Abstract
The present clinical trial investigates the sustaining anesthetic effect of Ropivacaine when administered as epidural injection followed by transdermal patch with and without Reverse electrodialysis (RED) system in order to maintain anesthesia in children. It also focuses on rate of release of drug in-vitro when administered with RED system. The transdermal patch of Ropivacaine was prepared using evaporation technique enclosing 25 mg of Local anesthetic Ropivacaine. Thus prepared patches were evaluated for physical parameters like folding endurance, tensile strength, in vitro drug release etc. The thicknesses of the patches were in the range of 0.02 ±0.006 to 0.04 ± 0.007 mm with 95.79 ±1.85 to 97.45±0.07 % drug content. The average weight and tensile strength was found to be 0.15±0.2 to 0.17±0.18 gm and 0.42±0.006 to 0.58±0.002 kg/cm2. The folding endurance of the patches was in range of 155.21 ±0.2 to 167± 0.29 and content of moisture was 1.43±0.23 % to 2.97±0.23 %. The formulation shows In - vitro release in Phosphate buffer pH 7.4 as 55.56 % to 89.23 ± 0.24 % in 24 hr with reverse electrodialysis system attached and 43.76 % to 81.23 ± 0.14 % in 24 hr without reverse electrodialysis system. The children of different age groups, different body weight with no premedication of anesthetic of analgesic were selected as subjects with written informed consent and divided into two groups depending upon RED system to be attached or not. The patches with and without RED system were attached to forearm of subjects and trial is run. The results obtained showed that patch when attached with reverse electrodialysis system showed greater potential for thermal threshold, lowering of cool sensation and depth of pain. Keywords: Child Anesthesia, Iontophoresis, Reverse Electrodialysis ,Ropivacaine, Transdermal Patch.
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