Formulation and Evaluation of Transdermal Patch for Atomoxetine hydrochloride
Abstract
The aim of this study was to develop transdermal patch of Atomoxetine hydrochloride which has good mechanical properties. The transdermal patches were preapared used solvent casting method. Different groups of films with drug were prepared using different amalgamations of polymers such as HPMC (various grades), Polyox303, Eudragit RL 100.Considering solubility of drug and polymer, the solvent system of water: ethanol was chosen.In-vitro release of drug substance was performed using phosphate buffer solution (PBS) pH 7.4. Compatibility of drug with different excipient (drug: excipient in the ratio 1:1) was carried out using Fourier Transform Infra-Red Spectroscopy (FTIR). Evaluation test such as weight variation, content uniformity, drug content, folding endurance, thickness, in-vitro dissolution and in-vitro disintegration were done. The folding endurance of the all batches found less than 500 times.The percentages of drug distribution was found in between 72 to 100%.The formulation F4 containing a combination of HPMC and Eudragit showed maximum drug release of 95.26%. The method employed to prepare patches was capable of producing patches with almost uniform drug distribution. Stability studies were conducted as per ICH guidlines (40±2○C at 75±5% RH) for optimized formulations and was found to be stable.
Keywords: Atomoxetine hydrochloride, Transdermal Patch
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