The use of gastrointestinal intubation studies for controlled release development

British Journal of Clinical Pharmacology

Volumn 68, Issue 3, 2009, Pages 342-354

  Sutton, Steven C ^a,b  

^a UNIVERSITY OF NEW ENGLAND   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Clinical pharmacokinetics; Colon; Controlled release; Intubation; Relative bioavailability

Indexed keywords

(4 (2 (2 (6 AMINOPYRIDIN 3 YL) 2 HYDROXYETHYLAMINO) ETHOXY) PHENYL) ACETIC ACID; 2 (3 BENZYL 4 HYDROXYCHROMAN 7 YL) 4 TRIFLUOROMETHYLBENZOIC ACID; 4 [3 [4 (2 METHYLIMIDAZOL 1 YL)PHENYLTHIO]]PHENYL 3,4,5,6 TETRAHYDRO 2H PYRAN 4 CARBOXAMIDE METHANESULFONATE; 4 OXO 4,5,6,7 TETRAHYDRO 1H INDOLE 3 CARBOXYLIC ACID (4 METHYLAMINOMETHYL PHENYL) AMIDE; AZITHROMYCIN; CAPROMORELIN; CJ 13610; CJ 13670; CP 331684; CP 409092; SERTRALINE; TROVAFLOXACIN; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CELL STRAIN CACO 2; CLINICAL TRIAL; COLON ABSORPTION; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIGESTIVE TRACT INTUBATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG PENETRATION; DRUG SOLUBILITY; DRUG TRANSPORT; FEMALE; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; SMALL INTESTINE ABSORPTION; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANIMALS; AZITHROMYCIN; COLON; DELAYED-ACTION PREPARATIONS; DOGS; FLUOROQUINOLONES; HUMANS; IMIDAZOLES; INTESTINAL ABSORPTION; INTUBATION, GASTROINTESTINAL; NAPHTHYRIDINES; PERMEABILITY; SERTRALINE; SOLUBILITY; SULFIDES;

EID: 69949138207     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03432.x     Document Type: Article

References (35)

1. FDA. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/ Active Ingredients Based on a Biopharmaceutics Classification System. Rockville 2000.
2. Sutton SC, Evans L, Fortner J, McCarthy JM, Sweeney K. Dog colonoscopy model for predicting human colon absorption. Pharmaceutical Res 2006 23 : 1554 1563.
3. Mano T, Stevens RW, Ando K, Nakao K, Okumura Y, Sakakibara M, Okumura T, Miyamoto K, Tamura T. CJ-13610: design of an orally active and safe 5-LO inhibitor. In: 22nd Symp Med Chem, Shizuoka, Japan, 2002; 1P-19.
4. Bach MA, Cambria M. Growth hormone releasing peptides: growth studies. Curr Opin Endocrinol Diabetes 1999 6 : 100 105.
5. MacAndrew JT, Ellery SS, Parry MA, Pan LC, Black SC. Efficacy of a growth hormone-releasing peptide mimetic in cardiac ischemia/reperfusion injury. Eur J Pharmacol 2001 432 : 195 202.
6. Fiese EF. General pharmaceutics - the new physical pharmacy. J Pharm Sci 2003 92 : 1331 1342.
7. Sutton SC, Rinaldi MTS, McCarthy JM, Vukovinsky KE. A statistical method for the determination of absorption rate constant estimated using the rat single pass intestinal perfusion model and multiple linear regression. J Pharm Sci 2002 91 : 1046 1053.
8. Sutton SC, Rinaldi MTS, Vukovinsky KE. Comparison of the gravimetric, phenol red and 14C-PEG-3350 methods to determine water absorption in the rat single pass intestinal perfusion model. The AAPS Journal 2001 3 : 93 7.
9. Dalvie DK, O'Donnell JP. Metabolism of CP-195,543, a leukotriene B4 receptor antagonist, in the Long± Evans rat and Cynomolgus monkey. Xenobiotica 1999 29 : 1123 1140.
10. Yee S, Lin Z, Gunduz M, Jaw-Tsai S, Nelson FR. Effect of P-glycoprotein on the oral absorption and brain penetration of CP-409, 092 in rats and mice. Drug Metab Rev 2000 32 : 194.
11. Carpino PA, Lefker BA, Toler SM, Pan LC, Hadcock J, Dasilva-Jardine P, Pettersen J, Thompson D. Short- and Long-acting Growth Hormone Secretagogues: Discovery and SAR of Capromorelin Tartrate (CP-424391-18). Chicago, IL : American Chemical Society National Meeting, 2001.
12. Shepard RM, Duthu GS, Ferraina RA, Mullins MA. HPLC assay with EC detection of azithromycin in serum and tissues. J Chromatogr B Biomed Appl 1991 565 : 321 337.
13. Axelson DA, Perel JM, Birmaher B, Rudolph GR, Nuss S, Bridge J, Brent DA. Sertraline pharmacokinetics and dynamics in adolescents. J Am Acad Child Adolesc Psychiatry 2002 41 : 1037 1044.
14. Teng R, Tensfeldt TG, Liston TE, Foulds G. Determination of trovafloxacin, a new quinolone antibiotic, in biological samples by reversed-phase high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1996 675 : 53 9.
15. Gupta E, Barends DM, Yamashita E, Lentz KA, Harmsze AM, Shah VP, Dressman JB, Lipper RA. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. Eur J Pharm Sci 2006 29 : 315 324.
16. Luke D, Going P, Foulds G, Melnik G. Bioavailability of azithromycin when delivered as a rectal solution to healthy subjects. In: The Third International Conference on the Mac rolides, Azalides and Streptogramins, Lisbon, Portugal, 1996: Abstract #4.25.
17. Thombre AG, Cardinal JR, DeNoto AR, Herbig SM, Smith KL. Asymmetric membrane capsules for osmotic drug delivery. I. Development of a manufacturing process. J Control Release 1999 57 : 55 64.
18. Lacy MK, Nicolau DP, Nightingale CH, Geffken A, Teng R, Vincent J, Quintiliani R. Oral bioavailability and pharmacokinetics of trovafloxacin in patients with AIDS. Antimicrob Agents Chemother 1999 43 : 3005 3007.
19. Kramer WG. Absorption of isosorbide-5-mononitrate at specific sites in the gastrointestinal tract. J Clin Pharmacol 1994 34 : 1218 1221.
20. Tay LK, Dixon F Jr., Sostrin MB, Barr WH, Farmen RH, Pittman KA. The site of gastrointestinal absorption of gepirone in humans. J Clin Pharmacol 1992 32 : 827 832.
21. Triscari J, O'Donnell D, Zinny M, Pan HY. Gastrointestinal absorption of pravastatin in healthy subjects. J Clin Pharmacol 1995 35 : 142 144.
22. Charman WN, Rogge MC, Boddy AW, Barr WH, Berger BM. Absorption of danazol after administration to different sites of the gastrointestinal tract and the relationship to single- and double-peak phenomena in the plasma profiles. J Clin Pharmacol 1993 33 : 1207 1213.
23. Godbillon J, Evard D, Vidon N, Duval M, Schoeller JP, Bernier JJ, Hirtz J. Investigation of drug absorption from the gastrointestinal tract of man. III. Metoprolol in the colon. Br J Clin Pharmacol 1985 19 : 113S 118S. (Pubitemid 16193630)
24. Gleiter CH, Antonin KH, Bieck P, Godbillon J, Schonleber W, Malchow H. Colonoscopy in the investigation of drug absorption in healthy volunteers. Gastrointest Endosc 1985 31 : 71 3.
25. Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. N Engl J Med 2008 358 : 2316 2317.
26. Alpert JS. Dealing with ethical conflicts in clinical research. Am J Med 2008 121 : 457 457.
27. Wilding I. Site-specific drug delivery in the gastrointestinal tract review Crit Rev Ther Drug Carrier Syst 2000 17 : 557 620.
28. Nyberg L, Månsson W, Abrahamsson B, Seidegård J, Borgå O. A convenient method for local drug administration at predefined sites in the entire gastrointestinal tract: experiences from 13 phase I studies. Eur J Pharm Sci 2007 30 : 432 440.
29. Lee L, Hossain M, Wang Y, Sedek G. Absorption of rivastigmine from different regions of the gastrointestinal tract in humans. J Clin Pharmacol 2004 44 : 599 604.
30. Collett A, Stephens RH, Harwood MD, Humphrey M, Dallman L, Bennett J, Davis J, Carlson GL, Warhurst G. Investigation of regional mechanisms responsible for poor oral absorption in humans of a modified release preparation of the {alpha}-Adrenoreceptor antagonist, 4-Amino-6,7-dimethoxy-2-(5- methanesulfonamido-1,2,3,4 tetrahydroisoquinol-2-yl)-5-(2-pyridyl)quinazoline (UK-338,003): the rational use of ex vivo intestine to predict in vivo absorption. Drug Metab Dispos 2008 36 : 87 94.
31. Warner P, Brouwer K, Hussey E, Dukes G, Heizer W, Donn K, Davis I, Powell J. Sumatriptan absorption from different regions of the human gastrointestinal tract. Pharm Res 1995 12 : 138 143.
32. Riley SA, Kim M, Sutcliffe F, Rowland M, Turnberg LA. Absorption of polar drugs following caecal instillation in healthy volunteers. Alimentary Pharmacology & Therapeutics 1992 6 : 701 706.
33. Bode H, Brendel E, Ahr G, Fuhr U, Harder S. Investigation of nifedipine absorption in different regions of the human git after simultaneous administration of 13C and 12C nifedipine. Eur J Clin Pharmacol 1996 50 : 195 201.
34. Buch A, Barr W. Absorption of propranolol in humans following oral, jejunal, and ileal administration. Pharm Res 1998 15 : 953 957.
35. Staib AH, Loew D, Harder S, Graul EH, Pfab R. Measurement of theophylline absorption from different regions of the gastro-intestinal tract using a remote controlled drug delivery device. European Journal of Clinical Pharmacology 1986 30 : 691 697.