Convolution and validation of in vitro–in vivo correlation of water-insoluble sustained-release drug (domperidone) by first-order pharmacokinetic one-compartmental model fitting equation

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• 作者：Anirbandeep Bose (1)
  Wong Tin Wui (1)
  
• 关键词：Domperidone ; In vitro–in vivo ; Bioequivalent ; Similarity factor ; Convolution ; Deconvolution
• 刊名：European Journal of Drug Metabolism and Pharmacokinetics
• 出版年：2013
• 出版时间：September 2013
• 年：2013
• 卷：38
• 期：3
• 页码：191-200
• 全文大小：724KB
• 参考文献：1. Bose A, Bhaumik U, Ghosh A, Chatterjee B, Sarkar AK, Chakrabarty US, Das A, Pal TK (2009) Liquid chromatography–tandem mass spectrometry method for simultaneous determination of itopride hydrochloride and domperidone in human plasma. Chromatographia 69:1233-241 CrossRef
  2. Eddington ND, Ashraf M, Augsburger LL, Leslie JL, Fossler MJ, Lesko LJ, Shah VP, Rekhi GS (1998) Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets. Pharm Dev Technol 3:535-47
  3. Emami Jaber (2006) In vitro-in vivo correlation: from theory to application. J Pharm Pharmaceut Sci 9(2):169-89
  4. Emara LH, El-Menshawi BS, Estefan MY (2000) In vitro–in vivo correlation and comparative bioavailablity of vincamine in prolonged-release preparations. Drug Dev Ind Pharm 26(3):243-51 CrossRef
  5. European Agency for the Evaluation of Medicinal Products (1999) Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation). Human Medicines Evaluation Unit, Committee for Proprietary Medicinal Products, CPMP/EWP/280/96; London
  6. Ghosh A, Bhaumik U, Bose A, Mandal U, Gowda VK, Chatterjee B, Chakraborty US, Pal TK (2008) Extended release dosage form of glipizide: development and validation of a level A in vitro–in vivo correlation (IVIVC). Bio Pharm Bull 31(10):1946-951 CrossRef
  7. Gibaldi M, Perrier D (1982) Pharmacokinetics, 2nd edn. Marcel Dekker Inc, New York
  8. Guidance for industry (1997) Extended release oral dosage forms: development, evaluation and application of an in vitro / /in vivo correlation. FDA, CDER
  9. Hussein Z, Friedman M (1990) Release and absorption characteristics of novel theophylline sustained-release formulations: in vitro–in vivo correlation. Pharm Res 7:1167-171 CrossRef
  10. Mandal U, Roy KK, Gowda VK, Ghosh A, Pal TK (2007) In vitro and in vivo correlation for two gliclazide extended release tablets. J Pharmacy Pharmacol 59(7):971-76 CrossRef
  11. Philip AK, Pathak K (2008) Wet process induced phase transited drug delivery system: a?means for achieving osmotic, controlled and level A IVIVC for poorly water soluble drug. Drug Dev Ind Pharm 34(7):735-43 CrossRef
  12. Roshdy Maichel N, Schnaare Roger L, Sugita Edwin T, Schwartz Joseph B (2002) The effect of controlled release tablet performance and hydrogel strength on in vitro / /in vivo correlation. Pharma Development Technol 7(2):155-68 CrossRef
  13. Siddique S, Bose A, Khanam J (2011) Modulation of drug (metoprolol succinate) release by inclusion of hydrophobic polymer in hydrophilic matrix. Drug Dev Ind Pharm 37(9):1016-025 CrossRef
  14. Singh B, Ahuja N (2002) Development of controlled-release buccoadhesive hydrophilic matrices of diltiazem hydrochloride: optimization of bioadhesion, dissolution and diffusion parameters. Drug Dev Ind Pharm 28:431-42 CrossRef
  15. Singh B, Ahuja N (2004) Response surface optimization of drug delivery system. In: Jain NK (ed) Progress in controlled and novel drug delivery systems. CBS Publishers and Distributors, New Delhi
  16. Singh B, Kumar R, Ahuja N (2005) Optimizing drug delivery systems using systematic “design of experiments-Part I Fundamental aspects. Crit Rev Ther Drug Carrier Syst 22:27-05 CrossRef
  17. Skelley JP, Amidon GL, Barr WH, Benet IJ, Carter JE, Robinson JR, Shah VP, Yacobi A (1990) Report of the workshop on in vitro and in vivo testing and correlation for oral controlled/modified-release dosage forms. J Pharm Sci 79:849-54 CrossRef
  18. Takka S, Sakr A, Goldberg A (2003).Development and validation of an in vitro–in vivo correlation for buspirone hydrochloride extended release tablets. J Control Release 88(1):147-57
  19. United States Pharmacopoei (2004). In vitro and In vivo Evaluations of Dosage Forms, 27th edition, Revision, Mack Publishing Co., Easton, PA
  20. USP Subcommittee on Biopharmaceutics (1988) In vitro in vivo correlation for extended release oral dosage forms. Pharm Forum 14(4):4160-161
  21. Wagner JG, Nelson E (1968) Kinetic analysis of blood levels and urinary excretion in the absorptive phase after single doses of drug (1964). J Pharm Sci 53(11):1392-403 CrossRef
  22. Wei Q, Yang F, Luan L (2012) Preparation and in vitro / /in vivo evaluation of a ketoprofen orally disintegrating/sustained release tablet. Drug Dev Ind Pharm. doi:10.3109/03639045.2012.664146
  23. Wu MS, Gao L, Cai XH, Wang GJ (2002) Determination of domperidone in human plasma by LC–MS and its pharmacokinetics in healthy Chinese volunteers. Acta Pharmacol Sin 23(3):285-88
  24. Zhang D, Chen K, Teng Y, Zhang J, Liu S, Wei C, Wang B, Liu X, Yuan G, Zhang R, Guo R (2012) Determination of domperidone in human plasma using liquid chromatography coupled to tandem mass spectrometry and its pharmacokinetic study. Arzneimittelforschung 62(3):128-33 CrossRef
  
• 作者单位：Anirbandeep Bose (1)
  Wong Tin Wui (1)
  
  1. Particle design Research Group/Non-destructive Biomedical and Pharmaceutical Research Centre, Universiti Teknologi MARA, 42300 Puncak alam, Selangor, Malaysia
  

文摘

The experimental study presents a brief and comprehensive perspective on the methods of developing a Level A in vitro–in vivo correlation (IVIVC) for extended oral dosage forms of water-insoluble drug domperidone. The study also evaluates the validity and predictability of in vitro–in vivo correlation using the convolution technique by one-compartmental first-order kinetic equation. The IVIVC can be substituted as a surrogate for in vivo bioavailability study for the documentation of bioequivalence studies as mandatory from any regulatory authorities. The in vitro drug release studies for different formulations (fast, moderate, slow) were conducted in different dissolution mediums. The f (2) metric (similarity factor) was used to analyze the dissolution data for determination of the most discriminating dissolution method. The in vivo pharmacokinetics parameters of all the formulations were determined by using liquid chromatography mass spectrometry (LC/MS) methods. The absorption rate constant and percentage of absorption of drugs at different time intervals were calculated by using data convolution. In vitro drug release and in vivo absorption correlation were found to be a linear correlation model, which was developed by using percent absorbed drug release versus percent drug dissolved from the three formulations. Internal and external validation was performed to validate the IVIVC. Predicted domperidone concentrations were obtained by convolution technique using first-order one-compartmental fitting equation. Prediction errors estimated for C (max) and AUC (0–infinity) were found to be within the limit.