Comprehensive Evaluation of Push–Pull Osmotic Pump Tablets Using Biopredictive Dissolution Tests in Advanced Modular Platform, MRI Visualizations, and Pharmacokinetic Simulations

Authors: Danielak, Dorota^aff1, Paszkowska, Jadwiga^aff1, Martin, Larry^aff2, Gimbel, Jeffrey^aff2, Ferrizzi, David^aff2, Dobosz, Justyna^aff1, Romański, Michał^aff3, Baran, Ewelina^aff5, Kulinowski, Piotr^aff5, Winiarski, Maciej^aff4, Smoleński, Michał^aff1, Staniszewska, Marcela^aff1, Myslitska, Daria^aff1, Rajabi-Siahboomi, Ali^aff2, Garbacz, Grzegorz^aff1

Source: Molecular Pharmaceutics. 22(9):5576-5591

Availability: https://pubs.acs.org/doi/10.1021/acs.molpharmaceut.5c00612

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Authors: Pepin, Xavier, Arora, Sumit, Borges, Luiza, Cano-Vega, Mario, Carducci, Tessa, Chatterjee, Parnali, Chen, Grace, Cristofoletti, Rodrigo, Dallmann, Andre, Delvadia, Poonam, Dressman, Jennifer, Fotaki, Nikoletta, Gray, Elizabeth, Heimbach, Tycho, Holte, Oyvind, Kijima, Shinichi, Kotzagiorgis, Evangelos, Lennernäs, Hans, Lindahl, Anders, Loebenberg, Raimar, Mackie, Claire, Malamatari, Maria, McAllister, Mark, Mitra, Amitava, Moody, Rebecca, Mudie, Deanna, Tshinanu, Flora Musuamba, Polli, James E., Rege, Bhagwant, Ren, Xiaojun, Rullo, Gregory, Scherholz, Megerle, Song, Ivy, Stillhart, Cordula, Suarez-Sharp, Sandra, Tannergren, Christer, Tsakalozou, Eleftheria, Veerasingham, Shereeni, Wagner, Christian, Seo, Paul

Source: Molecular Pharmaceutics. 21(8):3697-3731

Subject Terms: PBBM, biopredictive dissolution, permeability, solubility, precipitation, modeling, IVIVC, IVIVR, bioequivalence, CQAs

File Description: electronic

Access URL: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-540618
https://doi.org/10.1021/acs.molpharmaceut.4c00526

More Than a Gut FeelingA Combination of Physiologically Driven Dissolution and Pharmacokinetic Modeling as a Tool for Understanding Human Gastric Motility

Authors: Romański, Michał^aff1, Staniszewska, Marcela^aff2, Dobosz, Justyna^aff2, Myslitska, Daria^aff2, Paszkowska, Jadwiga^aff2, Kołodziej, Bartosz^aff2, Romanova, Svitlana^aff2, Banach, Grzegorz^aff2, Garbacz, Grzegorz^aff2, Sarcevica, Inese^aff3, Huh, Yeamin^aff4, Purohit, Vivek^aff4, McAllister, Mark^aff3, Wong, Suet M.^aff3, Danielak, Dorota^aff1

Source: Molecular Pharmaceutics. 21(8):3824-3837

Availability: https://pubs.acs.org/doi/10.1021/acs.molpharmaceut.4c00117

In Vitro Simulation of the Fasted Gastric Conditions and Their Variability to Elucidate Contrasting Properties of the Marketed Dabigatran Etexilate Pellet-Filled Capsules and Loose Pellets

Authors: Staniszewska, Marcela^aff1, Myslitska, Daria^aff1, Romański, Michał^aff2, Polak, Sebastian^aff3, Garbacz, Grzegorz^aff1, Dobosz, Justyna^aff1, Smoleński, Michał^aff1, Paszkowska, Jadwiga^aff1, Danielak, Dorota^aff2

Source: Molecular Pharmaceutics. 21(5):2456-2472

Availability: https://pubs.acs.org/doi/10.1021/acs.molpharmaceut.4c00025

Simulation-guided dissolution testing: Coupling DDDPlus™ and GastroPlus® to predict aripiprazole oral bioperformance

Authors: Krstevska, Aleksandra, Nedelkov, Ivana, Petrović, Maša, Ivković, Branka, Dobričić, Vladimir, Cvijić, Sandra

Source: Journal of Drug Delivery Science and Technology

Subject Terms: DDDPlus™, Solubility, Biopredictive dissolution, Aripiprazole, GastroPlus®, Permeability

Access URL: https://farfar.pharmacy.bg.ac.rs/handle/123456789/6287

Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules

Authors: Bi, Fulin, Yuan, Tong, Zhang, Baohong, Li, Jixia, Lin, Yan, Yang, Jin^{Aff1, IDs12249024030062_cor1}

Source: AAPS PharmSciTech: An Official Journal of the American Association of Pharmaceutical Scientists. 26(1)

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

Authors: Mackie, Claire^aff1, Arora, Sumit^aff1, Seo, Paul^aff2, Moody, Rebecca^aff3, Rege, Bhagwant^aff3, Pepin, Xavier^aff4, Heimbach, Tycho^aff5, Tannergren, Christer^aff6, Mitra, Amitava^aff7, Suarez-Sharp, Sandra^aff4, Borges, Luiza Novaes^aff8, Kijima, Shinichi^aff9, Kotzagiorgis, Evangelos^aff10, Malamatari, Maria^aff11, Veerasingham, Shereeni^aff12, Polli, James E.^aff13, Rullo, Gregory^aff14

Source: Molecular Pharmaceutics. 21(5):2065-2080

Availability: https://pubs.acs.org/doi/10.1021/acs.molpharmaceut.4c00202

An extension of biorelevant fed-state dissolution tests to clinical pharmacokinetics – A study on gastrointestinal factors influencing rivaroxaban exposure and efficacy in atrial fibrillation patients

Authors: Romański, Michał ^{a, 1}, Giebułtowicz, Joanna ^{b, ⁎}, Gniazdowska, Elżbieta ^{b, f}, Piotrowski, Roman ^c, Żuk, Anna ^c, Kułakowski, Piotr ^c, Paszkowska, Jadwiga ^d, Myslitska, Daria ^d, Sczodrok, Jaroslaw ^e, Garbacz, Grzegorz ^{d, e}, Danielak, Dorota ^{a, 1}

Source: In International Journal of Pharmaceutics 5 January 2024 649

Toward Biopredictive Dissolution for Enteric Coated Dosage Forms

Authors: Al-Gousous, J.^aff1, Amidon, G. L.^aff2, Langguth, P.^aff1

Source: Molecular Pharmaceutics. 13(6):1927-1936

Availability: https://pubs.acs.org/doi/10.1021/acs.molpharmaceut.6b00077

Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development

Authors: Wu, Di, Li, Min^{Aff2, IDs11095022033730_cor2}

Source: Pharmaceutical Research: An Official Journal of the American Association of Pharmaceutical Scientists. :1-16

Biorelevant dissolution testing and physiologically based absorption modeling to predict in vivo performance of supersaturating drug delivery systems

Authors: Thakore, Samarth D ¹, Sirvi, Arvind ¹, Joshi, Vikram C, Panigrahi, Sanjali S, Manna, Arijita, Singh, Ridhima, Sangamwar, Abhay T, Bansal, Arvind K ^⁎

Source: In International Journal of Pharmaceutics 25 September 2021 607

Physiologically relevant dissolution conditions towards improved in vitro - in vivo relationship – A case study with enteric coated pantoprazole tablets

Authors: Amaral Silva, Daniela ^{a, 1}, Gomes Davanço, Marcelo ^{b, 1}, Davies, Neal M. ^a, Krämer, Johannes ^c, de Oliveira Carvalho, Patricia ^b, Löbenberg, Raimar ^{a, ⁎}

Source: In International Journal of Pharmaceutics 10 August 2021 605

Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets

Authors: Tsume, Yasuhiro^{Aff1, IDs12248023007937_cor1}, Ashworth, Lee, Bermejo, Marival, Cheng, Joan, Cicale, Vincent, Dressman, Jennifer^{Aff6, Aff7}, Fushimi, Masahiro, Gonzalez-Alvarez, Isabel, Guo, Yiwang, Jankovsky, Corinne, Lu, Xujin, Matsui, Kazuki, Patel, Sanjaykumar, Sanderson, Natalie, Sun, Changquan Calvin, Thakral, Naveen K., Yamane, Miki, Zöller, Laurin

Source: The AAPS Journal: An Official Journal of the American Association of Pharmaceutical Scientists. 25(3)

A Rational approach to predicting immediate release formulation behavior in multiple gastric motility patterns : a combination of a biorelevant apparatus, design of experiments, and machine learning

Authors: Staniszewska, Marcela, Romański, Michał, Polak, Sebastian, Garbacz, Grzegorz, Dobosz, Justyna, Myslitska, Daria, Romanova, Svitlana, Paszkowska, Jadwiga, Danielak, Dorota

Subject Terms: biopredictive dissolution testing, individual dissolution profiles, design of experiments, machine learning, motility patterns, mechanical stress events

Relation: Pharmaceutics, T. 15, nr 8; https://ruj.uj.edu.pl/xmlui/handle/item/319456

Availability: https://ruj.uj.edu.pl/xmlui/handle/item/319456
https://doi.org/10.3390/pharmaceutics15082056
https://www.mdpi.com/1999-4923/15/8/2056

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets

Authors: Gustavo Vaiano Carapeto, Marcelo Dutra Duque, Michele Georges Issa, Humberto Gomes Ferraz

Source: Pharmaceutics, Vol 15, Iss 5, p 1544 (2023)

Subject Terms: PBBM, DoE, desvenlafaxine, biopredictive dissolution method, Taguchi, Pharmacy and materia medica, RS1-441

Relation: https://www.mdpi.com/1999-4923/15/5/1544; https://doaj.org/toc/1999-4923; https://doaj.org/article/885c5b212a4e4fc49f51943eb3803d11

Availability: https://doi.org/10.3390/pharmaceutics15051544
https://doaj.org/article/885c5b212a4e4fc49f51943eb3803d11

Quality control dissolution data is biopredictive for a modified release ropinirole formulation : virtual experiment with the use of re-developed and verified PBPK model

Authors: Shuklinova, Olha, Dorożyński, Przemysław, Kulinowski, Piotr, Polak, Sebastian

Subject Terms: ropinirole, Parkinson’s disease, biopredictive dissolution, physiologically based pharmacokinetic modeling

Relation: Pharmaceutics, T. 14, nr 4; https://ruj.uj.edu.pl/xmlui/handle/item/297959

Availability: https://ruj.uj.edu.pl/xmlui/handle/item/297959
https://doi.org/10.3390/pharmaceutics14071514
https://www.mdpi.com/1999-4923/14/7/1514

Application of the Gastrointestinal Simulator (GIS) Coupled with In Silico Modeling to Measure the Impact of Coca-Cola(R)on the Luminal and Systemic Behavior of Loratadine (BCS Class 2b)

Authors: Hens, Bart, Bermejo, Marival, Augustijns, Patrick, Cristofoletti, Rodrigo, Amidon, Gregory E., Amidon, Gordon L.

Source: ISSN:1999-4923 ; Pharmaceutics, vol. 12 (6), Art.No. ARTN 566.

Subject Terms: Science & Technology, Life Sciences & Biomedicine, Pharmacology & Pharmacy, biopharmaceutics classification system (BCS), low aqueous solubility, oral bioavailability, oral drug absorption, in silico modeling, biopredictive dissolution testing, physiologically-based biopharmaceutics modeling (PBBM), BEVERAGE COCA-COLA, HUMAN PLASMA, PRECIPITATION BEHAVIOR, LIQUID-CHROMATOGRAPHY, TABLET FORMULATIONS, MASS-SPECTROMETRY, DRUG ABSORPTION, PHARMACOKINETICS, DISSOLUTION, SINGLE, 1115 Pharmacology and Pharmaceutical Sciences, 3214 Pharmacology and pharmaceutical sciences

File Description: application/pdf

Relation: https://lirias.kuleuven.be/handle/123456789/657593; https://doi.org/10.3390/pharmaceutics12060566; https://pubmed.ncbi.nlm.nih.gov/32570975

Availability: https://lirias.kuleuven.be/handle/123456789/657593
https://lirias.kuleuven.be/retrieve/c4c83e58-ee60-4128-9735-110bd8893085
https://lirias.kuleuven.be/retrieve/5147bc37-67a1-4692-bc5f-312eb272717f
https://doi.org/10.3390/pharmaceutics12060566
https://pubmed.ncbi.nlm.nih.gov/32570975

In Vitro Biopredictive Methods: A Workshop Summary Report

Authors: Pepin, Xavier J.H. ^{a, r, ∗}, Dressman, Jennifer ^{b, r}, Parrott, Neil ^c, Delvadia, Poonam ^d, Mitra, Amitava ^e, Zhang, Xinyuan ^f, Babiskin, Andrew ^g, Kolhatkar, Vidula ^d, Seo, Paul ^d, Taylor, Lynne S. ^h, Sjögren, Erik ⁱ, Butler, James M. ^j, Kostewicz, Edmund ^k, Tannergren, Christer ^l, Koziolek, Mirko ^{m, n}, Kesisoglou, Filippos ^o, Dallmann, André ^p, Zhao, Yang ^d, Suarez-Sharp, Sandra ^q

Source: In Journal of Pharmaceutical Sciences February 2021 110(2):567-583

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

Authors: Pepin, Xavier J.H. ^a, Parrott, Neil ^b, Dressman, Jennifer ^c, Delvadia, Poonam ^d, Mitra, Amitava ^{e, h}, Zhang, Xinyuan ^f, Babiskin, Andrew ^g, Kolhatkar, Vidula ^d, Suarez-Sharp, Sandra ^{d, ∗, i}

Source: In Journal of Pharmaceutical Sciences February 2021 110(2):555-566