Abstract

Objective: This study's goals were to develop a minimally invasive array of biocompatible polymeric solid microneedles and formulate a transdermal patch of drug Ɣ-Oryzanol as per poke and patch technology. Methods: Scanning electron microscopy was used to analyse the morphology of the solid microneedle arrays, which were created using a stereolithography (SLA) printer with high-resolution capabilities (25 and 140 microns for the z and x axes, respectively). Transdermal Patches of Ɣ-Oryzanol were formulated and evaluated for various characterization parameters. Further, the produced microneedle-transdermal drug delivery system of Ɣ-Oryzanol was examined for microneedle insertion skin and permeation of the drug across the porcine skin. Results: Solid microneedle arrays were manufactured using biocompatible Class I Dental SG resin having dimensions of 600 µm height and 300 µm width with tip diameters of 30 µm and 1.85 mm interspacing (Distance from tip to tip) and they were strong enough to penetrate porcine skin to a depth of 381.356 µm crossing the stratum corneum layer without causing any structural changes. Transdermal patches containing Ɣ-Oryzanol were formulated using different ratios of HPMC: Eudragit E-100. Good, consistent, and transparent films were formulated when the thickness of the film ranges between 0.516±0.25-0.628±0.21 mm, average weights ranged from 168.23±2.61to171.22±1.25(10/cm2), folding endurance ranged in between 10 folds to 12 folds for all the formulations with tensile strength lie between the 0.365 kg/mm2 to 0.465 kg/mm2. All the formulations showed good drug content between 99.3±0.06%-90.4±1.64% with 100% flat surfaces. Moisture content was found in the range of 2.012±0.013 to 4.213±0.031. Drug permeation studies reveal that compound Ɣ-Oryzanol transdermal patches didn’t show significant permeation across porcine skin (4.802.25 g/cm2) without piercing with microneedles while after poking skin using microneedles (74.502.35 g/cm2) drug showed good penetration properties. It was found that the amount of drug delivered increased to 44.251.57 g/cm2 at 2 min, which was 14.502.35 g/cm2 at 1 min to 4 min 74.502.35 g/cm2. Conclusion: Successful preparation of the Microneedle-Transdermal drug delivery system of Ɣ-Oryzanol and their evaluation indicated that the quality and consistency of the formulated preparation were excellent. With advantages in terms of lowered dose frequency, better patient compliance, and bioavailability, this may find use in the therapeutic field.

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