Ethanol and polysorbate-20 as permeability enhancer for iontophoretic administration of glucosamine sulphate in patients with low back pain

Abstract

Transdermal drug administration through iontophoresis may require permeation enhancer because most drugs do not achieve sufficient concentration in tissues. 95% Ethanol are usually used as surfactants while polysorbate 20 is rarely utilized for skin preparation during the procedure of iontophoresis in the management of cases of Low Back Pain (LBP). The primary aim was to compare the effects of ethanol and polysorbate 20 as glucosamine sulphate permeability enhancer in the management of symptoms of Low Back Pain. Fifty – four subjects with symptomatic low back pain were recruited. Electrical muscle stimulator (MS-Dx-07 muscle stimulator) was used to administer glucosamine sulphate using galvanic current. Ethanol, Polysorbate 20 and Tap water were used as skin cleansing agents prior to administration of glucosamine sulphate cream for participants with LBP in groups 1, 2 and 3 respectively.
The Low back Pain Rating Scale Questionnaire was used to assess back and leg pain, disability index and physical impairments. Each patient was treated twice a week for a period of 6 weeks. Descriptive, Paired t-test (dependent) and Repeated Analysis of Variance (ANOVA) statistics were used to analyse the data obtained. The level of significance was set at 0.05. At onset, there was no significant difference in all the clinical and disability indices excluding physical impairment of Ethanol group that was significantly higher than that of polysorbate group (p = 0.01). Same trend was observed after six weeks (p = 0.008). The within group assessment for polysorbate-20 showed that there was significant decrease in the pain and disability indices after six weeks (t = 13.02, p = 0.001; t = 5.14, p = 0.001). Similar trends were observed for physical impairments and spinal range of motion. However, there was no significant difference between spinal flexibility at onset and six weeks post intervention. There were no significant differences in all the clinical indices, pre and post intervention after six weeks for both Ethanol and Tap water groups.
It was concluded that Polysorbate-20 was a better permeation enhancer for glucosamine sulphate iontophoresis than Ethanol and Tap water in the management of symptoms of low back pain.

Key words:

Glucosamine sulphate iontophoresis, surfactants, polysorbate-20, ethanol, tap water, low back pain

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