Application of mathematical modeling for the development and optimization formulation with bioactive copper complex

Drug Development and Industrial Pharmacy

Volumn 39, Issue 7, 2013, Pages 1084-1090

  Savic, Ivana M ^a   Nikolic, Katarina ^b   Nikolac, Goran ^a   Savec, Ivan ^a   Agbaba, Danica ^b   Cakic, Milorad ^a  

^a UNIVERSITY OF NI   (Serbia)

^b UNIVERSITY OF BELGRADE   (Serbia)

Author keywords

Copper; Experimental design; Full factorial; Partial least squares

Indexed keywords

COPPER COMPLEX; CUPRIC ION; DISINTEGRATING AGENT; FILLER; LACTOSE; LUBRICATING AGENT; MAGNESIUM STEARATE; POVIDONE; PULLULAN; SILICON DIOXIDE; STARCH;

ARTICLE; COPPER DEFICIENCY; DRUG RELEASE; DRUG SOLUBILITY; IN VITRO STUDY; MATHEMATICAL MODEL; PARTIAL LEAST SQUARES REGRESSION; PH; PREFORMULATION; TABLET COMPRESSION; TABLET FORMULATION; TABLET FRIABILITY; TABLET HARDNESS;

CHEMISTRY, PHARMACEUTICAL; COPPER; HYDROGEN-ION CONCENTRATION; LEAST-SQUARES ANALYSIS; MODELS, THEORETICAL; POVIDONE; SOLUBILITY; TABLETS;

EID: 84878892367     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2012.707208     Document Type: Article

References (35)

1. Grillo AO, Kane M, Penn N, Perkins M. (2010). Characterizing the Formulation Design Space. BioPharm International, 23:3.
2. Hwang R, Noack RM. (2011). Application of design of experiments to pharmaceutical formulation development. Int J Exp Desig Process Optimis, 2:58-65.
3. Dabhi MR, Sheth NR. (2012). Formulation development of physiological environment responsive periodontal drug delivery system for local delivery of metronidazole benzoate. Drug Dev Ind Pharm. DOI: 10.3109/03639045.2012.662505.
4. Pinillos JF, Lopera CM. (2009).A pharmaceutical formulation development using a experimental mixture design. Vitae, 16:338-353.
5. Wongpoowarak W, Wongpoowarak P, Boonme P. (2008). Simulation tool for teaching multivariate experimental design on paracetamol syrup formulation. Silpakorn U Science Tech J, 2:45-52.
6. Choi DH, Shin S, Viet Truong NK, Jeong SH. (2012). A new experimental design method to optimize formulations focusing on a lubricant for hydrophilic matrix tablets. Drug Dev Ind Pharm. DOI:10.3109/03639045.2011.641563.
7. Shastri PN, Ubale RV, D'Souza MJ. (2012). Implementation of mixture design for formulation of albumin containing entericcoated spray-dried microparticles. Drug Dev Ind Pharm. DOI: 10.3109/03639045.2012.664148.
8. Zhou YZ, Alany RG, Chuang V, Wen J. (2012). Optimization of PLGA nanoparticles formulation containing L-DOPA by applying the central composite design. Drug Dev Ind Pharm. DOI: 10.3109/03639045.2012.681054.
9. Goutte F, Guemguem F, Dragan C, Vergnault G, Wehrlé P. (2002). Power of experimental design studies for the validation of pharmaceutical processes: case study of a multilayer tablet manufacturing process. Drug Dev Ind Pharm, 28:841-848.
10. Soh JL, Wang F, Boersen N, Pinal R, Peck GE, Carvajal MT et al. (2008). Utility of multivariate analysis in modeling the effects of raw material properties and operating parameters on granule and ribbon properties prepared in roller compaction. Drug Dev Ind Pharm, 34:1022-1035.
11. Martinello T, Kaneko TM, Velasco MV, Taqueda ME, Consiglieri VO. (2006). Optimization of poorly compactable drug tablets manufactured by direct compression using the mixture experimental design. Int J Pharm, 322:87-95.
12. NRC. (1980). Copper: Recommended Dietary Allowances, Food and Nutrition Board, National Research Council (NRC) and National Academy of Sciences (NAS), 9th edn. Washington, DC: National Academy Press. pp. 151-154.
13. Collins JF, Prohaska JR, Knutson MD. (2010). Metabolic crossroads of iron and copper. Nutr Rev, 68:133-147.
14. Iolascon A, De Falco L, Beaumont C. (2009). Molecular basis of inherited microcytic anemia due to defects in iron acquisition or heme synthesis. Haematologica, 94:395-408.
15. Carmichael D, Hegenauer J, Lem M, Ripley L, Saltman P, Hatlen L. (1977). Iron supplementation of the lactating mouse and suckling neonates. J Nutr, 107:1377-1384.
16. Cerdán-Vidal A, Maurí-Aucejo A, Pascual-Martí M, Lobat-Estellés M. (2009). Identification and determination of amphetamine and methamphetamine in street drugs. J Anal Chem, 64:201-205.
17. Lind A, Glynn Wicklund A. (1999).Intestinal absorption of copper from drinking water containing fuvlic acids and an inflant formula mixture studied in a suckling rat model. BioMetals, 12:181-187.
18. Cakic M, Mitic Z, Nikolic GS, Ilic lj, Nikolic GM. (2008).Deconvoluted Fourier-transform LNT-IR study of coordination copper(II) ion compounds with dextran derivatives. Spectoscopy Int J, 22:177-185.
19. Ilic Lj, Mitic Z, Nikolic G. (2003). Testing acute toxicity of preparation based on Cu (II) with dextran, V Symposium "Modern Technologies and Economic Development", Serbia, Leskovac. Book of abstract, OHT-8. p 47.
20. Mitic Z, Nikolic GS, Cakic M, Premovic P, Ilic Lj. (2009). FTIR spectroscopic characterization of Cu(II) coordination compounds with exopolysaccharide pullulan and its derivatives. J Molec Struc, 924-926: 264-273.
21. Mitic Z, Nikolic G, Cakic M, Nikolic R, Ilic Lj. (2007). Synthesis and spectroscopic characterization of copper(II) dextran complexes. Rus J Phys Chem A, 81:1433-1437.
22. Cakic M, Nikolic G, Mitic Z, Ilic Lj. (2004). 4th International Conference of the Chemical Societies of the South-East European Countries, Belgrade. p 72.
23. Nikolic GM, Ilic Lj, Cakic M, Nikolic GS, Nikolic R, Mitic Z. (2004). Conference Proceeding, 7th International conference on Fundamental and Applied Aspects of Physical Chemistry, Belgrade, SCG. Vol. II. pp 775-777.
24. Mashkovski MD. (1998). Medications. Kharkov, Torsing, 1:165-167.
25. Leech F, McSporran KD, McLaren DG. Patent WO 02/087598, 2002.
26. Savic IM, Nikolic GS, Savic IM, Cakic MD. (2010). Conductometric studies on the stability of copper complexes with different oligosaccharides. Cent Eur J Chem, 8:1078-1085.
27. Ferreira AC, Das M, Korn GA, Ferreira SLC. (2004). Multivariate optimization in preconcentration procedure for manganese determination in seawater samples by FAAS. Microchim Acta, 146:271-278.
28. Bolton S. (1990). Pharmaceutical statistics. 2nd ed. New York: Marcel Decker Inc, p 234.
29. Franz RM, Browne JE, Lewis AR. (1988). Experiment design, modeling and optimization strategies for product and process development. In: Libermann HA, Reiger MM, Banker GS, eds. Pharmaceutical Dosage Forms: Disperse Systems. Vol 1. New York: Marcel Dekker Inc. pp 427-519.
30. Rowe RC, Sheskey PJ, Weller PJ. (2006). Handbook of Pharmaceutical Excipients, 5th ed. London: Pharmaceutical Press and American Pharmaceutical Association. pp 534-774.
31. Umetrics, Umea, SIMCA P+ program, Version 12.0.0.0, 2008, www. umetrics.com
32. European Pharmacopoeia 6th Edition Supplement 6.2. Council of Europe European Directorate for the Quality of medicine, Hardback 2008.
33. Savic I, Nikolic G, Savic I, Cakic M. (2010). Development and validation of gel-chromatographic and spectrophotometric methods for quantitative analysis of bioactive copper complexes in new antihypocupremical formulations. Acta Chromatographica, 22:375-390.
34. Jovanovic M. (1990). Tablets, Faculty of Pharmacy, Belgrade, Serbia.
35. Bezerra MA, Santelli RE, Oliveira EP, Villar LS, Escaleira LA. (2008). Response surface methodology (RSM) as a tool for optimization in analytical chemistry. Talanta, 76:965-977.