Journal of Pharmaceutical Investigation最新文献

{"title":"Meta-analysis of levamisole absorption and disposition across diverse species using a minimal physiologically-based pharmacokinetic model.","authors":"ChunFu Cheng, Yoo-Seong Jeong, William J Jusko","doi":"10.1007/s40005-025-00770-6","DOIUrl":"10.1007/s40005-025-00770-6","url":null,"abstract":"<p><strong>Purpose: </strong>Pharmacokinetic (PK) data for levamisole, an important immunostimulant and antiparasitic agent, were identified in 18 species providing sufficient PK data following oral (PO) and/or intravenous (IV) administration for assessment and comparison.</p><p><strong>Methods: </strong>Pharmacokinetic parameters were sought in all species for traditional allometric assessment. Among these, 2 bird and 6 mammalian species provided sufficient data for joint modeling using traditional compartmental PK and minimal physiologically-based pharmacokinetic (mPBPK) methods.</p><p><strong>Results: </strong>Simple allometric scaling was first used examine clearance (<i>CL</i>), steady-state volume of distribution (<i>V</i> _<i>ss</i> ), absorption rate constant (<i>k</i> _<i>a</i> ), and bioavailability (<i>F</i>) in relation to body weight (<i>BW</i>) across species. The <i>V</i> _<i>ss</i> correlated well with <i>BW (Parameter = α·BW</i> ^<i>b</i> <i>)</i> with <i>b</i> = 0.89 (R² = 0.81) whereas <i>CL</i> (<i>b</i> = 0.26, R² = 0.46), <i>k</i> _<i>a</i> (<i>b</i> = 0.25, R² = 0.14), and <i>F</i> (<i>b</i> = 0.08, R² = 0.70) showed weaker correlations with ducks appearing as outliers for <i>CL</i>. Biexponential PK profiles were adequately captured using an allometric two-compartment model (2CM). Joint fitting of IV PK data from 8 species to a generalized mPBPK model, incorporating unified distribution parameters (e.g., tissue partition coefficient <i>K</i> _<i>p</i> and fractional distribution parameter <i>f</i> _<i>d</i> ), yielded good performance across species. The mPBPK model assuming high tissue permeability and species-specific <i>K</i> _<i>p</i> values for pig and chicken (<i>K</i> _{<i>p, pig</i>} and <i>K</i> _{<i>p, chicken</i>} ) best described the observed profiles. Oral bioavailability(<i>F</i>) was highly consistent across all species (50-80%), with the exception of goats.</p><p><strong>Conclusion: </strong>This study demonstrates that levamisole with rapid absorption and extensive metabolism exhibits largely consistent PK properties across species. Minimal PBPK modeling offers advantageous comparison of interspecies determinants of levamisole PK.</p><p><strong>Supplementary information: </strong>The online version contains supplementary material available at 10.1007/s40005-025-00770-6.</p>","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"56 1","pages":"171-183"},"PeriodicalIF":5.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12769651/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Zwitterionic alginate derivative as a new delivery platform for enhanced blood circulation.","authors":"Hyeri Lee, Yan Li, Kai Bao, Seon Sook Lee, Homan Kang, Hak Soo Choi, Yongdoo Choi","doi":"10.1007/s40005-024-00703-9","DOIUrl":"10.1007/s40005-024-00703-9","url":null,"abstract":"<p><strong>Purpose: </strong>Poly(ethylene glycol) (PEG), a synthetic polymer known for its hydrophilicity and biocompatibility, has long been used in drug delivery systems to prevent non-specific protein adsorption and to extend the blood circulation time of drug carriers and protein drugs. However, PEG has several drawbacks including poor stability, accumulated toxicity, and immunogenicity induced by repeated injections. Recently, zwitterionic polymers, known for their super-hydrophilic and antifouling properties, have been considered excellent alternatives to PEG. In this study, we synthesized a new zwitterionic polymer from biocompatible sodium alginate and lysine.</p><p><strong>Methods: </strong>Sodium alginate (Alg) was conjugated with lysine (Lys) using the EDC/sulfo-NHS chemistry to form a zwitterionic alginate derivative (Alg-Lys). The biocompatibility was evaluated using in vitro cellular assays and in vivo animal studies. After further conjugation of zwitterionic near-infrared (NIR) fluorescent dye ZW800, an in vivo NIR fluorescence imaging study was conducted to evaluate the ability of Alg-Lys to enhance blood circulation time.</p><p><strong>Results: </strong>Characterization of Alg-Lys showed that the carboxylic acid groups in Alg were completely replaced by Lys molecules. No cytotoxic effects were observed in the in vitro cytotoxicity tests of Alg-Lys-treated cancer cells and normal cells. Serum biochemical analysis confirmed the biocompatibility of Alg-Lys. ZW800-conjugated Alg-Lys exhibited strong fluorescence signals throughout the body 24 h after intravenous injection, whereas ZW800-conjugated Alg was rapidly removed from the body.</p><p><strong>Conclusion: </strong>The zwitterionic alginate derivative showed potential utility as a new delivery platform for imaging agents and drugs.</p>","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"55 1","pages":"143-154"},"PeriodicalIF":5.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12360706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144883069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of abiraterone acetate tablets with enhanced oral bioavailability","authors":"Jin Wook Tak, T. Kwon, Yong-Il Kim, Jung Hyun Cho, Jeonghwan Kim, Jong Oh Kim","doi":"10.1007/s40005-023-00654-7","DOIUrl":"https://doi.org/10.1007/s40005-023-00654-7","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"39 14","pages":""},"PeriodicalIF":5.5,"publicationDate":"2024-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139442781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multicompartmental pharmacokinetic evaluation of enavogliflozin eye drop formulation: Understanding its distribution to posterior segments","authors":"Seok-jin Cho, Dong Wook Kang, Ju Hee Kim, Go-Wun Choi, Minhyung Kang, Hea‐Young Cho","doi":"10.1007/s40005-023-00653-8","DOIUrl":"https://doi.org/10.1007/s40005-023-00653-8","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"8 6","pages":""},"PeriodicalIF":5.5,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139445294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A two-step design of experiments approach to investigate the simultaneous effects of ion-pairing and chemical enhancers to improve the permeability of lornoxicam in a topical hydrogel patch","authors":"Huu-Manh Nguyen, The-Khang Duong, Van-Khuyen Nguyen, Thi-Khanh-Ly Nguyen, Thi-Hoang-Yen Dong, Canh-Hung Nguyen, Nguyen-Thach Tung","doi":"10.1007/s40005-023-00660-9","DOIUrl":"https://doi.org/10.1007/s40005-023-00660-9","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"52 19","pages":""},"PeriodicalIF":5.5,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transferrin modified PEG–PLGA nanoparticles: highly effective notoginsenoside R1 formulations for the treatment of ulcerative colitis","authors":"Limei Zhou, Yunxia Shang, Yaru Wang, Xiaohui Wei","doi":"10.1007/s40005-023-00657-4","DOIUrl":"https://doi.org/10.1007/s40005-023-00657-4","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"33 4","pages":""},"PeriodicalIF":5.5,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139385973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Applying polyvinyl alcohol to the preparation of various nanoparticles","authors":"Bomin Song, Cheong-Weon Cho","doi":"10.1007/s40005-023-00649-4","DOIUrl":"https://doi.org/10.1007/s40005-023-00649-4","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"16 12","pages":""},"PeriodicalIF":5.5,"publicationDate":"2024-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139450921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of a spray-dried amorphous solid dispersion formulation of ID11916, a new molecular entity with dual inhibition mechanisms targeting the androgen receptor and phosphodiesterase type-5","authors":"Tae-Kwang Kim, Fabrizio Fina, Francesco Rossignolo, Sang-Hyun Kim, Haneul Lee, Kyuho Jeong, Xiaoyan Xu, Chiara Pignaffo, Cheng Yang, Jina Koo, Myongjae Lee, Min-Jun Baek, Dahan Kim, Dae-Duk Kim","doi":"10.1007/s40005-023-00652-9","DOIUrl":"https://doi.org/10.1007/s40005-023-00652-9","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"334 12","pages":""},"PeriodicalIF":5.5,"publicationDate":"2023-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139152547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strategic design and clinical evaluation of a fixed-dose combination tablet comprising valsartan, amlodipine, rosuvastatin and ezetimibe for patients with hypertension and dyslipidemia","authors":"Tae-Kwang Kim, Jeong-Eun Lee, Kyuho Jeong, Min-Jun Baek, Dahan Kim, Jun-Young Jeon, Sangyoung Lee, Dae-Duk Kim","doi":"10.1007/s40005-023-00651-w","DOIUrl":"https://doi.org/10.1007/s40005-023-00651-w","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":"122 49","pages":""},"PeriodicalIF":5.5,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138953784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In vitro–in vivo correlation of microsphere formulations: recent advances and challenges","authors":"Sung Soo Kim, Simpson Ro, Dong Hee Na","doi":"10.1007/s40005-023-00655-6","DOIUrl":"https://doi.org/10.1007/s40005-023-00655-6","url":null,"abstract":"","PeriodicalId":16702,"journal":{"name":"Journal of Pharmaceutical Investigation","volume":" 94","pages":""},"PeriodicalIF":5.5,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138961338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}