Application of the Simplex Lattice Design Method to Determine the Optimal Formula of Diclofenac Sodium Nanoemulsion
Background: The success of making nanoemulsions with the aim of producing good characteristic values is determined by the ratio of each component. The Design of Experimental (DoE) approach using the Simplex Lattice Design (SLD) method can be used to determine the optimal formula for nanoemulsion, with variable factors consisting of oleic acid, Tween 20:ethanol (4:1), and water. The response variables observed included droplet size, PDI, and pH. Objective: DoE can help reduce energy, costs, and time needed to make the optimal formula of diclofenac sodium nanoemulsion. Methods: Nanoemulsions were prepared using a low-energy emulsification method. Their characteristics were evaluated and analyzed with Design Expert software. Result: The optimal nanoemulsion formulation consists of 4.17% oleic acid, 37.5% emulsifier (Tween 20 : ethanol 4:1), and 58.33% water. The results of nanoemulsion characteristics were good, with 20.37 nm droplet size, 0.42 PDI, and 4.75 pH. The observed values were not significantly different from the predicted values, and the formula could trap 1% diclofenac sodium well. Conclusion: The simplex lattice design method is very useful in pharmaceutical development, such as nanoemulsion optimization.
Annisa, R. (2021). Pengembangan self nanoemulsifying drug delivery system (SNEEDS) untuk penghantaran ekstrak etanol bawang dayak (Eleutherine palmifolia) dengan menggunakan pendekatan desain D-optimal. Disertasi: Universitas Airlangga.
Bashir, M., Ahmad, J., Asif, M., Khan, S. U. D., Irfan, M., Ibrahim, A. Y., Asghar, S., Khan, I. U., Iqbal, M. S., Haseeb, A., Khalid, S. H., & Abourehab, M. A. S. (2021). Nanoemulgel, an innovative carrier for diflunisal topical delivery with profound anti-inflammatory effect: in vitro and in vivo evaluation. International Journal of Nanomedicine, 16, 1457–1472. https://doi.org/10.2147/IJN.S294653
Donthi, M. R., Munnangi, S. R., Krishna, K. V., Saha, R. N., Singhvi, G., & Dubey, S. K. (2023). Nanoemulgel: a novel nano carrier as a tool for topical drug delivery. Pharmaceutics, 15(164), 1–28. https://doi.org/10.3390/pharmaceutics15010164
Duangjit, S., Mehr, L. M., Kumpugdee-Vollrath, M., & Ngawhirunpat, T. (2014). Role of simplex lattice statistical design in the formulation and optimization of microemulsions for transdermal delivery. Biological and Pharmaceutical Bulletin, 37(12), 1948–1957. https://doi.org/10.1248/bpb.b14-00549
Fadhel, A. Y., & Rajab, N. A. (2022). Tizanidine nanoemulsion: formulation and in-vitro characterization. Journal of Pharmaceutical Negative Results, 13(3), 572–581. https://doi.org/10.47750/pnr.2022.13.03.086
Fithri, N. A., Mardiyanto, M., Novita, R. P., & Andrean, V. (2017). Furosemide self nano emulsifying drug delivery system (SNEDDS) formulation comprising of capryol-90, polysorbate-80, and PEG-400 with simplex-lattice-design. Science and Technology Indonesia, 2(4), 85–88. https://doi.org/10.26554/sti.2017.2.4.85-88
Gul, U., Khan, M. I., Madni, A., Sohail, M. F., Rehman, M., Rasul, A., & Peltonen, L. (2022). Olive oil and clove oil-based nanoemulsion for topical delivery of terbinafine hydrochloride: in vitro and ex vivo evaluation. Drug Delivery, 29(1), 600–612. https://doi.org/10.1080/10717544.2022.2039805
Hendradi, E., Hidayati, F. ., & Erawati, T. (2021). Characteristic of nanostructured lipid carrier (NLC) diclofenac diethylammonium as function of ratio of glyceryl monostearate and caprylic acid. Res. J. Pharm. Technol, 14(3), 1699–1704.
Hendradi, E., Rosita, N., & Rahmadhanniar, E. (2017). Effect of lipid ratio of stearic acid and oleic acid on characteristics of nanostructure lipid carrier (NLC) system of diethylammonium diclofenac. Indonesian Journal of Pharmacy, 28(4), 198–204. https://doi.org/10.14499/indonesianjpharm28iss4pp198
Hidayat, I. R., Zuhrotun, A., & Sopyan, I. (2020). Design-expert software sebagai alat optimasi formulasi sediaan farmasi. Majalah Farmasetika, 6(1), 99–120. https://doi.org/10.24198/mfarmasetika.v6i1.27842
Indrati, O., Martien, R., Rohman, A., & Nugroho, A. K. (2020). Application of simplex lattice design on the optimization of andrographolide self nanoemulsifying drug delivery system (SNEDDS). Indonesian Journal of Pharmacy, 31(2), 124–130. https://doi.org/10.14499/indonesianjpharm31iss2pp124
Jadhav, R. P., Koli, V. W., Kamble, A. B., & Bhutkar, M. A. (2020). A review on nanoemulsion. Asian Journal of Research in Pharmaceutical Science, 10(2), 103–108. https://doi.org/10.5958/2231-5659.2020.00020.x
Jintapattanakit, A. (2018). Preparation of nanoemulsions by phase inversion temperature (PIT) method. Pharmaceutical Sciences Asia, 45(1), 1–12. https://doi.org/10.29090/psa.2018.01.001
Latifah, L., Isadiartuti, D., Yuwono, M., Rahman, F., & Hendradi, E. (2023). Physical properties, release and penetration tests of membrane-type diclofenac sodium patch using nanostructured lipid carrier as reservoir. Tropical Journal of Natural Product Research, 7(12), 5534–5539. https://doi.org/10.26538/tjnpr/v7i12.24
Manjunatha, K. M., Ramana, M. ., & Satyaranayana, D. (2007). Design and evaluation of diclofenac sodium controlled drug delivery systems. Indian Journal of Pharmaceutical Sciences, May-June, 384–389.
Md, S., Alhakamy, N. A., Aldawsari, H. M., Kotta, S., Ahmad, J., Akhter, S., Alam, M. S., Khan, M. A., Awan, Z., & Sivakumar, P. M. (2020). Improved analgesic and anti-inflammatory effect of diclofenac sodium by topical nanoemulgel: formulation development—in vitro and in vivo studies. Journal of Chemistry, 2020, 1–10. https://doi.org/10.1155/2020/4071818
Nasser, N., Hathout, R. M., Abd-Allah, H., & Sammour, O. A. (2024). Simplex lattice design and machine learning methods for the optimization of novel microemulsion systems to enhance p-coumaric acid oral bioavailability: in vitro and in vivo studies. AAPS PharmSciTech, 25(3), 1–18. https://doi.org/10.1208/s12249-024-02766-1
Nastiti, C. M. R. R., Ponto, T., Abd, E., Grice, J. E., Benson, H. A. E., & Roberts, M. S. (2017). Topical nano and microemulsions for skin delivery. Pharmaceutics, 9(4), 1–25. https://doi.org/10.3390/pharmaceutics9040037
Poggio, C., Ceci, M., Beltrami, R., Colombo, M., & Dagna, A. (2015). Viscosity of endodontic irrigants: influence of temperature. Dental Research Journal, 12(5), 425–430. https://doi.org/10.4103/1735-3327.166189
Rao, M., Reddy, R. B., & Kumar, R. (2015). Formulation and development and evaluation of diclofenac sodium microemulsion. Indo American Journal of Pharmaceutical Sciences, 2(12), 1673–1688.
Rowe, R. C., Sheskey, P. J., Cook, W. G., Quinn, M. E., Owen, S. C., & Weller, P. J. (2012). Handbook of Pharmaceutical Excipients, 7th Ed. London: The Pharmaceutical Press.
Sacha, M., Faucon, L., Hamon, E., Ly, I., & Haltner-Ukomadu, E. (2019). Ex vivo transdermal absorption of a liposome formulation of diclofenac. Biomedicine and Pharmacotherapy, 111(December 2018), 785–790. https://doi.org/10.1016/j.biopha.2018.12.079
Santana, R. C., Perrechil, F. A., & Cunha, R. L. (2013). High- and low-energy emulsifications for food applications: a focus on process parameters. Food Engineering Reviews, 5(2), 107–122. https://doi.org/10.1007/s12393-013-9065-4
Shaker, D. S., Ishak, R. A. H., Ghoneim, A., & Elhuoni, M. A. (2019). Nanoemulsion: a review on mechanisms for the transdermal delivery of hydrophobic and hydrophilic drugs. Scientia Pharmaceutica, 87(3). https://doi.org/10.3390/scipharm87030017
Sintov, A. ., & Shapiro, L. (2004). New microemulsion vehicle facilitates percutaneous penetration in vitro and cutaneous drug bioavaibility. J.Cont.Rel, 95, 173–183.
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