Bioequivalence evaluation of two brands of lisinopril tablets by in vitro comparative dissolution test and in vivo bioequivalence test

Arzneimittel-Forschung/Drug Research

Volumn 58, Issue 1, 2008, Pages 11-17

  Meong, Cheol Shin ^a   Kim, Jin Ki ^a   Kim, Chong Kook ^a  

^a Seoul National University   (South Korea)

Author keywords

Angiotensin converting enzyme inhibitors; CAS 83915 83 7; Lisinopril, bioequivalence, dissolution; Nanopril

Indexed keywords

LISINOPRIL; NANOPRIL; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SCREENING; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IN VIVO STUDY; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET FORMULATION;

EID: 38949194198     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296460     Document Type: Article

References (20)

1. El-Emam AA, Hansen SH, Moustafa MA, El-Ashry SM, ElSherbiny DT. Determination of lisinopril in dosage forms and spiked human plasma through derivatization with 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole(NBD-Cl) followed by spectrophotometry or HPLC with fluorimetric detection. J Pharm Biomed Anal. 2004;34:35-44.
2. Sagirli O, Ersoy L. An HPLC method for the determination of lisinopril in human plasma and urine with fluorescence detection. J Chromatogr B. 2004;809:159-165.
3. Padua AAF, Barrientos-Astigarraga RE, Rezende VM, Mendes GD, Nucci GD. Lisinopril quantification in human plasma by liquid chromatography-electrospray tandem mass spectrometry. J Chromatogr B. 2004;809:211-216.
4. Brown NJ, Vaughan DE. Angiotensin-Converting Enzyme Inhibitors. Circulation. 1998;97:1411-1420.
5. Jocobi J, Schmieder RE. Nephroprotection by antihypertensive therapy. Basic Res Cardiol. 1998;93 Suppl 2:109-119.
6. Chrysant SG, Chrysant GS. Pharmacological and clinical profile of moexipril: A concise review. J Clin Pharmacol. 2004;44:827-836.
7. Rosenthal T, Ben-arie J, Carrol J, Fiedel J, Kisch E, Leiba M, et al. Improving quality of life in patients with hypertension: lisinopril as a replacement therapy. Curr Ther Res Clin Exp. 1995;56:57-61.
8. Tamimi JJI, Salem II, Alam SM, Zaman Q, Dham R. Bioequivalence Evaluation of Two Brands of Lisinopril Tablets (Lisotec and Zestril) in Healthy Human Volunteers. Biopharm Drug Dispos. 2005;26:335-339.
9. Georgarakis M, Tsakalof A, Zougrou F, Kontopoulos G, Tsiptsios I. Evaluation of the bioequivalence and pharmacokinetics of two lisinopril tablet formulations after single oral administration in healthy volunteers. Arzneimittel-Forschung (Drug Research). 2004;54(1):15-19.
10. Huang J, Xu Y, Liu F, Gao S, Guo Q. Development of a liquid chromatography/tandem mass spectrometry assay for the quantification of lisinopril in human plasma. Rapid Commun Mass Spectrom. 2006;20:248-252.
11. World Health Organization, Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. 2005.
12. The United States Pharmacopeia The National Formulary, 29th ed. Rockville: United States Pharmacopeia Convention, Inc. 2006.
13. Aktas ES, Ersoy L, Sagirli O. A new spectrofluorimetric method for the determination of lisinopril in tablets. Il Farmaco. 2003;58:165-168.
14. Razak OA, Belal SF, Bedair MM, Barakat NS, Haggag RS. Spectrophotometric and polarographic determination of enalapril and lisinopril using 2,4-dinitrofluorobenzene. J Pharm Biomed Anal. 2003;31:701-711.
15. El-Gindy A, Ashour A, Abdel-Fattah L, Shabana MM. Spectrophotometric, septrofluorimetric and LC determination of lisinopril. J Pharm Biomed Anal. 2001;25:913-922.
16. Tsakalof A, Bairachtari K, Georgarakis M. Development of a liquid chromatography-mass spectrometry method for monitoring the angiotensin- converting enzyme inhibitor lisinopril in serum. J Chromatogr B. 2003;783:425-432.
17. Leis HJ, Fauler G, Raspotnig G, Windischofer W. An improved method for the measurement of the angiotensin-converting enzyme inhibitor lisinopril in human plasma by stable isotope dilution gas chromatography/negative ion chemical ionization mass spectrometry. Rapid Commun Mass Spectrom. 1999;13(8):650-653.
18. Leis HJ, Fauler G, Raspotnig G, Windischofer W. Quantitative Determination of the Angiotensin-converting Enzyme Inhibitor Lisinopril in Human Plasma by Stable Isotope Dilution Gas Chromatography/Negative Ion Chemical Ionization Mass Spectrometry. Rapid Commun Mass Spectrom. 1998;12:1591-1594.
19. Korea Food and Drug Administration, KFDA Guideline for Bioequivalence Test. 2002.
20. Lipka E, Amidon GL. Setting bioequivalence requirements for drug development based on preclinical data: optimizing oral drug delivery systems. J Control Release. 1999;62:41-49.