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44 results on '"Gao, Zongming"'

1. Drug Dissolution in Oral Drug Absorption: Workshop Report

Author

Raines, Kimberly, Agarwal, Payal, Augustijns, Patrick, Alayoubi, Alaadin, Attia, Lucas, Bauer-Brandl, Annette, Brandl, Martin, Chatterjee, Parnali, Chen, Hansong, Yu, Yuly Chiang, Coutant, Carrie, Coutinho, Ana Luisa, Curran, David, Dressman, Jennifer, Ericksen, Bryan, Falade, Leah, Gao, Yi, Gao, Zongming, Ghosh, Debasis, Ghosh, Tapash, Govada, Anitha, Gray, Elizabeth, Guo, Ruiqiong, Hammell, Dana, Hermans, Andre, Jaini, Rohit, Li, Hanlin, Mandula, Haritha, Men, Shuaiqian, Milsmann, Johanna, Moldthan, Huong, Moody, Rebecca, Moseson, Dana E., Müllertz, Anette, Patel, Roshni, Paudel, Kalpana, Reppas, Christos, Savkur, Rajesh, Schaefer, Kerstin, Serajuddin, Abu, Taylor, Lynne S., Valapil, Rutu, Wei, Kevin, Weitschies, Werner, Yamashita, Shinji, and Polli, James E.

Published
2023
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10. Use of physiologically‐based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended‐release nifedipine.

Author

Tan, Ming‐Liang, Gao, Zongming, Babiskin, Andrew, Kim, Myong‐Jin, Fang, Lanyan, Zhang, Lei, and Zhao, Liang

Subjects
*ORAL drug administration, *OMEPRAZOLE, *PHARMACOKINETICS, *DOSAGE forms of drugs, *NIFEDIPINE, *PROTON pump inhibitors, *H2 receptor antagonists, *DRUG solubility
Abstract

Proton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating the gastric pH. Our recent clinical study has demonstrated that drug–drug interactions (DDIs) exist between a PPI, omeprazole, and nifedipine extended‐release formulations, where systemic exposure of nifedipine was increased in subjects after multiple‐dose pretreatment of omeprazole. However, the mechanism of the observed DDIs between omeprazole and nifedipine has not been well‐understood, as the DDI may also be mediated through CYP3A4 enzyme inhibition in addition to the elevated gastric pH caused by omeprazole. This study used physiologically‐based pharmacokinetic (PBPK) modeling and simulations to investigate the underlying mechanism of these complex DDIs. A formulation exhibiting differences in in vitro dissolution across physiological pH range and another formulation where pH does not impact dissolution appreciably (e.g., an osmotic pump) were chosen to characterize the potential impact of pH. The PBPK models incorporated two‐stage in vitro release profiles via US Pharmacopeia 2 apparatus. PBPK simulations suggest that the elevated gastric pH following multiple‐dose administration of omeprazole has a minimal effect on nifedipine pharmacokinetics (PKs), whereas CYP3A4‐mediated DDI is likely the main driver to the observed change of nifedipine PKs in the presence of omeprazole. Compared to the osmotic formulation, the slightly increased exposure of nifedipine can be accounted for by the enhanced drug release in the pH‐dependent formulation. The reported model‐based approach may be useful in DDI risk assessments, product formulation designs, and bioequivalence evaluations. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Drug Dissolution in Oral Drug Absorption:Workshop Report

Author

Raines, Kimberly, Agarwal, Payal, Augustijns, Patrick, Alayoubi, Alaadin, Attia, Lucas, Bauer-Brandl, Annette, Brandl, Martin, Chatterjee, Parnali, Chen, Hansong, Yu, Yuly Chiang, Coutant, Carrie, Coutinho, Ana Luisa, Curran, David, Dressman, Jennifer, Ericksen, Bryan, Falade, Leah, Gao, Yi, Gao, Zongming, Ghosh, Debasis, Ghosh, Tapash, Govada, Anitha, Gray, Elizabeth, Guo, Ruiqiong, Hammell, Dana, Hermans, Andre, Jaini, Rohit, Li, Hanlin, Mandula, Haritha, Men, Shuaiqian, Milsmann, Johanna, Moldthan, Huong, Moody, Rebecca, Moseson, Dana E., Müllertz, Anette, Patel, Roshni, Paudel, Kalpana, Reppas, Christos, Savkur, Rajesh, Schaefer, Kerstin, Serajuddin, Abu, Taylor, Lynne S., Valapil, Rutu, Wei, Kevin, Weitschies, Werner, Yamashita, Shinji, Polli, James E., Raines, Kimberly, Agarwal, Payal, Augustijns, Patrick, Alayoubi, Alaadin, Attia, Lucas, Bauer-Brandl, Annette, Brandl, Martin, Chatterjee, Parnali, Chen, Hansong, Yu, Yuly Chiang, Coutant, Carrie, Coutinho, Ana Luisa, Curran, David, Dressman, Jennifer, Ericksen, Bryan, Falade, Leah, Gao, Yi, Gao, Zongming, Ghosh, Debasis, Ghosh, Tapash, Govada, Anitha, Gray, Elizabeth, Guo, Ruiqiong, Hammell, Dana, Hermans, Andre, Jaini, Rohit, Li, Hanlin, Mandula, Haritha, Men, Shuaiqian, Milsmann, Johanna, Moldthan, Huong, Moody, Rebecca, Moseson, Dana E., Müllertz, Anette, Patel, Roshni, Paudel, Kalpana, Reppas, Christos, Savkur, Rajesh, Schaefer, Kerstin, Serajuddin, Abu, Taylor, Lynne S., Valapil, Rutu, Wei, Kevin, Weitschies, Werner, Yamashita, Shinji, and Polli, James E.

Abstract

The in-person workshop “Drug Dissolution in Oral Drug Absorption” was held on May 23–24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout sessions. Three common topics that were re-visited by various lecturers were amorphous solid dispersions (ASDs), dissolution/permeation interplay, and in vitro methods to predict in vivo biopharmaceutics performance and risk. Topics that repeatedly surfaced across breakout sessions were the following: (1) meaning and assessment of “dissolved drug,” particularly of poorly water soluble drug in colloidal environments (e.g., fed conditions, ASDs); (2) potential limitations of a test that employs sink conditions for a poorly water soluble drug; (3) non-compendial methods (e.g., two-stage or multi-stage method, dissolution/permeation methods); (4) non-compendial conditions (e.g., apex vessels, non-sink conditions); and (5) potential benefit of having both a quality control method for batch release and a biopredictive/biorelevant method for biowaiver or bridging scenarios. An identified obstacle to non-compendial methods is the uncertainty of global regulatory acceptance of such methods.

Published
2023

22. In Vitro Analysis ofN-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions

Author

Gao, Zongming, primary, Karfunkle, Michael, additional, Ye, Wei, additional, Marzan, Tim Andres, additional, Yang, Jingyue, additional, Lex, Timothy, additional, Sommers, Cynthia, additional, Rodriguez, Jason D., additional, Han, Xiaomei, additional, Florian, Jeffry, additional, Strauss, David G., additional, and Keire, David A., additional

Published
2021
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30. Dissolution Test of Tacrolimus Capsule: Effects of Filtration and Glass Adsorption.

Author

Zeng, Kui, Gao, Zongming, Trehy, Michael, and Jiang, Wenlei

Abstract

Tacrolimus is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Dissolution tests are widely used to evaluate drug product quality and performance. Analysis of tacrolimus during dissolution testing is sensitive to several factors, such as sample solution storage time and container material. The filtration process, tacrolimus glass adsorption, and sample solution storage time are found to impact the tacrolimus dissolution results. Based on observations in this work, the use of G4 or equivalent filter flush before collection and polypropylene test tubes or vials instead of glass test tubes or vials are recommended for tacrolimus drug product dissolution test. [ABSTRACT FROM AUTHOR]

Published
2018
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31. Use of Enzymes in the Dissolution Testing of Gelatin Capsules and Gelatin-Coated Tablets-Revisions to Dissolution <711> and Disintegration and Dissolution of Dietary Supplements <2040>

Author

Gray, Vivian A., primary, C. Marques, Margareth R., additional, Cole, Ewart, additional, Riva Toma, Joan M. D., additional, Ghidorsi, Luigi, additional, Guo, Jian-Hwa, additional, Han, Jian-Hwa, additional, Han, Feixue, additional, Hosty, Christopher T., additional, Kochling, Jianmei D., additional, Kraemer, Johannes, additional, Langdon, Thomas, additional, Leinbach, Steven R., additional, Martin, Gregory P., additional, Meyerhoffer, Steven M., additional, Moreton, Richard C., additional, Raghaven, Krishnaswamy S., additional, Shneyvas, Edward, additional, Suggett, Jason A., additional, Tindal, Stephen, additional, Vudathala, Madhusudan, additional, Wang, Hu, additional, Anand, Om, additional, Gao, Zongming, additional, Shah, Rakhi, additional, Xia, Li, additional, Fotso, Joe, additional, Hussain, Munir A., additional, Schmidt, Vi N., additional, Ghosh, Tapash, additional, Davydova, Natalia, additional, Brown, William E., additional, Fringer, Jeanne M., additional, Stippler, Erika S., additional, and Eranui, Tovmasian, additional

Published
2014
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43. Poly(dimethylsiloxane) coatings for controlled drug release. II. Mechanism of the crosslinking reaction in emulsion

Author

Gao, Zongming, Nahrup, Julia Schulze, Mark, James E., and Sakr, Adel

Abstract

Earlier work focused on the crosslinking of hydroxyl-terminated poly(dimethylsiloxane) (PDMS) particles in a stable latex suitable for spraying onto drug tablets, and established the conditions for eliminating the usual toxic catalysts that would be unacceptable in such pharmaceutical coating materials. Use of these coatings for controlling the rate of release of a drug, however, requires a better understanding of their properties and thus clarification of the mechanism through which the crosslinking occurs. The present study approaches this goal by documenting the effects of anionic, cationic, and nonionic surfactants at various concentrations, and in acidic, neutral, or basic media. FTIR spectroscopy was used to monitor the transportation of crosslinker from the water phase into the hydrophobic PDMS phase. The results suggest a possible mechanism for the crosslinking in sufficient detail to be used to optimize the coatings for drug-release applications. © 2003 Wiley Periodicals, Inc. J Appl Polym Sci 91: 2186–2194, 2004

Published
2004
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44. The Study of Polydimethylsiloxane (PDMS) Coatings for Controlled Drug Release

Author

Gao, Zongming

Subjects
Chemistry, Polymer
Abstract

The present study has developed a new method to prepare stable PDMS latexes suitable for spraying-coating drug tablets without the need for colloidal silica and organic tin catalyst. The approach taken consisted of preparing water-based emulsions of hydroxyl-terminated PDMS with sodium lauryl sulfate (SLS) as surfactant, and then cross linking on restriction of the pH of the system to the acidic range with HCl. Optimizing the coatings for drug-release applications requires a better understanding of their properties and thus clarification of the mechanism through which the cross-linking reaction takes place. The present study also approaches this goal by documenting the effects of anionic, cationic and nonionic surfactants at various concentrations, and in acidic, neutral, or basic media. Analytical methods were set up to monitor the transport of crosslinker from the water phase into the hydrophobic PDMS phase. A possible mechanism for the PDMS cross-linking reaction in emulsion without organic tin as catalyst has been developed. Additionally, to prepare coated tablets for controlled drug release studies, an economical and efficient lab-scale coating system has been developed. Furthermore, in-vitro evaluations were performed to study the effects of the amount of channeling agents, the addition of colloidal silica, and the pH of the dissolution media used. The study involved hydrochlorothiazide (as a marker drug) released from compressed tablets, which had been spray coated using PDMS latexes with various polyethylene glycols (PEG) loadings as channeling agents. The dissolution results showed that coated tablets containing up to 25% (w/w) PEG could have constant release rates. Higher amounts of PEG resulted in non-linear release patterns. Also, the addition of colloidal silica decreased the rates of drug release. Since the pH of dissolution media affected the structures of the exposed PDMS films, it had significant effects on the drug release behavior.

Published
2004

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