Formulation and evaluation of salicylic acid hydrogel based on hydrotropic solubility enhancement technique

Sara  Assif Younis; Nozad  Rashid Hussein

doi:10.15218/zjms.2024.17

Authors

Sara Assif Younis Department of Pharmaceutics, College of Pharmacy, Hawler Medical University, Erbil, Iraq.
Nozad Rashid Hussein Department of Pharmaceutics, College of Pharmacy, Hawler Medical University, Erbil, Iraq.

DOI:

https://doi.org/10.15218/zjms.2024.17

Keywords:

Salicylic acid, Hydrotropism, Sodium citrate, Sodium acetate, Gel

Abstract

Background and objective: Salicylic acid (SA) has keratolytic activities and it is used topically to treat dandruff and seborrheic dermatitis. The hydrotropic phenomenon in pharmaceutical preparations is utilized to enhance the solubility of water-insoluble drug molecules that promoted to prepare the salicylic acid as a hair gel for local effect and it can extend its keratolytic action for a longer period compared to the salicylic acid solution.

Methods: Preformulation study was performed to exclude any unwanted chemical interaction between SA and excipients using Fourier-transform infrared spectroscopy (FTIR). The solubility of SA was determined separately in sodium acetate and sodium citrate solutions at a concentration of 1, 3, and 5 %w/v, using distilled water as a solvent. An optimum gel formulation was developed and it was used to prepare the SA gel formulation. Characterizations were performed in terms of physical appearance, viscosity, pH, and spreadability, in-vitro studies were performed in physiological pH, and ex-vivo diffusion studies were performed utilizing rats’ skin.

Results: FTIR did not show any chemical interaction between the drug and sodium citrate. The hydrotropic solution of sodium citrate with a concentration of 5% w/v increased the solubility of SA by 28 folds, while the sodium acetate solutions with a concentration of 5% w/v increased the solubility of SA by 19 folds. The optimum gel formula (F1) with a drug content of 97% showed a slow dissolution rate and minimum diffusion through the skin.

Conclusion: The hydrotropic solubilization technique significantly influenced the solubilization of salicylic acid in the water and the highest solubility rate was achieved from 5% w/v sodium citrate solution. The formulated hydrogels using carbopol 971P as gelling agent decreased the diffusion rate of SA.

Metrics

Metrics Loading ...

References

Helal DA, El-Rhman DA, Abdel-Halim SA, El-Nabarawi MA. Formulation and evaluation of fluconazole topical gel. Int J Pharm Pharm Sci 2012; 4(5):176–83.

Thomas LM, Abeer HK. Topical treatment of seborrhoeic dermatitis and dandruff: an overview. Ann Trop Med Public Health 2020; 23(18)231823.http://doi.org/10.36295/ASRO.2020.231823.

Narshana M, Ravikumar P. An overview of dandruff and novel formulations as a treatment strategy. Int J Pharm Sci Res 2018; 9(2):417–31. http://dx.doi.org/10.13040/IJPSR.0975-8232.9(2).417-31.

Rathod HJ, Mehta DP. A review on pharmaceutical gel. Int J Pharm Sci. 2015; 1(1):33–47.

Dubey I, Jatav RK, Patel SS, Jatav RK, Sheorey RV. Formulation and evaluation of salicylic acid and urea gel for treatment of psoriasis. Current Research in Pharmaceutical Sciences 2012; 3(5):166–170.

Jouyban A, Panahi-Azar V, Khonsari F. Solubility of salicylic acid in ethanol, propylene glycol, and N-methyl-2-pyrrolidone at various temperatures and their binary mixtures at 298.2 K. J Mol Liq 2011; 160(1):14–6. https://doi.org/10.1016/j.molliq.2011.02.001.

Singh D, Bedi N, Tiwary AK. Enhancing solubility of poorly aqueous soluble drugs: Critical appraisal of techniques. Journal of Pharmaceutical Investigation 2018; 48(5):509–26. https://doi.org/10.1007/s40005-017-0357-1.

Mitan R. Gokulgandhi, Ashaben P, Kishore C, Megha B, Ashim K, et al. Nanoscale drug delivery systems. Advanced Drug Delivery. Canada; John Wiley & Sons Inc; 2014. P.141–155.

Vishwas DV, Pradeep MP. Advances in hydrotropic solutions: an updated review. St. Petersburg Polytechnic University Journal: Physics and Mathematics 2015; 30(4):119–38. http://dx.doi.org/10.1016/j.spjpm.2015.12.006

Kumar VS, Raja C, Jayakumar C. A review on solubility enhancement using hydrotropic phenomena. Int J Pharm Pharm Sci 2013; 6(6):7.

Saeed AM, Hamzah MJ, Ahmed NQ. Quantitative assay of aspirin and salicylic acid and heavy metals as impuraties in iraqi’s market aspirin tablets using different analytical methods. Int J App Pharm 2018; 10(5):167. http://dx.doi.org/10.22159/ijap.2018v10i5.26820.

Ibrahim NJ, Smail SS, Hussein NR, Abdullah TA. Solubility enhancement of nimodipine using mixed hydrotropic solid dispersion technique. Zanco J Med Sci 2020; 24(3):386–94. https://doi.org/10.15218/zjms.2020.046.

Maheshwari RK, Indurkhya A. Formulation and evaluation of aceclofenac injection made by mixed hydrotropic solubilization technique. Iran J Pharm Res. 2010; 9(3):233.

Chouhan S, Patel M, Vengurlekar S. Development and evaluation of hair gel for the treatment of dandruff. Journal of Drug Delivery & Therapeutics 2017; 7(7):29–31. https://doi.org/10.22270/jddt.v7i7.1577.

Abdul KalamAPJ, Indore MP, Sharma J, Neetu C, Ajay S. Formulation and evaluation of antidandruff hair gel. Int J Adv Res 2017; 5(12):1581–90. http://dx.doi.org/10.21474/IJAR01/6122

Dhamane SP, Tayade NV, Potnis VV, Kulkarni AS, Gadekar AS. Formulation and evaluation of antidandruff hair gel for treatment of seborrhoeic dermatitis. World J Pharm Res 2015; 4(5):12.

Mahtab A, Anwar M, Mallick N, Naz Z, Jain GK, Ahmad FJ. Transungual delivery of ketoconazole nanoemulgel for the effective management of onychomycosis. AAPS Pharm Sci Tech 2016; 17(6):1477–90. https://doi.org/10.1208/s12249-016-0488-0.

Vincent N, Ramya Devi D, Hari BV. Research Journal of Pharmaceutical, Biological and Chemical Sciences 2014; 5(4):1299.

Kashyap A, Das A, Ahmed AB. Formulation and evaluation of transdermal topical gel of ibuprofen. JDDT 2020; 10(2):20–5. https://doi.org/10.22270/jddt.v10i2.3902

Elmataeeshy ME, Sokar MS, Bahey-El-Din M, Shaker DS. Enhanced transdermal permeability of Terbinafine through novel nanoemulgel formulation; Development, in vitro and in vivo characterization. Future Journal of Pharmaceutical Sciences 2018; 4(1):18–28. https://doi.org/10.1016/j.fjps.2017.07.003.

Kanfer I, Rath S, Purazi P, Mudyahoto NA. In vitro release testing of semi-solid dosage forms. Dissolut. Technol 2017; 24(3):52–60. http://dx.doi.org/10.14227/DT240317P52.

Patil PS, Reddy VM, Biradar KV, Patil CB, Rao KS. Development and evaluation of anti dandruff hair gel. IJRPC 2011; 1:936–44.

Trivedi M, Branton A, Trivedi D, Shettigar H, Bairwa K, Jana S. Fourier transform infrared and ultraviolet-visible spectroscopic characterization of biofield treated salicylic acid and sparfloxacin. Natural Products Chemistry & Research 2015; 5(3). doi:10.4172/2329-6836.1000186.

Injeti N. Hydroxy Acids: The Booming OTC Skincare Trend. Int J Clin Pharm Med Sci 2021; 1(2):22–8. https://doi.org/10.26452/ijcpms.v1i2.195

Spielberg ET, Campbell PS, Szeto KC, Mallick B, Schaumann J, Mudring AV. Sodium Salicylate: An In‐Depth Thermal and Photophysical Study. Chemistry–A European Journal 2018; 24(58):15638–48. https://doi.org/10.1002/chem.201803045.

Damiati SA, Martini LG, Smith NW, Lawrence MJ, Barlow DJ. Application of machine learning in prediction of hydrotrope-enhanced solubilisation of indomethacin. International Journal of Pharmaceutics 2017; 530(1-2):99–106.https://doi.org/10.1016/j.ijpharm.2017.07.048.

European Commission. Directorate General for Health and Food Safety. Opinion on salicylic acid (CAS 69-72-7). LU: Publications Office, 2018 (Accessed 2022 Aug 15, at https://data.europa.eu/doi/10.2875/081047).

Jamagondi LN, Katte AS, Rumane MB, Pathan M, Kale AR. Formulation and evaluation of topical antifungal gel containing itraconazole. American Journal of PharmTech Research 2019; 9(02):333–8.

Lukić M, Pantelić I, Savić SD. Towards optimal ph of the skin and topical formulations: From the current state of the art to tailored products. Cosmetics 2021; 8(3):69. https://doi.org/10.3390/cosmetics8030069.

Sandeep DS. Development, Characterization, and In vitro Evaluation of AceclofenacEmulgel. Asian J Pharm 2020; 14(03)1–7.

Manjula D, Jenita JJ, Premakumari KB, Shanaz B. Formulation and evaluation of flaxseed hair gel: a natural hair tamer. International Journal of Research in Pharmacy and Chemistry 2018; 8(3):487–91.

Mohan R, Singh S, Kumar G, Srivastava M. Evaluation of gelling behavior of natural gums and their formulation prospects. Indian J Pharm Educ 2020; 54(4):1016–23. https://doi.org/10.5530/ijper.54.4.195.