Physiologically based pharmacokinetic models in the prediction of oral drug exposure over the entire pediatric age range-sotalol as a model drug

AAPS Journal

Volumn 16, Issue 2, 2014, Pages 226-239

  Khalil, Feras ^a   Läer, Stephanie ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

administration (oral); child; computer simulation; pharmacokinetics; sotalol

Indexed keywords

SOTALOL;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AREA UNDER THE CURVE; ARTICLE; CHILD; CONTROLLED STUDY; DRUG CLEARANCE; DRUG EFFECT; DRUG EXPOSURE; FEMALE; HUMAN; MALE; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; PHYSIOLOGICALLY BASED PHARMACOKINETIC MODEL; PREDICTION; PROCESS DEVELOPMENT; PROCESS MODEL; SCHOOL CHILD; TIME TO MAXIMUM PLASMA CONCENTRATION; VALIDATION PROCESS;

ADMINISTRATION, ORAL; ADULT; CHILD; HUMANS; INFANT, NEWBORN; MODELS, BIOLOGICAL; PHARMACOKINETICS; SOTALOL;

EID: 84895872547     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9555-6     Document Type: Article

References (61)

1. Parrott N, Lave T. Applications of physiologically based absorption models in drug discovery and development. Mol Pharm. 2008;5(5):760-75.
2. Rowland M, Peck C, Tucker G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol. 2011;51:45-73.
3. Espie P, Tytgat D, Sargentini-Maier M, Poggesi I, Watelet J. Physiologically based pharmacokinetics (PBPK). Drug Metab Rev. 2009;41(3):391-407.
4. Johnson TN, Rostami-Hodjegan A. Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice. Paediatr Anaesth. 2011;21(3):291-301.
5. Khalil F, Laer S. Physiologically based pharmacokinetic modeling: methodology, applications, and limitations with a focus on its role in pediatric drug development. J Biomed Biotechnol. 2011;2011:907461.
6. Bouzom F, Walther B. Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling. Fundam Clin Pharmacol. 2008;22(6):579-87.
7. Laer S, Barrett JS, Meibohm B. The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy. J Clin Pharmacol. 2009;49(8):889-904.
8. Bellanti F, Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol. 2011;67 Suppl 1:75-86.
9. Jadhav PR, Kern SE. The need for modeling and simulation to design clinical investigations in children. J Clin Pharmacol. 2010;50(9 Suppl):121S-9S.
10. Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, et al. Role of modeling and simulation in pediatric investigation plans. Paediatr Anaesth. 2011;21(3):214-21.
11. Barrett JS, Della Casa Alberighi O, Laer S, Meibohm B. Physiologically based pharmacokinetic (PBPK) modeling in children. Clin Pharmacol Ther. 2012;92(1):40-9.
12. International Conference on Harmonisation; Guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice. Fed Regist. 2000; 65(242):78493-4.
13. Commission of the European Communities. Regulation (EC) No 1901/2006 on medicinal products for paediatric use and amending Regulation (EC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Off J Eur Communities L378 27/12/, 2006:1-19.
14. Ginsberg G, Hattis D, Russ A, Sonawane B. Physiologically based pharmacokinetic (PBPK) modeling of caffeine and theophylline in neonates and adults: implications for assessing children's risks from environmental agents. J Toxicol Environ Health A. 2004;67(4):297-329. (Pubitemid 38200033)
15. Bjorkman S. Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: theophylline and midazolam as model drugs. Br J Clin Pharmacol. 2005;59(6):691-704. (Pubitemid 40835503)
16. Edginton AN, Schmitt W, Willmann S. Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin Pharmacokinet. 2006;45(10):1013-34. (Pubitemid 44436004)
17. Kersting G, Willmann S, Wurthwein G, Lippert J, Boos J, Hempel G. Physiologically based pharmacokinetic modelling of high- and low-dose etoposide: from adults to children. Cancer Chemother Pharmacol. 2012;69(2):397-405.
18. Maharaj AR, Barrett JS, Edginton AN. A Workflow Example of PBPK Modeling to Support Pediatric Research and Development: Case Study with Lorazepam. AAPS J 2013.
19. Parrott N, Davies B, Hoffmann G, Koerner A, Lave T, Prinssen E, et al. Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants. Clin Pharmacokinet. 2011;50(9):613-23.
20. Dumont C, Mentre F, Gaynor C, Brendel K, Gesson C, Chenel M. Optimal sampling times for a drug and its metabolite using SIMCYP ((R)) simulations as prior information. Clin Pharmacokinet. 2013;52(1):43-57.
21. Edginton AN, Ritter L. Predicting plasma concentrations of bisphenol A in children younger than 2 years of age after typical feeding schedules, using a physiologically based toxicokinetic model. Environ Health Perspect. 2009;117(4):645-52.
22. Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet. 2006;45(9):931-56. (Pubitemid 44299829)
23. Edginton AN, Schmitt W, Voith B, Willmann S. A mechanistic approach for the scaling of clearance in children. Clin Pharmacokinet. 2006;45(7):683-704. (Pubitemid 43990570)
24. Hanyok JJ. Clinical pharmacokinetics of sotalol. Am J Cardiol. 1993;72(4):19A-26A. (Pubitemid 23238408)
25. Tjandramaga TB. Altered pharmacokinetics of beta-adrenoceptor blocking drugs in patients with renal insufficiency. Arch Int Pharmacodyn Ther. 1980; Suppl:38-53. (Pubitemid 11239654)
26. Anttila M, Arstila M, Pfeffer M, Tikkanen R, Vallinkoski V, Sundquist H. Human pharmacokinetics of sotalol. Acta Pharmacol Toxicol (Copenh). 1976;39(1):118-28.
27. Salazar DE, Much DR, Nichola PS, Seibold JR, Shindler D, Slugg PH. A pharmacokinetic-pharmacodynamic model of d-sotalol Q-Tc prolongation during intravenous administration to healthy subjects. J Clin Pharmacol. 1997;37(9):799-809. (Pubitemid 27441136)
28. Uematsu T, Kanamaru M, Nakashima M. Comparative pharmacokinetic and pharmacodynamic properties of oral and intravenous (+)-sotalol in healthy volunteers. J Pharm Pharmacol. 1994;46(7):600-5. (Pubitemid 24213289)
29. Somberg JC, Preston RA, Ranade V, Molnar J. Developing a safe intravenous sotalol dosing regimen. Am J Ther. 2010;17(4):365-72.
30. Rehm KD, Schnelle K, Dyde CJ, Blumner E, Arendts W. Plasma level and action of sotalol-HCL on the ECG interval after parenteral administration in healthy subjects. Arzneimittelforschung. 1987;37(9):1058-62. (Pubitemid 17131383)
31. Poirier JM, Jaillon P, Lecocq B, Lecocq V, Ferry A, Cheymol G. The pharmacokinetics of d-sotalol and d,l-sotalol in healthy volunteers. Eur J Clin Pharmacol. 1990;38(6):579-82. (Pubitemid 20206031)
32. Kimura M, Umemura K, Ikeda Y, Kosuge K, Mizuno A, Nakanomyo H, et al. Pharmacokinetics and pharmacodynamics of (+/-)-sotalol in healthy male volunteers. Br J Clin Pharmacol. 1996;42(5):583-8. (Pubitemid 26385262)
33. Kahela P, Anttila M, Tikkanen R, Sundquist H. Effect of food, food constituents and fluid volume on the bioavailability of sotalol. Acta Pharmacol Toxicol (Copenh). 1979;44(1):7-12. (Pubitemid 9089637)
34. Ochs HR, Greenblatt DJ, Arendt RM, Schafer-Korting M, Mutschler E. Single-dose kinetics of oral propranolol, metoprolol, atenolol, and sotalol: relation to lipophilicity. Arzneimittelforschung. 1985;35(10):1580-2. (Pubitemid 16236130)
35. Laer S, Neumann J, Scholz H. Interaction between sotalol and an antacid preparation. Br J Clin Pharmacol. 1997;43(3):269-72. (Pubitemid 27116066)
36. Liebau. Versuche zur Wechselwirkung zwischen Sotalol und Colestyramin bei Menschen. Degree "Maguna cum laude". Hamburg; 1999.
37. Laer S, Elshoff J, Meibohm B, Weil J, Mir TS, Zhang W, et al. Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia. J Am Coll Cardiol. 2005;46(7):1322-30. (Pubitemid 41615557)
38. Simcyp®: Simcyp Ltd, Sheffield, UK. http://www.simcyp.com.
39. PK-Sim®: Bayer Technology Services. http://www.systemsbiology.com/ products/pk-sim.html.
40. Willmann S, Lippert J, Sevestre M, Solodenko J, Fois F, Schmitt W. PK-Sim®: a physiologically based pharmacokinetic 'whole-body' model. BIOSILICO. 2003;1(4):121-4. (Pubitemid 40416764)
41. Jamei M, Marciniak S, Feng K, Barnett A, Tucker G, Rostami-Hodjegan A. The Simcyp population-based ADME simulator. Expert Opin Drug Metab Toxicol. 2009;5(2):211-23.
42. Rodgers T, Rowland M. Physiologically based pharmacokinetic modelling 2: predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions. J Pharm Sci. 2006;95(6):1238- 57.
43. McDevitt DG. Comparison of pharmacokinetic properties of beta-adrenoceptor blocking drugs. Eur Heart J. 1987;8:9-14. (Pubitemid 18088431)
44. Riddell JG, Harron DW, Shanks RG. Clinical pharmacokinetics of beta-adrenoceptor antagonists. An update. Clin Pharmacokinet. 1987;12(5):305-20. (Pubitemid 17075436)
45. Jamei M, Turner D, Yang J, Neuhoff S, Polak S, Rostami-Hodjegan A, et al. Population-based mechanistic prediction of oral drug absorption. AAPS J. 2009;11(2):225-37.
46. Willmann S, Schmitt W, Keldenich J, Lippert J, Dressman JB. A physiological model for the estimation of the fraction dose absorbed in humans. J Med Chem. 2004;47(16):4022-31. (Pubitemid 38970963)
47. Yang Y, Faustino PJ, Volpe DA, Ellison CD, Lyon RC, Yu LX. Biopharmaceutics classi fi cation of selected beta-blockers: solubility and permeability class membership. Mol Pharm. 2007;4(4):608-14. (Pubitemid 47310172)
48. Alt A, Potthast H, Moessinger J, Sickmuller B, Oeser H. Biopharmaceutical characterization of sotalol-containing oral immediate release drug products. Eur J Pharm Biopharm. 2004;58(1):145-50. (Pubitemid 38781015)
49. Graff J, Brinch K, Madsen JL. Gastrointestinal mean transit times in young and middle-aged healthy subjects. Clin Physiol. 2001;21(2):253-9.
50. Gentilcore D, Hausken T, Horowitz M, Jones KL. Measurements of gastric emptying of low- and high-nutrient liquids using 3D ultrasonography and scintigraphy in healthy subjects. Neurogastroenterol Motil. 2006;18(12):1062- 8.
51. van Den Driessche M, Veereman-Wauters G. Gastric emptying in infants and children. Acta Gastroenterol Belg. 2003;66(4):274-82.
52. Barbosa L, Vera H, Moran S, Del Prado M, Lopez-Alarcon M. Reproducibility and reliability of the 13C-acetate breath test to measure gastric emptying of liquid meal in infants. Nutrition. 2005;21(3):289-94. (Pubitemid 40387925)
53. Barnett C, Snel A, Omari T, Davidson G, Haslam R, Butler R. Reproducibility of the 13C-octanoic acid breath test for assessment of gastric emptying in healthy preterm infants. J Pediatr Gastroenterol Nutr. 1999;29(1):26-30. (Pubitemid 30345823)
54. Staelens S, van den Driessche M, Barclay D, Carrie-Faessler A, Haschke F, Verbeke K, et al. Gastric emptying in healthy newborns fed an intact protein formula, a partially and an extensively hydrolysed formula. Clin Nutr. 2008;27(2):264-8.
55. Khin M, Bolin TD, Tin-Oo, Thein-Win-Nyunt, Kyaw-Hla S, Thein-Thein-Myint. Investigation of small-intestinal transit time in normal and malnourished children. J Gastroenterol. 1999;34(6):675-9.
56. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9(4):503-12.
57. MATLAB: Mathworks. http://www.mathworks.com/products/matlab/.
58. Dahan A, Miller JM, Hil finger JM, Yamashita S, Yu LX, Lennernas H, et al. High-permeability criterion for BCS classification: segmental/pH dependent permeability considerations. Mol Pharm. 2010;7(5):1827-34.
59. Edginton AN, Fotaki N. Oral drug absorption in pediatric populations. In: Oral drug absorption: prediction and assessment. 2nd edn. New York: Informa Healthcare, 2010, pp. 108-126.
60. Rodgers T, Rowland M. Mechanistic approaches to volume of distribution predictions: understanding the processes. Pharm Res. 2007;24(5):918-33. (Pubitemid 46675393)
61. Kromeyer-Hauschild K, Wabitsch M, Kunze D, Geller F, Geiß HC, Hesse V, et al. Perzentile für den body-mass-index für das Kindes- und Jugendalter unter Heranziehung verschiedener deutscher Stichproben. Monatsschr Kinderheilkunde. 2001;149:807-18. (Pubitemid 32830649)