DESIGN AND EVALUATION OF TRANSDERMAL PATCHES OF DULOXETINE HYDROCHLORIDE Development and Assessment of Transdermal Patches for Duloxetine Hydrochloride
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Abstract
Duloxetine hydrochloride is a selective serotonin and noradrenaline reuptake inhibitor (SSNRI) used for anxiety, diabetic neuropathy and fibromyalgia. The present investigation of this study was to develop the transdermal patches of duloxetine HCl as a once-day dosage form. The patches are prepared by solvent casting technique by using hydrophilic polymers HPMC E5 and HPMC E15 in different ratios. From the preformulation studies for drug excipient compatibility (DSC), it was observed that there was no interaction between polymers and drug. The developed patches were evaluated for weight variation, thickness, % of drug content, folding endurance, flatness, moisture absorption, moisture loss, and mechanical properties. The study results revealed that the obtained results were within the accepted limits. The in vitro release studies showed good release linearity along with acceptable flux for F3,& F4. The formulations F3, and F4 have shown Higuchi model drug release. In ex vivo studies permeation enhancer (d-limonene) is used, formulation (F4) containing HPMC E15 along with d-limonene as a chemical enhancer had shown extended ex-vivo drug release for 24hrs and shown maximum flux (125µg/sqcm/hr) with good release linearity when compared with control formulation and F4 formulation is optimized as it contains lower polymer content when compared to F3 formulation.
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