The impact of preparation parameters on sustained release aceclofenac microspheres: A design of experiments

Advanced Powder Technology

Volumn 26, Issue 1, 2015, Pages 244-252

  Deshmukh, Rameshwar K ^a   Naik, Jitendra B ^a  

^a NORTH MAHARASHTRA UNIVERSITY   (India)

Author keywords

Aceclofenac; IV optimal design; Microencapsulation; Microspheres; Statistical experimental design

Indexed keywords

DESIGN; DESIGN OF EXPERIMENTS; DRUG PRODUCTS; EFFICIENCY; EMULSIFICATION; ENCAPSULATION; FIELD EMISSION MICROSCOPES; FOURIER TRANSFORM INFRARED SPECTROSCOPY; MICROENCAPSULATION; OPTIMAL SYSTEMS; POLYMERS; SCANNING ELECTRON MICROSCOPY;

ACECLOFENAC; ENCAPSULATION EFFICIENCY; IV-OPTIMAL DESIGNS; OPTIMIZATION CAPABILITIES; PHYSICOCHEMICAL CHARACTERISTICS; RESPONSE SURFACE METHODOLOGY; STATISTICAL EXPERIMENTAL DESIGN; X-RAY POWDER DIFFRACTOMETRY;

MICROSPHERES;

EID: 84922594563     PISSN: 09218831     EISSN: 15685527     Source Type: Journal    
DOI: 10.1016/j.apt.2014.10.004     Document Type: Article

References (63)

1. J.L. Arias, M. Lopez-Viota, J. Lopez-Viota, and A.V. Delgado Development of iron/ethylcellulose (core/shell) nanoparticles loaded with diclofenac sodium for arthritis treatment Int. J. Pharm. 382 2009 270 276
2. J.T. Edelson, A.N. Tosteson, and P. Sax Cost-effectiveness of misoprostol for prophylaxis against nonsteroidal anti-inflammatory drug-induced gastrointestinal tract bleeding JAMA 264 1990 41 47
3. C.H. Barrier, and B.I. Hirschowitz Controversies in the detection and management of nonsteroidal anti-inflammatory drug-induced side effects of the upper gastrointestinal tract Arthritis Rheum. 32 1989 926 932
4. T. Pincus, and M. Griffin Gastrointestinal disease associated with nonsteroidal anti-inflammatory drugs: new insights from observational studies and functional status questionnaires Am. J. Med. 91 1991 209 212
5. C. Sostres, C.J. Gargallo, M.T. Arroyo, and A. Ganas Adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs, aspirin and coxibs) on upper gastrointestinal tract Best Pract. Res. Clin. Gastroenterol. 24 2010 121 132
6. S.-Y. Rhim, J.-H. Park, Y.-S. Park, M.-H. Lee, L.M. Shaw, and J.-S. Kang Bioequivalence and pharmacokinetic evaluation of two branded formulations of aceclofenac 100 mg: a single-dose, randomized, open-label, two-period crossover comparison in healthy korean adult volunteers Clin. Ther. 30 2008 633 640
7. A. Lamprecht, H.R. Torres, U. Schafer, and C.M. Lehr Biodegradable microparticles as a two-drug controlled release formulation: a potential treatment of inflammatory bowel disease J. Control. Release 69 2000 445 454
8. J. Herrmann, and R. Bodmeier Somatostatin containing biodegradable microspheres prepared by a modified solvent evaporation method based on W/O/W-multiple emulsions Int. J. Pharm. 126 1995 129 138
9. H.S. Yoo Preparation of biodegradable polymeric hollow microspheres using O/O/W emulsion stabilized by Labrafil® Colloid Surf. B 52 2006 47 51
10. E. Polard, P.S. Corre, F. Chevanne, and R.L. Verge In vitro and in vivo evaluation of polylactide and polylactide-co-glycolide microspheres of morphine for site-specific delivery Int. J. Pharm. 134 1996 37 46
11. J.B. Naik, R.K. Deshmukh, and V.V. Kamble Development of sustained released microparticles of diclofenac sodium using polymer complex by spray drier Am. J. PharmTech Res. 3 2013 892 904
12. R. Bodmeier, H. Chen, P. Tyle, and P. Jarosz Pseudoephedrine HCL microspheres formulated into an oral suspension dosage form J. Control. Release 15 1991 65 77
13. M. Li, O. Rouaud, and D. Poncelet Microencapsulation by solvent evaporation: state of the art for process engineering approaches Int. J. Pharm. 363 2008 26 39
14. S. Freitas, H.P. Merkle, and B. Gander Microencapsulation by solvent extraction/evaporation: reviewing the state of the art of microsphere preparation process technology J. Control. Release 102 2005 313 332
15. J.B. Naik, A.B. lokhande, R.D. Kulkarni, and S. Mishra Development of sustained release micro-nano particles using different solvent emulsion technique: a review Int. J. Pharm. Biosci. 3 2012 573 590
16. P.C. Wu, Y.B. Huang, J.S. Chang, M.J. Tsai, and Y.H. Tsai Design and evaluation of sustained release microspheres of potassium chloride prepared by Eudragit Eur. J. Pharm. Sci. 19 2003 115 122
17. M. Barzegar-Jalali, M. Alaei-Beirami, Y. Javadzadeh, G. Mohammadi, A. Hamidi, S. Andalib, and K. Adibkia Comparison of physicochemical characteristics and drug release of diclofenac sodium-eudragit RS100 nanoparticles and solid dispersion Powder Technol. 219 2012 211 216
18. R. Bodmeier, and H. Chen Preparation and characterization of microspheres containing the anti-inflammatory agents, indomethacin, ibuprofen, and ketoprofen J. Control. Release 10 1989 167 175
19. P.C. Wu, Y.B. Huang, J.I. Chang, M.J. Tsai, and Y.H. Tsai Preparation and evaluation of sustained release microspheres of potassium chloride prepared with ethylcellulose Int. J. Pharm. 260 2003 115 121
20. H.L. Lai, K. Pitt, and D.Q.M. Craig Characterisation of the thermal properties of ethylcellulose using differential scanning and quasi-isothermal calorimetric approaches Int. J. Pharm. 386 2010 178 184
21. N. Grattard, M. Pernin, B. Marty, G. Roudaut, D. Champion, and M.L. Meste Study of release kinetics of small and high molecular weight substances dispersed into spray-dried ethylcellulose microspheres J. Control. Release 84 2002 125 135
22. M. Saravanan, and B. Anupama Development and evaluation of ethylcellulose floating microspheres loaded with ranitidine hydrochloride by novel solvent evaporation-matrix erosion method Carbohyd. Polym. 85 2011 592 598
23. M. Kilicarslan, and T. Baykara The effect of the drug/polymer ratio on the properties of the verapamil HCl loaded microspheres Int. J. Pharm. 252 2003 99 109
24. Eudragit Data Sheets, Industrial Product Division, Röhm Pharma GmbH, Weiterstadt, Germany.
25. R.C. Rowe, P.J. Sheskey, and M.E. Quinn Handbook of Pharmaceutical Excipients sixth ed. 2009 Pharmaceutical Press and American Pharmacists Association Washington, DC, USA
26. M.A. Alhnan, and A.W. Basit Engineering polymer blend microparticles: an investigation into the influence of polymer blend distribution and interaction Eur. J. Pharm. Sci. 42 2011 30 36
27. M. Song, N. Li, S. Sun, L.R. Tiedt, W. Liebenberg, and M.M. deVilliers Effect of viscosity and concentration of wall former, emulsifier and pore-inducer on the properties of amoxicillin microcapsules prepared by emulsion solvent evaporation II Farmaco 60 2005 261 267
28. D. Bas, and I.H. Boyaci Modeling and optimization I: usability of response surface methodology J. Food Eng. 78 2007 836 845
29. S. Chopra, G.V. Patil, and S.K. Motwani Release modulating hydrophilic matrix systems of losartan potassium: optimization of formulation using statistical experimental design Eur. J. Pharm. Biopharm. 66 2007 73 82
30. S. Kehoe, N. Kilcup, and D. Boyd Evaluation of cytotoxicity for novel composite embolic microspheres: material optimization by response surface methodology Mater. Lett. 86 2012 13 17
31. P. Wang, Z.W. Wang, and Z.C. Wu Insights into the effect of preparation variables on morphology and performance of polyacrylonitrile membranes using Plackett-Burman design experiments Chem. Eng. J. 193 2012 50 58
32. S.A. Martins, D.M. Prazeres, L.P. Fonseca, and G.A. Monteiro Application of central composite design for DNA hybridization onto magnetic microparticles Anal. Biochem. 391 2009 17 23
33. R.S. Liu, and Y.J. Tang Tuber melanosporum fermentation medium optimization by Plackett-Burman design coupled with Draper-Lin small composite design and desirability function Bioresour. Technol. 101 2010 3139 3146
34. J.S. Lee, H.W. Kim, D. Chung, and H.G. Lee Catechin-loaded calcium pectinate microparticles reinforced with liposome and hydroxypropylmethylcellulose: optimization and in vivo antioxidant activity Food Hydrocolloid 23 2009 2226 2233
35. N. Kettaneh-Wold Use of experimental design in the pharmaceutical industry J. Pharm. Biomed. Anal. 9 1991 605 610
36. R. Ragonese, M. Macka, J. Hughes, and P. Petocz The use of the Box-Behnken experimental design in the optimisation and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation J. Pharm. Biomed. Anal. 27 2002 995 1007
37. E. Hamed, and A. Sakr Application of multiple response optimization technique to extended release formulation design J. Control. Release 73 2001 329 338
38. S. Jose, J.F. Fangueiro, J. Smitha, T.A. Cinu, A.J. Chacko, K. Premaletha, and E.B. Souto Cross-linked chitosan microspheres for oral delivery of insulin: Taguchi design and in vivo testing Colloid Surf. B 92 2012 175 179
39. S. Pund, A. Joshi, K. Vasu, M. Nivsarkar, and C. Shishoo Multivariate optimization of formulation and process variables influencing physico-mechanical characteristics of site specific release isoniazid pellets Int. J. Pharm. 388 2010 64 72
40. A. Billon, B. Bataille, G. Cassanas, and M. Jacob Development of spray-dried acetaminophen microparticles using experimental designs Int. J. Pharm. 203 2000 159 168
41. G.Y. Li, M. Zhong, Z.D. Zhou, Y.D. Zhong, P. Ding, and Y. Huang Formulation optimization of chelerythrine loaded O-carboxymethylchitosan microspheres using response surface methodology Int. J. Biol. Macromol. 49 2011 970 978
42. L. Al haushey, M.A. Bolzinger, C. Bordes, J.Y. Gauvrit, and S. Briancon Improvement of a bovine serum albumin microencapsulation process by screening desing Int. J. Pharm. 344 2007 16 25
43. D. Krishnaiah, A. Bono, R. Sarbatly, R. Nithyanandam, and S.M. Anisuzzaman Optimisation of spray drying operating conditions of Morinda citrifolia L. fruit extract using response surface methodology J. King Saud Univ. - Eng. Sci. 2012 10.1016/j.jksues.2012.10.004
44. S. Bolton, and C. Bon Pharmaceutical Statistics Practical and Clinical Application fifth ed. 2009 Informa Healthcare New York, London
45. R.K. Deshmukh, and J.B. Naik Diclofenac sodium-loaded Eudragit® microspheres: optimization using statistical experimental design J. Pharm. Innov. 8 2013 276 287
46. Indian Pharmacopoeia Commission, Ghaziabad, India, Indian Pharmacopoeia, 2010, pp. 587-562.
47. R. Korsemeyer, R. Gurny, and N. Peppas Mechanism of solute release from porous hydrophilic polymers Int. J. Pharm. 15 1983 25 35
48. J.G. Wagner Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules J. Pharm. Sci. 58 1969 1253 1257
49. M. Gibaldi, and S. Feldman Establishment of sink conditions in dissolution rate determination: theoretical consideration and application to nondisintegrating dosage forms J. Pharm. Sci. 56 1967 1238 1242
50. T. Higuchi Rate of release of medicaments from ointment bases containing drugs in suspension J. Pharm. Sci. 50 1961 874 875
51. T. Higuchi Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices J. Pharm. Sci. 52 1963 1145 1149
52. N.A. Peppas Analysis of Fickian and non-Fickian drug release from polymers Pharm. Acta Helv. 60 1985 110 111
53. A.W. Hixson, and J.H. Crowell Dependence of reaction velocity upon surface and agitation Ind. Eng. Chem. 23 1931 923 931
54. R.S. Harland, A. Gazzaniga, M.E. Sangalli, P. Colombo, and N.A. Peppas Drug/polymer matrix swelling and dissolution Pharm. Res. 5 1988 488 494
55. M. Bamba, F. Puisieux, J. Marty, and J. Carstensen Mathematical model for release of drug from gel-forming sustained release preparations Int. J. Pharm. 3 1979 87 92
56. R.H. Meyer, and D.C. Montgomery Response Surface Methodology: Process and Product Optimization Using Designed Experiments 2002 John Wiley & Sons New York
57. D.C. Montgomery Introduction to Statistical Quality Control fourth ed. 2008 John Wiley & Sons New York
58. R.K. Deshmukh, and J.B. Naik Aceclofenac microspheres: quality by design approach Mater. Sci. Eng. C 2013 10.1016/j.msec.2013.12.024
59. A. Ahad, M. Aqil, K. Kohli, Y. Sultana, M. Mujeeb, and A. Ali Formulation and optimization of nanotransfersomes using experimental design technique for accentuated transdermal delivery of valsartan Nanomed.-Nanotechnol. 8 2012 237 249
60. A.K. Nayak, D. Pal, J. Pradhan, and M.S. Hasnain Fenugreek seed mucilage-alginate mucoadhesive beads of metformin HCl: design, optimization and evaluation Int. J. Biol. Macromol. 54 2013 144 154
61. B. Conti, I. Genta, T. Modena, and F. Pavanetto Investigation on process parameters involved in polylactide-co-glycolide microspheres preparation Drug Dev. Ind. Pharm. 21 1995 615 622
62. D.T. O'Hagan, H. Jeffrey, and S.S. Davis The preparation and characterisation of poly(lactide-co-glycolide) microparticles. III. Microparticle/polymer degradation rates and the in vitro release of a model protein Int. J. Pharm. 103 1994 37 45
63. G. Acharya, C.S. Shin, K. Vedantham, M. Mcdermott, T. Rish, K. Hansen, Y. Fu, and K. Park A study of drug release from homogeneous PLGA microstructures J. Control. Release 142 2010 201 206