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118. Battle of GLP-1 delivery technologies

Author

Yu, Minzhi, primary, Benjamin, Mason M., additional, Srinivasan, Santhanakrishnan, additional, Morin, Emily E., additional, Shishatskaya, Ekaterina I., additional, Schwendeman, Steven P., additional, and Schwendeman, Anna, additional

Published
2018
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120. Biosimilarity under stress: A forced degradation study of Remicade® and Remsima™

Author

Pisupati, Karthik, primary, Benet, Alexander, additional, Tian, Yuwei, additional, Okbazghi, Solomon, additional, Kang, Jukyung, additional, Ford, Michael, additional, Saveliev, Sergei, additional, Sen, K. Ilker, additional, Carlson, Eric, additional, Tolbert, Thomas J., additional, Ruotolo, Brandon T., additional, Schwendeman, Steven P., additional, and Schwendeman, Anna, additional

Published
2017
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121. A Multidimensional Analytical Comparison of Remicade and the Biosimilar Remsima

Author

Pisupati, Karthik, primary, Tian, Yuwei, additional, Okbazghi, Solomon, additional, Benet, Alexander, additional, Ackermann, Rose, additional, Ford, Michael, additional, Saveliev, Sergei, additional, Hosfield, Christopher M., additional, Urh, Marjeta, additional, Carlson, Eric, additional, Becker, Christopher, additional, Tolbert, Thomas J., additional, Schwendeman, Steven P., additional, Ruotolo, Brandon T., additional, and Schwendeman, Anna, additional

Published
2017
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124. Benefits of Multifaceted Chemopreventives in the Suppression of the Oral Squamous Cell Carcinoma (OSCC) Tumorigenic Phenotype

Author

Mallery, Susan R., primary, Wang, Daren, additional, Santiago, Brian, additional, Pei, Ping, additional, Schwendeman, Steven P., additional, Nieto, Kari, additional, Spinney, Richard, additional, Tong, Meng, additional, Koutras, George, additional, Han, Brian, additional, Holpuch, Andrew, additional, and Lang, James, additional

Published
2017
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125. Effect of Manufacturing Variables and Raw Materials on the Composition-Equivalent PLGA Microspheres for 1-Month Controlled Release of Leuprolide

Author

Zhou, Jia, Walker, Jennifer, Ackermann, Rose, Olsen, Karl, Hong, Justin K. Y., Wang, Yan, and Schwendeman, Steven P.

Abstract

The 1-month Lupron Depot (LD) is a 75/25 acid-capped poly(lactic-co-glycolic acid) (PLGA) microsphere product encapsulating water-soluble leuprolide acetate with no generic products available in the U.S. Composition-equivalent PLGA microsphere formulations to the LD as a function of raw material and manufacturing variables were developed by using the solvent evaporation encapsulation method. The following variables were adjusted: polymer supplier/polymerization type, gelatin supplier/bloom number, polymer concentration, first homogenization speed and time, volume of primary water phase, second homogenization time, volume of secondary water phase, and stirring rate. The loading and encapsulation efficiency (EE) of leuprolide and gelatin were determined to identify a large number of composition-equivalent formulations within a ±10% specification of the LD. Key physical–chemical properties of the formulations (e.g., morphology, particle size distribution, glass transition temperature (Tg), residual moisture and solvent, and porosity) were characterized to determine the effect of manufacturing variables on the product attributes. The EE of gelatin across all formulations prepared (101 ± 1%) was observed to be much higher than the EE of leuprolide (57 ± 1%). Judicious adjustment of polymer concentration, second homogenization time, and volume of second water phase was key to achieving high EE of leuprolide, although EE higher than 70% was not easily achievable owing to the difficulty of emulsifying highly viscous primary emulsion into homogeneous small droplets that could prevent peptide loss during the second homogenization under the conditions and equipment used. The in vitro release kinetics of the formulations was highly similar to the LD in a zero-order manner after ∼20% initial burst release, indicating a critical role of the composition on peptide release in this formulation. The characterization of composition-equivalent formulations described here could be useful for further development of generic leuprolide PLGA microspheres and for guiding decisions on the influence of process variables on product physicochemical attributes and release performance.

Published
2020
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126. Self‐healing encapsulation and controlled release of vaccine antigens from PLGA microparticles delivered by microneedle patches.

Author

Mazzara, J. Maxwell, Ochyl, Lukasz J., Hong, Justin K. Y., Moon, James J., Prausnitz, Mark R., and Schwendeman, Steven P.

Subjects
VACCINES, CONTROLLED release drugs, DRUG delivery systems, SUBCUTANEOUS injections, MICROENCAPSULATION
Abstract

There is an urgent need to reduce reliance on hypodermic injections for many vaccines to increase vaccination safety and coverage. Alternative approaches include controlled release formulations, which reduce dosing frequencies, and utilizing alternative delivery devices such as microneedle patches (MNPs). This work explores development of controlled release microparticles made of poly (lactic‐co‐glycolic acid) (PLGA) that stably encapsulate various antigens though aqueous active self‐healing encapsulation (ASE). These microparticles are incorporated into rapid‐dissolving MNPs for intradermal vaccination. PLGA microparticles containing Alhydrogel are loaded with antigens separate from microparticle fabrication using ASE. This avoids antigen expsoure to many stressors. The microparticles demonstrate bi‐phasic release, with initial burst of soluble antigen, followed by delayed release of Alhydrogel‐complexed antigen over approximately 2 months in vitro. For delivery, the microparticles are incorporated into MNPs designed with pedestals to extend functional microneedle length. These microneedles readily penetrate skin and rapidly dissolve to deposit microparticles intradermally. Microparticles remain in the tissue for extended residence, with MNP‐induced micropores resealing readily. In animal models, these patches generate robust immune responses that are comparable to conventional administration techniques. This lays the framework for a versatile vaccine delivery system that could be self‐applied with important logistical advantages over hypodermic injections. [ABSTRACT FROM AUTHOR]

Published
2019
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128. Effect of Polymer Porosity on Aqueous Self-Healing Encapsulation of Proteins in PLGA Microspheres

Author

Reinhold, Samuel E. and Schwendeman, Steven P.

Subjects
Drug Compounding, Water, Biocompatible Materials, Serum Albumin, Bovine, Article, Microspheres, Molecular Weight, Kinetics, Polylactic Acid-Polyglycolic Acid Copolymer, Coumarins, Microscopy, Electron, Scanning, Animals, Cattle, Magnesium, Muramidase, Lactic Acid, Particle Size, Porosity, Polyglycolic Acid, Enzyme Assays
Abstract

Self-healing (SH) poly(lactic-co-glycolic acid) (PLGA) microspheres are a unique class of functional biomaterials capable of microencapsulating process-sensitive proteins by simple mixing and heating the drug-free polymer in aqueous protein solution. Drug-free SH microspheres of PLGA 50/50 with percolating pore networks of varying porosity (ϵ = 0.49-73) encapsulate increasing lysozyme (≈1 to 10% w/w) with increasing ϵ, with typically ≈20 to 25% pores estimated accessible to entry by the enzyme from the external solution. Release kinetics of lysozyme under physiological conditions is continuous over more than two weeks and most strongly influenced by ϵ and protein loading before reaching a lag phase until 28 d at the study completion. Recovered enzyme after release is typically predominantly monomeric and active. Formulations containing acid-neutralizing MgCO3 at ≥ 4.3% exhibit97% monomeric and active protein after the release with full mass balance recovery. Hence, control of SH polymer ϵ is a key parameter to development of this new class of biomaterials.

Published
2013

131. Fenretinide Perturbs Focal Adhesion Kinase in Premalignant and Malignant Human Oral Keratinocytes. Fenretinide's Chemopreventive Mechanisms Include ECM Interactions

Author

Han, Byungdo B., primary, Li, Suyang, additional, Tong, Meng, additional, Holpuch, Andrew S., additional, Spinney, Richard, additional, Wang, Daren, additional, Border, Michael B., additional, Liu, Zhongfa, additional, Sarode, Sachin, additional, Pei, Ping, additional, Schwendeman, Steven P., additional, and Mallery, Susan R., additional

Published
2015
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136. Model Features of a Cardiac lontophoretic Drug Delivery Implant

Author

Department of Pediatrics and Communicable Diseases, and the College of Pharmacy, The University of Michigan, Ann Arbor, Michigan, 48109-0576, Department of Pediatrics and Communicable Diseases, and the College of Pharmacy, The University of Michigan, Ann Arbor, Michigan, 48109-0576; Department of Chemical Engineering, Massachusetts Institute of Technology, E25-342, Cambridge, Massachusetts, 02139, Ann Arbor, Levy, Robert J., Labhasetwar, Vinod, Schwendeman, Steven P., Department of Pediatrics and Communicable Diseases, and the College of Pharmacy, The University of Michigan, Ann Arbor, Michigan, 48109-0576, Department of Pediatrics and Communicable Diseases, and the College of Pharmacy, The University of Michigan, Ann Arbor, Michigan, 48109-0576; Department of Chemical Engineering, Massachusetts Institute of Technology, E25-342, Cambridge, Massachusetts, 02139, Ann Arbor, Levy, Robert J., Labhasetwar, Vinod, and Schwendeman, Steven P.

Published
2006

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