A Quantitative Review and Meta-Models of the Variability and Factors Affecting Oral Drug Absorption—Part I: Gastrointestinal pH

AAPS Journal

Volumn 18, Issue 5, 2016, Pages 1309-1321

  Abuhelwa, Ahmad Y ^a   Foster, David J R ^a   Upton, Richard N ^a  

^a UNIVERSITY OF SOUTH AUSTRALIA   (Australia)

Author keywords

fed state pH; gastric pH; gastrointestinal pH; meal caloric content; meta analysis

Indexed keywords

ARTICLE; ASCENDING COLON; COLON PH; DESCENDING COLON; DIET RESTRICTION; DIGESTIVE TRACT PARAMETERS; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG SOLUBILITY; DUODENUM PH; FOOD; GASTROINTESTINAL PH; HUMAN; JEJUNOILEAL PH; MATHEMATICAL MODEL; PLOTS AND CURVES; POSTPRANDIAL STATE; QUANTITATIVE ANALYSIS; STOMACH; STOMACH PH; SYSTEMATIC REVIEW; TRANSVERSE COLON; ANIMAL; DRUG EFFECTS; GASTROINTESTINAL TRACT; GASTROINTESTINAL TRANSIT; INTESTINE ABSORPTION; METABOLISM; ORAL DRUG ADMINISTRATION; PHYSIOLOGY;

DRUG;

ADMINISTRATION, ORAL; ANIMALS; GASTROINTESTINAL TRACT; GASTROINTESTINAL TRANSIT; HUMANS; INTESTINAL ABSORPTION; PHARMACEUTICAL PREPARATIONS;

EID: 84983002219     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-016-9952-8     Document Type: Article

References (45)

1. Ogata H, Aoyagi N, Kaniwa N, Ejima A, Sekine N, Kitamura M, et al. Gastric acidity dependent bioavailability of cinnarizine from two commercial capsules in healthy volunteers. Int J Pharm. 1986;29(2):113–20.
2. Abuhelwa AY, Mudge S, Hayes D, Upton RN, Foster DJ. Population in vitro-in vivo correlation model linking gastrointestinal transit time, pH, and pharmacokinetics: itraconazole as a model drug. Pharm Res. 2016;33(7):1782–94.
3. Simonian HP, Vo L, Doma S, Fisher RS, Parkman HP. Regional postprandial differences in pH within the stomach and gastroesophageal junction. Dig Dis Sci. 2005;50(12):2276–85.
4. Lindahl A, Ungell A-L, Knutson L, Lennernäs H. Characterization of fluids from the stomach and proximal jejunum in men and women. Pharm Res. 1997;14(4):497–502.
5. McLauchlan G, Fullarton G, Crean G, McColl K. Comparison of gastric body and antral pH: a 24 hour ambulatory study in healthy volunteers. Gut. 1989;30(5):573–8.
6. Koziolek M, Grimm M, Becker D, Iordanov V, Zou H, Shimizu J, et al. Investigation of pH and temperature profiles in the GI tract of fasted human subjects using the Intellicap® system. J Pharm Sci. 2014;104:2855–63.
7. Dressman JB, Berardi RR, Dermentzoglou LC, Russell TL, Schmaltz SP, Barnett JL, et al. Upper gastrointestinal (GI) pH in young, healthy men and women. Pharm Res. 1990;7(7):756–61.
8. Russell TL, Berardi RR, Barnett JL, Dermentzoglou LC, Jarvenpaa KM, Schmaltz SP, et al. Upper gastrointestinal pH in seventy-nine healthy, elderly, North American men and women. Pharm Res. 1993;10(2):187–96.
9. Lu P-J, Hsu P-I, Chen C-H, Hsiao M, Chang W-C, Tseng H-H, et al. Gastric juice acidity in upper gastrointestinal diseases. World J Gastroenterol: WJG. 2010;16(43):5496.
10. Savarino V, Mela GS, Scalabrini P, Sumberaz A, Fera G, Celle G. 24-hour study of intragastric acidity in duodenal ulcer patients and normal subjects using continuous intraluminal pH-metry. Dig Dis Sci. 1988;33(9):1077–80.
11. Youngberg CA, Berardi RR, Howatt WF, Hyneck ML, Amidon GL, Meyer JH, et al. Comparison of gastrointestinal pH in cystic fibrosis and healthy subjects. Dig Dis Sci. 1987;32(5):472–80.
12. Press A, Hauptmann I, Hauptmann L, Fuchs B, Fuchs M, Ewe K, et al. Gastrointestinal pH profiles in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 1998;12(7):673–8.
13. Fallingborg J, Pedersen P, Jacobsen BA. Small intestinal transit time and intraluminal pH in ileocecal resected patients with Crohn’s disease. Dig Dis Sci. 1998;43(4):702–5.
14. Sasaki Y, Hada R, Nakajima H, Fukuda S, Munakata A. Improved localizing method of radiopill in measurement of entire gastrointestinal pH profiles: colonic luminal pH in normal subjects and patients with Crohn’s disease. Am J Gastroenterol. 1997;92(1):114–8.
15. Ibekwe VC, Fadda HM, McConnell EL, Khela MK, Evans DF, Basit AW. Interplay between intestinal pH, transit time and feed status on the in vivo performance of pH responsive ileo-colonic release systems. Pharm Res. 2008;25(8):1828–35.
16. Lydon A, Murray C, McGinley J, Plant R, Duggan F, Shorten G. Cisapride does not alter gastric volume or pH in patients undergoing ambulatory surgery. Can J Anesth. 1999;46(12):1181–4.
17. Kalantzi L, Goumas K, Kalioras V, Abrahamsson B, Dressman JB, Reppas C. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies. Pharm Res. 2006;23(1):165–76.
18. McCloy R, Greenberg G, Baron J. Duodenal pH in health and duodenal ulcer disease: effect of a meal, Coca-Cola, smoking, and cimetidine. Gut. 1984;25(4):386–92.
19. Lalezari D. Gastrointestinal pH profile in subjects with irritable bowel syndrome. Ann Gastroenterol. 2012;25(4):333.
20. Rune SJ, Viskum K. Duodenal pH values in normal controls and in patients with duodenal ulcer. Gut. 1969;10(7):569–71.
21. Mojaverian P, Chan K, Desai A, John V. Gastrointestinal transit of a solid indigestible capsule as measured by radiotelemetry and dual gamma scintigraphy. Pharm Res. 1989;6(8):719–24.
22. Fallingborg J, Christensen L, Ingeman‐Nielsen M, Jacobsen B, Abildgaard K, Rasmussen H. pH‐profile and regional transit times of the normal gut measured by a radiotelemetry device. Aliment Pharmacol Ther. 1989;3(6):605–14.
23. 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(8):1035–41.
24. Bown R, Gibson J, Sladen G, Hicks B, Dawson A. Effects of lactulose and other laxatives on ileal and colonic pH as measured by a radiotelemetry device. Gut. 1974;15(12):999–1004.
25. Raimundo A, Evans D, Rogers J, Silk D. Gastrointestinal pH profiles in ulcerative colitis. Gastroenterology. 1992;102(7).
26. Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw. 2010;36(3):1–48.
27. Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14(1):135.
28. R Core Team. R: a language and environment for statistical computing Vienna, Austria R Foundation for Statistical Computing; 2014.
29. Card NA. Applied meta-analysis for social science research: Guilford Press; 2011.
30. Viechtbauer W. metafor: meta-analysis package for R. R package version. 2010;2010:1-0.
31. Viechtbauer W. Bias and efficiency of meta-analytic variance estimators in the random-effects model. J Educ Behav Stat. 2005;30(3):261–93.
32. Sterne JA, Egger M. Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. J Clin Epidemiol. 2001;54(10):1046–55.
33. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629–34.
34. Beal S, Sheiner LB, Boeckmann A, Bauer RJ, editors. NONMEM user’s guides, part V. (1989-2009). Ellicott City: Icon Development Solutions; 2009.
35. Ewe K, Schwartz S, Petersen S, Press AG. Inflammation does not decrease intraluminal pH in chronic inflammatory bowel disease. Dig Dis Sci. 1999;44(7):1434–9.
36. Ette EI. Stability and performance of a population pharmacokinetic model. J Clin Pharmacol. 1997;37(6):486–95.
37. Sifrim D, Gardner J, Zhang X, Tack J, Janssens J, editors. Gastric emptying and postprandial gastric acidity. Gastroenterology; 2004: WB Saunders Co-Elsevier Inc 1600 John F Kennedy Boulevard, STE 1800, Philadelphia, PA 19103-2899 USA.
38. Lennard-Jones J, Fletcher J, Shaw D. Effect of different foods on the acidity of the gastric contents in patients with duodental ulcer. 3. Effect of altering the proportions of protein and carbohydrate. Gut. 1968;9(2):177–82.
39. Brooks FP. Effect of diet on gastric secretion. Am J Clin Nutr. 1985;42(5):1006–19.
40. Lake-Bakaar G, Elsakr M, Hagag N, Lyubsky S, Ahuja J, Craddock B, et al. Changes in parietal cell structure and function in HIV disease. Dig Dis Sci. 1996;41(7):1398–408.
41. Banka S, Ryan K, Thomson W, Newman WG. Pernicious anemia—genetic insights. Autoimmun Rev. 2011;10(8):455–9.
42. Lohitnavy M, Lohitnavy O, Thangkeattiyanon O, Srichai W. Reduced oral itraconazole bioavailability by antacid suspension. J Clin Pharm Ther. 2005;30(3):201–6.
43. 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;57c:300-21.
44. Bergstrand M, Söderlind 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(3):695–706.
45. Bergstrand M, Söderlind 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(2):574–84.