Application ofthe experimental design method to photostability studies of karvileks tablet

Indian Journal of Pharmaceutical Education and Research

Volumn 46, Issue 3, 2012, Pages 275-282

  Savic, Ivana ^a   Marinkovc, Valentina ^b   Savic, Ivan ^a   Sibinovic, Predrag ^c   Cekic, Nebojsa ^d  

^a UNIVERSITY OF NI   (Serbia)

^b Faculty of Pharmacy   (Serbia)

^c Pharmaceutical and Chemical Industry Zdravlje Actavis   (Serbia)

^d DCP Hemigal ^*  (Serbia)

Author keywords

Design; Experimental; Karvileks; Photostability

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARVEDILOL; KARVILEKS; UNCLASSIFIED DRUG;

ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; DRUG IMPURITY; DRUG PACKAGING; DRUG STABILITY; EXPERIMENTAL DESIGN; IRRADIATION; LIGHT EXPOSURE; PHOTOCHEMISTRY; QUALITY CONTROL; RADIATION RESPONSE; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

EID: 84867700305     PISSN: 00195464     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (37)

1. Jin X, Zhang Y, Xiao L, Zhao Z. Optimization of extended zero-order release gliclazide tablets usin D-optimal mixtur design. Journal ofthe Pharmaceutical Society of Japan 2008; 128:1475-83.
2. Seth AK, Misra AN. Mathematical modelingof preparation ofacyclovir liposomes: Reverse phase evaporation method. Journal of Pharmacy and Pharmaceutical Sciences 2002;5:285-91.
3. Sanchez-Lafuente C, Furlanetto S, Fernandez-Arevalo M. Didanosine extended-release matrix tablets: optimization of formulation variables using statistical experimental design. International Journal ofPharmaceutics 2002;237:107-18.
4. Guan J, Xiang R, Pan Y, Pan H, Su X, Zhou L, Cui Y, Pan W. Design and evaluation of a novel formulation prediction system. International Journal of Pharmaceutics 2010;402(1-2):129-39.
5. Mura P, Furlanetto S, Cirri M, Maestrelli F, Marras AM, Pinzauti S. Optimization of glibenclamide tablet composition through the combined use of differential scanning calorimetry and d-optimal mixture experimental design. Journal of Pharmaceutical and Biomedical Analysis 2005;37:65-71.
6. Chang LC, Wu SC, Tsai JW, Yu TJ, Tsai TR. Optimization of epirubicin nanoparticles using experimental design for enhanced intravesical drug delivery. International Journal of Pharmaceutics 2009;6(1-2):195-203.
7. El-Malah Y, Nazzal S, Khanfar NM. D-optimal mixture design: optimization of ternary matrix blends for controlled zero-order drug release from oral dosage forms. Drug Development and Industrial Pharmacy 2006;32:1207-18.
8. Rhee Y, Chang S, Park W, Chi S, Park E. Optimization of ibuprofen gel formulations using experimental design technique for enhanced transdermal penetration. International Journal of Pharmaceutics 2008;364(1):14-20.
9. Bodea A, Leucuta SE. Optimization of hydrophilic matrix tablets using a D-optimal design. International Journal of Pharmaceutics 1997;153:247-55.
10. Bendjaballah M, Canselier JP, Oumeddour R. Optimization of oil-in-water emulsion stability: experimental design, multiple light scattering, and acoustic attenuation spectroscopy. Journal of Dispersion Science and Technology 2010;31(9):1260-72.
11. Marinkovic V, Karljikovic-Rajic K, Agbaba D, Nikolic M. Experimental design as a quality improvment function. EOQ Conference; 2004 Sept 5-7; Moscow, Russia.
12. Ozil P, Rochat MH. Experimental design, an efficient tool forstudying the stability of parenteral nutrition. International Journal of Pharmaceutics 1988;42(1-3):11-14.
13. Yoshioka S, Aso Y, Uchiyama M. Statistical evaluation of non-isothermal prediction of drug stability. II. Experimental design for practical drug products. International Journal of Pharmaceutics 1988;46:121-32.
14. Horhota ST, Burgio J, Lonski L, Rhodes CT. Effect of storage at specified temperature and humidity on properties of three directly compressible tablet formulations. Journal of Pharmaceutical Sciences 1976;65:1746-49.
15. El-Banna HM, Ismail AA, Gadalla MAF. Factorial experiment for stability studies in the development of a tabletformulation. Pharmazie 1984;39:163-65.
16. Dick CF, Klassen RA, Amidon GE. Determination ofthe sensitivity of a tablet formulation to variations in excipient levels and processing conditions using optimization techniques. International Journal of Pharmaceutics 1987;38:23-31.
17. Bos CE. Tropical tablets: the development of tablet formulations for use in tropical countries, [dissertation], UniversityofGroningen; 1990.
18. Bos CE, Bolhuis GK, Lerk CF. Optimization of tablet formulations based on starchflactose granulations for use in tropical countries. Drug Development and Industrial Pharmacy 1991;17:2373-89.
19. Bos CE, Bolhuis GK, Lerk CF, De Boer JH, Duineveld CAA, Smilde AK, Doornbos DA. The use of a factorial design to evaluate the physical stability of tablets prepared by direct compression; A new approach based on the relative change in tablet parameters. European Journal of Pharmaceutics and Biopharmaceutics 1991;37:204-09.
20. Bos CE, Bolhuis GK, Lerk CF, De Boer JH, Duineveld CAA, Smilde AK, Doornbos DA. The use of a factorial design to evaluate the physical stability of tablets prepared by direct compression; The selection of excipients suitable for use under tropical storage conditions. European Journal of Pharmaceutics and Biopharmaceutics 1991;37:210-15.
21. Stojanovic J, Vladimirov S, Marinkovic V, Velickovic D, Sibinovic P. Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method. Journal of the Serbian Chemical Society 2007;72(1):37-44.
22. Hokama N, Hobara N, Kameya H, Ohsiro S, Sakanashi M. Rapid and simple micro-determination of carvedilol in rat plasma by high-performance liquid chromatography. Journal of Chromatography B 1999;732:233-38.
23. Ptacek P, Macek J, Klima J. Liquid chromatographic determination of carvedilol in human plasma. Journal of Chromatography B 2003;789:405-10.
24. Eisenberg EJ, Patterson AM, Kahn GC. High-performance liquid chromatographic method for the simultaneous determination of the enantiomers of carvedilol and its o-desmethyl metabolite in human plasma after chiral derivatization. Journal of Chromatography 1989;493:105-15.
25. Behn F, Laer S, Scolz H. Determination ofcarvedilol in human cardiac tissue by high-performance liquid chromatography. Journal of Chromatographic Science 2001;39(3):121-24.
26. Yang E, Wang S, Kratz J, Cyronak MJ. Stereoselective analysis of carvedilol in human plasma using HPLC/MS/MS after chiral derivatization. Journal of Pharmaceutical and Biomedical Analysis 2004;36:609-15.
27. Saito M, Kawana J, Ohnob T, Kaneko M, Hanada K, Sugita R, Okada N, Osato S, Nagayama M, Sumiyoshi T, Ogata H. Enantioselective and highly sensitive determination of carvedilol in human plasma and whole blood after administration ofthe racemate using normal-phase high-performance liquid chromatography. Journal of Chromatography B 2006;843:73-77.
28. Larnprecht G, Gruber L, Stoschitzky K, Lindner W. Enantioselective analysis of (R)-and (S)-carvedilol in human plasma by high-performance liquid chromatography. Chromatographia 2002;56:S25-S30.
29. Gergov M, Robson JN, Duchoslav E, Ojanpera I. Automated liquid chromatographic/tandem mass spectrometric method for screening β-blocking drugs in urine. Journal of Mass Spectrometry 2000;35:912-18.
30. Machida M, Watanabe M, Takechi S, Kakinoki S, Nomura A. Measurement of carvedilol in plasma by high-performance liquid chromatography with electrochemical detection. Journal of Chromatography B 2003;798:187-91.
31. Carmo Borges NC, Mendesb GD, Silva DO, Rezende VM, Barrientos-Astigarraga RE, Nucci G. Quantification of carvedilol in human plasma by highperformance liquid chromatography coupled to electrospray tandem mass spectrometry: application to bioequivalence study. Journal of Chromatography B 2005;822:253-62.
32. Behn E, Laer S, Mir TS, Scholz H. HPLC quantification of carvedilol in small plasma volumes from children. Chromatographia 2001;53:641-44.
33. Rathod R, Prasad LP, Rani S, Nivsarkar M, Padh H. Estimation of carvedilol in human plasma by using HPLC-fluorescence detector and its application to pharmacokinetic study. Journal of Chromatography B 2007;857(2):219-23.
34. Zarghi A, Foroutan SM, Shafaati A, Khoddamc A. Quantification of carvedilol in human plasma by liquid chromatography using fluorescence detection: Application in pharmacokinetic studies. Journal of Pharmaceutical and Biomedical Analysis 2007;44:250-53.
35. Sripalakit P, Kaewnok S, Tubtonglang S. Development of carvedilol assay in tablet dosage form using HPLC with fluorescence detection. Maejo International Journal of Science and Technology 2010;4(01):8-19.
36. Rizwan M, Aqil M, Azeem A, Sultana Y, Talegaonkar S, Ali A. Studyof the degradation kinetics of carvedilol by use of a validated stability-indicating LC method. Chromatographia 2009;70:1283-86.
37. ICH-Q1A(R2), Stability testing of new drug substances and products. International Conference on Harmonization: Geneva; 2003.