Development of meloxicam in situ implant formulation by quality by design principle

Drug Development and Industrial Pharmacy

Volumn 40, Issue 1, 2014, Pages 66-73

  Ibrahim, Hany M ^a,b   Ahmed, Tarek A ^a,c   Hussain, Muhammad D ^a   Rahman, Ziyaur ^a   Samy, Ahmed M ^b   Kaseem, Ala A ^b   Nutan, Mohammad T H ^a  

^a TEXAS A AND M HEALTH SCIENCE CENTER   (United States)

^b Al Azhar University   (Egypt)

^c KING ABDULAZIZ UNIVERSITY   (Saudi Arabia)

Author keywords

Box Behnken design; Non steroidal anti inflammatory drug; Optimization; Poly(lactide co glycolide); Rheumatoid arthritis; Sustained release

Indexed keywords

1 METHYL 2 PYRROLIDINONE; CYCLOOXYGENASE 2; MELOXICAM; PIROXICAM; POLYGLACTIN;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DESIGN; DRUG FORMULATION; DRUG IMPLANT; DRUG RELEASE; DRUG SOLUBILITY; FISHERMAN; IC 50; INFRARED SPECTROSCOPY; MALE; MAXIMUM PLASMA CONCENTRATION; MUSCULOSKELETAL DISEASE; NONHUMAN; PHYSICAL CHEMISTRY; PLASMA CONCENTRATION-TIME CURVE; RAT; SCANNING ELECTRON MICROSCOPY; TIME TO MAXIMUM PLASMA CONCENTRATION; VISCOSITY; X RAY POWDER DIFFRACTION;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; DRUG CARRIERS; DRUG COMPOUNDING; DRUG IMPLANTS; GELS; INHIBITORY CONCENTRATION 50; LACTIC ACID; MALE; MICROSCOPY, ELECTRON, SCANNING; POLYGLYCOLIC ACID; PYRROLIDINONES; RATS; RATS, SPRAGUE-DAWLEY; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; THIAZINES; THIAZOLES; VISCOSITY; X-RAY DIFFRACTION;

EID: 84890489473     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2012.746360     Document Type: Article

References (35)

1. Suleyman H, Demircan B, Karagoz Y. Anti-inflammatory and side effects of cyclooxygenase inhibitors. Pharmacol Rep 2007;59:247-58.
2. Hosie J, Distel M, Bluhmki E. Meloxicam in osteoarthritis: a 6- month, double-blind comparison with diclofenac sodium. Rheumatology 1996;35:39-43.
3. Han HK, Amidon GL. Targeted prodrug design to optimize drug delivery. AAPS Pharmsci 2000;2:article 6.
4. Ah YC, Choi JK, Choi YK, et al. A novel transdermal patch incorporating meloxicam: in-vitro and in-vivo characterization. Int J Pharm 2010;385:12-19.
5. Duangjit S, Opanasopit P, Rojanarata T, Ngawhirunpat T. Characterization and in-vitro skin permeation of meloxicamloaded liposomes versus transfersomes. J Drug Del 2011;Article ID 418316:9pp.
6. Dunn R. Application of the Atrigel implant drug delivery technology for patient-friendly, cost-effective product development. Drug Dev Deliv 2003;3:article 2.
7. Tipton AJ, Fujita SM. A biodegradable injectable delivery system for nonsteroidal anti-inflammatory drugs. Pharm Res 1991;9:S-196.
8. Shah NH, Railkar AS, Chen FC, et al. A biodegradable injectable implant for delivering micro and macromolecules using poly (lactic-co-glycolic) acid (PLGA) copolymers. J Control Rel 1993;27:139-47.
9. Hatefi A, Amsden B. Biodegradable injectable in-situ forming drug delivery systems. J Control Rel 2001;80:9-28.
10. ICH. Tripartite guideline on pharmaceutical development. International Conference on Harmonization 2009;Q8(R2).
11. Karnachi AA, Khan MA. Box-Behnken design for the optimization of formulation variables of indomethacin coprecipitates with polymer mixtures. Int J Pharm 1996;131:9-17.
12. Box GEP, Behnken DW. Some new three level designs for the study of quantitative variables. J Technometrics 1960;2:455-75.
13. Nutan MTH, Soliman MS, Taha EI, Khan MA. Optimization and characterization of controlled release multi-particulate beads coated with starch acetate. Int J Pharm 2005;294:89-101.
14. Montgomery DC. Design and analysis of experiments. 4th ed. New York: Wiley; 1996.
15. Singh SK, Dodge J, Durrani MJ, Khan MA. Optimization and characterization of controlled release pellets coated with an experimental latex I. Anionic drug. Int J Pharm 1995;125:243-55.
16. Yu T, Jagdish S. Controlled delivery of aspirin: effect of aspirin on polymer degradation and in-vitro release from PLGA based phase sensitive systems. Int J Pharm 2008;357:119-25.
17. Bae J, Kim M, Jang C, Lee S. Determination of meloxicam in human plasma using a HPLC method with UV detection and its application to a pharmacokinetic study. J Chromatography B 2007;859:69-73.
18. FDA Guidance for industry bioanalytical method validation. Food and Drug Administration [Online] 2001. Available from: http:// www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm070107.pdf [last accessed 15 Jun 2012].
19. NIH Guide for the Care and Use of Laboratory Animals. US National Institutes of Health 1996 (revised), publication no. 85-23.
20. Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J 2007;22:659-61.
21. Pharmacokinetic Software. Available from: http://www.boomer.org/ pkin/soft.html [last accessed 19 Oct 2012].
22. Wischkel C, Schwendeman SP. Principles of encapsulating hydrophobic drugs in PLA/PLGA. Int J Pharm 2008;364:298-327.
23. Rahman Z, Zidan AS, Habib MJ, Khan MA. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm 2010;389:186-94.
24. Bodmer D, Kissel T, Traechslin E. Factors influencing the release of peptides and proteins from biodegradable parenteral depot systems. J Control Release 1992;21:129-38.
25. Tan LP, Venkatraman SS, Sung PF, Wang XT. Effect of plasticization on heparin release from biodegradable matrices. Int J Pharm 2004;283:89-96.
26. Gabor F, Ertl B, Wirth M, Mallinger R. Ketoprofen-poly(D,L-lacticco- glycolic acid) microspheres: influence of manufacturing parameters and type of polymer on the release characteristics. J Microencapsul 1999;16:1-12.
27. Chan JM, Zhang L, Yuet KP, et al. PLGA-lecithin-PEG core-shell nanoparticles for controlled drug delivery. Biomaterials 2009;30:1627-34.
28. Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol 1975;27:48-9.
29. Blanco FJ, Guitian R, Moreno J, et al. Effect of antiinflammatory drugs on COX-1 and COX-2 activity in human articular chondrocytes. J Rheumatol 1999;26:1366-73.
30. Zolnik BS, Burgess DJ. Evaluation of in vivo-in vitro release of dexamethasone from PLGA microspheres. J Control Release 2008;127:137-45.
31. Galeska I, Kim TK, Patil S, et al. Controlled release of dexamethasone from PLGA microspheres embedded within polyacid- containing PVA hydrogels. AAPS J 2005;7:E231-40.
32. Anderson J, Miller K. Biomaterials biocompatibility and the macrophage. Biomaterials 1984;5:5-10.
33. Zhao Q, Topham N, Anderson J, et al. Foreign body giant cells and polyurethane biostability: in-vivo correlation of cell adhesion and surface cracking. J Biomed Mater Res 1991;25:177-83.
34. van Dijkhuizen-Radersma R, Wright SJ, Taylor LM, et al. In vitro/ in vivo correlation for 14C-methylated lysozyme release from poly(ether-ester) microspheres. Pharm Res 2004;21:484-91.
35. Ronneberger B, Kao W, Anderson J, Kissel T. In-vivo biocompatibility of ABA triblock copolymers consisting of poly(l-lactic-coglycolic acid) A blocks attached to central poly(oxyethylene) B blocks. J Biomed Mater Res 1996;30:31-40.