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Effect of gamma sterilization on the properties of microneedle array transdermal patch system
Honnavar Parthasarathy Swathi1, Vishwanath Anusha Matadh1, Jhimli Paul Guin2
1Institute for Drug Delivery and Biomedical Research, Bengaluru, India.
Drug Development and Industrial Pharmacy
|March 25, 2020
Summary
Gamma irradiation effectively sterilizes soluble microneedles (MNs). Polyvinylpyrrolidone K90 (PVP K90) and sodium hyaluronate (HU) microneedles maintained structural integrity and dissolution properties post-sterilization, indicating their suitability for drug delivery applications.
Area of Science:
- Materials Science
- Pharmaceutical Technology
- Biotechnology
Background:
- Soluble microneedles (MNs) offer a minimally invasive drug delivery platform.
- Sterilization is crucial for MN safety and efficacy, but can affect material properties.
- Evaluating polymer stability under sterilization conditions is essential for developing viable MN formulations.
Purpose of the Study:
- To assess the impact of gamma irradiation sterilization on the properties of four hydrophilic polymers for soluble MN fabrication.
- To identify suitable polymers for sterile soluble MNs with preserved structural and dissolution characteristics.
Main Methods:
- Fabrication of soluble MNs using sodium carboxymethyl cellulose (CMC), polyvinylpyrrolidone (PVP) K30, PVP K90, and sodium hyaluronate (HU) via mold casting.
- Sterilization of MNs using 25 kGy gamma radiation.
- Characterization using bright field microscopy, scanning electron microscopy (SEM), Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and Powder X-ray Diffraction (PXRD).
- Evaluation of in vitro and in vivo dissolution profiles.
Main Results:
- CMC and PVP K30 MNs exhibited poor mechanical properties and deformation post-irradiation.
- PVP K90 and HU MNs retained their morphology and structural integrity after gamma sterilization, as confirmed by SEM and FTIR.
- DSC showed no change in glass transition temperature for PVP K90 MNs, while HU showed reduced crystallinity.
- In vitro and in vivo dissolution studies demonstrated similar profiles for sterile PVP K90 and HU MNs compared to un-irradiated controls.
Conclusions:
- PVP K90 and HU are suitable hydrophilic polymers for fabricating soluble microneedles intended for gamma sterilization.
- Gamma irradiation at 25 kGy effectively sterilizes soluble MNs without significantly compromising the structural, morphological, microstructural, or dissolution properties of PVP K90 and HU.
- These findings support the potential of PVP K90 and HU based soluble MNs for safe and effective drug delivery applications.
