Author(s):
Anjali Sharma, Kumar Guarve, Ranjit Singh
Email(s):
ranjitsps@gmail.com
DOI:
10.52711/0974-360X.2021.01089
Address:
Anjali Sharma1,2, Kumar Guarve1, Ranjit Singh2*
1Guru Gobind Singh College of Pharmacy, Yamunanagar-135001, Haryana.
2Adarsh Vijendra Institute of Pharmaceutical Sciences, Shobhit University, Gangoh, Saharanpur-247001, Uttar Pradesh.
*Corresponding Author
Published In:
Volume - 14,
Issue - 12,
Year - 2021
ABSTRACT:
Background: The aim of the present investigation was to develop optimized Aceclofenac-loaded microsponges using Box-Behnken design (BBD) and desirability function. Material and Method: Aceclofenac-loaded microsponges were developed using ethyl cellulose, ethanol and polyvinyl alcohol (PVA). Initially, a trial batch was developed using quasi-emulsion solvent diffusion method, and by optimizing the drug-polymer ratio. A 3-level, 3-factor BBD was used to investigate the effect of PVA, ethanol and stirring speed on particle size and entrapment efficiency (EE). The models used for the optimization were analyzed through ANOVA and diagnostic plots. Finally, the desirability function was used for the selection of optimized formulation composition. Results: A drug-polymer ratio of 1.5:1 was taken as optimized ratio for all the formulations. The developed microsponges were of the spherical shape having size and %EE in the range of 22.54±2.85 µm to 49.08±5.01 µm and 70.57±4.19% to 86.43±2.58 %, respectively. The amounts of PVA, ethanol and stirring speed were noted to have a significant impact on particle size and %EE. Finally, an optimized formulation (size-22.69 and %EE-86.42) was developed with a desirability value of 0.9967. Conclusion: The BBD is a valuable tool for the development of optimized microsponges with desired properties.
Cite this article:
Anjali Sharma, Kumar Guarve, Ranjit Singh. Application of Box–Behnken Design and Desirability function in the Optimization of Aceclofenac-Loaded Micropsonges for Topical Application. Research Journal of Pharmacy and Technology. 2021; 14(12):6295-3. doi: 10.52711/0974-360X.2021.01089
Cite(Electronic):
Anjali Sharma, Kumar Guarve, Ranjit Singh. Application of Box–Behnken Design and Desirability function in the Optimization of Aceclofenac-Loaded Micropsonges for Topical Application. Research Journal of Pharmacy and Technology. 2021; 14(12):6295-3. doi: 10.52711/0974-360X.2021.01089 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-12-19
REFERENCES:
1. Brogden RN, Wiseman LR. Aceclofenac. A review of its pharmacodynamic properties and therapeutic potential in the treatment of rheumatic disorders and in pain management. Drugs.1996; 52(1):113-124.
2. Sridhar G, et al. A comparative study of efficacy and tolerability of tramadol and Aceclofenac in treatment of osteoarthritis. J Evid Based Med Healthc. 2016; 3(14):462-467.
3. Henrotin Y, et al. In vitro effects of Aceclofenac and its metabolites on the production by chondrocytes of inflammatory mediators, InflammRes. 2001;50(8):391-399.
4. Batlle-Gualda E, et al. Aceclofenac vs paracetamol in the management of symptomatic osteoarthritis of the knee: a double-blind 6-week randomized controlled trial. OsteoarthrCartil. 2007; 15(8):900-908.
5. Sharma V, et al. Comparison of efficacy of diclofenac versus Aceclofenac in post-operative pain in lower limb fractures: a double blind, randomized study, Internet J Orthop Surg. 2012;19(2):1–5.
6. Noh K, et al. Absolute bioavailability and metabolism of Aceclofenac in rats. Arch 2015;38(1):68-72.
7. Phatak, A. A., Chaudhari, P. D. Development and evaluation of nanogel as a carrier for transdermal delivery of Aceclofenac. Asian Journal of Pharmacy and Technology,2012., 2(4), 125-132.
8. Osmani RAM, et al. Microsponges based novel drug delivery system for augmented arthritis therapy. Saudi Pharm J. 2015; 23:562-572.
9. Wang Y, et al. Transdermal drug delivery system of Aceclofenac for rheumatoid arthritis and the effect of permeation enhancers: in vitro and in vivo characterization. Inter jpharmacol. 2015;11(5):456-462.
10. D'souza, J. I., and More, H. N. Topical anti-inflammatory gels of fluocinolone acetonide entrapped in eudragit based microsponge delivery system. Research Journal of Pharmacy and Technology, 2008.,1(4), 502-506.
11. Bhimavarapu, R., Devi, R. R., Nissankararao, S., Devarapalli, C., and Paparaju, S. (2013). Microsponges as a Novel Imperative for Drug Delivery System. Research Journal of Pharmacy and Technology, 6(8), 842-848.
12. Jangde, R. Microsponges for colon targeted drug delivery system: An overview. Asian Journal of Pharmacy and Technology,2011., 1(4), 87-93.
13. Gangadharappa HV, et al. Current trends in microsponge drug delivery system. Curr Drug Deliv. 2013;10(4), 453–465.
14. Junqueira MV, Bruschi ML. A Review about the drug delivery from microsponges. AAPS PharmSciTech. 2018; 19:1501-1511.
15. Kaity S, et al. Microsponges: A novel strategy for drug delivery system. J Adv Pharm Tech Res. 2010;1(3):283-290.
16. Umamaheswari, R., and Kothai, S. Effectiveness of Copper nanoparticles loaded microsponges on Drug release study, Cytotoxicity and Wound healing activity. Research Journal of Pharmacy and Technology, 2020., 13(9), 4357-4360.
17. Osmani RA, et al. Microsponges based novel drug delivery system for augmented arthritis therapy. Saudi Pharmaceutical Journal. 2015;23(5):562–572.
18. Veni, D. K., and Gupta, N. V., Quality by Design approach in the development of Solid Lipid Nanoparticles of Linagliptin. Research Journal of Pharmacy and Technology, 2019.,12(9), 4454-4462.
19. Mishal, A., and Rathod, Quality by Design: A New Era of Development of Quality in Pharmaceuticals. Research Journal of Pharmacy and Technology, 2014.,7(5), 581-591.
20. Das, V., Bhairav, B., and Saudagar, R. B. Quality by design approaches to analytical method development. Research Journal of Pharmacy and Technology, 2017.,10(9), 3188-3194.
21. ICHQ8(R2). The international conference on harmonization of technical requirements for registration of pharmaceuticals for human use, quality guideline Q8(R2) pharmaceutical development.2009.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf. (Accessed 18thMay 2020).
22. ICH Q9. The international conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline Q9 Quality risk Management. 2005.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. (Accessed 18thMay 2020).
23. ICHQ10. The international conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline, Q 10 pharmaceutical quality system. 2008 https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf. (Accessed 18thMay 2020).
24. Bezerra MA et al. Response surface methodology (RSM) as a tool for optimization in analytical chemistry. Talanta. 2008; 76:965-977.
25. Makela M. Experimental design and response surface methodology in energy applications: A tutorial review. Energy Convers Manag. 2017; 151:630–640.
26. Zaman M et al. Application of quasi-emulsification and modified double emulsification techniques for formulation of tacrolimus microsponges. Int J Nanomed. 2018; 10:4537-4548.
27. Hans M et al. Formulation and evaluation of fluconazole microsponge using Eudragit L 100 by quasi emulsion solvent diffusion method. JDrug DelivThera. 2019;9(3):366-373.
28. Pathak, G. K., Chopra, H., and Sharma, G. K. Formulation, development and evaluation of bioadhesive floating Microsponges of Domperidone. Research Journal of Pharmacy and Technology,2020., 13(1), 383-390.
29. D'souza, J. I., and More, H. N. Study on Factors Influencing Drug Release from Fluconazole-Microsponges Prepared by Suspension Polymerization. Research Journal of Pharmacy and Technology, 2008., 1(3), 235-239.
30. Desavathu M et al. Design, development and characterization of valsartan microsponges by quasi emulsion technique and the impact of stirring rate on microsponge formation. J Applied Pharm Sci.2017; 7:193-198.
31. Osman RM, et al. Microsponge based drug delivery system for augmented gastroparesis therapy: Formulation development and evaluation. Asian J Pharm Sci. 2015;10(5):442-451.
32. Maiti S et al. Development and evaluation of xanthan gum-facilitated ethyl cellulose microsponges for controlled percutaneous delivery of diclofenac sodium. Acta Pharm. 2011; 61:257–270.