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Transferosomal Formulation of Rotigotine Hcl and Rasagiline Mesylate: a Step Towards Minimally Invasive Parkinson's Disease Therapy

· 2024-10-15

DOI: 10.21203/rs.3.rs-4761605/v1

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Research overview

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Abstract Background Parkinson’s disease (PD) is a clinical syndrome with symptoms like rest tremor, rigidity, bradykinesia, instability of posture, and a diversity of other motor and non-motor symptoms. The disease study prognosis is that the number of PD cases will double from 7 million in 2015 to 13 million in 2040. The majority of the treatments for PD include surgery and medications. The drawback of available treatments is that they are invasive and lead to systemic side effects. Aim This research aims to prepare transferosome patches of both drugs of different BCS classes, Rotigotine HCL (RTG) BCS class II and Rasagiline mesylate (RSM) BCS class III, and evaluate them with different parameters to check the synergistic effects of both drugs with the in vivo study. Method A transferosomal patch of drugs was prepared by thin film hydration followed by a homogenization casting method. The patches were optimized with the central composite design. The optimized batch was further evaluated with various parameters like thickness, folding endurance, drug content, in vitro drug release, ex vivo drug permeation, pharmacokinetics, and in vivo skin irritancy studies. Results After the evaluation of the drugs, loaded transferosome patches show good tensile strength; drug content was found within the range in both cases and shows the controlled release of the drugs; pharmacokinetic studies show the quick onset of action; and in vivo, skin irritancy results show no damage to the tissue at the site of action. Conclusion From the results, it has been observed that the prepared transferosome patch can treat PD with the synergistic effects of the drugs via the topical route.

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