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Biowaiver Monographs for Immediate‐Release Solid Oral Dosage Forms: Codeine Phosphate

dc.contributor.authorDahan, Ariken_US
dc.contributor.authorWolk, Omrien_US
dc.contributor.authorZur, Moranen_US
dc.contributor.authorAmidon, Gordon L.en_US
dc.contributor.authorAbrahamsson, Bertilen_US
dc.contributor.authorCristofoletti, Rodrigoen_US
dc.contributor.authorGroot, D. W.en_US
dc.contributor.authorKopp, Sabineen_US
dc.contributor.authorLangguth, Peteren_US
dc.contributor.authorPolli, James E.en_US
dc.contributor.authorShah, Vinod P.en_US
dc.contributor.authorDressman, Jennifer B.en_US
dc.date.accessioned2014-05-23T15:59:27Z
dc.date.availableWITHHELD_14_MONTHSen_US
dc.date.available2014-05-23T15:59:27Z
dc.date.issued2014-06en_US
dc.identifier.citationDahan, Arik; Wolk, Omri; Zur, Moran; Amidon, Gordon L.; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D. W.; Kopp, Sabine; Langguth, Peter; Polli, James E.; Shah, Vinod P.; Dressman, Jennifer B. (2014). "Biowaiver Monographs for Immediate‐Release Solid Oral Dosage Forms: Codeine Phosphate." Journal of Pharmaceutical Sciences 103(6): 1592-1600.en_US
dc.identifier.issn0022-3549en_US
dc.identifier.issn1520-6017en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/106898
dc.publisherThe Macmillian Companyen_US
dc.publisherWiley Periodicals, Inc.en_US
dc.subject.otherPermeabilityen_US
dc.subject.otherDissolutionen_US
dc.subject.otherSolubilityen_US
dc.subject.otherAbsorptionen_US
dc.subject.otherBioequivalenceen_US
dc.subject.otherBiopharmaceutics Classification System (BCS)en_US
dc.subject.otherCodeine Phosphateen_US
dc.subject.otherBioavailabilityen_US
dc.titleBiowaiver Monographs for Immediate‐Release Solid Oral Dosage Forms: Codeine Phosphateen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelPharmacy and Pharmacologyen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/106898/1/jps23977.pdf
dc.identifier.doi10.1002/jps.23977en_US
dc.identifier.sourceJournal of Pharmaceutical Sciencesen_US
dc.identifier.citedreferenceYalkowsky SH, Johnson JL, Sanghvi T, Machatha SG. 2006. A ‘rule of unity’ for human intestinal absorption. Pharm Res 23 ( 10 ): 2475 – 2481.en_US
dc.identifier.citedreferenceDahan A, Miller JM, Hilfinger JM, Yamashita S, Yu LX, Lennernäs H, Amidon GL. 2010. High‐permeability criterion for BCS classification: Segmental/p H dependent permeability considerations. Mol Pharm 7 ( 5 ): 1827 – 1834.en_US
dc.identifier.citedreferenceFairstein M, Swissa R, Dahan A. 2013. Regional‐dependent intestinal permeability and BCS classification: Elucidation of p H ‐related complexity in rats using pseudoephedrine. AAPS J 15 ( 2 ): 589 – 597.en_US
dc.identifier.citedreferenceZur M, Gasparini M, Wolk O, Amidon GL, Dahan A. 2014. The low/high BCS permeability class boundary: Physicochemical comparison of metoprolol and labetalol. Mol Pharmaceutics. [Epub ahead of print]en_US
dc.identifier.citedreferenceBeig A, Miller JM, Dahan A. 2012. Accounting for the solubility‐permeability interplay in oral formulation development for poor water solubility drugs: the effect of PEG‐400 on carbamazepine absorption. European Journal of Pharmaceutics and Biopharmaceutics 81 ( 2 ) 386 – 91.en_US
dc.identifier.citedreferenceDahan A, Amidon GL. 2010. MRP2 mediated drug‐drug interaction: indomethacin increases sulfasalazine absorption in the small intestine, potentially decreasing its colonic targeting. International Journal of Pharmaceutics 386 ( 1‐2 ) 216 – 20.en_US
dc.identifier.citedreferenceBeig A, Agbaria R, Dahan A. 2013. Oral delivery of lipophilic drugs: The tradeoff between solubility increase and permeability decrease when using cyclodextrin‐based formulations. PLoS ONE 8 ( 7 ): e68237.en_US
dc.identifier.citedreferenceDahan A, Beig A, Ioffe‐Dahan V, Agbaria R, Miller J. 2013. The twofold advantage of the amorphous form as an oral drug delivery practice for lipophilic compounds: Increased apparent solubility and drug flux through the intestinal membrane. AAPS J 15 ( 2 ): 347 – 353.en_US
dc.identifier.citedreferenceMiller JM, Beig A, Carr RA, Webster GK, Dahan A. 2012. The solubility–permeability interplay when using cosolvents for solubilization: Revising the way we use solubility‐enabling formulations. Mol Pharm 9 ( 3 ): 581 – 590.en_US
dc.identifier.citedreferenceCDER/FDA. 2000. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate‐release solid oral dosage forms based on a biopharmaceutics classification system.en_US
dc.identifier.citedreferenceMeylan WM, Howard PH. 1995. Atom/fragment contribution method for estimating octanol–water partition coefficients. J Pharm Sci 84 ( 1 ): 83 – 92.en_US
dc.identifier.citedreferenceFuguet E, Reta M, Gibert C, Roses M, Bosch E, Rafols C. 2008. Critical evaluation of buffering solutions for p K a determination by capillary electrophoresis. Electrophoresis 29 ( 13 ): 2841 – 2851.en_US
dc.identifier.citedreferenceBodd E, Beylich KM, Christophersen AS, Morland J. 1987. Oral administration of codeine in the presence of ethanol: A pharmacokinetic study in man. Pharmacol Toxicol 61 ( 5 ): 297 – 300.en_US
dc.identifier.citedreferenceVree TB, Verwey‐van Wissen CP. 1992. Pharmacokinetics and metabolism of codeine in humans. Biopharm Drug Dispos 13 ( 6 ): 445 – 460.en_US
dc.identifier.citedreferenceSkolnik S, Lin X, Wang J, Chen XH, He T, Zhang B. 2010. Towards prediction of in vivo intestinal absorption using a 96‐well C aco‐2 assay. J Pharm Sci 99 ( 7 ): 3246 – 3265.en_US
dc.identifier.citedreferenceDahan A, Sabit H, Amidon GL. 2009. Multiple efflux pumps are involved in the transepithelial transport of colchicine: Combined effect of P ‐gp and MRP 2 leads to decreased intestinal absorption throughout the entire small intestine. Drug Metab Dispos 37 ( 10 ): 2028 – 2036.en_US
dc.identifier.citedreferenceHubatsch I, Ragnarsson EGE, Artursson P. 2007. Determination of drug permeability and prediction of drug absorption in C aco‐2 monolayers. Nat Protoc 2 ( 9 ): 2111 – 2119.en_US
dc.identifier.citedreferenceMoolenaar F, Grasmeijer G, Visser J, Meijer DK. 1983. Rectal versus oral absorption of codeine phosphate in man. Biopharm Drug Dispos 4 ( 2 ): 195 – 199.en_US
dc.identifier.citedreferenceCao X, Gibbs S, Fang L, Miller H, Landowski C, Shin H‐C, Lennernas H, Zhong Y, Amidon G, Yu L, Sun D. 2006. Why is it challenging to predict intestinal drug absorption and oral bioavailability in human using rat model. Pharm Res 23 ( 8 ): 1675 – 1686.en_US
dc.identifier.citedreferenceQuiding H, Anderson P, Bondesson U, Boréus LO, Hynning PÅ. 1986. Plasma concentrations of codeine and its metabolite, morphine, after single and repeated oral administration. Eur J Clin Pharm 30 ( 6 ): 673 – 677.en_US
dc.identifier.citedreferenceYue QY, Hasselstrom J, Svensson JO, Sawe J. 1991. Pharmacokinetics of codeine and its metabolites in C aucasian healthy volunteers: Comparisons between extensive and poor hydroxylators of debrisoquine. Br J Clin Pharmacol 31 ( 6 ): 635 – 642.en_US
dc.identifier.citedreferenceSomogyi AA, Barratt DT, Coller JK. 2007. Pharmacogenetics of opioids. Clin Pharmacol Ther 81 ( 3 ): 429 – 444.en_US
dc.identifier.citedreferenceAmmon S, Marx C, Behrens C, Hofmann U, Murdter T, Griese E‐U, Mikus G. 2002. Diclofenac does not interact with codeine metabolism in vivo: A study in healthy volunteers. BMC Clin Pharmacol 2 ( 1 ): 2.en_US
dc.identifier.citedreferenceCaraco Y, Sheller J, Wood AJJ. 1999. Impact of ethnic origin and quinidine coadministration on codeine's disposition and pharmacodynamic effects. J Pharmacol Exp Ther 290 ( 1 ): 413 – 422.en_US
dc.identifier.citedreferenceGil Berglund E, Johannsson G, Beck O, Bengtsson BÅ, Rane A. 2002. Growth hormone replacement therapy induces codeine clearance. Eur J Clin Invest 32 ( 7 ): 507 – 512.en_US
dc.identifier.citedreferenceMohammed SS, Ayass M, Mehta P, Kedar A, Gross S, Derendorf H. 1993. Codeine disposition in sickle cell patients compared with healthy volunteers. J Clin Pharmacol 33 ( 9 ): 811 – 815.en_US
dc.identifier.citedreferenceRogers JF, Findlay JWA, Hull JH, Butz RF, Jones EC, Bustrack JA, Welch RM. 1982. Codeine disposition in smokers and nonsmokers. Clin Pharm Ther 32 ( 2 ): 218 – 227.en_US
dc.identifier.citedreferenceDahan A, Wolk O, Kim YH, Ramachandran C, Crippen GM, Takagi T, Bermejo M, Amidon GL. 2013. Purely in silico BCS classification: Science based quality standards for the world's drugs. Mol Pharm 10 ( 11 ): 4378 – 4390.en_US
dc.identifier.citedreferencePham‐The H, Garrigues T, Bermejo M, González‐Álvarez I, Monteagudo MC, Cabrera‐Pérez MÁ. 2013. Provisional classification and in silico study of biopharmaceutical system based on C aco‐2 cell permeability and dose number. Mol Pharm 10 ( 6 ): 2445 – 2461.en_US
dc.identifier.citedreferenceZhao YH, Le J, Abraham MH, Hersey A, Eddershaw PJ, Luscombe CN, Boutina D, Beck G, Sherborne B, Cooper I, Platts JA. 2001. Evaluation of human intestinal absorption data and subsequent derivation of a quantitative structure–activity relationship ( QSAR ) with the Abraham descriptors. J Pharm Sci 90 ( 6 ): 749 – 784.en_US
dc.identifier.citedreferenceKasim NA, Whitehouse M, Ramachandran C, Bermejo M, Lennernas H, Hussain AS, Junginger HE, Stavchansky SA, Midha KK, Shah VP, Amidon GL. 2004. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification. Mol Pharm 1 ( 1 ): 85 – 96.en_US
dc.identifier.citedreferenceTakagi T, Ramachandran C, Bermejo M, Yamashita S, Yu LX, Amidon GL. 2006. A provisional biopharmaceutical classification of the top 200 oral drug products in the U nited S tates, G reat B ritain, S pain, and J apan. Mol Pharm 3 ( 6 ): 631 – 643.en_US
dc.identifier.citedreferenceBenet LZ, Broccatelli F, Oprea TI. 2011. BDDCS applied to over 900 drugs. AAPS J 13 ( 4 ): 519 – 547.en_US
dc.identifier.citedreferenceGoodman L, Gilman A. 2006. The pharmacological basis of therapeutics. 11th ed. New York: The Macmillian Company.en_US
dc.identifier.citedreferenceAylward M, Maddock J, Davies DE, Protheroe DA, Leideman T. 1984. Dextromethorphan and codeine: Comparison of plasma kinetics and antitussive effects. Eur J Respir Dis 65 ( 4 ): 283 – 291.en_US
dc.identifier.citedreferenceFreestone C, Eccles R. 1997. Assessment of the antitussive efficacy of codeine in cough associated with common cold. J Pharm Pharmacol 49 ( 10 ): 1045 – 1049.en_US
dc.identifier.citedreferenceHutchings HA, Eccles R. 1994. The opioid agonist codeine and antagonist naltrexone do not affect voluntary suppression of capsaicin induced cough in healthy subjects. Eur Respir J 7 ( 4 ): 715 – 719.en_US
dc.identifier.citedreferenceBolser DC. 2006. Cough suppressant and pharmacologic protussive therapy: ACCP evidence‐based clinical practice guidelines. Chest 129 ( 1 Suppl ): 238S – 249S.en_US
dc.identifier.citedreferenceMignat C, Wille U, Ziegler A. 1995. Affinity profiles of morphine, codeine, dihydrocodeine and their glucuronides at opioid receptor subtypes. Life Sci 56 ( 10 ): 793 – 799.en_US
dc.identifier.citedreferenceVolpe DA, McMahon Tobin GA, Mellon RD, Katki AG, Parker RJ, Colatsky T, Kropp TJ, Verbois SL. 2011. Uniform assessment and ranking of opioid mu receptor binding constants for selected opioid drugs. Regul Toxicol Pharmacol 59 ( 3 ): 385 – 390.en_US
dc.identifier.citedreferenceChau TT, Harris LS. 1980. Comparative studies of the pharmacological effects of the d‐ and l‐isomers of codeine. J Pharmacol Exp Ther 215 ( 3 ): 668 – 672.en_US
dc.identifier.citedreferenceKahan M, Mailis‐Gagnon A, Wilson L, Srivastava A. 2011. C anadian guideline for safe and effective use of opioids for chronic noncancer pain: Clinical summary for family physicians. Part 1: General population. Can Fam Physician 57 ( 11 ): 1257 – 1266, e407–e418.en_US
dc.identifier.citedreferenceGasche Y, Daali Y, Fathi M, Chiappe A, Cottini S, Dayer P, Desmeules J. 2004. Codeine intoxication associated with ultrarapid CYP 2 D 6 metabolism. N Engl J Med 351 ( 27 ): 2827 – 2831.en_US
dc.identifier.citedreferenceCrews KR, Gaedigk A, Dunnenberger HM, Klein TE, Shen DD, Callaghan JT, Kharasch ED, Skaar TC. 2012. C linical P harmacogenetics I mplementation C onsortium ( CPIC ) guidelines for codeine therapy in the context of cytochrome P 450 2 D 6 ( CYP 2 D 6) genotype. Clin Pharmacol Ther 91 ( 2 ): 321 – 326.en_US
dc.identifier.citedreferenceKelly LE, Madadi P. 2012. Is there a role for therapeutic drug monitoring with codeine ? Ther Drug Monit 34 ( 3 ): 249 – 256.en_US
dc.identifier.citedreferenceLeppert W. 2011. CYP 2 D 6 in the metabolism of opioids for mild to moderate pain. Pharmacology 87 ( 5–6 ): 274 – 285.en_US
dc.identifier.citedreferenceKelly LE, Rieder M, van den Anker J, Malkin B, Ross C, Neely MN, Carleton B, Hayden MR, Madadi P, Koren G. 2012. More codeine fatalities after tonsillectomy in N orth A merican children. Pediatrics 129 ( 5 ): e1343 – e1347.en_US
dc.identifier.citedreferenceCiszkowski C, Madadi P, Phillips MS, Lauwers AE, Koren G. 2009. Codeine, ultrarapid‐metabolism genotype, and postoperative death. N Engl J Med 361 ( 8 ): 827 – 828.en_US
dc.identifier.citedreferenceBrousseau DC, McCarver DG, Drendel AL, Divakaran K, Panepinto JA. 2007. The effect of CYP 2 D 6 polymorphisms on the response to pain treatment for pediatric sickle cell pain crisis. J Pediatr 150 ( 6 ): 623 – 626.en_US
dc.identifier.citedreferenceZur M, Hanson AS, Dahan A. 2014. The complexity of intestinal permeability: Assigning the correct BCS classification through careful data interpretation. Eur J Pharm Sci. [Epub ahead of print]en_US
dc.identifier.citedreferenceDahan A, Amidon GL. 2009. Small intestinal efflux mediated by MRP 2 and BCRP shifts sulfasalazine intestinal permeability from high to low, enabling its colonic targeting. Am J Physiol Gastrointest Liver Physiol 297 ( 2 ): G371 – G377.en_US
dc.identifier.citedreferenceDahan A, Amidon GL. 2009. Grapefruit juice and its constituents augment colchicine intestinal absorption: Potential hazardous interaction and the role of p‐glycoprotein. Pharm Res 26 ( 4 ): 883 – 892.en_US
dc.identifier.citedreferenceDahan A, Amidon GL. 2009. Segmental dependent transport of low permeability compounds along the small intestine due to P ‐glycoprotein: The role of efflux transport in the oral absorption of BCS class III drugs. Mol Pharm 6 ( 1 ): 19 – 28.en_US
dc.identifier.citedreferenceDahan A, Lennernäs H, Amidon GL. 2012. The fraction dose absorbed, in humans, and high jejunal human permeability relationship. Mol Pharm 9 ( 6 ): 1847 – 1851.en_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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