P.J. Faustino

Journal of Pharmaceutical Sciences · DOI: 10.1016/j.xphs.2024.07.022

2024

Evaluation of in vitro Skin Permeation of Clascoterone From Clascoterone Topical Cream, 1% (w/w)

Y. Yang, J. Wang, A. Wanasathop, M. Niu, P. Ghosh, A. Zidan, J. Gu, R. Hunt, P. Faustino, M. Ashraf, X. Xu

AAPS PharmSciTech · DOI: 10.1208/s12249-024-02887-7

2024

Manufacturing process of liposomal Formation: A coarse-grained molecular dynamics simulation

T. Duran, A.P. Costa, J. Kneski, X. Xu, D.J. Burgess, H. Mohammadiarani, B. Chaudhuri

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2024.124288

2024

Analysis of Copolymerization with Simultaneous Reversibility and Transesterification by Stochastic Model Regression

L. Kuehster, J. Dai, A. Thompson, Y.K. Jhon, Y. Wang, B. Qin, W.C. Smith, X. Xu, F. Zhang, N.A. Lynd

Macromolecules · DOI: 10.1021/acs.macromol.4c00037

2024

Food selection and effect of home preparation procedure for antibiotic food mixtures on homogeneity, stability, and dissolution

R. Huang, D. Zhu, J. Wang, Y. Berko, P.A. Yu, C.M. Parker, Y.C. Yu, X. Feng, X. Xu, M. Ashraf

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2024.123993

2024

In vitro test methods for evaluating high molecular weight polyethylene oxide polymer induced hemolytic and thrombotic potential

D. Kim, R. Natu, R. Malinauskas, J.H. Baek, P.W. Buehler, X. Feng, H. Qu, J. Pinto, X. Xu, L. Herbertson

Toxicology in Vitro · DOI: 10.1016/j.tiv.2024.105793

2024

Development of an Accelerated Rotator-based Drug Release Method for the Evaluation of Bupivacaine Multivesicular Liposomes

Z. Xia, M. Yu, Y. Liu, W. Yuan, Y. Wang, X. Xu, J. Bae, A. Schwendeman

Pharmaceutical Research · DOI: 10.1007/s11095-023-03651-5

2023

Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

M.A. Costello, J. Liu, L. Kuehster, Y. Wang, B. Qin, X. Xu, Q. Li, W.C. Smith, N.A. Lynd, F. Zhang

Molecular Pharmaceutics · DOI: 10.1021/acs.molpharmaceut.3c00742

2023

Manufacturing dexamethasone intravitreal implants: Process control and critical quality attributes

M.A. Costello, J. Liu, Y. Wang, B. Qin, X. Xu, Q. Li, W.C. Smith, N.A. Lynd, F. Zhang

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2023.123515

2023

Selection of an appropriate tracer to measure the residence time distribution (RTD) of continuous powder blending operations

S.M. Razavi, A.D. Román-Ospino, P. Bhalode, J. Scicolone, G. Callegari, A. Dubey, A. Koolivand, S. Krull, G. Tian, X. Xu, T. O'Connor, M. Ierapetritou, F. Muzzio

Powder Technology · DOI: 10.1016/j.powtec.2023.118864

2023

Asymmetrical Flow Field Flow Fractionation for Molar Mass Characterization of Polyethylene Oxide in Abuse-Deterrent Formulations

H. Qu, W.C. Smith, X. Feng, J. Wang, J. Pinto, X. Xu, P.J. Faustino

Journal of Chromatography A · DOI: 10.1016/j.chroma.2023.464186

2023

Topical pharmacokinetics of brinzolamide suspensions in rabbits and variability analysis for sample size and design considerations

V. Naageshwaran, H. Bigonne, G. Gum, S. Malla, C. del Sol, C. Bon, X. Xu, A. Vo, W. Smith, A. O'Reilly Beringhs, D. Kozak, M.L. Tan, A. Babiskin, A. Urtti, E.M. del Amo, V.P. Ranta

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2023.123183

2023

Drug release mechanisms of high-drug-load, melt-extruded dexamethasone intravitreal implants

M.A. Costello, J. Liu, B. Chen, Y. Wang, B. Qin, X. Xu, Q. Li, N.A. Lynd, F. Zhang

European Journal of Pharmaceutics and Biopharmaceutics · DOI: 10.1016/j.ejpb.2023.04.003

2023

Characterization of exparel bupivacaine multivesicular liposomes

M. Yu, W. Yuan, Z. Xia, Y. Liu, Y. Wang, X. Xu, J. Zheng, A. Schwendeman

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2023.122952

2023

The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation

K.W. Wu, K. Zheng, L. Tian, L. Xia, S.Y. Hwang, P.E. Nwakama, W.J. Sun, M.J. Kim, N. Tampal, X. Xu, H. Boyce, X. Feng

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2023.122737

2023

Reverse engineering the Ozurdex dexamethasone intravitreal implant

M.A. Costello, J. Liu, Y. Wang, B. Qin, X. Xu, Q. Li, N.A. Lynd, F. Zhang

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2023.122625

2023

Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions

A. Belenos, E.L. Wood, M. Hu, D. Kozak, X. Xu, A.C. Fisher

The AAPS Journal · DOI: 10.1208/s12248-023-00781-x

2023

Orthogonal and complementary measurements of properties of drug products containing nanomaterials

C.G. Simon, S.E. Borgos, L. Calzolai, B.C. Nelson, J. Parot, E.J. Petersen, M. Roesslein, X. Xu, F. Caputo

Journal of Controlled Release · DOI: 10.1016/j.jconrel.2022.12.049

2023

Determining critical overlap concentration of polyethylene oxide to support excipient safety assessment of opioid products

W.C. Smith, H. Qu, K. Zheng, J.H. Baek, Y. Gao, P.W. Buehler, X. Feng, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2022.122557

2023

Assessing residence time distributions and hold-up mass in continuous powder blending using discrete element method

W. Yang, S. Krull, N. Pavurala, X. Xu, T. O’Connor, G. Tian

Chemical Engineering Research and Design · DOI: 10.1016/j.cherd.2022.12.005

2023

Understanding syringeability and injectability of high molecular weight PEO solution through time-dependent force-distance profiles

X. Feng, K.W. Wu, V. Balajee, J. Leissa, M. Ashraf, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2022.122486

2022

Physicochemical surrogates for in vitro toxicity assessment of liposomal amphotericin B

R. Marx, J. Lee, Y. Svirkin, S. Yoon, N. Landrau, M. Abul Kaisar, B. Qin, J.H. Park, K. Alam, D. Kozak, Y. Wang, X. Xu, J. Zheng, B. Rivnay

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2022.122273

2022

Deep Learning Models for Predicting Gas Adsorption Capacity of Nanomaterials

W. Guo, J. Liu, F. Dong, R. Chen, J. Das, W. Ge, X. Xu, H. Hong

Nanomaterials · DOI: 10.3390/nano12193376

2022

Scanning Analysis of Sequential Semisolvent Vapor Impact To Study Naltrexone Release from Poly(lactide-co-glycolide) Microparticles

J. Garner, S. Skidmore, J. Hadar, H. Park, K. Park, A. Otte, Y.K. Jhon, X. Xu, B. Qin, Y. Wang

Molecular Pharmaceutics · DOI: 10.1021/acs.molpharmaceut.2c00595

2022

Stochastic and Deterministic Analysis of Reactivity Ratios in the Partially Reversible Copolymerization of Lactide and Glycolide

L. Kuehster, Y.K. Jhon, Y. Wang, W.C. Smith, X. Xu, B. Qin, F. Zhang, N.A. Lynd

Macromolecules · DOI: 10.1021/acs.macromol.2c00757

2022

Amphotericin B release rate is the link between drug status in the liposomal bilayer and toxicity

Y. Svirkin, J. Lee, R. Marx, S. Yoon, N. Landrau, M.A. Kaisar, B. Qin, J.H. Park, K. Alam, D. Kozak, Y. Wang, X. Xu, J. Zheng, B. Rivnay

Asian Journal of Pharmaceutical Sciences · DOI: 10.1016/j.ajps.2022.04.007

2022

Impact of critical process parameters and critical material attributes on the critical quality attributes of liposomal formulations prepared using continuous processing

G. Yenduri, A.P. Costa, X. Xu, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2022.121700

2022

Coarse-Grained Molecular Dynamics Simulations of Paclitaxel-Loaded Polymeric Micelles

T. Duran, A. Costa, A. Gupta, X. Xu, H. Zhang, D. Burgess, B. Chaudhuri

Molecular Pharmaceutics · DOI: 10.1021/acs.molpharmaceut.1c00800

2022

Cyclosporine release and distribution in ophthalmic emulsions determined by pulsatile microdialysis

R.A. Bellantone, K.B. Shah, P.G. Patel, M. Kaplan, X. Xu, V. Li, B. Newman, M. Abul Kaisar

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2022.121521

2022

Machine Learning Models for Predicting Cytotoxicity of Nanomaterials

Z. Ji, W. Guo, E.L. Wood, J. Liu, S. Sakkiah, X. Xu, T.A. Patterson, H. Hong

Chemical Research in Toxicology · DOI: 10.1021/acs.chemrestox.1c00310

2021

Research and Education Needs for Complex Generics

S. Stern, J. Coghlan, V. Krishnan, S.G. Raney, A. Babiskin, W. Jiang, R. Lionberger, X. Xu, A. Schwendeman, J.E. Polli

Pharmaceutical Research · DOI: 10.1007/s11095-021-03149-y

2021

Continuous processing of paclitaxel polymeric micelles

A. Gupta, A.P. Costa, X. Xu, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2021.120946

2021

Impact of particle flocculation on the dissolution and bioavailability of injectable suspensions

W.C. Smith, J. Bae, Y. Zhang, B. Qin, Y. Wang, D. Kozak, M. Ashraf, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2021.120767

2021

Artificial neural networks in tandem with molecular descriptors as predictive tools for continuous liposome manufacturing

S. Sansare, T. Duran, H. Mohammadiarani, M. Goyal, G. Yenduri, A. Costa, X. Xu, T. O'Connor, D. Burgess, B. Chaudhuri

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2021.120713

2021

Adaptive perfusion: An in vitro release test (IVRT) for complex drug products

D. Patel, Y. Zhang, Y. Dong, H. Qu, D. Kozak, M. Ashraf, X. Xu

Journal of Controlled Release · DOI: 10.1016/j.jconrel.2021.03.024

2021

Analyzing ophthalmic suspension particle size distributions using laser diffraction: Placebo background subtraction method

A. Vo, X. Feng, W.C. Smith, D. Zhu, M. Patel, D. Kozak, Y. Wang, J. Zheng, M. Ashraf, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2021.120401

2020

Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations

M. Le Merdy, J. Spires, V. Lukacova, M.L. Tan, A. Babiskin, X. Xu, L. Zhao, M.B. Bolger

Pharmaceutical Research · DOI: 10.1007/s11095-020-02965-y

2020

Identification of critical formulation parameters affecting the in vitro release, permeation, and rheological properties of the acyclovir topical cream

N.S. Kamal, Y.S.R. Krishnaiah, X. Xu, A.S. Zidan, S. Raney, C.N. Cruz, M. Ashraf

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2020.119914

2020

Evaluating drug distribution and release in ophthalmic emulsions: Impact of release conditions

Y. Dong, L. Hengst, R. Hunt, X. Feng, D. Kozak, S. Choi, M. Ashraf, X. Xu

Journal of Controlled Release · DOI: 10.1016/j.jconrel.2020.08.020

2020

In vitro physicochemical characterization and dissolution of brinzolamide ophthalmic suspensions with similar composition

A. Vo, X. Feng, D. Patel, A. Mohammad, M. Patel, J. Zheng, D. Kozak, S. Choi, M. Ashraf, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2020.119761

2020

Polyethylene Oxide Molecular Size Determines the Severity of Atypical Thrombotic Microangiopathy in a Guinea Pig Model of Acute Intravenous Exposure

J.H. Baek, H.K.H. Shin, S.M. Koo, Y. Gao, H. Qu, X. Feng, X. Xu, J. Pinto, U. Katneni, C. Kimchi-Sarfaty, P.W. Buehler

Toxicological Sciences · DOI: 10.1093/toxsci/kfaa099

2020

Factors affecting the particle size distribution and rheology of brinzolamide ophthalmic suspensions

A. Vo, X. Feng, D. Patel, A. Mohammad, D. Kozak, S. Choi, M. Ashraf, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2020.119495

2020

Formulation and characterization of curcumin loaded polymeric micelles produced via continuous processing

A. Gupta, A.P. Costa, X. Xu, S.L. Lee, C.N. Cruz, Q. Bao, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2020.119340

2020

Coexistence of oil droplets and lipid vesicles in propofol drug products

Y. Wu, S. Manna, P. Petrochenko, B. Koo, L. Chen, X. Xu, S. Choi, D. Kozak, J. Zheng

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2019.118998

2020

Assessing Drug Release from Manipulated Abuse Deterrent Formulations

X. Feng, A. Zidan, N.S. Kamal, X. Xu, D. Sun, R. Walenga, H. Boyce, C.N. Cruz, M. Ashraf

AAPS PharmSciTech · DOI: 10.1208/s12249-019-1595-5

2019

Understanding drug distribution and release in ophthalmic emulsions through quantitative evaluation of formulation-associated variables

Y. Dong, L. Hengst, R. Hunt, D. Patel, A. Vo, S. Choi, M. Ashraf, C.N. Cruz, X. Xu

Journal of Controlled Release · DOI: 10.1016/j.jconrel.2019.09.010

2019

Evaluation of Abuse-Deterrent Characteristics of Tablets Prepared via Hot-Melt Extrusion

X. Xu, A. Siddiqui, C. Srinivasan, A. Mohammad, Z. Rahman, M. Korang-Yeboah, X. Feng, M. Khan, M. Ashraf

AAPS PharmSciTech · DOI: 10.1208/s12249-019-1448-2

2019

An in vitro approach for evaluating the oral abuse deterrence of solid oral extended-release opioids with properties intended to deter abuse via chewing

A. Externbrink, S. Sharan, D. Sun, W. Jiang, D. Keire, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2019.03.017

2019

A Kinetic Approach to Determining Drug Distribution in Complex Biphasic Systems

Y. Dong, L. Hengst, D. Patel, R. Hunt, H. Qu, S. Choi, M. Ashraf, C.N. Cruz, X. Xu

Journal of Pharmaceutical Sciences · DOI: 10.1016/j.xphs.2019.01.003

2019

Probing the mechanism of bupivacaine drug release from multivesicular liposomes

S. Manna, Y. Wu, Y. Wang, B. Koo, L. Chen, P. Petrochenko, Y. Dong, S. Choi, D. Kozak, B. Oktem, X. Xu, J. Zheng

Journal of Controlled Release · DOI: 10.1016/j.jconrel.2018.12.029

2018

Analytical considerations for measuring the globule size distribution of cyclosporine ophthalmic emulsions

P.E. Petrochenko, N. Pavurala, Y. Wu, S. Yee Wong, H. Parhiz, K. Chen, S.M. Patil, H. Qu, P. Buoniconti, A. Muhammad, S. Choi, D. Kozak, M. Ashraf, C.N. Cruz, J. Zheng, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2018.08.030

2018

Formulation characteristics and in vitro release testing of cyclosporine ophthalmic ointments

Y. Dong, H. Qu, N. Pavurala, J. Wang, V. Sekar, M.N. Martinez, R. Fahmy, M. Ashraf, C.N. Cruz, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2018.04.042

2018

Development and validation of a UPLC–MS method for the determination of galantamine in guinea pig plasma and its application to a pre‐clinical bioavailability study of novel galantamine formulations

J. Wang, N. Pavurala, X. Xu, Y.S.R. Krishnaiah, P.J. Faustino

Biomedical Chromatography · DOI: 10.1002/bmc.4275

2018

Application of Ultra-Centrifugation and Bench-Top 19F NMR for Measuring Drug Phase Partitioning for the Ophthalmic Oil-in-Water Emulsion Products

X. Wang, S.M. Patil, D.A. Keire, X. Xu, K. Chen

AAPS PharmSciTech · DOI: 10.1208/s12249-018-0973-8

2018

Asymmetric flow field flow fractionation for the characterization of globule size distribution in complex formulations: A cyclosporine ophthalmic emulsion case

H. Qu, J. Wang, Y. Wu, J. Zheng, Y.S.R. Krishnaiah, M. Absar, S. Choi, M. Ashraf, C.N. Cruz, X. Xu

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2018.01.012

2017

Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films

S. Mazumder, N. Pavurala, P. Manda, X. Xu, C.N. Cruz, Y.S.R. Krishnaiah

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2017.05.048

2017

Hyperspectral imaging using near infrared spectroscopy to monitor coat thickness uniformity in the manufacture of a transdermal drug delivery system

N. Pavurala, X. Xu, Y.S.R. Krishnaiah

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2017.03.022

2017

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities

K.M. Tyner, N. Zheng, S. Choi, X. Xu, P. Zou, W. Jiang, C. Guo, C.N. Cruz

The AAPS Journal · DOI: 10.1208/s12248-017-0084-6

2016

Assessing impact of formulation and process variables on in-vitro performance of directly compressed abuse deterrent formulations

Z. Rahman, Y. Yang, M. Korang-Yeboah, A. Siddiqui, X. Xu, M. Ashraf, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2016.02.029

2016

Risk based in vitro performance assessment of extended release abuse deterrent formulations

X. Xu, A. Gupta, M. Al-Ghabeish, S.N. Calderon, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2016.01.031

2016

Liposome Formation Using a Coaxial Turbulent Jet in Co-Flow

A.P. Costa, X. Xu, M.A. Khan, D.J. Burgess

Pharmaceutical Research · DOI: 10.1007/s11095-015-1798-8

2016

Regulatory Perspective on the Development of Polymer Nanomaterials

X. Xu, M.A. Khan

Polymer Nanoparticles for Nanomedicines · DOI: 10.1007/978-3-319-41421-8_19

2015

Kinetics of drug release from ointments: Role of transient-boundary layer

X. Xu, M. Al-Ghabeish, Y.S.R. Krishnaiah, Z. Rahman, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2015.07.077

2015

Formulation and process factors influencing product quality and in vitro performance of ophthalmic ointments

X. Xu, M. Al-Ghabeish, Z. Rahman, Y.S.R. Krishnaiah, F. Yerlikaya, Y. Yang, P. Manda, R.L. Hunt, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2015.07.066

2015

Influence of drug loading and type of ointment base on the in vitro performance of acyclovir ophthalmic ointment

M. Al-Ghabeish, X. Xu, Y.S.R. Krishnaiah, Z. Rahman, Y. Yang, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2015.08.096

2014

Development of performance matrix for generic product equivalence of acyclovir topical creams

Y.S.R. Krishnaiah, X. Xu, Z. Rahman, Y. Yang, U. Katragadda, R. Lionberger, J.R. Peters, K. Uhl, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2014.07.034

2014

Quality by Design Approach for Understanding the Critical Quality Attributes of Cyclosporine Ophthalmic Emulsion

Z. Rahman, X. Xu, U. Katragadda, Y.S.R. Krishnaiah, L. Yu, M.A. Khan

Molecular Pharmaceutics · DOI: 10.1021/mp400484g

2014

Formulation parameters of crystalline nanosuspensions on spray drying processing: A DoE approach

S. Kumar, X. Xu, R. Gokhale, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2014.01.013

2014

Freeze-Anneal-Thaw Cycling of Unilamellar Liposomes: Effect on Encapsulation Efficiency

A.P. Costa, X. Xu, D.J. Burgess

Pharmaceutical Research · DOI: 10.1007/s11095-013-1135-z

2013

Focused beam reflectance measurement to monitor nimodipine precipitation process

X. Xu, A. Siddiqui, M.A. Khan

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2013.08.083

2013

Development and Validation of a HPLC Method for Dissolution and Stability Assay of Liquid-Filled Cyclosporine Capsule Drug Products

X. Xu, A. Gupta, P. Faustino, P.M. Sathe, V.A. Sayeed, M.A. Khan

AAPS PharmSciTech · DOI: 10.1208/s12249-013-9983-8

2013

Process Analytical Technology to Understand the Disintegration Behavior of Alendronate Sodium Tablets

X. Xu, A. Gupta, V.A. Sayeed, M.A. Khan

Journal of Pharmaceutical Sciences · DOI: 10.1002/jps.23488

2012

Effect of Dexamethasone-Loaded Poly(Lactic-Co-Glycolic Acid) Microsphere/Poly(Vinyl Alcohol) Hydrogel Composite Coatings on the Basic Characteristics of Implantable Glucose Sensors

Y. Wang, S. Vaddiraju, L. Qiang, X. Xu, F. Papadimitrakopoulos, D.J. Burgess

Journal of Diabetes Science and Technology · DOI: 10.1177/193229681200600626

2012

Langmuir Balance Investigation of Superoxide Dismutase Interactions with Mixed-Lipid Monolayers

A.P. Costa, X. Xu, D.J. Burgess

Langmuir · DOI: 10.1021/la301614t

2012

Application of quality by design to formulation and processing of protein liposomes

X. Xu, A.P. Costa, M.A. Khan, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2012.06.002

2012

Characterization of Medicinal Compounds Confined in Porous Media by Neutron Vibrational Spectroscopy and First-Principles Calculations: A Case Study with Ibuprofen

K.K. Qian, W. Zhou, X. Xu, T.J. Udovic

Pharmaceutical Research · DOI: 10.1007/s11095-012-0771-z

2012

Protein Encapsulation in Unilamellar Liposomes: High Encapsulation Efficiency and A Novel Technique to Assess Lipid-Protein Interaction

X. Xu, A. Costa, D.J. Burgess

Pharmaceutical Research · DOI: 10.1007/s11095-012-0720-x

2012

A two-stage reverse dialysis in vitro dissolution testing method for passive targeted liposomes

X. Xu, M.A. Khan, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2012.01.030

2012

Predicting hydrophilic drug encapsulation inside unilamellar liposomes

X. Xu, M.A. Khan, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2011.12.019

2012

A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale

X. Xu, M.A. Khan, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2011.11.036

2012

Liposomes as Carriers for Controlled Drug Delivery

X. Xu, D.J. Burgess

Long Acting Injections and Implants · DOI: 10.1007/978-1-4614-0554-2_11

2011

A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment

X. Xu, M.A. Khan, D.J. Burgess

International Journal of Pharmaceutics · DOI: 10.1016/j.ijpharm.2011.07.012

2006

Effect of ionic strength on the temperature‐dependent behavior of hydroxypropyl methylcellulose solution and matrix tablet

X.M. Xu, Y.M. Song, Q.N. Ping, Y. Wang, X.Y. Liu

Journal of Applied Polymer Science · DOI: 10.1002/app.24393