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Screening of novel excipients for freeze-dried protein formulations. Eur J Pharm Biopharm. 2021;160:55–64.",{"doi":446},"10.1016\u002Fj.ejpb.2021.01.008",{"id":18,"text":448,"url":18,"identifiers":449},"Koepf E, Eisele S, Schroeder R, Brezesinski G, Friess W. Notorious but not understood: how liquid-air interfacial stress triggers protein aggregation. Int J Pharm. 2018;537(1–2):202–12.",{"doi":450},"10.1016\u002Fj.ijpharm.2017.12.043",{"id":18,"text":452,"url":18,"identifiers":453},"Vaclaw C, Merritt K, Pringle V, Whitaker N, Gokhale M, Carvalho T, Pan D, Liu Z, Bindra D, Khossravi M, Bolgar M, Volkin DB, Ogunyankin MO, Dhar P. Impact of polysorbate 80 grade on the interfacial properties and interfacial stress induced subvisible particle formation in monoclonal antibodies. J Pharm Sci. 2021;110(2):746–59.",{"doi":454},"10.1016\u002Fj.xphs.2020.09.035",{"id":18,"text":456,"url":18,"identifiers":457},"Kiese S, Papppenberger A, Friess W, Mahler HC. Shaken, not stirred: mechanical stress testing of an IgG1 antibody. J Pharm Sci. 2008;97(10):4347–66.",{"doi":458},"10.1002\u002Fjps.21328",{"id":18,"text":460,"url":18,"identifiers":461},"Usami A, Ohtsu A, Takahama S, Fujii T. The effect of pH, hydrogen peroxide and temperature on the stability of human monoclonal antibody. J Pharm Biomed Anal. 1996;14(8–10):1133–40.",{"doi":462},"10.1016\u002FS0731-7085(96)01721-9",{"id":18,"text":464,"url":18,"identifiers":465},"Zheng S, Qiu D, Adams M, Li J, Mantri RV, Gandhi R. Investigating the degradation behaviors of a therapeutic monoclonal antibody associated with pH and buffer species. AAPS PharmSciTech. 2017;18(1):42–8.",{"doi":466},"10.1208\u002Fs12249-015-0403-0",{"id":18,"text":468,"url":18,"identifiers":469},"Mahler HC, Friess W, Grauschopf U, Kiese S. Protein aggregation: pathways, induction factors and analysis. J Pharm Sci. 2009;98(9):2909–34.",{"doi":470},"10.1002\u002Fjps.21566",{"id":18,"text":472,"url":18,"identifiers":473},"Sudrik CM, Cloutier T, Mody N, Sathish HA, Trout BL. Understanding the role of preferential exclusion of sugars and polyols from native state IgG1 monoclonal antibodies and its effect on aggregation and reversible self-association. Pharm Res. 2019;36(8):109.",{"doi":474},"10.1007\u002Fs11095-019-2642-3",{"id":18,"text":476,"url":18,"identifiers":477},"Kamerzell TJ, Esfandiary R, Joshi SB, Middaugh CR, Volkin DB. Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development. Adv Drug Deliv Rev. 2011;63(13):1118–59.",{"doi":478},"10.1016\u002Fj.addr.2011.07.006",{"id":18,"text":480,"url":18,"identifiers":481},"Wang W. Protein aggregation and its inhibition in biopharmaceutics. Int J Pharm. 2005;289(1–2):1–30.",{"doi":482},"10.1016\u002Fj.ijpharm.2004.11.014",{"id":18,"text":484,"url":18,"identifiers":485},"Wang W, Nema S, Teagarden D. Protein aggregation–pathways and influencing factors. Int J Pharm. 2010;390(2):89–99.",{"doi":486},"10.1016\u002Fj.ijpharm.2010.02.025",{"id":18,"text":488,"url":18,"identifiers":489},"Hauptmann A, Podgoršek K, Kuzman D, Srčič S, Hoelzl G, Loerting T. Impact of buffer, protein concentration and sucrose addition on the aggregation and particle formation during freezing and thawing. Pharm Res. 2018;35(5):101.",{"doi":490},"10.1007\u002Fs11095-018-2378-5",{"id":18,"text":492,"url":18,"identifiers":493},"Zhang C, Bye JW, Lui LH, Zhang H, Hales J, Brocchini S, Curtis RA, Dalby PA. Enhanced thermal stability and reduced aggregation in an antibody Fab fragment at elevated concentrations. Mol Pharm. 2023;20(5):2650–61.",{"doi":494},"10.1021\u002Facs.molpharmaceut.3c00081",{"id":18,"text":496,"url":18,"identifiers":497},"Schersch K, Betz O, Garidel P, Muehlau S, Bassarab S, Winter G. Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins, part 2: stability during storage at elevated temperatures. J Pharm Sci. 2012;101(7):2288–306.",{"doi":498},"10.1002\u002Fjps.23121",false,{"id":501,"createTime":502,"updateTime":503,"relativeEntities":504,"slug":505,"properties":506,"entityType":176,"verifyStatus":17,"verifyTime":515,"verifyNote":516,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"primaryUrl":517,"fullTextUrl":18,"authors":518,"publicationType":313,"publisherRelationship":586,"citationCount":18,"citationInfo":18,"publishDate":619,"publishYear":620,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":18,"isForceReanalyzing":499},"7ed8fbb6-0faf-4390-a350-c21212596c30","2024-01-18T00:37:56.664+00:00","2025-01-27T23:59:45.641+00:00",[],"Controlled-Gastric-Emptying-II-In-Vitro-Erosion-and-Gastric-Residence-Times-of-an-Erodible-Device-in-Beagle-Dogs",{"references":507,"abstract":509,"title":511,"doi":513},{"VOID":508},"C. Gardner. In R. Borchardt, A. Repta, and V. Stella (eds.), Directed Drug Delivery, Humana Press, Clifton, N.J., 1985, pp. 61–82.\nS. S. Davis. In R. Borchardt, A. Repta, and V. Stella (eds.), Directed Drug Delivery, Humana Press, Clifton, N.J., 1985, pp. 319–340.\nR. Cargill, L. Caldwell, K. Engle, J. A. Fix, P. A. Porter, and C. R. Gardner. Pharm Res. (in press).\nASTM. ASTM D 790 (Vol. 8.01), Annual Book of ASTM Standards, Philadelphia, Pa., 1987.\nJ. Heller. Biomaterials 1:51–57 (1980).\nR. V. Sparer, C. Shih, C. D. Ringeisen, and K. S. Himmelstein. J. Cont. Rel. 1:23–32 (1984).",{"EN":510},"An erodible gastric retention device fabricated from various polymeric blends was examined in vitro for its dissolution properties and in vivo in fasting dogs for assessment of its gastric retention potential. Dissolution studies were conducted with extruded rods of polymer blends to assess their potential as candidates for the erodible component of a gastrically retained device. Based on results from dissolution studies, rods of poly(ortho ester)\u002Fpolyethylene blends (POE\u002FPE) (45% erosion at pH 1.5 and 24 hr) were used to fabricate arms for tetrahedron-shaped devices. Corners for the tetrahedral device were fabricated from Silastic 382 loaded with 15% barium sulfate for X-ray visualization. Beagle dogs were dosed with tetrahedron-shaped test devices administered in gelatin capsules and gastric retention monitored by X ray over a 24-hr period. A comparison of in vitro erosion rates and in vivo performance of various polymer blends indicated a definite trend for increased gastric retention of devices made from the more slowly eroding blends. The results indicate that the blending of erodible and nonerodible polymers is a valid approach for obtaining materials that will provide the necessary structural properties to achieve gastric retention yet lose integrity within a desired time.",{"EN":512},"Controlled Gastric Emptying. II. In Vitro Erosion and Gastric Residence Times of an Erodible Device in Beagle Dogs",{"VOID":514},"10.1023\u002FA:1015976709043","2025-01-27T23:59:45.640+00:00","Author affiliation is blank","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1023\u002FA:1015976709043",[519,527,542,549,564,579],{"id":520,"sortIndex":296,"researcher":18,"roles":521,"affiliations":523,"properties":524},"897ec552-edbf-4d76-ade0-77f7a689185e",[522],"AUTHOR",[],{"title":525},{"VI":526},"Randall V. Sparer",{"id":528,"sortIndex":259,"researcher":18,"roles":529,"affiliations":530,"properties":539},"50684f27-81df-4533-9daa-3d5d7a5e4f50",[522],[531],{"id":18,"sortIndex":19,"affiliation":532,"properties":18},{"id":533,"createTime":534,"updateTime":534,"relativeEntities":535,"slug":18,"properties":536,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"122f2543-4c3d-465a-9050-f3ef6574c4b1","2024-01-18T00:37:56.709+00:00",[],{"title":537},{"VI":538},"Department of Pathology, The University of Texas, Health Science Center",{"title":540},{"VI":541},"Patricia Porter",{"id":543,"sortIndex":185,"researcher":18,"roles":544,"affiliations":545,"properties":546},"17e4c950-b949-4449-845c-5506feea84aa",[522],[],{"title":547},{"VI":548},"Joseph A. Fix",{"id":550,"sortIndex":227,"researcher":18,"roles":551,"affiliations":552,"properties":561},"7c1240ff-f852-4017-947c-44a093e49a57",[522],[553],{"id":18,"sortIndex":19,"affiliation":554,"properties":18},{"id":555,"createTime":556,"updateTime":556,"relativeEntities":557,"slug":18,"properties":558,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"8b5dcf14-1f15-49dc-82f0-42939301d31d","2024-01-18T00:37:56.696+00:00",[],{"title":559},{"VI":560},"Merck, Sharp and Dohme Research Laboratories, Pharmaceutical Research, West Point",{"title":562},{"VI":563},"Colin R. Gardner",{"id":565,"sortIndex":19,"researcher":18,"roles":566,"affiliations":567,"properties":576},"7cfde203-981a-4be9-861d-c10a668da361",[522],[568],{"id":18,"sortIndex":19,"affiliation":569,"properties":18},{"id":570,"createTime":571,"updateTime":571,"relativeEntities":572,"slug":18,"properties":573,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"c72d6a5b-7fe2-4687-aa52-043c9fcaa642","2024-01-18T00:37:56.679+00:00",[],{"title":574},{"VI":575},"INTERx-Merck, Sharp and Dohme Research Laboratories, Lawrence",{"title":577},{"VI":578},"Robyn Cargill",{"id":580,"sortIndex":244,"researcher":18,"roles":581,"affiliations":582,"properties":583},"99d0f2b2-e1f6-4b62-88ce-2dbe71771986",[522],[],{"title":584},{"VI":585},"Karen Engle",{"url":517,"publisher":587,"properties":614},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":588,"slug":10,"properties":589,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":592,"manageAffiliations":593,"indexDatabases":594,"url":18,"thumbnailPath":18,"statistic":609,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":590,"title":591},{"VOID":13},{"EN":15},[],[],[595,602],{"id":116,"indexDatabase":596,"url":129,"indexYears":130,"academicFieldIds":601,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":597,"label":598,"description":599,"key":126,"publicationTags":600,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":603,"url":111,"indexYears":18,"academicFieldIds":608,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":604,"label":605,"description":606,"key":107,"publicationTags":607,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":610,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":611,"totalCitation":146,"totalCitationByYear":612,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":613,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},{"volume":615,"pages":617},{"VOID":616},"6",{"VOID":618},"506-509","1989-06-01",1989,{"id":622,"createTime":623,"updateTime":624,"relativeEntities":625,"slug":626,"properties":627,"entityType":176,"verifyStatus":177,"verifyTime":624,"verifyNote":178,"syncStatus":17,"languages":636,"translateLanguages":18,"viewCount":19,"primaryUrl":637,"fullTextUrl":18,"authors":638,"publicationType":313,"publisherRelationship":709,"citationCount":18,"citationInfo":18,"publishDate":742,"publishYear":743,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":744,"isForceReanalyzing":499},"6e12bd89-3454-4864-8ee0-166780e2c9aa","2024-04-19T04:48:42.053+00:00","2024-12-24T23:59:31.559+00:00",[],"A-Theoretical-Basis-for-a-Biopharmaceutic-Drug-Classification-The-Correlation-of-in-Vitro-Drug-Product-Dissolution-and-in-Vivo-Bioavailability",{"keywords":628,"abstract":630,"title":632,"doi":634},{"EN":629},"",{"EN":631},"A biopharmaceutics drug classification scheme for correlating in vitro drug product dissolution and in vivo bioavailability is proposed based on recognizing that drug dissolution and gastrointestinal permeability are the fundamental parameters controlling rate and extent of drug absorption. This analysis uses a transport model and human permeability results for estimating in\nvivo drug absorption to illustrate the primary importance of solubility and permeability on drug absorption. The fundamental parameters which define oral drug absorption in humans resulting from this analysis are discussed and used as a basis for this classification scheme. These Biopharmaceutic Drug Classes are defined as: Case 1. High solubility-high permeability drugs, Case 2. Low solubility-high permeability drugs, Case 3. High solubility-low permeability drugs, and Case 4. Low solubility-low permeability drugs. Based on this classification scheme, suggestions are made for setting standards for in vitro drug dissolution testing methodology which will correlate with the in vivo process. This methodology must be based on the physiological and physical chemical properties controlling drug absorption. This analysis points out conditions under which no\nin vitro-in vivo correlation may be expected e.g. rapidly dissolving low permeability drugs. Furthermore, it is suggested for example that for very rapidly dissolving high solubility drugs, e.g. 85% dissolution in less than 15 minutes, a simple one point dissolution test, is all that may be needed to insure bioavailability. For slowly dissolving drugs a dissolution profile is required with multiple time points in systems which would include low pH, physiological pH, and surfactants and the in vitro conditions should mimic the in vivo processes. This classification scheme provides a basis for establishing in vitro-in vivo correlations and for estimating the absorption of drugs based on the fundamental dissolution and permeability properties of physiologic importance.",{"EN":633},"A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability",{"VOID":635},"10.1023\u002FA:1016212804288",[180],"https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1023\u002FA:1016212804288",[639,657,675,691],{"id":640,"sortIndex":244,"researcher":18,"roles":641,"affiliations":642,"properties":654},"f276cb53-d978-4239-8f85-748abddd081a",[],[643],{"id":644,"sortIndex":19,"affiliation":645,"properties":18},"0265b5ef-aec3-49a6-974f-048c3b1cc591",{"id":646,"createTime":647,"updateTime":648,"relativeEntities":649,"slug":650,"properties":651,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"44ba90f9-bb32-49ff-9b45-448431fa7e48","2024-04-19T04:48:42.073+00:00","2024-06-20T18:40:21.030+00:00",[],"School-of-Pharmacy-Uppsala-University-Sweden",{"title":652},{"EN":653},"School of Pharmacy, Uppsala University, Sweden",{"title":655},{"EN":656},"Hans Lennernäs",{"id":658,"sortIndex":227,"researcher":18,"roles":659,"affiliations":660,"properties":672},"f7cf0b93-e387-41f1-9c4a-a259d37cbd5b",[],[661],{"id":662,"sortIndex":19,"affiliation":663,"properties":18},"acaefdd5-0078-4eeb-839a-9101fd20fdfe",{"id":664,"createTime":665,"updateTime":666,"relativeEntities":667,"slug":668,"properties":669,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"e811f03f-373c-4645-b59d-12d6b78ed649","2024-04-19T04:48:42.086+00:00","2024-06-02T21:11:25.694+00:00",[],"PDA-HFD-602-Rockville",{"title":670},{"EN":671},"PDA, HFD-602, Rockville",{"title":673},{"EN":674},"Vinod P. 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Amidon",{"url":18,"publisher":710,"properties":737},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":711,"slug":10,"properties":712,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":715,"manageAffiliations":716,"indexDatabases":717,"url":18,"thumbnailPath":18,"statistic":732,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":713,"title":714},{"VOID":13},{"EN":15},[],[],[718,725],{"id":116,"indexDatabase":719,"url":129,"indexYears":130,"academicFieldIds":724,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":720,"label":721,"description":722,"key":126,"publicationTags":723,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":726,"url":111,"indexYears":18,"academicFieldIds":731,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":727,"label":728,"description":729,"key":107,"publicationTags":730,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":733,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":734,"totalCitation":146,"totalCitationByYear":735,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":736,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},{"volume":738,"pages":740},{"VOID":739},"12",{"VOID":741},"413-420","1995-03-01",1995,[745,747,749,751,753,755,757,759,761,763,765,767,769,771,773,775,777,779,781,783,785,787,789,791,793,795,797,799,801,803,805,807,809],{"id":18,"text":746,"url":18,"identifiers":18},"N.F.H. Ho, H.P. Merkle, and W.I. Higuchi. Quantitative, Mechanistic and Physiologically Realistic Approach to the Biopharmaceutical Design of Oral Drug Delivery Systems. Drug Dev. and Ind. Pharm. 9:1111–1184 (1983).",{"id":18,"text":748,"url":18,"identifiers":18},"P.J. Sinko, G.D. Leesman, and G.L. Amidon, Predicting fraction dose absorbed in humans using a macroscopic mass balance approach, Pharm. Res., 8:979–988 (1991).",{"id":18,"text":750,"url":18,"identifiers":18},"D-M Oh, R.L. Curl, and G.L. Amidon. Estimating the Fraction Dose Absorbed From Suspensions of Poorly Soluble Compounds in Humans: A Mathematical Model. Pharm. Res. 10:264–270 (1993)",{"id":18,"text":752,"url":18,"identifiers":18},"J.B. Dressman and D. Fleisher. Mixing-tank Model for Predicting Dissolution Rate Control of Oral Absorption. J. Pharm. Sci. 75:109–116 (1986).",{"id":18,"text":754,"url":18,"identifiers":18},"R.B. Hintz and K.C. Johnson. The Effect of Particle Size Distribution on Dissolution and Oral Absorption. Int J Pharm, 51:9–17 (1989).",{"id":18,"text":756,"url":18,"identifiers":18},"G.D. Leesman, R.L. Oberle, G.L. Amidon, The Use of Error Functions in Characterizing Gastric Emptying in Humans, Pharm Res, 8:S-254 (1991).",{"id":18,"text":758,"url":18,"identifiers":18},"R.L. Oberle, The Influence of the Interdigestive Migrating Myoelectric Complex on the Gastric Emptying of Liquids and Oral Absorption of Cimetidine, Ph.D. Thesis, The University of Michigan, Ann Arbor, MI (1988).",{"id":18,"text":760,"url":18,"identifiers":18},"R.L. Oberle, and G.L. Amidon, The influence of variable gastric emptying and intestineal transit rates on the plasma level curve of cimetidine; an explaination for the double peak phenomenon, J Pharmacok Biopharm, 15:529 (1987).",{"id":18,"text":762,"url":18,"identifiers":18},"R.L. Oberle, T-S Chen, C. lloyd, J.L. Barnett, C. Owyang, J. Meyer, G.L. Amidon, The Influence of the Interdigestive Migrating Myoelectrc Complex on the Gastric Emptying of Liquids. Gastroenterology, 99:1275–1282 (1990).",{"id":18,"text":764,"url":18,"identifiers":18},"P.J. Sinko, G.D. Leesman, and G.L. Amidon, Mass Balance Approaches for Estimating the Intestinal Absorption and Metabolism of Peptides and Analogues: Theoretical Development and Applications, Pharm. Res. 10:271–275 (1993).",{"id":18,"text":766,"url":18,"identifiers":18},"G.L. Amidon, P.J. Sinko, D. Fleisher, Estimating human oral fraction dose absorbed: A correlation using rat intestinal membrane permeability for passive and carrier-mediated compounds, Pharm. Res. 5:651–654 (1988).",{"id":18,"text":768,"url":18,"identifiers":18},"D-M Oh, Estimating Oral Drug Absorption in Humans, Ph.D. Thesis. The University of Michigan, Ann Arbor, MI. (1991).",{"id":18,"text":770,"url":18,"identifiers":18},"J.R. Crison. Estimating the Dissolution and Absorption of Water Insoluble Drugs in the Small Intestine. Ph.D. Thesis, The University of Michigan, Ann Arbor, MI. (1993).",{"id":18,"text":772,"url":18,"identifiers":18},"E.L. Cussler, Diffusion, Mass transfer in fluid systems, Cambridge University Press, NY (1986).",{"id":18,"text":774,"url":18,"identifiers":18},"H. Lennernas, O. Ahrenstedt, R. Hallgren, L. Knutson, M. Ryde, L.K. Paalzow, Regional Jejunal Perfusion, A New in Vivo Approach to Study Oral Drug Absorption in Man, Pharm Res, 9:1243–1255 (1992).",{"id":18,"text":776,"url":18,"identifiers":18},"J.B. Dressman, D. Fleisher, and G.L. Amidon. Physicochemical Model for Dose-Dependent Drug Absorption, J Pharm Sci, 73: 1274 (1984).",{"id":18,"text":778,"url":18,"identifiers":18},"E.M. Topp, Physiological Flow Models for Intestinal Absorption and Plasma Kinetics of Aspirin, Thesis, The University of Michigan (1986).",{"id":18,"text":780,"url":18,"identifiers":18},"G.D. Leesman, P.J. Sinko, and G.L. Amidon, Simulation of Oral Drug Absorption: Gastric Emptying and Gastrointestinal Motility, in: Pharmacokinetics, P.W. Welling and F.L.S. Tse, Editors, Marcel Dekker, Inc., (NY) 1988, Ch 6, p 267.",{"id":18,"text":782,"url":18,"identifiers":18},"P.F. Ni, N.F.H. Ho, J.L. Fox, H. Leuenberger, and W.I. Higuchi. Theoretical Model Studies of Intestinal Drug Absorption V. Non-Steady-State Fluid Flow and Absorption. Int. J. Pharm., 5:33–47 (1980).",{"id":18,"text":784,"url":18,"identifiers":18},"G.L. Amidon, J. Kou, R.L. Elliott, and E.N. Lightfoot, Analysis of Models for Determining Intestinal Wall Permeabilities, J Pharm Sci, 69: 1370 (1980).",{"id":18,"text":786,"url":18,"identifiers":18},"J.H. Kou, D. Fleisher, and G.L. Amidon, Calculation of the aqueous diffusion layer resistence for absorption in a tube: application to intestinal membrane permeability determination, Pharm Res, 8:298 (1991).",{"id":18,"text":788,"url":18,"identifiers":18},"V.G. Levich, Physico-Chemical Hydrodynamics, Prentice-Hall, Englewood Cliffs, NJ (1962).",{"id":18,"text":790,"url":18,"identifiers":18},"H. Lennernäs, Intestinal Absorption Characteristics of Three Model Drugs, Thesis, The University of Uppsala, Sweden (1992).",{"id":18,"text":792,"url":18,"identifiers":18},"U. Fagerholm, L. Borgström, Ö. Ahrenstedt, H. Lenneräs, The lack of effect of induced net fluid absorption on the in vivo permeability of terbutaline in the human jejunum. J. Drug Targeting. In press (1995).",{"id":18,"text":794,"url":18,"identifiers":18},"H. Lenneräs, D. Nilsson, S-M. Aquilonius, O. Ahrenstedt, L. Knutson, L.K. Paalzow, The effect of L-leucine on the absorption of levodopa, studied by regional jejunal perfusion in man. Br. J. Clin. Pharmacol., 35:243–250 (1993).",{"id":18,"text":796,"url":18,"identifiers":18},"H. Lenneräs, Ö. Ahrenstedt, A-L. Ungell, Intestinal drug absorption during induced net water absorption in man; A mechanistic study using antipyrine, atenolol, and enalaprilat. Br. J. Clin. Pharmacol., 37:589–596 (1994).",{"id":18,"text":798,"url":18,"identifiers":18},"A.J. Jounela, P.J. Pentikainen, A. Sothman, Effect of Particle Size on the Bioavailability of Digoxin, Europ J clin Pharmacol, 8:365–370 (1975).",{"id":18,"text":800,"url":18,"identifiers":18},"M. Kraml, J. Dubuc, R. Gaudry, Gastrointestinal Absorption of Griseofulvin: II. Influence of Particle Size in Man, Antibiotics and Chemotherapy, 12:239–242 (1962).",{"id":18,"text":802,"url":18,"identifiers":18},"H.M. Abdou, Dissolution, Bioavailability, & Bioequivalence, A. Gennaro, B. Migdalof, G.L. Hassert and T. Medwick (Eds), Mack Publishing Co., Easton PA (1989).",{"id":18,"text":804,"url":18,"identifiers":18},"V.P. Shah, J.J. Konecny, R.L. Everett, B. McCullough, A.C. Noorizadeh, J.P. Skelly, In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactacts, Pharm Res., 6:612:618 (1989).",{"id":18,"text":806,"url":18,"identifiers":18},"P.E. Macheras, M.A. Koupparis and S.G. Antimisiaris. Effect of Temperature and Fat Content on the Solubility of Hydrochlorothiazide and Chlorothiazide im Milk. J. Pharm. Sci., 78:933–936 (1989).",{"id":18,"text":808,"url":18,"identifiers":18},"The Merck Index, Tenth Edition, Merck & Co., Inc., Rahway, NJ (1983).",{"id":18,"text":810,"url":18,"identifiers":18},"S.S. Davis, J.G. Hardy and J.W. Fara, Transit of Pharmaceutical Dosage Forms Through the Small Intestine, Gut, 27:886–892 (1986).",{"id":812,"createTime":813,"updateTime":814,"relativeEntities":815,"slug":816,"properties":817,"entityType":176,"verifyStatus":177,"verifyTime":814,"verifyNote":178,"syncStatus":17,"languages":825,"translateLanguages":18,"viewCount":19,"primaryUrl":826,"fullTextUrl":18,"authors":827,"publicationType":313,"publisherRelationship":867,"citationCount":18,"citationInfo":18,"publishDate":895,"publishYear":896,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":897,"isForceReanalyzing":499},"f1d05c96-a5e2-4a59-8bd4-c59ddd980a4e","2024-04-09T11:43:58.299+00:00","2024-12-19T23:58:53.674+00:00",[],"Excipient-Interaction-with-Cetylpyridinium-Chloride-Activity-in-Tablet-Based-Lozenges",{"keywords":818,"abstract":819,"title":821,"doi":823},{"EN":629},{"EN":820},"\nPurpose. The purpose of the investigation was to determine the effect of tablet excipients on the activity of cetylpyridinium chloride (CPC) and the relative interaction between excipients and CPC. \nMethods. An analytical assay was developed to evaluate the interaction between CPC and the excipients. In vivo activity was investigated using six volunteers by determining the reduction in colony forming units recoverable from the oropharynx after sucking each proprietary lozenge separately on different days. In vitro determinations investigated the relative antimicrobial activity of aqueous solutions of the lozenges and, the effect of pH and tablet base excipients on that activity against Staphylococcus aureus, Streptococcus pyogenes and Candida albicans. \nResults. Both in vivo and in vitro results showed that the tablet based lozenges had markedly reduced antimicrobial activities compared with previous results with a candy based lozenge (in\nvivo and in vitro) or the same concentration of aqueous CPC (in vitro}. Magnesium stearate suspensions in CPC 250 µg\u002Fml indicated that magnesium stearate adsorbed CPC and at 0.4% lozenge weight and above significantly reduced the antimicrobial activity of CPC 250 µg\u002Fml. \nConclusions. The reduced activity of CPC in tablet based lozenges resulted from a decreased availability of CPC in solution due to an adsorption of CPC on magnesium stearate. To avoid this reduction in activity tablet based lozenges containing CPC 250 µg\u002Fml, or similar concentrations, plus magnesium stearate should contain not more than 0.3% w\u002Fw lozenge weight of the lubricant.",{"EN":822},"Excipient Interaction with Cetylpyridinium Chloride Activity in Tablet Based Lozenges",{"VOID":824},"10.1023\u002FA:1016084824877",[180],"https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1023\u002FA:1016084824877",[828,843,855],{"id":829,"sortIndex":19,"researcher":18,"roles":830,"affiliations":831,"properties":840},"cbab83ef-a3e2-419b-8b0d-bc05484c95b1",[],[832],{"id":18,"sortIndex":19,"affiliation":833,"properties":18},{"id":834,"createTime":835,"updateTime":835,"relativeEntities":836,"slug":18,"properties":837,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"3fc119f2-7c9d-4f0d-9d55-17239ff94ac7","2024-01-20T13:22:53.137+00:00",[],{"title":838},{"VI":839},"School of Pharmacy, The Robert Gordon University, Aberdeen, United Kingdom",{"title":841},{"EN":842},"R. Michael E. Richards",{"id":844,"sortIndex":244,"researcher":18,"roles":845,"affiliations":846,"properties":852},"cec16f7f-9c05-4a7d-91b5-3bad7d9ae879",[],[847],{"id":18,"sortIndex":19,"affiliation":848,"properties":18},{"id":834,"createTime":835,"updateTime":835,"relativeEntities":849,"slug":18,"properties":850,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":851},{"VI":839},{"title":853},{"EN":854},"James Z. Xing",{"id":856,"sortIndex":227,"researcher":18,"roles":857,"affiliations":858,"properties":864},"6a4d57af-37e8-4a25-99ca-acc3b10ddc8d",[],[859],{"id":18,"sortIndex":19,"affiliation":860,"properties":18},{"id":834,"createTime":835,"updateTime":835,"relativeEntities":861,"slug":18,"properties":862,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":863},{"VI":839},{"title":865},{"EN":866},"Kirsty M. B. Mackay",{"url":18,"publisher":868,"properties":18},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":869,"slug":10,"properties":870,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":873,"manageAffiliations":874,"indexDatabases":875,"url":18,"thumbnailPath":18,"statistic":890,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":871,"title":872},{"VOID":13},{"EN":15},[],[],[876,883],{"id":116,"indexDatabase":877,"url":129,"indexYears":130,"academicFieldIds":882,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":878,"label":879,"description":880,"key":126,"publicationTags":881,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":884,"url":111,"indexYears":18,"academicFieldIds":889,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":885,"label":886,"description":887,"key":107,"publicationTags":888,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":891,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":892,"totalCitation":146,"totalCitationByYear":893,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":894,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},"1996-08-01",1996,[898,900,902,904,906,908,910,912,914,916,918,920,922,924,926],{"id":18,"text":899,"url":18,"identifiers":18},"R. M. E. Richards. Inhibitory activity of lozenges on oral bacteria. Pharmacotherapy. 8:52, (1988).",{"id":18,"text":901,"url":18,"identifiers":18},"R. M. E. Richards and G. Cowie. Evaluation of the number of viable bacteria recovered from the mouth after sucking lozenges. Pharm. J. 241 (Practice Res. Suppl.): R26–27, (1988).",{"id":18,"text":903,"url":18,"identifiers":18},"R. M. E. Richards, G. Cowie and G. J. McCague. In vivo investigations of the antibacterial activity of lozenges and mouthwashes on the aerobic bacterial flora of the mouth and throat. Pharm. J. 242:659–663, (1989).",{"id":18,"text":905,"url":18,"identifiers":18},"R. M. E. Richards and L. M. Rochester. Influence of formulation on the effectiveness of antimicrobials in the oropharynx. 49th. FIP, Int. Cong. Abstracts, Abstr. 120, 1989.",{"id":18,"text":907,"url":18,"identifiers":18},"R. M. E. Richards and D. K. L. Xing. In vitro evaluation of the antimicrobial activities of selected lozenges. J. Pharm. Sci. 82:1218–1220, (1993).",{"id":18,"text":909,"url":18,"identifiers":18},"R. M. E. Richards, J. Z. Xing and L. Weir. The effect of formulation on the antimicrobial activity of cetylpyridinium chloride in candy based lozenges. Pharm. Res. 13:581–585, (1996).",{"id":18,"text":911,"url":18,"identifiers":18},"Cetylpyridinium chloride, In The United States Pharmacopeia XXII. United States Pharmacopeial Convention, Inc., United States, 1990, pp.268.",{"id":18,"text":913,"url":18,"identifiers":18},"Magnesium stearate, In British Pharmacopoeia. London HMSO, United Kingdom, 1993, pp. 397–398.",{"id":18,"text":915,"url":18,"identifiers":18},"J. Murdoch and J. A. Barnes. Statistical Tables, Macmillan Education Ltd., London, 1991.",{"id":18,"text":917,"url":18,"identifiers":18},"P. R. Nelson. Design and analysis of experiments. In H. M. Wadsworth, Jr. (ed.), Handbook of Statistical Methods for Engineers and Scientists. McGraw-Hill Publishing Company, United States, 1990, pp. 14.21-14.23.",{"id":18,"text":919,"url":18,"identifiers":18},"G. Levy and R. H. Gumtow. Effect of certain formulation factors on dissolution rate of the active ingredient III: tablet lubricants. J. Pharm. Sci. 52:1139–1144, (1963).",{"id":18,"text":921,"url":18,"identifiers":18},"H. C. Caldwell. Dissolution of lithium and magnesium from lithium carbonate capsules containing magnesium stearate. J. Pharm. Sci. 63:770–773, (1972).",{"id":18,"text":923,"url":18,"identifiers":18},"M. S. H. Hussain, P. York and P. Timmins. Effect of commercial and high purity magnesium on in-vitro dissolution of paracetamol DC tablets. Int. J. Pharm. 78:203–207, (1992).",{"id":18,"text":925,"url":18,"identifiers":18},"R. A. Nash. Sorbitol. In A. Wade and P. J. Weller (ed.) Handbook of Pharmaceutical Excipients, (2nd. Ed.) The Pharmaceutical Press, London, 1986, pp.477-480.",{"id":18,"text":927,"url":18,"identifiers":18},"H. E. C. Worthington and P. M. Olinger. Xylitol. In A. Wade and P. J. Weller (ed.) Handbook of Pharmaceutical Excipients, (2nd. Ed.) The Pharmaceutical Press, London, 1986, pp.564-567.",{"id":929,"createTime":930,"updateTime":931,"relativeEntities":932,"slug":933,"properties":934,"entityType":176,"verifyStatus":177,"verifyTime":931,"verifyNote":178,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"primaryUrl":943,"fullTextUrl":18,"authors":944,"publicationType":313,"publisherRelationship":1099,"citationCount":18,"citationInfo":18,"publishDate":1132,"publishYear":1133,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":18,"isForceReanalyzing":499},"026ee9c3-6afa-46ab-a19b-2a7311fba41a","2024-02-19T01:04:17.739+00:00","2025-01-24T23:58:39.452+00:00",[],"Physiology-Based-IVIVE-Predictions-of-Tramadol-from-in-Vitro-Metabolism-Data",{"references":935,"abstract":937,"title":939,"doi":941},{"VOID":936},"Grond S. Clinical pharmacology of tramadol. 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Arzneimittelforschung. 1986;36–2(8):1278–83.\nLintz W, Barth H, Becker R, Frankus E, Schmidt-Bothelt E. Pharmacokinetics of tramadol and bioavailability of enteral tramadol formulations—2nd communication: drops with ethanol. Arzneimittelforschung. 1998;48(5):436–45.\nLintz W, Barth H, Osterloh G, Schmidt-Bothelt E. Pharmacokinetics of tramadol and bioavailability of enteral tramadol formulations—3rd communication: suppositories. Arzneimittelforschung. 1998;48(9):889–99.\nQuetglas EG, Azanza JR, Cardenas E, Sadaba B, Campanero MA. Stereoselective pharmacokinetic analysis of tramadol and its main phase I metabolites in healthy subjects after intravenous and oral administration of racemic tramadol. Biopharm Drug Dispos. 2007;28(1):19–33.\nRodgers T, Leahy D, Rowland M. Physiologically based pharmacokinetic modeling 1: predicting the tissue distribution of moderate-to-strong bases. J Pharm Sci. 2005;94(6):1259–76.\nChen Y, Liu L, Nguyen K, Fretland AJ. 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Comparison of the use of liver models for predicting drug clearance using in vitro kinetic data from hepatic microsomes and isolated hepatocytes. Pharm Res. 2004;21(5):785–92.\nFoster JA, Houston JB, Hallifax D. Comparison of intrinsic clearances in human liver microsomes and suspended hepatocytes from the same donor livers: clearance-dependent relationship and implications for prediction of in vivo clearance. Xenobiotica. 2011;41(2):124–36.\nBerezhkovskiy LM, Liu N, Halladay JS. Consistency of the novel equations for determination of hepatic clearance and drug time course in liver that account for the difference in drug ionization in extracellular and intracellular tissue water. J Pharm Sci. 2012;101(2):516–8.\nBerezhkovskiy L, Wong S, Halladay J. On the maintenance of hepatocyte intracellular pH 7.0 in the in-vitro metabolic stability assay. J Pharmacokinet Pharmacodyn. 2013;40(6):683–9.\nPoulin P, Hop CECA, Ho Q, Halladay JS, Haddad S, Kenny JR. Comparative assessment of in vitro-in vivo extrapolation methods used for predicting hepatic metabolic clearance of drugs. J Pharm Sci. 2012;101(11):4308–26.",{"EN":938},"To predict the tramadol in vivo pharmacokinetics in adults by using in vitro metabolism data and an in vitro-in vivo extrapolation (IVIVE)-linked physiologically-based pharmacokinetic (PBPK) modeling and simulation approach (Simcyp®). Tramadol metabolism data was gathered using metabolite formation in human liver microsomes (HLM) and recombinant enzyme systems (rCYP). Hepatic intrinsic clearance (CLintH) was (i) estimated from HLM corrected for specific CYP450 contributions from a chemical inhibition assay (model 1); (ii) obtained in rCYP and corrected for specific CYP450 contributions by study-specific intersystem extrapolation factor (ISEF) values (model 2); and (iii) scaled back from in vivo observed clearance values (model 3). The model-predicted clearances of these three models were evaluated against observed clearance values in terms of relative difference of their geometric means, the fold difference of their coefficients of variation, and relative CYP2D6 contribution. Model 1 underpredicted, while model 2 overpredicted the total tramadol clearance by −27 and +22%, respectively. The CYP2D6 contribution was underestimated in both models 1 and 2. Also, the variability on the clearance of those models was slightly underpredicted. Additionally, blood-to-plasma ratio and hepatic uptake factor were identified as most influential factors in the prediction of the hepatic clearance using a sensitivity analysis. IVIVE-PBPK proved to be a useful tool in combining tramadol’s low turnover in vitro metabolism data with system-specific physiological information to come up with reliable PK predictions in adults.",{"EN":940},"Physiology-Based IVIVE Predictions of Tramadol from in Vitro Metabolism Data",{"VOID":942},"10.1007\u002Fs11095-014-1460-x","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002Fs11095-014-1460-x",[945,960,972,985,1002,1014,1033,1045,1057,1072,1084],{"id":946,"sortIndex":185,"researcher":18,"roles":947,"affiliations":948,"properties":957},"c6930190-fcfa-46f2-a73d-fd61567ea1ab",[522],[949],{"id":18,"sortIndex":19,"affiliation":950,"properties":18},{"id":951,"createTime":952,"updateTime":952,"relativeEntities":953,"slug":18,"properties":954,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"319d49ec-5cd8-4ed1-aa5b-b4651357d405","2024-02-19T01:04:17.822+00:00",[],{"title":955},{"VI":956},"Division of Janssen Pharmaceutica NV, Janssen Research and Development, Beerse, Belgium",{"title":958},{"VI":959},"Filip Cuyckens",{"id":961,"sortIndex":144,"researcher":18,"roles":962,"affiliations":963,"properties":969},"ea64c546-31c2-4661-93f4-ad6e6aecdeaf",[522],[964],{"id":18,"sortIndex":19,"affiliation":965,"properties":18},{"id":951,"createTime":952,"updateTime":952,"relativeEntities":966,"slug":18,"properties":967,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":968},{"VI":956},{"title":970},{"VI":971},"Achiel Van 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Mannens",{"id":986,"sortIndex":19,"researcher":18,"roles":987,"affiliations":988,"properties":999},"38eeeefb-0310-4a5a-a772-f7aaf2aba1ca",[522],[989],{"id":18,"sortIndex":19,"affiliation":990,"properties":18},{"id":991,"createTime":992,"updateTime":993,"relativeEntities":994,"slug":995,"properties":996,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"4c995428-2b8e-4f2c-af60-6a471483620a","2024-02-19T01:04:17.856+00:00","2024-10-14T05:20:16.622+00:00",[],"Laboratory-of-Medical-Biochemistry-and-Clinical-Analysis-Faculty-of-Pharmaceutical-Sciences-Ghent-University-Ghent-Belgium",{"title":997},{"VI":998},"Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium",{"title":1000},{"VI":1001},"Huybrecht T’jollyn",{"id":1003,"sortIndex":259,"researcher":18,"roles":1004,"affiliations":1005,"properties":1011},"ed351833-e8e8-440d-8896-bcb3ffa8c303",[522],[1006],{"id":18,"sortIndex":19,"affiliation":1007,"properties":18},{"id":991,"createTime":992,"updateTime":993,"relativeEntities":1008,"slug":995,"properties":1009,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1010},{"VI":998},{"title":1012},{"VI":1013},"Jan Van Bocxlaer",{"id":1015,"sortIndex":276,"researcher":18,"roles":1016,"affiliations":1017,"properties":1030},"a0d51e1e-b8c4-491a-84b2-b04e3ab9b501",[522],[1018,1023],{"id":18,"sortIndex":19,"affiliation":1019,"properties":18},{"id":991,"createTime":992,"updateTime":993,"relativeEntities":1020,"slug":995,"properties":1021,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1022},{"VI":998},{"id":1024,"sortIndex":244,"affiliation":1025,"properties":1029},"61dee462-6d23-4ee8-8bc9-5c3de9e33198",{"id":951,"createTime":952,"updateTime":952,"relativeEntities":1026,"slug":18,"properties":1027,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1028},{"VI":956},{},{"title":1031},{"VI":1032},"An Vermeulen",{"id":1034,"sortIndex":244,"researcher":18,"roles":1035,"affiliations":1036,"properties":1042},"6ac41379-af41-47aa-83ea-82aeac574a45",[522],[1037],{"id":18,"sortIndex":19,"affiliation":1038,"properties":18},{"id":951,"createTime":952,"updateTime":952,"relativeEntities":1039,"slug":18,"properties":1040,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1041},{"VI":956},{"title":1043},{"VI":1044},"Jan Snoeys",{"id":1046,"sortIndex":227,"researcher":18,"roles":1047,"affiliations":1048,"properties":1054},"12d5959a-0f8c-472e-9548-709d0ff6a5e3",[522],[1049],{"id":18,"sortIndex":19,"affiliation":1050,"properties":18},{"id":991,"createTime":992,"updateTime":993,"relativeEntities":1051,"slug":995,"properties":1052,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1053},{"VI":998},{"title":1055},{"VI":1056},"Pieter Colin",{"id":1058,"sortIndex":296,"researcher":18,"roles":1059,"affiliations":1060,"properties":1069},"093885d5-b0cd-4b5c-b30b-25e72a671d17",[522],[1061],{"id":18,"sortIndex":19,"affiliation":1062,"properties":18},{"id":1063,"createTime":1064,"updateTime":1064,"relativeEntities":1065,"slug":18,"properties":1066,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"7a0ed1b2-39d1-4810-8842-98a822908b2d","2024-01-09T07:17:36.800+00:00",[],{"title":1067},{"VI":1068},"Drug Delivery and Disposition, KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium",{"title":1070},{"VI":1071},"Pieter Annaert",{"id":1073,"sortIndex":92,"researcher":18,"roles":1074,"affiliations":1075,"properties":1081},"ab83471d-a703-4b90-9cf6-e8503c7247c2",[522],[1076],{"id":18,"sortIndex":19,"affiliation":1077,"properties":18},{"id":991,"createTime":992,"updateTime":993,"relativeEntities":1078,"slug":995,"properties":1079,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1080},{"VI":998},{"title":1082},{"VI":1083},"Koen Boussery",{"id":1085,"sortIndex":80,"researcher":18,"roles":1086,"affiliations":1087,"properties":1096},"b6e6c4bf-0dcc-4eb4-b66e-3191ff0e5ab1",[522],[1088],{"id":18,"sortIndex":19,"affiliation":1089,"properties":18},{"id":1090,"createTime":1091,"updateTime":1091,"relativeEntities":1092,"slug":18,"properties":1093,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"f454a299-478e-4201-a59f-90ef6e65de11","2024-02-19T01:04:17.839+00:00",[],{"title":1094},{"VI":1095},"Department of Development and Regeneration, KU Leuven and Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium",{"title":1097},{"VI":1098},"Karel Allegaert",{"url":943,"publisher":1100,"properties":1127},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":1101,"slug":10,"properties":1102,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":1105,"manageAffiliations":1106,"indexDatabases":1107,"url":18,"thumbnailPath":18,"statistic":1122,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":1103,"title":1104},{"VOID":13},{"EN":15},[],[],[1108,1115],{"id":116,"indexDatabase":1109,"url":129,"indexYears":130,"academicFieldIds":1114,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":1110,"label":1111,"description":1112,"key":126,"publicationTags":1113,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":1116,"url":111,"indexYears":18,"academicFieldIds":1121,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":1117,"label":1118,"description":1119,"key":107,"publicationTags":1120,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":1123,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":1124,"totalCitation":146,"totalCitationByYear":1125,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":1126,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},{"volume":1128,"pages":1130},{"VOID":1129},"32",{"VOID":1131},"260-274","2014-07-22",2014,{"id":1135,"createTime":1136,"updateTime":1137,"relativeEntities":1138,"slug":1139,"properties":1140,"entityType":176,"verifyStatus":177,"verifyTime":1137,"verifyNote":178,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"primaryUrl":1147,"fullTextUrl":18,"authors":1148,"publicationType":313,"publisherRelationship":1164,"citationCount":18,"citationInfo":18,"publishDate":1197,"publishYear":1198,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":18,"isForceReanalyzing":499},"b0bc6966-8bd0-4ac7-8544-282e6ee5f283","2024-01-29T12:56:59.589+00:00","2024-12-08T23:58:25.952+00:00",[],"Determination-of-Solute-Polymer-Interaction-Properties-via-Two-Stage-Extraction",{"references":1141,"title":1143,"doi":1145},{"VOID":1142},"I. C. Sanchez, S. S. Chang, and L. E. Smith. Migration models for polymer additives. Polym. News 6:249–256 (1980).\nL. A. Cruz, M. P. Jenke, R. A. Kenley, M. J. Chen, and D. R. Jenke. Influence of solute degradation on the accumulation of solutes migrating into solution from polymeric parenteral containers. Pharm. Res. 9:967–972 (1990).\nD. R. Jenke, E. K. Chess, D. C. Zietlow, and B. E. Rabinow. Model for estimating the accumulation of solutes leaching from polymeric containers into parenteral solutions. Int. J. Pharm. 78:115–122 (1992).\nD. R. Jenke, E. K. Chess, and G. Jakubowski. Modeling of the leachables impact on the engineering of parenteral product container systems. Int. J. Pharm. (in press).\nJ. C. Dearden and G. A. Bresnen. The measurement of partition coefficients. Quant. Struct. Act. Relat. 7:133–144 (1988).\nA. Leo, C. Hansch, and D. Elkins. Partition coefficients and their uses. Chem. Rev. 71:525–616 (1971).",{"EN":1144},"Determination of Solute–Polymer Interaction Properties via Two-Stage Extraction",{"VOID":1146},"10.1023\u002FA:1018953002508","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1023\u002FA:1018953002508",[1149],{"id":1150,"sortIndex":19,"researcher":18,"roles":1151,"affiliations":1152,"properties":1161},"e70ea0fe-72a4-42db-9180-41ab9b3acdf2",[522],[1153],{"id":18,"sortIndex":19,"affiliation":1154,"properties":18},{"id":1155,"createTime":1156,"updateTime":1156,"relativeEntities":1157,"slug":18,"properties":1158,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"e001dbac-7f2c-47e9-8374-133f7eac4989","2024-01-29T12:56:59.599+00:00",[],{"title":1159},{"VI":1160},"William B. Graham Science Center, Baxter Healthcare Corporation, Round Lake",{"title":1162},{"VI":1163},"Dennis R. Jenke",{"url":1147,"publisher":1165,"properties":1192},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":1166,"slug":10,"properties":1167,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":1170,"manageAffiliations":1171,"indexDatabases":1172,"url":18,"thumbnailPath":18,"statistic":1187,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":1168,"title":1169},{"VOID":13},{"EN":15},[],[],[1173,1180],{"id":116,"indexDatabase":1174,"url":129,"indexYears":130,"academicFieldIds":1179,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":1175,"label":1176,"description":1177,"key":126,"publicationTags":1178,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":1181,"url":111,"indexYears":18,"academicFieldIds":1186,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":1182,"label":1183,"description":1184,"key":107,"publicationTags":1185,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":1188,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":1189,"totalCitation":146,"totalCitationByYear":1190,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":1191,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},{"volume":1193,"pages":1195},{"VOID":1194},"11",{"VOID":1196},"774-775","1994-05-01",1994,{"id":1200,"createTime":1201,"updateTime":1202,"relativeEntities":1203,"slug":1204,"properties":1205,"entityType":176,"verifyStatus":177,"verifyTime":1214,"verifyNote":178,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"primaryUrl":1215,"fullTextUrl":18,"authors":1216,"publicationType":313,"publisherRelationship":1246,"citationCount":18,"citationInfo":18,"publishDate":1279,"publishYear":1280,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":18,"isForceReanalyzing":499},"b98da55f-3d83-4557-87ba-f9697b07e3f1","2024-01-27T02:00:09.058+00:00","2024-12-12T23:58:25.126+00:00",[],"Diffusion-of-lonizable-Solutes-Across-Planar-Lipid-Bilayer-Membranes-Boundary-Layer-pH-Gradients-and-the-Effect-of-Buffers",{"references":1206,"abstract":1208,"title":1210,"doi":1212},{"VOID":1207},"W. D. Stein. Transport and Diffusion Across Cell Membranes, Academic Press, Orlando, FL, 1986.\nR. N. McElhaney. Membrane lipid, not polarized water, is responsible for the semipermeable properties of living cells. Biophys. J. 15:777–784 (1975).\nA. Finkelstein. Water and nonelectrolyte permeability of lipid bilayer membranes. J. Gen. Physiol. 68:127–135 (1976).\nT.-X. Xiang, X. Chen, and B. D. Anderson. Transport methods for probing the barrier domain of lipid bilayer membranes. Biophys. J. 63:78–88 (1992).\nT.-X. Xiang, and B. D. Anderson. Functional group contributions to lipid bilayer permeability. Biophys. J. (submitted).\nP. H. Barry and J. M. Diamond. Effects of unstirred layers on membrane phenomena. Physiol. Rev. 64:763–872 (1984).\nJ. Gutknecht and D. C. Tosteson. Diffusion of weak acids across lipid bilayer membranes: Effects of chemical reactions in the unstirred layers. Science 182:1258–1261 (1973).\nA. Walter, D. Hastings, and J. Gutknecht. Weak acid permeability through lipid bilayer membranes. Role of chemical reactions in the unstirred layer. J. Gen. Physiol. 79:917–933 (1982).\nJ. W. Nichols, M. W. Hill, A. D. Bangham, and D. W. Deamer. Measurement of net proton-hydroxyl permeability of large uni-lamellar liposomes with the fluorescent pH probe, 9-aminoacridine. Biochim. Biophys. Acta 596:393–403 (1980).\nY. Toyoshima and T. E. Thompson. Chloride flux in bilayer membranes: The electrically silent chloride flux in semispherical bilayers. Biochemistry 14:1518–1524 (1975).\nJ. Gutknecht and A. Walter. Transport of protons and hydrochloric acid through lipid bilayer membranes. Biochim. Biophys. Acta 641:183–188 (1981).\nIn J. A. Dean (ed.), Lange's Handbook of Chemistry. McGraw-Hill, New York, 1973, pp. 5–14.\nD. D. Perrin. Dissociation Constants of Inorganic Acid and Bases in Aqueous Solution, Butterworth, London, 1969.\nP. Mueller, D. O. Rudin, H. T. Tien, and W. C. Wescott. Methods for the formation of single bimolecular lipid membranes in aqueous solution. J. Phys. Chem. 67:534–535 (1963).\nJ. S. Anderson and K. Saddington. The use of radioactive isotopes in the study of the diffusion of ions in solutions. J. Chem. Soc. 1:S381–S386 (1949).\nW. Hayduk and H. Laudie. Prediction of diffusion coefficients for nonelectrolytes in dilute aqueous solutions. AIChE J. 20:611–615 (1974).\nJ. T. Edward. Molecular volumes and the Stokes-Einstein equation. J. Chem. Ed. 47:261–270 (1970).\nD. D. Perrin and B. Dempsey. Buffers for pH and Metal Ion Control, Chapman and Hall, London, 1974.\nA. Walter and J. Gutknecht. Monocarboxylic acid permeation through lipid bilayer membranes. J. Membr. Biol. 77:255–264 (1984).\nD. E. Bidstrup and C. J. Greenkoplis. Aqueous molecular diffusivities for carboxylic acids. J. Chem. Eng. Data 8:170–173 (1963).\nW. J. Albery, A. R. Greenwood, and R. K. Kibble. Diffusion coefficients of carboxylic acids. Trans. Faraday Soc. 63:360–368 (1967).\nB. H. Billings and D. E. Gray (eds.). American Institute of Physics Handbook, McGraw-Hill, New York, 1963, pp. 2–210.\nP. W. Atkins (ed.). Physical Chemistry, W. H. Freeman, New York, 1982, p. 905.",{"EN":1209},"The diffusion of weak acids or bases across planar lipid bilayer membranes results in aqueous boundary layer pH gradients. If not properly taken into account, such pH gradients will lead to errors in estimated membrane permeability coefficients, P\nm. The role of the permeant concentration, the buffer capacity, and the physicochemical properties of both permeant and buffer on the magnitude and impact of such pH gradients have been explored. A theoretical model has been developed to describe the diffusion of both permeant and buffer species. Significant pH gradients develop depending on solution pH and the pK\na's, concentrations, and P\nm values of both permeant and buffer. The relative error in experimentally determined P\nm values was calculated as the ratio, r, between apparent P\nm values (obtained from flux measurements using an equation which neglected boundary layer pH gradients) and its true value. Simulated r values ranged from 1 (0% error) to \u003C0.01 (>100% error) for weak acids, decreasing with decreasing buffer capacity and increasing solute flux. The buffer capacity required for an r > 0.95 was calculated versus pH for permeants varying in pK\na and P\nm. Membrane-permeable buffers significantly reduce boundary layer pH gradients through a feedback effect due to buffer cotransport. Apparent P\nm values of p-hydroxymethyl benzoic acid across lecithin bilayer membranes at 25°C were obtained as a function of permeant concentration in various buffers [glycolic, 2-(N-morpholino)ethane-sulfonic, and formic acids]. Predictions agreed closely with experimental fluxes.",{"EN":1211},"Diffusion of lonizable Solutes Across Planar Lipid Bilayer Membranes: Boundary-Layer pH Gradients and the Effect of Buffers",{"VOID":1213},"10.1023\u002FA:1018989107129","2024-12-12T23:58:25.125+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1023\u002FA:1018989107129",[1217,1234],{"id":1218,"sortIndex":244,"researcher":18,"roles":1219,"affiliations":1220,"properties":1231},"80c79be1-2654-43d6-8375-4508e61eb81a",[522],[1221],{"id":18,"sortIndex":19,"affiliation":1222,"properties":18},{"id":1223,"createTime":1224,"updateTime":1225,"relativeEntities":1226,"slug":1227,"properties":1228,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"41e5f11b-5028-4b38-9b2f-54425a6b6ad0","2023-12-06T09:49:41.361+00:00","2024-09-02T05:44:56.991+00:00",[],"Department-of-Pharmaceutics-and-Pharmaceutical-Chemistry-University-of-Utah-Salt-Lake-City",{"title":1229},{"VI":1230},"Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, Salt Lake City",{"title":1232},{"VI":1233},"Bradley D. Anderson",{"id":1235,"sortIndex":19,"researcher":18,"roles":1236,"affiliations":1237,"properties":1243},"0337600a-deaa-4599-9b23-8f10f69f5274",[522],[1238],{"id":18,"sortIndex":19,"affiliation":1239,"properties":18},{"id":1223,"createTime":1224,"updateTime":1225,"relativeEntities":1240,"slug":1227,"properties":1241,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1242},{"VI":1230},{"title":1244},{"VI":1245},"Tian-xiang Xiang",{"url":1215,"publisher":1247,"properties":1274},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":1248,"slug":10,"properties":1249,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":1252,"manageAffiliations":1253,"indexDatabases":1254,"url":18,"thumbnailPath":18,"statistic":1269,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":1250,"title":1251},{"VOID":13},{"EN":15},[],[],[1255,1262],{"id":116,"indexDatabase":1256,"url":129,"indexYears":130,"academicFieldIds":1261,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":1257,"label":1258,"description":1259,"key":126,"publicationTags":1260,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":1263,"url":111,"indexYears":18,"academicFieldIds":1268,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":1264,"label":1265,"description":1266,"key":107,"publicationTags":1267,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":1270,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":1271,"totalCitation":146,"totalCitationByYear":1272,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":1273,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},{"volume":1275,"pages":1277},{"VOID":1276},"10",{"VOID":1278},"1654-1661","1993-11-01",1993,{"id":1282,"createTime":1283,"updateTime":1284,"relativeEntities":1285,"slug":1286,"properties":1287,"entityType":176,"verifyStatus":177,"verifyTime":1284,"verifyNote":178,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"primaryUrl":1296,"fullTextUrl":18,"authors":1297,"publicationType":313,"publisherRelationship":1402,"citationCount":18,"citationInfo":18,"publishDate":1435,"publishYear":1436,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":18,"isForceReanalyzing":499},"95544251-4b38-4180-a76a-187fc18a9d64","2024-01-25T19:30:59.731+00:00","2025-02-03T23:58:12.919+00:00",[],"Mechanistic-Modeling-of-the-Effect-of-Recombinant-Human-Hyaluronidase-rHuPH20-on-Subcutaneous-Delivery-of-Cetuximab-in-Rats",{"references":1288,"abstract":1290,"title":1292,"doi":1294},{"VOID":1289},"Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(8):493–507.\nLu RM, Hwang YC, Liu IJ, Lee CC, Tsai HZ, Li HJ, Wu HC. Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci. 2020;27(1):1.\nBittner B, Richter WF, Hourcade-Potelleret F, Herting F, Schmidt J. Non-clinical pharmacokinetic\u002Fpharmacodynamic and early clinical studies supporting development of a novel subcutaneous formulation for the monoclonal antibody rituximab. Drug Res (Stuttg). 2014;64(11):569–75.\nJackisch C, Muller V, Maintz C, Hell S, Ataseven B. Subcutaneous Administration of Monoclonal Antibodies in oncology. Geburtshilfe Frauenheilkd. 2014;74(4):343–9.\nBookbinder LH, Hofer A, Haller MF, Zepeda ML, Keller GA, Lim JE, Edgington TS, Shepard HM, Patton JS, Frost GI. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114(2):230–41.\nWasserman RL, Melamed I, Stein MR, Gupta S, Puck J, Engl W, Leibl H, McCoy B, Empson VG, Gelmont D, Schiff RI. Igsc wrSG. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol. 2012;130(4):951–7 e911.\nBittner B, Richter W, Schmidt J. Subcutaneous Administration of Biotherapeutics: an overview of current challenges and opportunities. BioDrugs. 2018;32(5):425–40.\nAlberts B. Essential cell biology : an introduction to the molecular biology of the cell. New York: Garland Pub; 1998.\nWiig H, Swartz MA. Interstitial fluid and lymph formation and transport: physiological regulation and roles in inflammation and cancer. Physiol Rev. 2012;92(3):1005–60.\nSimpson MA, de la Motte C, Sherman LS, Weigel PH. Advances in Hyaluronan biology: signaling, regulation, and disease mechanisms. Int J Cell Biol. 2015;2015:690572.\nLee-Sayer SS, Dong Y, Arif AA, Olsson M, Brown KL, Johnson P. The where, when, how, and why of hyaluronan binding by immune cells. Front Immunol. 2015;6:150.\nHenriksen JH. Degradation of bioactive substances : physiology and pathophysiology. Boca Raton, Fla: CRC Press; 1991.\nHarris EN, Weigel JA, Weigel PH. Endocytic function, glycosaminoglycan specificity, and antibody sensitivity of the recombinant human 190-kDa hyaluronan receptor for endocytosis (HARE). J Biol Chem. 2004;279(35):36201–9.\nFrost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4(4):427–40.\nHechter O. Reconstitution of the dermal barrier to fluid diffusion following administration of hyaluronidase. Proc Soc Exp Biol Med. 1948;67(3):343.\nWasserman RL. Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin infusion in primary immunodeficiency diseases. Immunotherapy. 2017;9(12):1035–50.\nCarlson J, Cox K, Bedwell K, Ku M. Rituximab for subcutaneous delivery: clinical management principles from a nursing perspective. Int J Nurs Pract. 2015;21(Suppl 3):1–13.\nDanieli MG, Pulvirenti F, Rocchi V, Morariu R, Quinti I. Self-administered hyaluronidase-facilitated subcutaneous immunoglobulin therapy in complicated primary antibody deficiencies. Immunotherapy. 2016;8(9):995–1002.\nWasserman RL, Melamed I, Kobrynski L, Puck J, Gupta S, Doralt J, Sharkhawy M, Engl W, Leibl H, Gelmont D, Yel L. Recombinant human hyaluronidase facilitated subcutaneous immunoglobulin treatment in pediatric patients with primary immunodeficiencies: long-term efficacy, safety and tolerability. Immunotherapy. 2016;8(10):1175–86.\nAlberts BJA, Lewis J, et al. The Extracellular Matrix of Animals in Molecular Biology of the Cell. Garland Science. In: Molecular Biology of the Cell. New York: Garland Science; 2002.\nKang DW, Oh DA, Fu GY, Anderson JM, Zepeda ML. Porcine model to evaluate local tissue tolerability associated with subcutaneous delivery of protein. J Pharmacol Toxicol Methods. 2013;67(3):140–7.\nBittner B, Richter WF, Hourcade-Potelleret F, McIntyre C, Herting F, Zepeda ML, Schmidt J. Development of a subcutaneous formulation for trastuzumab - nonclinical and clinical bridging approach to the approved intravenous dosing regimen. Arzneimittelforschung. 2012;62(9):401–9.\nStyles IK, Feeney OM, Nguyen TH, Brundel DHS, Kang DW, Clift R, McIntosh MP, Porter CJH. Removal of interstitial hyaluronan with recombinant human hyaluronidase improves the systemic and lymphatic uptake of cetuximab in rats. J Control Release. 2019;315:85–96.\nKagan L, Mager DE. Mechanisms of subcutaneous absorption of rituximab in rats. Drug Metab Dispos. 2013;41(1):248–55.\nGalizia G, Lieto E, De Vita F, Orditura M, Castellano P, Troiani T, Imperatore V, Ciardiello F. Cetuximab, a chimeric human mouse anti-epidermal growth factor receptor monoclonal antibody, in the treatment of human colorectal cancer. Oncogene. 2007;26(25):3654–60.\nAzzopardi N, Lecomte T, Ternant D, Boisdron-Celle M, Piller F, Morel A, Gouilleux-Gruart V, Vignault-Desvignes C, Watier H, Gamelin E, Paintaud G. Cetuximab pharmacokinetics influences progression-free survival of metastatic colorectal cancer patients. Clin Cancer Res. 2011;17(19):6329–37.\nTol J, Punt CJ. Monoclonal antibodies in the treatment of metastatic colorectal cancer: a review. Clin Ther. 2010;32(3):437–53.\nJadin L, Bookbinder LH, Frost GI. A comprehensive model of hyaluronan turnover in the mouse. Matrix Biol. 2012;31(2):81–9.\nConnor RJ, Blouw B, Cowell J, Chen K, Zhao C, Kang DW. A preclinical investigation into the effects of aging on dermal Hyaluronan properties and reconstitution following recombinant human hyaluronidase PH20 administration. Dermatol Ther (Heidelb). 2020;10(3):503–13.\nArmstrong SE, Bell DR. Relationship between lymph and tissue hyaluronan in skin and skeletal muscle. Am J Physiol Heart Circ Physiol. 2002;283(6):H2485–94.\nChapy H, Kagan L. Evaluation of the effects of animal growth and previous exposure on the pharmacokinetics of rituximab in rats. J Pharm Sci. 2018;107(7):1987–94.\nKagan L, Turner MR, Balu-Iyer SV, Mager DE. Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res. 2012;29(2):490–9.\nKagan L, Zhao J, Mager DE. Interspecies pharmacokinetic modeling of subcutaneous absorption of rituximab in mice and rats. Pharm Res. 2014;31(12):3265–73.\nNecas J, Bartosikova L, Brauner P, Kolar J. Hyaluronic acid (hyaluronan): a review. Veterinarni Medicina. 2008;53:397–411.\nConnor RJ, Taverna DM, Thrall K, LaBarre MJ, Kang DW. Use of computed tomography to assess subcutaneous drug dispersion with recombinant human hyaluronidase PH20 in a swine model. J Pharmacol Toxicol Methods. 2020;106:106936.\nAlmasa Bass AP, Mridha K, Sattler C, Kim AM, Plowchalk DR. Pharmacokinetics, pharmacodynamics, and safety of bococizumab, a monoclonal antibody against proprotein convertase subtilisin\u002Fkexin type 9, in healthy subjects when administered in co-mixture with recombinant human hyaluronidase: A phase 1 randomized trial. Health Sci Rep. 2018;1(9).\nLuo FR, Yang Z, Dong H, Camuso A, McGlinchey K, Fager K, Flefleh C, Kan D, Inigo I, Castaneda S, Rose WC, Kramer RA, Wild R, Lee FY. Correlation of pharmacokinetics with the antitumor activity of Cetuximab in nude mice bearing the GEO human colon carcinoma xenograft. Cancer Chemother Pharmacol. 2005;56(5):455–64.\nCowman MK, Lee HG, Schwertfeger KL, McCarthy JB, Turley EA. The content and size of Hyaluronan in biological fluids and tissues. Front Immunol. 2015;6:261.",{"EN":1291},"To evaluate the duration of effect of rHuPH20 on SC absorption of cetuximab and to develop a mechanistic pharmacokinetic model linking the kinetics of rHuPH20 action with  hyaluronan (HA) homeostasis and absorption of cetuximab from the SC space. Serum pharmacokinetics of cetuximab was evaluated after IV and SC  dosing at 0.4 and 10 mg\u002Fkg (control groups). In test groups, SC cetuximab was administered simultaneously with rHuPH20 (Co-Injection) or 12 h after injection of rHuPH20 (Pre-Injection). Mechanistic pharmacokinetic model was developed to simultaneously capture cetuximab kinetics in all groups. Administration of rHuPH20 resulted in a faster absorption of cetuximab; the difference between co-injection and pre-injection groups appeared to be dependent on the dose level. The model combined three major components: kinetics of rHuPH20 at SC site; HA homeostasis and its disruption by rHuPH20; and cetuximab systemic disposition and the effect of HA disruption on cetuximab SC absorption. The model provided good description of experimental data obtained in this study and collected previously. Proposed model can serve as a potential translational framework for capturing the effect of rHuPH20 across multiple preclinical species and in human studies and can be used for optimization of SC delivery of biotherapeutics.",{"EN":1293},"Mechanistic Modeling of the Effect of Recombinant Human Hyaluronidase (rHuPH20) on Subcutaneous Delivery of Cetuximab in Rats",{"VOID":1295},"10.1007\u002Fs11095-022-03294-y","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002Fs11095-022-03294-y",[1298,1315,1337,1356,1375,1390],{"id":1299,"sortIndex":244,"researcher":18,"roles":1300,"affiliations":1301,"properties":1312},"b4fbf4d8-2e1e-4c32-baa5-d403001e6835",[522],[1302],{"id":18,"sortIndex":19,"affiliation":1303,"properties":18},{"id":1304,"createTime":1305,"updateTime":1306,"relativeEntities":1307,"slug":1308,"properties":1309,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"16072450-8d64-46cd-8cf2-9347aa10191d","2024-02-05T11:05:05.079+00:00","2024-09-28T02:58:29.686+00:00",[],"Department-of-Pharmaceutics-Ernest-Mario-School-of-Pharmacy-Rutgers-The-State-University-of-New-Jersey-Piscataway-USA",{"title":1310},{"VI":1311},"Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, USA",{"title":1313},{"VI":1314},"Jongbong Lee",{"id":1316,"sortIndex":227,"researcher":18,"roles":1317,"affiliations":1318,"properties":1334},"07083e89-c4d9-41d0-b327-24bbfd3bcf40",[522],[1319,1329],{"id":1320,"sortIndex":244,"affiliation":1321,"properties":1328},"88d83692-5355-47fd-a5de-daecd67509b4",{"id":1322,"createTime":1323,"updateTime":1323,"relativeEntities":1324,"slug":18,"properties":1325,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"634350bf-39f2-4075-9b4d-4ef8f516b1c3","2023-12-06T22:39:49.470+00:00",[],{"title":1326},{"VI":1327},"Center of Excellence for Pharmaceutical Translational Research and Education, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, USA",{},{"id":18,"sortIndex":19,"affiliation":1330,"properties":18},{"id":1304,"createTime":1305,"updateTime":1306,"relativeEntities":1331,"slug":1308,"properties":1332,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1333},{"VI":1311},{"title":1335},{"VI":1336},"Kiran Deshpande",{"id":1338,"sortIndex":185,"researcher":18,"roles":1339,"affiliations":1340,"properties":1353},"bad19905-f123-47c5-8906-dab8b4941ef1",[522],[1341,1348],{"id":1342,"sortIndex":244,"affiliation":1343,"properties":1347},"ef1bef66-ccd3-4768-9174-831a86e9eb7f",{"id":1322,"createTime":1323,"updateTime":1323,"relativeEntities":1344,"slug":18,"properties":1345,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1346},{"VI":1327},{},{"id":18,"sortIndex":19,"affiliation":1349,"properties":18},{"id":1304,"createTime":1305,"updateTime":1306,"relativeEntities":1350,"slug":1308,"properties":1351,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1352},{"VI":1311},{"title":1354},{"VI":1355},"Leonid Kagan",{"id":1357,"sortIndex":19,"researcher":18,"roles":1358,"affiliations":1359,"properties":1372},"b3c524da-3025-48b8-a31e-9680414db159",[522],[1360,1367],{"id":1361,"sortIndex":244,"affiliation":1362,"properties":1366},"4b84a7fe-674f-4bee-9def-852f386272e7",{"id":1322,"createTime":1323,"updateTime":1323,"relativeEntities":1363,"slug":18,"properties":1364,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1365},{"VI":1327},{},{"id":18,"sortIndex":19,"affiliation":1368,"properties":18},{"id":1304,"createTime":1305,"updateTime":1306,"relativeEntities":1369,"slug":1308,"properties":1370,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1371},{"VI":1311},{"title":1373},{"VI":1374},"Xizhe Gao",{"id":1376,"sortIndex":296,"researcher":18,"roles":1377,"affiliations":1378,"properties":1387},"49533631-dccd-44c2-9a3f-dfdf5adf2cd7",[522],[1379],{"id":18,"sortIndex":19,"affiliation":1380,"properties":18},{"id":1381,"createTime":1382,"updateTime":1382,"relativeEntities":1383,"slug":18,"properties":1384,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},"6e511f71-b263-42cd-b1fe-9b0d98aaebbb","2023-12-12T05:39:27.203+00:00",[],{"title":1385},{"VI":1386},"Halozyme Therapeutics, Inc., San Diego, USA",{"title":1388},{"VI":1389},"Anas M. Fathallah",{"id":1391,"sortIndex":259,"researcher":18,"roles":1392,"affiliations":1393,"properties":1399},"41f94090-106e-48c7-a5ff-54498d4e56f0",[522],[1394],{"id":18,"sortIndex":19,"affiliation":1395,"properties":18},{"id":1381,"createTime":1382,"updateTime":1382,"relativeEntities":1396,"slug":18,"properties":1397,"entityType":79,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19},[],{"title":1398},{"VI":1386},{"title":1400},{"VI":1401},"David W. Kang",{"url":1296,"publisher":1403,"properties":1430},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":1404,"slug":10,"properties":1405,"entityType":16,"verifyStatus":17,"verifyTime":18,"verifyNote":18,"syncStatus":17,"languages":18,"translateLanguages":18,"viewCount":19,"subjectFields":1408,"manageAffiliations":1409,"indexDatabases":1410,"url":18,"thumbnailPath":18,"statistic":1425,"gsStatistic":18,"type":18,"analyzePriority":18},[],{"issn":1406,"title":1407},{"VOID":13},{"EN":15},[],[],[1411,1418],{"id":116,"indexDatabase":1412,"url":129,"indexYears":130,"academicFieldIds":1417,"indexDatabaseRanking":138},{"id":118,"createTime":119,"updateTime":120,"relativeEntities":1413,"label":1414,"description":1415,"key":126,"publicationTags":1416,"standard":18},[],{"EN":123,"VI":123},{"EN":123,"VI":125},[128],[132,133,134,135,136,137],{"id":96,"indexDatabase":1419,"url":111,"indexYears":18,"academicFieldIds":1424,"indexDatabaseRanking":18},{"id":98,"createTime":99,"updateTime":100,"relativeEntities":1420,"label":1421,"description":1422,"key":107,"publicationTags":1423,"standard":18},[],{"EN":103,"VI":103},{"VI":105,"EN":106},[109,110],[113,114],{"impactFactor":19,"impactFactorByYear":1426,"i10Index":141,"i10IndexLast5Year":19,"totalPublication":142,"totalPublicationByYear":1427,"totalCitation":146,"totalCitationByYear":1428,"totalCitationPerPublication":150,"totalCitationPerPublicationByYear":1429,"hindexLast5Year":154,"hindex":154},{},{"2003":144,"2004":145},{"2003":148,"2004":149},{"2003":152,"2004":153},{"volume":1431,"pages":1433},{"VOID":1432},"39",{"VOID":1434},"1867-1880","2022-07-01",2022,{"id":1438,"createTime":1439,"updateTime":1440,"relativeEntities":1441,"slug":1442,"properties":1443,"entityType":176,"verifyStatus":177,"verifyTime":1440,"verifyNote":178,"syncStatus":17,"languages":1451,"translateLanguages":18,"viewCount":19,"primaryUrl":1452,"fullTextUrl":18,"authors":1453,"publicationType":313,"publisherRelationship":1536,"citationCount":18,"citationInfo":18,"publishDate":1568,"publishYear":743,"citationAnalyzeStatus":17,"lastCitationAnalyze":18,"indexDatabases":18,"openAccess":18,"references":1569,"isForceReanalyzing":499},"a7edbf30-56e9-4ac8-9015-b40dd1a769a4","2024-04-21T21:02:12.158+00:00","2024-12-26T23:58:11.548+00:00",[],"Proton-Cotransport-of-Pravastatin-Across-Intestinal-Brush-Border-Membrane",{"keywords":1444,"abstract":1445,"title":1447,"doi":1449},{"EN":629},{"EN":1446},"\nPurpose. The purpose of the present study is to clarify the intestinal brush-border transport mechanism of a weak organic acid, pravastatin, an HMG-CoA reductase inhibitor. \nMethods. The transport of pravastatin was studied by using intestinal brush-border membrane vesicles prepared from rabbit jejunum, and uptake by the membrane vesicles was measured using rapid filtration technique. \nResults. The initial uptake of [14C]pravastatin was markedly increased with decreases in extravesicular pH and showed a clear overshoot phenomenon in the presence of a proton gradient (pHin\u002Fout = 7.5\u002F5.5). A protonophore, carbonylcyanide p-trifluoromethoxyphenylhydrazone, significantly reduced the uptake of [14C]pravastatin. In addition, an ionophore for sodium, potassium and proton, nigericin, stimulated the uptake of [14C]pravastatin in the presence of a potassium gradient ([K + ]in\u002F[K+ ]out = 0\u002F145 mM). On the other hand, neither the imposition of an inwardly directed sodium gradient nor an outwardly directed bicarbonate gradient stimulated the uptake of [14C]pravastatin. In the presence of a proton gradient (pHin\u002Fout = 7.5\u002F5.5), the initial uptake of pravastatin was saturable with the apparent Kt of 15.2 ± 3.2 mM and Jmax of 10.6 ± 1.21 nmol\u002Fmg protein\u002F10 sec. The uptake of pravastatin was significantly inhibited by monocarboxylic acid compounds such as acetic acid and nicotinic acid in a competitive manner but not by di- or tri-carboxylic acids, or acidic amino acid. \nConclusions. It was concluded that a pH-dependent transport of pravastatin across the brush-border membrane occurs by a proton-gradient dependent carrier-mediated mechanism rather than by simple diffusion of its unionized form.",{"EN":1448},"Proton-Cotransport of Pravastatin Across Intestinal Brush-Border 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Pharmacol. 150:310–320 (1997).\nK. Sakurada, K. Matsubara, K. Shimizu, H. Shiono, Y. Seto, K. Tsuge, M. Yoshino, I. Sakai, H. Mukoyama, and T. Takatori. Pralidoxime iodide (2-PAM) penetrates across the blood–brain barrier. Neurochem. Res. 28(9):1401–1407 (2003).\nS. N. Dube, R. Bhattacharya, K. Husain, and A. K. Sikder. Enzymes of the Cholinesterase Family:Proceedings of the Fifth International Meeting on Cholinesterases Held in Madras, India, September 24–28, 1994, Kluwer, Boston, Massachusetts, 1995, pp. 375–379.\nL. P. A. De Jong, H. P. Benschop, G. R. Van den Berg, G. Z. Wolring, and D. C. De Korte. Reactivation of tabun-inhibited acetylcholinesterase by 1-(hetero)-arylmethylpyridinium oximes. Eur. J. Med. Chem. 16(3):257–262 (1981).\nM. Kataoka, N. Tsunoda, H. Ohta, K. Tsuge, H. Takesako, and Y. Seto. Effect of cation-exchange pretreatment of aqueous soil extracts on the gas chromatographic–mass spectrometric determination of nerve agent hydrolysis products after tert.-butyldimethylsilylation. J. Chromatgr. A 824:211–221 (1998).\nG. L. Ellman, K. D. Courtney, V. Andres Jr., and R. M. Featherstone. A new and rapid colorimetric determination of acetylcholinesterase activity. Biochem. Pharmacol. 7:88–95 (1961).\nS. P. Katrolia, A. K. Sikder, J. Acharya, N. Sikder, D. K. Jaiswal, R. Bhattacharya, K. Husain, S. N. Dube, D. Kumar, and S. Das Gupta. Antidotal efficacy of 1-alkyl pyridinium oximes in sarin intoxication. Pharmacol. Commun. 4(4):317–325 (1994).\nN. Sikder and A. K. Sikder. Hydrolysis of organophosphate catalysed by long chain hydroxyiminomethyl pyridinium type surfactants. Orient. J. Chem. 13(3):225–230 (1997).\nD. Knezevic, V. Tadic, and S. Cetkovic. The efficacy of different decontaminants in rats and pigs percutaneously poisoned with organophosphates. Vet. Hum. 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