Pharmacokinetics of carbamazepine polymorphs and dihydrate in rats, related to dogs and humans

Archives of Pharmacal Research

Volumn 34, Issue 11, 2011, Pages 1973-1982

  Xu, Caihong ^a   Zou, Meijuan ^a   Liu, Yi ^a   Ren, Jungang ^a,b   Tian, Ye ^a   Yan, Jing ^a   Wang, Yiping ^a   Cheng, Gang ^a  

^a SHENYANG PHARMACEUTICAL UNIVERSITY   (China)

^b HARBIN UNIVERSITY OF COMMERCE   (China)

Author keywords

Carbamazepine; Dogs; Humans; Pharmacokinetics; Polymorphism; Rats

Indexed keywords

CARBAMAZEPINE;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SENSITIVITY; DRUG SOLUBILITY; HUMAN; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PLASMA CONCENTRATION-TIME CURVE; RAT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, ORAL; ANIMALS; ANTICONVULSANTS; CARBAMAZEPINE; CRYSTALLIZATION; CRYSTALLOGRAPHY, X-RAY; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; INJECTIONS, INTRAVENOUS; INTESTINAL ABSORPTION; MALE; METABOLIC CLEARANCE RATE; MICROSCOPY, ELECTRON, SCANNING; PHYSICOCHEMICAL PHENOMENA; RANDOM ALLOCATION; RATS; RATS, SPRAGUE-DAWLEY; SPECIES SPECIFICITY; WATER;

EID: 83655197126     PISSN: 02536269     EISSN: 19763786     Source Type: Journal    
DOI: 10.1007/s12272-011-1118-8     Document Type: Article

References (48)

1. M. M. Alexishvili M. D. Rukhadze V. M. Okujava 1997 Simultaneous determination of carbamazepine and carbamazepine 10,11-epoxide by using microcolumn HPLC: study of pharmacokinetics of carbamazepine in a volunteer Biomed. Chromatogr. 11 36 41 9051215 10.1002/(SICI)1099-0801(199701)11:1<36:: AID-BMC622>3.0.CO;2-1 1:CAS:528:DyaK2sXht1WksLs%3D (Pubitemid 27081150)
2. M. Barzegar-Jalali A. M. Nayebi H. Valizadeh J. Hanaee A. Barzegar-Jalali K. Adibkia M. Anoush M. Sistanizad 2006 Evaluation of in vitro-in vivo correlation and anticonvulsive effect of carbamazepine after cogrinding with microcrystalline cellulose J. Pharm. Pharm. Sci. 9 307 316 17207414 1:CAS:528:DC%2BD28Xht1eitrvP (Pubitemid 46614340)
3. S. R. Carino D. C. Sperry M. Hawley 2006 Relative bioavailability estimation of carbamazepine crystal forms using an artificial stomach-duodenum model J. Pharm. Sci. 95 116 125 16315223 10.1002/jps.20495 1:CAS:528: DC%2BD28XlvVShtQ%3D%3D
4. L. M. Cotter M. J. Eadie W. D. Hooper C. M. Lander G. A. Smith J. H. Tyrer 1977 The pharmacokinetics of carbamazepine Eur. J. Clin. Pharmacol. 12 451 456 598420 10.1007/BF00561065 1:CAS:528:DyaE1cXktVSisb4%3D (Pubitemid 8253619)
5. A. Cvetkovskii R. Bettini Lj. Tasic M. Stupar I. Casini A. Rossi F. Giordano 2002 Thermal properties of binary mixtures of β-cyclodextrin with carbamazepine polymorphs J. Therm. Anal. Calorim. 68 669 678 10.1023/A:1016020709678 1:CAS:528:DC%2BD38XkvFegsbc%3D (Pubitemid 34614463)
6. J. B. Dressman 1986 Comparison of canine and human gastrointestinal physiology Pharm. Res. 3 123 131 10.1023/A:1016353705970 1:CAS:528: DyaL28XltVagu7w%3D (Pubitemid 17195382)
7. M. Eichelbaum K. Ekbom L. Bertilsson V. A. Ringberger A. Rane 1975 Plasma kinetics of carbamazepine and its epoxide metabolite in man after single and multiple doses Eur. J. Clin. Pharmacol. 8 337 341 1233232 10.1007/BF00562659 1:CAS:528:DyaE2MXlsVWktr4%3D
8. R. Elqidra N. Ünlü Y. Çapan G. Sahin T. Dalkara A. A. Hýncal 2004 Effect of polymorphism on in vitro - in vivo properties of carbamazepine conventional tablets J. Drug Del. Sci. Tech. 14 147 153 1:CAS:528:DC%2BD2cXlt1Kns7c%3D (Pubitemid 38506443)
9. A. Fleischman V. W. Chiang 2001 Carbamazepine overdose recognized by a tricyclic antidepressant assay Pediatrics 107 176 177 11134454 10.1542/peds.107.1.176 1:STN:280:DC%2BD3M%2FpsVWrtw%3D%3D (Pubitemid 32055435)
10. A. Gérardin J. P. Dubois J. Moppert L. Geller 1990 Absolute bioavailability of carbamazepine after oral administration of a 2% syrup Epilepsia 31 334 338 2344850 10.1111/j.1528-1157.1990.tb05384.x (Pubitemid 20181304)
11. P. M. Gosselin R. Thibert M. Preda J. N. McMullen 2003 Polymorphic properties of micronized carbamazepine produced by RESS Int. J. Pharm. 252 225 233 12550798 10.1016/S0378-5173(02)00649-X 1:CAS:528:DC%2BD3sXmtVCrtw%3D%3D (Pubitemid 36126631)
12. A. L. Grzesiak M. Lang K. Kim A. J. Matzger 2003 Comparison of the four anhydrous polymorphs of carbamazepine and the crystal structure of form I J. Pharm. Sci. 92 2260 2271 14603511 10.1002/jps.10455 1:CAS:528: DC%2BD3sXovFCrsL4%3D (Pubitemid 37356699)
13. M. B. Hickey M. L. Peterson L. A. Scoppettuolo S. L. Morrisette A. Vetter H. Guzmán J. F. Remenar Z. Zhang M. D. Tawa S. Haley M. J. Zaworotko O. Almarsson 2007 Performance comparison of a co-crystal of carbamazepine with marketed product Eur. J. Pharm. Biopharm. 67 112 119 17292592 10.1016/j.ejpb.2006.12.016 1:CAS:528:DC%2BD2sXntF2mtbs%3D (Pubitemid 46991320)
14. J. B. Houston A. Galetin 2003 Progress towards prediction of human pharmacokinetic parameters from in vitro technologies Drug Metab. Rev. 35 393 415 14705868 10.1081/DMR-120026870 1:CAS:528:DC%2BD3sXps1ygsL8%3D (Pubitemid 38018114)
15. P. Kahela R. Aaltonen E. Lewing M. Anttila E. Kristoffersson 1983 Pharmacokinetics and dissolution of two crystalline forms of carbamazepine Int. J. Pharm. 14 103 112 10.1016/0378-5173(83)90118-7 1:CAS:528:DyaL3sXitVChur4%3D (Pubitemid 13144971)
16. N. Kaneniwa T. Yamaguchi N. Watari M. Otsuka 1984 Hygroscopicity of carbamazepine crystalline powders Yakugaku Zasshi 104 184 190 6737229 1:CAS:528:DyaL2cXitFGgurk%3D (Pubitemid 14168035)
17. N. Kaneniwa J. Ichikawa T. Yamaguchi K. Hayashi N. Watari M. Sumi 1987 Dissolution behaviour of carba-mazepine polymorphs Yakugaku Zasshi 107 808 813 3440924 1:CAS:528:DyaL1cXis1yquw%3D%3D
18. T. T. Kararli 1995 Comparison of the gastrointestinal anatomy, physiology, and biochemistry of humans and commonly used laboratory animals Biopharm. Drug Dispos. 16 351 380 8527686 10.1002/bdd.2510160502 1:CAS:528:DyaK2MXmvFOls70%3D
19. Y. Kobayashi S. Ito S. Itai K. Yamamoto 2000 Physicochemical properties and bioavailability of carbamazepine polymorphs and dihydrate Int. J. Pharm. 193 137 146 10606776 10.1016/S0378-5173(99)00315-4 1:CAS:528:DyaK1MXnvFSltrw%3D (Pubitemid 30001856)
20. L. S. Koester J. B. Bertuol K. R. Groch C. R. Xavier R. Moellerke P. Mayorga T. Dalla Costa V. L. Bassani 2004 Bioavailability of carbamazepine:beta-cyclodextrin complex in beagle dogs from hydroxypropylmethylcellulose matrix tablets Eur. J. Pharm. Sci. 22 201 207 15158905 10.1016/j.ejps.2004.03.010 1:CAS:528:DC%2BD2cXkt1Slur0%3D (Pubitemid 38668685)
21. E. S. Kostewicz A. S. Carlsson G. Hanisch R. G. Nilsson L. LÖfgren B. Abrahamsson 2002 Comparison of dog and human intestinal fluid and its impact on solubility estimations Eur. J. Pharm. Sci. 17S S111 S132
22. W. Kou C. Cai S. Xu H. Wang J. Liu D. Yang T. Zhang 2011 In vitro and in vivo evaluation of novel immediate release carbamazepine tablets: complexation with hydroxypropyl-β-cyclodextrin in the presence of HPMC Int. J. Pharm. 409 75 80 21371541 10.1016/j.ijpharm.2011.02.042 1:CAS:528:DC%2BC3MXkslekt7o%3D
23. I. Kovacìviæ J. Parojèiæ I. Homsìk M. Tubiæ-Grozdanis P. Langguth 2009 Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation Mol. Pharm. 6 40 47 10.1021/mp800128y
24. F. U. Krahn J. B. Mielck 1987 Relations between several polymorphic forms and the dihydrate of carbamazepine Pharm. Acta Helv. 62 247 254 3423093 1:CAS:528:DyaL2sXmtVGju7w%3D (Pubitemid 18073853)
25. O. A. Lake M. Olling D. M. Barends 1999 In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers Eur. J. Pharm. Biopharm. 48 13 19 10477323 10.1016/S0939-6411(99)00016-8 1:CAS:528:DyaK1MXlslagsr0%3D (Pubitemid 29308920)
26. H. Lee S. A. Park H. Sah 2005 Surfactant effects upon dissolution patterns of carbamazepine immediate release tablet Arch. Pharm. Res. 28 120 126 15742820 10.1007/BF02975147 1:CAS:528:DC%2BD2MXht12ht7s%3D (Pubitemid 44698777)
27. C. Lefebvre A. M. Guyot-Hermann M. Draguet-Brughmans R. Bouché J. C. Guyot 1986 Polymorphic transitions of carbamazepine during grinding and compression Drug Dev. Ind. Pharm. 12 1913 1927 10.3109/03639048609042617 1:CAS:528:DyaL2sXpt1ym (Pubitemid 17178854)
28. P. Lehto J. Aaltonen M. Tenho J. Rantanen J. Hirvonen V. P. Tanninen L. Peltonen 2009 Solvent-mediated solid phase transformations of carbamazepine: Effects of simulated intestinal fluid and fasted state simulated intestinal fluid J. Pharm. Sci. 98 985 996 18661533 10.1002/jps.21490 1:CAS:528: DC%2BD1MXjt1Wltrk%3D
29. M. M. Lowes M. R. Caira A. P. Lötter J. G. Van der Watt 1987 Physicochemical properties and X-ray structural studies of the trigonal polymorph of carbamazepine J. Pharm. Sci. 76 744 752 11002813 10.1002/jps.2600760914 1:CAS:528:DyaL1cXksFClsbg%3D (Pubitemid 18026986)
30. L. E. McMahon P. Timmins A. C. Williams P. York 1996 Characterization of dihydrates prepared from carbamazepine polymorphs J. Pharm. Sci. 85 1064 1069 8897272 10.1021/js960117e 1:CAS:528:DyaK28XlsVynurc%3D (Pubitemid 26338919)
31. M. C. Meyer A. B. Straughn E. J. Jarvi G. C. Wood F. R. Pelsor V. P. Shah 1992 The bioinequivalence of carbamazepine tablets with a history of clinical failures Pharm. Res. 9 1612 1616 1488405 10.1023/A:1015872626887 1:CAS:528:DyaK3sXksFKgtQ%3D%3D
32. P. L. Morselli A. Frigerio 1975 Metabolism and Pharmacolinetics of Carbamazepine Drug Metab. Rev. 4 97 113 812689 10.3109/03602537508993750 1:CAS:528:DyaE2MXlsVWlsLs%3D
33. R. Nair S. Gonen S. W. Hoag 2002 Influence of polyethylene glycol and povidone on the polymorphic transformation and solubility of carbamazepine Int. J. Pharm. 240 11 22 12062497 10.1016/S0378-5173(02)00083-2 1:CAS:528: DC%2BD38Xktlarurg%3D (Pubitemid 34607698)
34. A. Nokhodchi N. Bolourtchian R. Dinarvand 2005 Dissolution and mechanical behaviors of recrystallized carbamazepine from alcohol solution in the presence of additives J. Cryst. Growth 274 573 584 10.1016/j.jcrysgro.2004.10.158 1:CAS:528:DC%2BD2MXmtFylug%3D%3D (Pubitemid 40114406)
35. M. Ono Y. Tozuka T. Oguchi S. Yamamura K. Yamamoto 2002 Effects of dehydration temperature on water vapor adsorption and dissolution behavior of carbamazepine Int. J. Pharm. 239 1 12 12052686 10.1016/S0378-5173(02)00007-8 1:CAS:528:DC%2BD38XktFeksL0%3D (Pubitemid 34615791)
36. S. Pynnönen 1979 Pharmacokinetics of Carbamazepine in man: a review Ther. Drug Monit. 1 409 431 555583 10.1097/00007691-197901030-00014 (Pubitemid 10097086)
37. R. P. Remmel M. W. Sinz J. C. Cloyd 1990 Dose-dependent pharmacokinetics of carbamazepine in rats: determination of the formation clearance of carbamazepine-10,11-epoxide Pharm. Res. 7 513 517 2367320 10.1023/A: 1015872901523 1:CAS:528:DyaK3cXkslSlt7k%3D (Pubitemid 20322204)
38. R. J. Roberts R. S. Payne R. C. Rowe 2000 Mechanical property predictions for polymorphs of sulphathiazole and carbamazepine Eur. J. Pharm Sci. 9 277 283 10594385 10.1016/S0928-0987(99)00065-2 1:CAS:528:DyaK1MXnslGrsLk%3D
39. C. Rustichelli G. Gamberini V. Ferioli M. C. Gamberini R. Ficarra S. Tommasini 2000 Solid-state study of polymorphic drugs: carbamazepine J. Pharm. Biomed. Anal. 23 41 54 10898153 10.1016/S0731-7085(00)00262-4 1:CAS:528:DC%2BD3cXktlCrtrw%3D (Pubitemid 30394550)
40. A. K. Salameh L. S. Taylor 2006 Physical stability of crystal hydrates and their anhydrates in the presence of excipients J. Pharm. Sci. 95 446 461 16380975 10.1002/jps.20532 1:CAS:528:DC%2BD28XhsFeksL4%3D (Pubitemid 43241985)
41. L. M. Sanftner J. A. Gibbons M. I. Gross B. M. Suzuki F. C. Gaeta K. W. Johnson 2009 Cross-species comparisons of the pharmacokinetics of ibudilast Xenobiotica 39 964 977 19925385 10.3109/00498250903254340 1:CAS:528: DC%2BD1MXhsVCisbjM
42. S. Sehiæ G. Betz S. Hadzidediæ S. K. El-Arini H. Leuenberger 2010 Investigation of intrinsic dissolution behavior of different carbamazepine samples Int. J. Pharm. 386 77 90 10.1016/j.ijpharm.2009.10.051
43. D. Singhal W. Curatolo 2004 Drug polymorphism and dosage form design: a practical perspective Adv. Drug Deliv. Rev. 56 335 347 14962585 10.1016/j.addr.2003.10.008 1:CAS:528:DC%2BD2cXhtV2msr4%3D (Pubitemid 38201429)
44. P. Veng-Pedersen J. V. Gobburu M. C. Meyer A. B. Straughn 2000 Carbamazepine level-A in vivo-in vitro correlation (IVIVC): a scaled convolution based predictive approach Biopharm. Drug Dispos. 21 1 6 11038432 10.1002/1099-081X(200001)21:1<1::AID-BDD207>3.0.CO;2-D 1:CAS:528:DC%2BD3cXnsl2ns74%3D
45. I. R. Wilding S. S. Davis J. G. Hardy C. S. Robertson V. A. John M. L. Powell M. Leal P. Lloyd S.M. Walker 1991 Relationship between systemic drug absorption and gastrointestinal transit after the simultaneous oral administration of carbamazepine as a controlled-release sys tem and as a suspension of 15N-labelled drug to healthy volunteers Br. J. Clin. Pharmacol. 32 573 579 1954073 1:CAS:528:DyaK38Xks1Wnsw%3D%3D
46. R. I. Winnicka B. Topaciñski W. M. Szymczak B. Szymañska 2002 Carbamazepine poisoning: elimination kinetics and quantitative relationship with carbamazepine 10,11-epoxide J. Toxicol. Clin. Toxicol. 40 759 765 12475188 10.1081/CLT-120015836 1:CAS:528:DC%2BD38Xps1yjt78%3D (Pubitemid 35428792)
47. Zhang, Y. P., Pharmacological experiment. 2nd ed. People's Medical Publishing House, p. 283, (1996).
48. L. Zhou Y. Jiang T. Yan G. Di Z. Shen Z. Shao J. Lu 2010 The prognostic role of cancer stem cells in breast cancer: a meta-analysis of published literatures Breast Cancer Res. Treat. 122 795 801 20571867 10.1007/s10549-010- 0999-4