{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T16:43:21Z","timestamp":1791650601633,"version":"4.3.4"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Towa pharmaceuticals"},{"DOI":"10.13039\/501100005405","name":"Ritsumeikan University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005405","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pharm Res"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The purpose of this study was to clarify the extent to which the dissolution profiles of immediate release (IR) products of various drugs differ between biorelevant bicarbonate buffer (BCB) and compendial phosphate buffer (PPB).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The dissolution profiles of the IR products of fifteen poorly soluble ionizable drugs were measured in BCB and PPB. BCB was set to be relevant to the small intestine (pH 6.8, 10 mM). The pH was maintained using the floating lid method. The Japanese pharmacopeia second fluid (JP2, 25 mM phosphate buffer, nominal pH 6.8) was used as compendial PPB. The compendial paddle apparatus was used for the dissolution tests (500 mL, 50 rpm, 37\u00b0C).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In 11\/15 cases, a difference in dissolved% (&lt;\u20090.8 or\u2009&gt;\u20091.25-fold) was observed at a time point. In 4\/15 cases, the ratio of the area under the dissolution curve was not equivalent (&lt;\u20090.8 or\u2009&gt;\u20091.25-fold). In the cases of free-form drugs, the dissolution rate tended to be slower in BCB than in JP2. In the case of salt-form drugs, a marked difference was observed for the cases that showed supersaturation. However, no trend was observed in the differences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Many IR products showed differences in the dissolution profiles between biorelevant BCB and compendial PPB. With the floating lid method, BCB is as simple and easy to use as PPB. Biorelevant BCB is recommended for dissolution testing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11095-024-03701-6","type":"journal-article","created":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T14:01:46Z","timestamp":1713880906000},"page":"959-966","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Dissolution Profiles of Immediate Release Products of Various Drugs in Biorelevant Bicarbonate Buffer: Comparison with Compendial Phosphate Buffer"],"prefix":"10.1007","volume":"41","author":[{"given":"Nanami","family":"Okamoto","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Higashino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hibiki","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5652-1786","authenticated-orcid":false,"given":"Kiyohiko","family":"Sugano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,4,23]]},"reference":[{"key":"3701_CR1","doi-asserted-by":"publisher","first-page":"2","DOI":"10.2174\/1874126601004020002","volume":"4","author":"N Fotaki","year":"2010","unstructured":"Fotaki N, Vertzoni M. Biorelevant dissolution methods and their applications in in vitro-in vivo correlations for oral formulations. Open Drug Deliv J. 2010;4:2\u201313.","journal-title":"Open Drug Deliv J"},{"key":"3701_CR2","doi-asserted-by":"publisher","first-page":"4192","DOI":"10.1021\/acs.molpharmaceut.7b00198","volume":"14","author":"J Mann","year":"2017","unstructured":"Mann J, Dressman J, Rosenblatt K, Ashworth L, Muenster U, Frank K, et al. Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study. Mol Pharm. 2017;14:4192\u2013201.","journal-title":"Mol Pharm"},{"key":"3701_CR3","doi-asserted-by":"publisher","first-page":"1374","DOI":"10.1021\/mp1001203","volume":"7","author":"M McAllister","year":"2010","unstructured":"McAllister M. Dynamic dissolution: A step closer to predictive dissolution testing? Mol Pharm. 2010;7:1374\u201387.","journal-title":"Mol Pharm"},{"key":"3701_CR4","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1016\/j.ejpb.2019.04.017","volume":"140","author":"P Berben","year":"2019","unstructured":"Berben P, Ashworth L, Beato S, Bevernage J, Bruel JL, Butler J, et al. Biorelevant dissolution testing of a weak base: Interlaboratory reproducibility and investigation of parameters controlling in vitro precipitation. Eur J Pharm Biopharm. 2019;140:141\u20138.","journal-title":"Eur J Pharm Biopharm"},{"key":"3701_CR5","doi-asserted-by":"publisher","first-page":"397","DOI":"10.1208\/s12248-010-9203-3","volume":"12","author":"S Klein","year":"2010","unstructured":"Klein S. The use of biorelevant dissolution media to forecast the in vivo performance of a drug. AAPS J. 2010;12:397\u2013406.","journal-title":"AAPS J"},{"key":"3701_CR6","doi-asserted-by":"publisher","first-page":"380","DOI":"10.1023\/A:1011071401306","volume":"18","author":"E Nicolaides","year":"2001","unstructured":"Nicolaides E, Symillides M, Dressman JB, Reppas C. Biorelevant dissolution testing to predict the plasma profile of lipophilic drugs after oral administration. Pharm Res. 2001;18:380\u20138.","journal-title":"Pharm Res"},{"key":"3701_CR7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s11095-019-2731-3","volume":"37","author":"C Litou","year":"2020","unstructured":"Litou C, Psachoulias D, Vertzoni M, Dressman J, Reppas C. Measuring pH and buffer capacity in fluids aspirated from the fasted upper gastrointestinal tract of healthy adults. Pharm Res. 2020;37:1\u201312.","journal-title":"Pharm Res"},{"key":"3701_CR8","doi-asserted-by":"publisher","first-page":"1388","DOI":"10.1021\/mp100149j","volume":"7","author":"DM Mudie","year":"2010","unstructured":"Mudie DM, Amidon GL, Amidon GE. Physiological parameters for oral delivery and in vitro testing. Mol Pharm. 2010;7:1388\u2013405.","journal-title":"Mol Pharm"},{"key":"3701_CR9","doi-asserted-by":"publisher","first-page":"5291","DOI":"10.1021\/acs.molpharmaceut.8b00783","volume":"15","author":"J Al-Gousous","year":"2018","unstructured":"Al-Gousous J, Sun KX, McNamara DP, Hens B, Salehi N, Langguth P, et al. Mass transport analysis of the enhanced buffer capacity of the bicarbonate-CO2 buffer in a phase-heterogenous system: physiological and pharmaceutical significance. Mol Pharm. 2018;15:5291\u2013301.","journal-title":"Mol Pharm"},{"key":"3701_CR10","doi-asserted-by":"publisher","first-page":"56","DOI":"10.1016\/j.ijpharm.2009.08.003","volume":"382","author":"HM Fadda","year":"2009","unstructured":"Fadda HM, Merchant HA, Arafat BT, Basit AW. Physiological bicarbonate buffers: stabilisation and use as dissolution media for modified release systems. Int J Pharm. 2009;382:56\u201360.","journal-title":"Int J Pharm."},{"key":"3701_CR11","doi-asserted-by":"crossref","unstructured":"Scott N, Patel K, Sithole T, Xenofontos K, Mohylyuk V, Liu F. Regulating the pH of bicarbonate solutions without purging gases: Application to dissolution testing of enteric coated tablets, pellets and microparticles. Int J Pharm. 2020;585:119562.","DOI":"10.1016\/j.ijpharm.2020.119562"},{"key":"3701_CR12","doi-asserted-by":"publisher","first-page":"517","DOI":"10.1208\/s12249-013-9933-5","volume":"14","author":"G Garbacz","year":"2013","unstructured":"Garbacz G, Ko\u0142odziej B, Koziolek M, Weitschies W, Klein S. An Automated System for Monitoring and Regulating the pH of Bicarbonate Buffers. AAPS PharmSciTech. 2013;14:517\u201322.","journal-title":"AAPS PharmSciTech"},{"key":"3701_CR13","doi-asserted-by":"publisher","first-page":"1375","DOI":"10.1211\/jpp.59.10.0007","volume":"59","author":"JE Boni","year":"2007","unstructured":"Boni JE, Brickl RS, Dressman J. Is bicarbonate buffer suitable as a dissolution medium? J Pharm Pharmacol. 2007;59:1375\u201382.","journal-title":"J Pharm Pharmacol."},{"key":"3701_CR14","doi-asserted-by":"publisher","first-page":"102447","DOI":"10.1016\/j.jddst.2021.102447","volume":"63","author":"A Sakamoto","year":"2021","unstructured":"Sakamoto A, Izutsu K, Yoshida H, Abe Y, Inoue D, Sugano K. Simple bicarbonate buffer system for dissolution testing: Floating lid method and its application to colonic drug delivery system. J Drug Deliv Sci Technol. 2021;63:102447.","journal-title":"J Drug Deliv Sci Technol"},{"key":"3701_CR15","doi-asserted-by":"publisher","first-page":"106326","DOI":"10.1016\/j.ejps.2022.106326","volume":"180","author":"S Ikuta","year":"2023","unstructured":"Ikuta S, Nakagawa H, Kai T, Sugano K. Development of bicarbonate buffer flow-through cell dissolution test and its application in prediction of in vivo performance of colon targeting tablets. Eur J Pharm Sci. 2023;180:106326.","journal-title":"Eur J Pharm Sci"},{"key":"3701_CR16","doi-asserted-by":"publisher","first-page":"104438","DOI":"10.1016\/j.jddst.2023.104438","volume":"83","author":"F Matsui","year":"2023","unstructured":"Matsui F, Sakamoto A, Sugano K. Development of pH shift bicarbonate buffer dissolution test using floating lid and its feasibility for evaluating enteric-coated tablet. J Drug Deliv Sci Technol. 2023;83:104438.","journal-title":"J Drug Deliv Sci Technol"},{"key":"3701_CR17","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1016\/j.ejpb.2021.09.009","volume":"171","author":"K Krollik","year":"2022","unstructured":"Krollik K, Lehmann A, Wagner C, Kaidas J, Kubas H, Weitschies W. The effect of buffer species on biorelevant dissolution and precipitation assays\u2013Comparison of phosphate and bicarbonate buffer. Eur J Pharm Biopharm. 2022;171:90\u2013101.","journal-title":"Eur J Pharm Biopharm."},{"key":"3701_CR18","doi-asserted-by":"publisher","first-page":"989","DOI":"10.1007\/s11095-023-03508-x","volume":"40","author":"A Sakamoto","year":"2023","unstructured":"Sakamoto A, Sugano K. Dissolution Profiles of Poorly Soluble Drug Salts in Bicarbonate Buffer. Pharm Res. 2023;40:989\u201398.","journal-title":"Pharm Res"},{"key":"3701_CR19","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1248\/cpb.c20-00247","volume":"68","author":"H Yoshida","year":"2020","unstructured":"Yoshida H, Abe Y, Tomita N, Izutsu K. Utilization of Diluted Compendial Media as Dissolution Test Solutions with Low Buffer Capacity for the Investigation of Dissolution Rate of Highly Soluble Immediate Release Drug Products. Chem Pharm Bull (Tokyo). 2020;68:664\u201370.","journal-title":"Chem Pharm Bull (Tokyo)"},{"key":"3701_CR20","doi-asserted-by":"crossref","unstructured":"Avdeef A.\u00a0Absorption and drug development: solubility, permeability, and charge state. John Wiley &\u00a0Sons; 2012.\u00a0pp. 31\u2013173.","DOI":"10.1002\/9781118286067"},{"key":"3701_CR21","doi-asserted-by":"publisher","first-page":"1640","DOI":"10.1021\/ed077p1640","volume":"77","author":"ET Urbansky","year":"2009","unstructured":"Urbansky ET, Schock MR. Understanding, Deriving, and Computing Buffer Capacity. J Chem Educ. 2009;77:1640.","journal-title":"J Chem Educ"},{"key":"3701_CR22","doi-asserted-by":"publisher","first-page":"501","DOI":"10.1021\/bi00903a019","volume":"2","author":"RC Phillips","year":"1963","unstructured":"Phillips RC, Phillips SJ, George P, Rutman RJ. Potentiometric Studies of the Secondary Phosphate Ionizations of AMP, ADP, and ATP, and Calculations of Thermodynamic Data for the Hydrolysis Reactions *. Biochemistry. 1963;2:501\u20138.","journal-title":"Biochemistry"},{"key":"3701_CR23","doi-asserted-by":"publisher","first-page":"1144","DOI":"10.1007\/s11095-011-0377-x","volume":"28","author":"JZ Duan","year":"2011","unstructured":"Duan JZ, Riviere K, Marroum P. In vivo bioequivalence and in vitro similarity factor (f2) for dissolution profile comparisons of extended release formulations: How and when do they match? Pharm Res. 2011;28:1144\u201356.","journal-title":"Pharm Res"},{"key":"3701_CR24","doi-asserted-by":"publisher","first-page":"18","DOI":"10.14227\/DT090102P18","volume":"9","author":"MC Gohel","year":"2002","unstructured":"Gohel MC, Panchal MK. Refinement of lower acceptance value of the similarity factor f2 in comparison of dissolution profiles. Dissolution Technol. 2002;9:18\u201322.","journal-title":"Dissolution Technol"},{"key":"3701_CR25","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1023\/A:1011976615750","volume":"15","author":"VP Shah","year":"1998","unstructured":"Shah VP, Tsong Y, Sathe P, Liu J-P. In vitro dissolution profile comparison\u2014statistics and analysis of the similarity factor, f2. Pharm Res. 1998;15:889\u201396.","journal-title":"Pharm Res"},{"key":"3701_CR26","doi-asserted-by":"publisher","first-page":"2626","DOI":"10.1021\/acs.molpharmaceut.9b00187","volume":"16","author":"J Al-Gousous","year":"2019","unstructured":"Al-Gousous J, Salehi N, Amidon GE, Ziff RM, Langguth P, Amidon GL. Mass transport analysis of bicarbonate buffer: effect of the CO2-H2CO3 hydration-dehydration kinetics in the fluid boundary layer and the apparent effective p Ka controlling dissolution of acids and bases. Mol Pharm. 2019;16:2626\u201335.","journal-title":"Mol Pharm"},{"key":"3701_CR27","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1021\/mp800148u","volume":"6","author":"JJ Sheng","year":"2009","unstructured":"Sheng JJ, McNamara DP, Amidon GL. Toward an in vivo dissolution methodology: A comparison of phosphate and bicarbonate buffers. Mol Pharm. 2009;6:29\u201339.","journal-title":"Mol Pharm"},{"key":"3701_CR28","doi-asserted-by":"publisher","first-page":"3870","DOI":"10.1021\/acs.molpharmaceut.0c00614","volume":"17","author":"N Salehi","year":"2020","unstructured":"Salehi N, Al-Gousous J, Mudie DM, Amidon GL, Ziff RM, Amidon GE. Hierarchical mass transfer analysis of drug particle dissolution, highlighting the hydrodynamics, pH, particle size, and buffer effects for the dissolution of ionizable and nonionizable drugs in a compendial dissolution vessel. Mol Pharm. 2020;17:3870\u201384.","journal-title":"Mol Pharm"},{"key":"3701_CR29","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.jpba.2018.08.028","volume":"161","author":"T Uekusa","year":"2018","unstructured":"Uekusa T, Sugano K. Precipitation behavior of pioglitazone on the particle surface of hydrochloride salt in biorelevant media. J Pharm Biomed Anal. 2018;161:45\u201350.","journal-title":"J Pharm Biomed Anal"},{"key":"3701_CR30","doi-asserted-by":"publisher","first-page":"1669","DOI":"10.1021\/acs.molpharmaceut.9b00006","volume":"16","author":"J Oki","year":"2019","unstructured":"Oki J, Watanabe D, Uekusa T, Sugano K. Mechanism of supersaturation suppression in dissolution process of acidic drug salt. Mol Pharm. 2019;16:1669\u201377.","journal-title":"Mol Pharm"},{"key":"3701_CR31","doi-asserted-by":"crossref","unstructured":"Uekusa T, Oki J, Omori M, Watanabe D, Inoue D, Sugano K. Effect of buffer capacity on dissolution and supersaturation profiles of pioglitazone hydrochloride. J Drug Deliv Sci Technol. 2020;55:101492.","DOI":"10.1016\/j.jddst.2019.101492"},{"key":"3701_CR32","doi-asserted-by":"crossref","unstructured":"Komasaka T, Dressman J. Simulation of oral absorption from non-bioequivalent dosage forms of the salt of raltegravir, a poorly soluble acidic drug, using a physiologically based biopharmaceutical modeling (PBBM) approach. Eur J Pharm Sci. 2021;157:105630.","DOI":"10.1016\/j.ejps.2020.105630"},{"key":"3701_CR33","doi-asserted-by":"publisher","first-page":"151","DOI":"10.1016\/j.ejpb.2011.01.001","volume":"78","author":"F Liu","year":"2011","unstructured":"Liu F, Merchant HA, Kulkarni RP, Alkademi M, Basit AW. Evolution of a physiological pH 6.8 bicarbonate buffer system: Application to the dissolution testing of enteric coated products. Eur J Pharm Biopharm. 2011;78:151\u20137.","journal-title":"Eur J Pharm Biopharm."},{"key":"3701_CR34","doi-asserted-by":"publisher","first-page":"467","DOI":"10.1111\/jphp.12540","volume":"68","author":"H Shibata","year":"2016","unstructured":"Shibata H, Yoshida H, Izutsu KI, Goda Y. Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets. J Pharm Pharmacol. 2016;68:467\u201374.","journal-title":"J Pharm Pharmacol"},{"key":"3701_CR35","doi-asserted-by":"publisher","first-page":"104857","DOI":"10.1016\/j.jddst.2023.104857","volume":"87","author":"Z Xiong","year":"2023","unstructured":"Xiong Z, Wu P, Wang N, Cong H, Chen XD. How bio-relevant buffering media affect dissolution and release kinetics of solid formula: Ibuprofen as a model. J Drug Deliv Sci Technol. 2023;87:104857.","journal-title":"J Drug Deliv Sci Technol"},{"key":"3701_CR36","doi-asserted-by":"publisher","first-page":"2119","DOI":"10.1007\/s11095-021-03153-2","volume":"38","author":"A Sakamoto","year":"2021","unstructured":"Sakamoto A, Sugano K. Dissolution kinetics of nifedipine\u2014ionizable polymer amorphous solid dispersion: comparison between bicarbonate and phosphate buffers. Pharm Res. 2021;38:2119\u201327.","journal-title":"Pharm Res"}],"container-title":["Pharmaceutical Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11095-024-03701-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11095-024-03701-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11095-024-03701-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T14:07:13Z","timestamp":1716473233000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11095-024-03701-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,23]]},"references-count":36,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["3701"],"URL":"https:\/\/doi.org\/10.1007\/s11095-024-03701-6","relation":{},"ISSN":["0724-8741","1573-904X"],"issn-type":[{"value":"0724-8741","type":"print"},{"value":"1573-904X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,23]]},"assertion":[{"value":"18 February 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 April 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 April 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Author(s) declare(s) that they have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}}]}}