Meta-analysis of Magnetic Marker Monitoring Data to Characterize the Movement of Single Unit Dosage Forms Though the Gastrointestinal Tract Under Fed and Fasting Conditions

详细信息    查看全文

• 作者：Emilie Hénin ; Martin Bergstrand ; Werner Weitschies…
• 关键词：Food effect ; GI transit ; Markov model ; Tablet movement
• 刊名：Pharmaceutical Research
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：33
• 期：3
• 页码：751-762
• 全文大小：1,214 KB
• 参考文献：1.Weitschies W, Blume H, Monnikes H. Magnetic marker monitoring: high resolution real-time tracking of oral solid dosage forms in the gastrointestinal tract. Eur J Pharm Biopharm. 2010;74:93–101.CrossRef PubMed
  2.Yuen KH. The transit of dosage forms through the small intestine. Int J Pharm. 2010;395:9–16.CrossRef PubMed
  3.Kenyon CJ, Hooper G, Tierney D, Butler J, Devane J, Wilding IR. The effect of food on the gastrointestinal transit and systemic absorption of naproxen from a novel sustained release formulation. J Control Release. 1995;34:31–6.CrossRef
  4.Davis SS, Hardy JG, Fara JW. Transit of pharmaceutical dosage forms through the small intestine. Gut. 1986;27:886–92.PubMedCentral CrossRef PubMed
  5.Devereux JE, Newton JM, Short MB. The influence of density on the gastrointestinal transit of pellets. J Pharm Pharmacol. 1990;42:500–1.CrossRef PubMed
  6.Yuen KH, Deshmukh AA, Newton JM, Short M, Melchor R. Gastrointestinal transit and absorption of theophylline from a multiparticulate controlled release formulation. Int J Pharm. 1993;97:61–77.CrossRef
  7.Billa N, Yuen KH, Khader MA, Omar A. Gamma-scintigraphic study of the gastrointestinal transit and in vivo dissolution of a controlled release diclofenac sodium formulation in xanthan gum matrices. Int J Pharm. 2000;201:109–20.CrossRef PubMed
  8.Fadda HM, McConnell EL, Short MD, Basit AW. Meal-induced acceleration of tablet transit through the human small intestine. Pharm Res. 2009;26:356–60.CrossRef PubMed
  9.Horton RE, Ross FG, Darling GH. Determination of the emptying-time of the stomach by use of enteric-coated barium granules. Br Med J. 1965;1:1537–9.PubMedCentral CrossRef PubMed
  10.Daly PB, Davis SS, Frier M, Hardy JG, Kennerley JW, Wilson CG. Scintigraphic assessment of the in vivo dissolution rate of a sustained release tablet. Int J Pharm. 1982;10:17–24.CrossRef
  11.Steinberg WH, Frey GH, Masci JN, Hutchins HH. Method for determining in vivo tablet disintegration. J Pharm Sci. 1965;54:747–52.CrossRef PubMed
  12.Evans DF, Pye G, Bramley R, Clark AG, Dyson TJ, Hardcastle JD. Measurement of gastrointestinal pH profiles in normal ambulant human subjects. Gut. 1988;29:1035–41.PubMedCentral CrossRef PubMed
  13.Read NW, Cammack J, Edwards C, Holgate AM, Cann PA, Brown C. Is the transit time of a meal through the small intestine related to the rate at which it leaves the stomach? Gut. 1982;23:824–8.PubMedCentral CrossRef PubMed
  14.Schiller C, Frohlich CP, Giessmann T, Siegmund W, Monnikes H, Hosten N, et al. Intestinal fluid volumes and transit of dosage forms as assessed by magnetic resonance imaging. Aliment Pharmacol Ther. 2005;22:971–9.CrossRef PubMed
  15.Sutton JA, Thompson S, Sobnack R. Measurement of gastric emptying rates by radioactive isotope scanning and epigastric impedance. Lancet. 1985;1:898–900.CrossRef PubMed
  16.Avill R, Mangnall YF, Bird NC, Brown BH, Barber DC, Seagar AD, et al. Applied potential tomography. A new noninvasive technique for measuring gastric emptying. Gastroenterology. 1987;92:1019–26.PubMed
  17.Maublant JC, Hassine H, Sournac M, Dapogny M, Veyre A, Aiache JM, et al. Ultrasonic visualization of tablets in the gastrointestinal tract. J Nucl Med. 1988;29:129.PubMed
  18.Casey DL, Beihn RM, Digenis GA, Shabhu MB. Method for monitoring hard gelatin capsule disintegration times in humans using external scintigraphy. J Pharm Sci. 1976;65:1412–3.CrossRef PubMed
  19.Alpsten M, Ekenved G, Solvell L. A profile scanning method of studying the release properties of different types of tablets in man. Acta Pharm Suec. 1976;13:107–22.PubMed
  20.Weitschies W, Wedemeyer J, Stehr R, Trahms L. Magnetic markers as a noninvasive tool to monitor gastrointestinal transit. IEEE Trans Biomed Eng. 1994;41:192–5.CrossRef PubMed
  21.Weitschies W, Kosch O, Monnikes H, Trahms L. Magnetic Marker Monitoring: an application of biomagnetic measurement instrumentation and principles for the determination of the gastrointestinal behavior of magnetically marked solid dosage forms. Adv Drug Deliv Rev. 2005;57:1210–22.CrossRef PubMed
  22.Goodman K, Hodges LA, Band J, Stevens HN, Weitschies W, Wilson CG. Assessing gastrointestinal motility and disintegration profiles of magnetic tablets by a novel magnetic imaging device and gamma scintigraphy. Eur J Pharm Biopharm. 2009;74:84–92.CrossRef PubMed
  23.Bergstrand M, Soderlind E, Weitschies W, Karlsson MO. Mechanistic modeling of a magnetic marker monitoring study linking gastrointestinal tablet transit, in vivo drug release, and pharmacokinetics. Clin Pharmacol Ther. 2009;86:77–83.CrossRef PubMed
  24.Rao C. Linear statistical inference and its applications. New York; 1973.
  25.Beal SL, Sheiner LB, Boeckmann A, Bauer RJ. NONMEM user’s guides (1989–2009). Ellicott City: Icon Development Solutions; 2009.
  26.Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)--a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75:85–94.CrossRef PubMed
  27.D.C.T. R. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2010.
  28.Jonssonand EN, Karlsson MO. Xpose--an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58:51–64.CrossRef
  29.Yano Y, Beal SL, Sheiner LB. Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J Pharmacokinet Pharmacodyn. 2001;28:171–92.CrossRef PubMed
  30.Bergstrand M, Soderlind E, Eriksson UG, Weitschies W, Karlsson MO. A semi-mechanistic modeling strategy to link in vitro and in vivo drug release for modified release formulations. Pharm Res. 2012;29:695–706.CrossRef PubMed
  31.Dinning PG, Bampton PA, Kennedy ML, Kajimoto T, Lubowski DZ, de Carle DJ, et al. Basal pressure patterns and reflexive motor responses in the human ileocolonic junction. Am J Physiol. 1999;276:G331–40.PubMed
  32.Dinning PG, Szczesniak MM, Cook IJ. Determinants of postprandial flow across the human ileocaecal junction: a combined manometric and scintigraphic study. Neurogastroenterol Motil. 2008;20:1119–26.CrossRef PubMed
  33.Henin E, Bergstrand M, Standing JF, Karlsson MO. A mechanism-based approach for absorption modeling: the Gastro-Intestinal Transit Time (GITT) model. AAPS J. 2012;14:155–63.PubMedCentral CrossRef PubMed
  34.Coupe AJ, Davis SS, Wilding IR. Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects. Pharm Res. 1991;8:360–4.CrossRef PubMed
  35.Hardoff R, Sula M, Tamir A, Soil A, Front A, Badarna S, et al. Gastric emptying time and gastric motility in patients with Parkinson’s disease. Mov Disord. 2001;16:1041–7.CrossRef PubMed
  36.Cammack J, Read NW, Cann PA, Greenwood B, Holgate AM. Effect of prolonged exercise on the passage of a solid meal through the stomach and small intestine. Gut. 1982;23:957–61.PubMedCentral CrossRef PubMed
  37.Dooley CP, Di Lorenzo C, Valenzuela JE. Variability of migrating motor complex in humans. Dig Dis Sci. 1992;37:723–8.CrossRef PubMed
  38.Sarna SK. Cyclic motor activity; migrating motor complex: 1985. Gastroenterology. 1985;89:894–913.PubMed
  39.Weitschies W, Friedrich C, Wedemeyer RS, Schmidtmann M, Kosch O, Kinzig M, et al. Bioavailability of amoxicillin and clavulanic acid from extended release tablets depends on intragastric tablet deposition and gastric emptying. Eur J Pharm Biopharm. 2008;70:641–8.CrossRef PubMed
  40.Bergstrand M, Soderlind E, Eriksson UG, Weitschies W, Karlsson MO. A semi-mechanistic modeling strategy for characterization of regional absorption properties and prospective prediction of plasma concentrations following administration of new modified release formulations. Pharm Res. 2012;29:574–84.CrossRef PubMed
  41.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. Eur J Clin Pharmacol. 1986;30:691–7.CrossRef PubMed
  42.Xitian P, Hongying L, Kang W, Yulin L, Xiaolin Z, Zhiyu W. A novel remote controlled capsule for site-specific drug delivery in human GI tract. Int J Pharm. 2009;382:160–4.CrossRef PubMed
  43.Stockis A, Sargentini-Maier ML, Otoul C, Connor A, Wilding I, Wray H. Assessment of levetiracetam bioavailability from targeted sites in the human intestine using remotely activated capsules and gamma scintigraphy: open-label, single-dose, randomized, four-way crossover study in healthy male volunteers. Clin Ther. 32:1813–21.
  44.Fuhr U, Staib AH, Harder S, Becker K, Liermann D, Schollnhammer G, et al. Absorption of ipsapirone along the human gastrointestinal tract. Br J Clin Pharmacol. 1994;38:83–6.PubMedCentral CrossRef PubMed
  45.Harder S, Fuhr U, Beermann D, Staib AH. Ciprofloxacin absorption in different regions of the human gastrointestinal tract. Investigations with the hf-capsule. Br J Clin Pharmacol. 1990;30:35–9.PubMedCentral CrossRef PubMed
  46.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.CrossRef PubMed
  47.Chan KK, Buch A, Glazer RD, John VA, Barr WH. Site-differential gastrointestinal absorption of benazepril hydrochloride in healthy volunteers. Pharm Res. 1994;11:432–7.CrossRef PubMed
  48.Connor A. Location, location, location: gastrointestinal delivery site and its impact on absorption. Ther Deliv. 2012;3:575–8.CrossRef PubMed
  49.Lennernas H, Aarons L, Augustijns P, Beato S, Bolger M, Box K, et al. Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo. Eur J Pharm Sci. 2014;57:292–9.CrossRef PubMed
  50.Kostewicz ES, Aarons L, Bergstrand M, Bolger MB, Galetin A, Hatley O, et al. PBPK models for the prediction of in vivo performance of oral dosage forms. Eur J Pharm Sci. 2014;57:300–21.CrossRef PubMed
  
• 作者单位：Emilie Hénin (1) (3)
  Martin Bergstrand (1)
  Werner Weitschies (2)
  Mats O. Karlsson (1)
  
  1. Pharmacometrics Group, Department of Pharmaceutical Biosciences, Uppsala University, Box 591, 75124, Uppsala, Sweden
  3. Université Claude Bernard, EMR 3738 Ciblage Thérapeutique en Oncologie - Faculté de Médecine Lyon Sud, BP12, 69921, Oullins Cedex, France
  2. Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, Greifswald, D-17487, Germany
  
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Pharmacology and Toxicology
  Pharmacy
  Biochemistry
  Medical Law
  Biomedical Engineering
  
• 出版者：Springer Netherlands
• ISSN：1573-904X

文摘

Purpose To develop a model predicting movement of non-disintegrating single unit dosage forms (or “tablet”) through the gastrointestinal tract and characterizing the effect of food intake, based on Magnetic Marker Monitoring data, allowing real-time location of a magnetically labeled formulation.