• USWATUL HASANAH Department of Pharmaceutics, Faculty of Pharmacy, Universitas Andalas, Padang, West Sumatra, 25163, Indonesia
  • LIZA WAHYUNI Department of Pharmaceutics, Faculty of Pharmacy, Universitas Andalas, Padang, West Sumatra, 25163, Indonesia
  • ERIZAL ZAINI Department of Pharmaceutics, Faculty of Pharmacy, Universitas Andalas, Padang, West Sumatra, 25163, Indonesia




Dissolution enhancement, Eutectic mixture, Fenofibric acid, Microparticles, Saccharin, Spray drying


Objective: This study aims to increase the solubility and dissolution rate of fenofibric acid by forming a micronized eutectic mixture of fenofibric acid-saccharin with spray drying technique.

Methods: Suspension of the eutectic mixture was prepared in ethanol: distilled water (3:1) followed by a spray drying method to obtain the microparticles. Microparticles characterization was performed by particle size analysis (PSA), powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), FT-IR spectroscopy, and scanning electron microscopy (SEM). Solubility test was carried out in CO2-free distilled water, meanwhile the dissolution rate study was conducted in phosphate buffer solution at pH 6.8.

Results: The results showed the mean of the samples’ particle size was 72.29±7.33 µm. Compared to the intact fenofibric acid, the micronized eutectic mixture sample has a decreased melting point, fusion enthalpy, and crystallinity without any wavenumber shifted in the FT-IR spectra. The solubility of micronized eutectic mixture was 2.2 times higher than intact fenofibric acid, while the amount of micronized eutectic mixture dissolved at 60 min was 11.7 times higher.

Conclusion: It can be concluded that the spray-dried micronized eutectic mixture of fenofibric acid-saccharin was having the ability to enhance the dissolution of fenofibric acid.


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Sun T, Hall ML, Isbester PK. White heat BR. Fenofibric acid polymorph; methods of making; and methods of use thereof. United states application publication. Vol. 56(4); 2009.

Shukla AK, Bishnoi RS, Dev SK, Khumar M, Fenin V. Biopharmaceutical classification system: tool-based prediction for drug dosage formulation. Adv Pharm J. 2017;2(6):204-10.

Windriyati YN, Sumirtapura YC, Pamudji JS. Comparative in vitro and in vivo evaluation of fenofibric acid as an antihyperlipidemic drug. Turk J Pharm Sci. 2020 Apr 1;17(2):203-10. doi: 10.4274/tjps.galenos.2019.27147, PMID 32454781.

Hens B, Brouwers J, Corsetti M, Augustijns P. Gastrointestinal behavior of nano- and microsized fenofibrate: in vivo evaluation in man and in vitro simulation by assessment of the permeation potential. Eur J Pharm Sci. 2015;77:40-7. doi: 10.1016/j.ejps.2015.05.023.

Anggraini D, Umar S, Arifin H, Zaini E. Dissolution rate enhancement and physicochemical characterization of a fenofibric acid–nicotinamide eutectic mixture. Trop J Nat Prod Res (TJNPR). 2021 Sep 1;5(9):1614-8. doi: 10.26538/tjnpr/v5i9.

Zaini E, Azhari D, Fitriani L. Identification and characterization of solid binary system of quercetin-nicotinamide. Orient J Chem. 2016 Jun 1;32(3):1545-50. doi: 10.13005/ojc/320330.

Saurav A, Kaushik M, Mohiuddin SM. Fenofibric acid for hyperlipidemia. Expert Opin Pharmacother. 2012;13(5):717-22. doi: 10.1517/14656566.2012.658774, PMID 22404421.

Nikalje AP. Nanotechnology and its applications in medicine. Med Chem. 2015;5(2):81-9. doi: 10.4172/2161-0444.1000247.

Yousaf AM, Mustapha O, Kim DW, Kim DS, Kim KS, Jin SG. Novel electrosprayed nanospherules for enhanced aqueous solubility and oral bioavailability of poorly water-soluble fenofibrate. Int J Nanomedicine. 2016;11:213-21. doi: 10.2147/IJN.S97496, PMID 26834471.

Fitriani L, Afriyanti I, Afriyani A, Ismed F, Zaini E. Solid dispersion of usnic acid–HPMC 2910 prepared by spray drying and freeze drying techniques. Orient J Chem. 2018;34(4):2083-8. doi: 10.13005/ojc/3404048.

Rowe R, Sheskey P, Quinn M. Handbook of pharmaceutical excipients. 6th ed. London: Pharmaceutical Press; 2009.

Umar S, Bandaro NP, Anggraini D, Zaini E. Multicomponent crystal of fenofibric acid-saccharin: characterization and antihyperlipidemic effectiveness. Adv Health Sci Res. 2021;40:104-9. doi: 10.2991/ahsr.k.211105.015.

Sosnik A, Seremeta KP. Advantages and challenges of the spray-drying technology for the production of pure drug particles and drug-loaded polymeric carriers. Adv Colloid Interface Sci. 2015;223:40-54. doi: 10.1016/j.cis.2015.05.003, PMID 26043877.

Rabiej S. A comparison of two X-ray diffraction procedures for crystallinity determination. Eur Polym J. 1991 Jan 1;27(9):947-54. doi: 10.1016/0014-3057(91)90038-P.

Zaini E, Khairun Nisak R, Dwi Utami R, Fitriani L, Ismed F. Effect of milling on physicochemical properties of usnic acid isolated from Usnea sp. Orient J Chem. 2017 Dec 1;33(6):3031-6. doi: 10.13005/ojc/330641.

Hiendrawan S, Veriansyah B, Tjandrawinata RR. Solid-state properties and solubility studies of novel pharmaceutical co-crystal of itraconazole. Int J Appl Pharm. 2018;8(10):5.

Variankaval N, McNevin M, Shultz S, Trzaska S. High-throughput screening to enable salt and polymorph screening, chemical purification, and chiral resolution. In: Comprehensive organic synthesis. 2nd ed; 2014.

Savjani KT, Gajjar AK, Savjani JK. Drug solubility: importance and enhancement techniques. ISRN Pharm. 2012;2012:195727. doi: 10.5402/2012/195727. PMID 22830056.

Schafroth N, Arpagaus C, Jadhav UY, Makne S, Douroumis D. Nano and microparticle engineering of water-insoluble drugs using a novel spray-drying process. Colloids Surf B Biointerfaces. 2012 Feb 1;90:8-15. doi: 10.1016/j.colsurfb.2011.09.038, PMID 22019455.

Bain DF, Munday DL, Smith A. Solvent influence on spray-dried biodegradable microspheres. J Microencapsul. 1999 Jan 1;16(4):453-74. doi: 10.1080/026520499288915, PMID 10420331.



How to Cite

HASANAH, U., WAHYUNI, L., & ZAINI, E. (2023). MICRONIZED EUTECTIC MIXTURE OF FENOFIBRIC ACID-SACCHARIN FORMATION FOR SOLUBILITY AND DISSOLUTION ENHANCEMENT. International Journal of Applied Pharmaceutics, 15(1), 56–60. https://doi.org/10.22159/ijap.2023.v15s1.47514



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