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Pharmaceutical Nanotechnology

Editor-in-Chief

ISSN (Print): 2211-7385
ISSN (Online): 2211-7393

Research Article

Vitamin E-based Folic Acid Nanoemulsion: Formulation and Physical Evaluation for Oral Administration

Author(s): Annis Catur Adi, Christanto Christanto, Heni Rachmawati and Amirah Adlia*

Volume 7, Issue 4, 2019

Page: [304 - 313] Pages: 10

DOI: 10.2174/2211738507666190717154040

Abstract

Background: Folic acid is essential in many metabolic processes and DNA synthesis. Nevertheless, folic acid is not stable, pH-sensitive, and deteriorated upon light exposure.

Objective: This work was aimed to improve folic acid stability within vitamin E-based nanoemulsion.

Methods: The nanoemulsion was prepared with self-nanoemulsification method by mixing vitamin E oil, Tween 20, and PEG 400. A pseudoternary phase diagram was constructed with aqueous titration to determine the optimum ratio for the mixture. The globule size, pH and entrapment efficiency were included in the nanoemulsion characterizations. In addition, the influence of centrifugation, storage, and pH on physical and chemical stabilities of folic acid nanoemulsion was evaluated.

Results: Optimum formula was obtained from vitamin E, Tween 20, and PEG 400 with the ratio of 1:11:1, and the folic acid amount was 8 mg. The size of folic acidloaded oil globule was 15.10 ± 1.51 nm, and the nanoemulsion pH was 6.24 ± 0.01. The nanoemulsion system was able to load the folic acid completely. Folic acid in nanoemulsion was stable after 14 days at room temperature, and it was more stable compared to folic acid in solution. In addition, the physical and chemical characteristics of folic acid in nanoemulsion was not affected by the simulated gastric condition.

Conclusion: Hence, nanoemulsion is a promising strategy to enhance folic acid stability.

Keywords: Folic acid, nanoemulsion, self-nanoemulsification, stability, vitamin E oil, entrapment efficiency.

Graphical Abstract
[1]
Gazzali AM, Lobry M, Colombeau L, et al. Stability of folic acid under several parameters. Eur J Pharm Sci 2016; 93: 419-30.
[2]
Scholl TO, Johnson WG. Folic acid: influence on the outcome of pregnancy. Am J Clin Nutr 2000; 71(5): 1295S-303S.
[3]
Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 1991; 338(8760): 131-7.
[4]
Reynolds EH. Benefits and risks of folic acid to the nervous system. J Neurol Neurosurg Psychiatry 2002; 72(5): 567-71.
[5]
Vignesh M, Sivakumar M, Parkavi V, Selvakumar K, Joysa Ruby J. Stabilization of folic acid in liquid dosage form: formulation development, method validation, and comparative analysis. Int J Pharmacol Clin Sci 2012; 1: 332-8.
[6]
Hashmi M. Assay of vitamins in pharmaceutical preparations. J Pharm Sci 1972; 7(10): 213-26.
[7]
Off MK, Steindal AE, Porojnicu AC, et al. Ultraviolet photodegradation of folic acid. J Photochem Photobiol B 2005; 80(1): 47-55.
[8]
Song QH, Hwang KC. Direct observation for photophysical and photochemical processes of folic acid in DMSO solution. J Photochem Photobiol Chem 2007; 185: 51-6.
[9]
Vora A, Riga A, Alexander K. Processes to identify the degradation mechanism of a solid which appears to undergo a complex reaction: folic acid. Instrum Sci Technol 2002; 30: 193-203.
[10]
Lowry OH, Bessey OA, Crawford EJ. Photolytic and enzymatic transformations of pteroylglutamic acid. J Biol Chem 1949; 180(1): 389-98.
[11]
Thomas AH, Suarez G, Cabrerizo FM, Martino R, Capparelli AL. Study of photolysis of folic acid and 6-formylpterin. J Photochem Photobiol Chem 2000; 135: 147-54.
[12]
John J, Liang D. Oral liquid formulation of Etravirine for enhanced bioavailability. J Bioequiv Bioavail 2014; 6(2): 46.
[13]
Patel J, Patel A, Raval M, Sheth N. Formulation and development of a self-nanoemulsifying drug delivery system of irbesartan. J Adv Pharm Technol Res 2011; 2(1): 9-16.
[14]
Eskandani M, Hamishehkar H, Ezzati Nazhad Dolatabadi J. Cyto/Genotoxicity study of polyoxyethylene (20) sorbitan monolaurate (tween 20). DNA Cell Biol 2013; 32(9): 498-503.
[15]
Ke WT, Lin SY, Ho HO, Sheu MT. Physical characterizations of microemulsion systems using tocopheryl polyethylene glycol 1000 succinate (TPGS) as a surfactant for the oral delivery of protein drugs. J Control Release 2005; 102(2): 489-507.
[16]
Szumała P, Szeląg H. Water Solubilization using nonionic surfactants from renewable sources in microemulsion systems. J Surfactants Deterg 2012; 15(4): 485-94.
[17]
Hou MJ, Shah DO. Effects of the molecular structure of the interface and continuous phase on solubilization of water in water/oil microemulsions. Langmuir 1987; 3(6): 1086-96.
[18]
Devarajan V, Ravichandran V. Nanoemulsions: as modified drug delivery tool. IJCP 2011; 2: 1-6.
[19]
Azeem A, Rizwan M, Ahmad FJ, et al. Nanoemulsion components screening and selection: a technical note. AAPS PharmSciTech 2009; 10(1): 69-76.
[20]
Craig DQM, Barker SA, Banning D, Booth SW. An investigation into the mechanisms of self-emulsification using particle size analysis and low frequency dielectric spectroscopy. Int J Pharm 1995; 114: 103-10.
[21]
Mohanraj V, Chen Y. Nanoparticles - a review. Trop J Pharm Res 2006; 5(1): 561-73.
[22]
Losa C, Marchal-Heussler L, Orallo F, Vila Jato JL, Alonso MJ. Design of new formulations for topical ocular administration: polymeric nanocapsules containing metipranolol. Pharm Res 1993; 10(1): 80-7.
[23]
Gao L, Zhang D, Chen M. Drug nanocrystals for the formulation of poorly soluble drugs and its application as a potential drug delivery system. J Nanopart Res 2008; 10: 845-62.
[24]
Opanasopit P, Ngawhirunpat T, Chaidedgumjorn A, et al. Incorporation of camptothecin into N-phthaloyl chitosan-g-mPEG self-assembly micellar system. Eur J Pharm Biopharm 2006; 64(3): 269-76.
[25]
Rambhau D, Phadke DS, Dorle AK. Evaluation of 0/W emulsion stability through zeta potential-I. Prediction of O/W emulsion stability through zeta potential by accelerated ageing tests. J Cosmet Sci 1977; 28: 183-96.

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