THE DEVELOPMENT FORMULATION OF ELEUTHERINE PALMIFOLIA EXTRACT-LOADED SELF NANOEMULSIFYING DRUG DELIVERY SYSTEM (SNEDDS) USING D-OPTIMAL MIXTURE DESIGN APPROACH
DOI:
https://doi.org/10.22159/ijap.2023v15i5.47645Keywords:
D-optimal mixture design, E. palmifolia, Self-nano emulsifying, SNEDDSAbstract
Objective: The develop a delivery system for extracting E. palmifolia as a model of medicinal ingredients in SNEDDS using a D-optimal design approach.
Methods: D-optimal mixture design optimizes E. palmifolia loaded SNEDDS by selecting SNEDDS composition as an independent factor (X) and characterizing SNEDDS as a response (Y). SNEDDS characterization in the optimal formula includes transmittance, emulsification time, pH, viscosity, particle size, and particle morphology. After obtaining one optimal formula, stability testing compares the initial characteristics (day one) with those of E. palmifolia-loaded SNEDDS.
Results: The SNEDDS was after storage for three months, namely day 30, day 60, and day 90. Miglyol 812, Tween 80, and polyethylene glycol (PEG) 400 were selected as oil, surfactant, and co-surfactant phases because they had the highest ability to dissolve E. palmifolia extract. The formula design with the D-optimal mixture design approach formulated E. palmifolia loaded SNEDDS with Miglyol 812, Tween 80, and PEG 400 components at an oil concentration of 2.13%, surfactant 5.81%, and co-surfactant 2.06% with stable characteristics in the storage period of 3 mo. Transmittance results in 96.75-98.74%, emulsification time 19.21-22.77 seconds, pH 6.69–7.71, viscosity 43.97-45.99 (cP), particle size 19.14-22.19 nm, spherical particle morphology.
Conclusion: The optimal formula for SNEDDS extract of E. palmifolia using the D-optimal design approach has physical and chemical characteristics that follow the SNEDDS specifications that have been determined.
Downloads
References
Martien R, Adhyatmika IDK, Irianto, Verda F, Dian PS. Perkembangan teknologi nanopartikel sebagai penghantaran obat. Majalah Farmaseutik. 2012;8(1):133-44.
Jing X, Deng L, Gao B, Xiao L, Zhang Y, Ke X. A novel polyethylene glycol mediated lipid nanoemulsion as drug delivery carrier for paclitaxel. Nanomedicine. 2014;10(2):371-80. doi: 10.1016/j.nano.2013.07.018, PMID 23969104.
Kesarwani K, Gupta R, Mukerjee A. Bioavailability enhancers of herbal origin: an overview. Asian Pac J Trop Biomed. 2013;3(4):253-66. doi: 10.1016/S2221-1691(13)60060-X, PMID 23620848.
Mutiah R, Listiyana A, Suryadinata A, Annisa R, Hakim A, Anggraini W. The activity inhibits the cell cycle and induces apoptosis in HeLa cancer cells with a combination of sabrang onion (Eleutherine palmifolia (L.) Merr.) and starfruit mistletoe (Macrosolen cochinchinensis (Lour.) Tiegh.). J Appl Pharm Sci. 2018;8(10):122-12.
Mutiah R, Listiyana A, Suryadinata A. Aktivitas antikanker kombinasi ekstrak benalu belimbing (Macrosolen cochinensis) dan bawang sabrang (Eleutherine palmifolia (L.) Merr.) pada sel kanker serviks (Sel HeLa). Trad Med. 2017;22(3):146-52.
McClements DJ, Decker EA, Weiss J. Emulsion-based delivery systems for lipophilic bioactive components. J Food Sci. 2007;72(8):R109-24. doi: 10.1111/j.1750-3841.2007.00507.x, PMID 17995616.
Huang QR, Yu HL, Ru QM. Bioavailability and delivery of nutraceuticals using nanotechnology. J Food Sci. 2010;75(1):R50-7. doi: 10.1111/j.1750-3841.2009.01457.x, PMID 20492195.
Villar AMS, Naveros BC, Campmany ACC, Trenchs MA, Rocabert CB, Bellowa LH. Design and optimization of self-nano emulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil. Int J Pharm. 2012;431(1-2):161-75. doi: 10.1016/j.ijpharm.2012.04.001, PMID 22498011.
Indrati O, Martien R, Rohman A, Nugroho AK. Application of simplex lattice design on optimizing andrographolide self nanoemulsifying drug delivery system (SNEDDS). Ind J Pharmacol. 2020;31:7.
Kumar R, Khursheed R, Kumar R, Awasthi A, Sharma N, Khurana S. Self-nanoemulsifying drug delivery system of fisetin: formulation, optimization, characterization and cytotoxicity assessment. J Drug Deliv Sci Technol. 2019;54:101252. doi: 10.1016/j.jddst.2019.101252.
Annisa R, Hendradi E, Yuwono M. Design and optimization of Eleutherine palmifolia extract-loaded SNEDDS using the HLB approach. J Res Pharm. 2020;24(6).
Annisa R, Hendradi E, Yuwono M. Effect of vegetable oil on self-nano emulsifying drug delivery system of Dayak onion [Eleutherine palmifolia (L.) Merr.] extract using hydrophilic-lipophilic balance approach: formulation, characterization. Int J Drug Deliv Technol. 2020;10(2):230-15.
Aboul Fotouh K, Allam AA, El-Badry M, El-Sayed AM. Development and in vitro/in vivo performance of self-nano emulsifying drug delivery systems loaded with candesartan cilexetil. Eur J Pharm Sci. 2017;109:503-13. doi: 10.1016/j.ejps.2017.09.001.
Shahba AA, Mohsin K, Alanazi FK. Novel self-nano emulsifying drug delivery systems (SNEDDS) for oral delivery of cinnarizine: design, optimization, and in vitro assessment. AAPS PharmSciTech. 2012;13(3):967-77. doi: 10.1208/s12249-012-9821-4, PMID 22760454.
Senapati PC, Sahoo SK, Sahu AN. Mixed surfactant-based (SNEDDS) self-nanoemulsifying drug delivery system presenting efavirenz for enhancement of oral bioavailability. Biomed Pharmacother. 2016;80:42-51. doi: 10.1016/j.biopha.2016.02.039, PMID 27133038.
Gautham S, Kuma SA. Self nanoemulsifying drug delivery system-a noval approach for improving bioavailability. J Drug Deliv Ther. 2014;4(6):33-8.
Nasr A, Gardouh A, Ghorab M. Novel solid self-nano emulsifying drug delivery system (S-SNEDDS) for oral delivery of olmesartan medoxomil: design, formulation, pharmacokinetic and bioavailability evaluation. Pharmaceutics. 2016;8(3):20. doi: 10.3390/pharmaceutics8030020, PMID 27355963.
Balakumar K, Raghavan CV, Selvan NT, Prasad RH, Abdu S. Self nano emulsifying drug delivery system (SNEDDS) of rosuvastatin calcium: design, formulation, bioavailability and pharmacokinetic evaluation. Colloids Surf B Biointerfaces. 2013;112:337-43. doi: 10.1016/j.colsurfb.2013.08.025, PMID 24012665.
Das S, Chaudhury A. Recent advances in lipid nanoparticle formulations with solid matrix for oral drug delivery. AAPS PharmSciTech. 2011;12(1):62-76. doi: 10.1208/s12249-010-9563-0, PMID 21174180.
Annisa R, Hendradi E, Melani D. Pengembangan sistem nanostructured lipid carriers (NLC) meloxicam dengan lipid monostearindan miglyol 808 menggunakan metode emulsifikasi. J Tro Pharm Chem. 2016;3(3).
Kazi M, Al-Swairi M, Ahmad A, Raish M, Alanazi FK, Badran MM. Evaluation of self-nano emulsifying drug delivery systems (SNEDDS) for poorly water-soluble talinolol: preparation, in vitro and in vivo assessment. Front Pharmacol. 2019;10:459. doi: 10.3389/fphar.2019.00459, PMID 31118895.
Anton N, Vandamme TF. The universality of low-energy nano-emulsification. Int J Pharm. 2009;377(1-2):142-7. doi: 10.1016/j.ijpharm.2009.05.014, PMID 19454306.
Patel H, Santwani P, Patel P, Akshay K, Ranch K, Shah D. A review on solid self emulsification techniques, dosage forms development and pharmaceutical application. J Biomed Pharm Res. 2013;2(4):53-6.
Divyakumar B, Priyanka B, Kiran B. Formulation and evaluation of self microemulsifying drug delivery system of low solubility drug for enhanced solubility and dissolution. Asian J Biomed PharmSci. 2012;2:7-14.
Fei Y, Kostewicz ES, Sheu M, Dressman JB. Analysis of the enhanced oral bioavailability of fenofibrate lipid formulations in fasted humans using an in vitro–in silico–in vivo approach. European Journal of Pharmaceutics and Biopharmaceutics. 2013;85(3):1274-84. doi: 10.1016/j.ejpb.2013.03.001.
Basalious EB, Shawky N, Badr Eldin SM. SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine. I: development and optimization. Int J Pharm. 2010;391(1-2):203-11. doi: 10.1016/j.ijpharm.2010.03.008. PMID 20214965.
Gottemukkula LD, Sampathi S. SNEDDS as lipid-based nanocarrier systems: concepts and formulation insights. Int J App Pharm. 2022;14(2):1-9. doi: 10.22159/ijap.2022v14i2.42930.
Baloch J, Sohail MF, Sarwar HS, Kiani MH, Khan GM, Jahan S. Self-nanoemulsifying drug delivery system (SNEDDS) for improved oral bioavailability of chlorpromazine: in vitro and in vivo evaluation. Medicina. 2019;55(5):210. doi: 10.3390/medicina55050210.
Published
How to Cite
Issue
Section
Copyright (c) 2023 RAHMI ANNISA, ROIHATUL MUTIAH, MOCHAMMAD YUWONO, ESTI HENDRADI
This work is licensed under a Creative Commons Attribution 4.0 International License.