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Risedronate transdermal delivery system based on a fumaric copolymer for therapy of osteoporosis
Magalí Pasqualone1, Héctor A Andreetta2, M Susana Cortizo1
1Instituto de Investigaciones Fisicoquímicas Teóricas y Aplicadas (INIFTA), CONICET, CCT-LaPlata, La Plata, Argentina.
Summary
A novel transdermal drug delivery system (TDDS) for risedronate offers a safer alternative for osteoporosis treatment. This polymer-based system demonstrates effective drug delivery and stability, potentially reducing adverse effects associated with oral administration.
Area of Science:
- Materials Science
- Pharmaceutical Sciences
- Polymer Chemistry
Background:
- Transdermal drug delivery systems (TDDS) offer an alternative to oral administration, potentially mitigating adverse effects.
- Osteoporosis treatment often involves bisphosphonates like risedronate (RI).
Purpose of the Study:
- To develop and characterize a novel TDDS for risedronate (RI) using a vinyl acetate-dioctylfumarate copolymer (poly(VA-co-DOF)).
- To evaluate the drug loading, stability, release kinetics, and potential for osteoporosis treatment.
Main Methods:
- Synthesis of poly(VA-co-DOF) copolymer.
- Fabrication of TDDS membranes with 6% and 12% (w/w) RI.
- Characterization using optical microscopy, FTIR, and DSC.
- Development and validation of a RP-HPLC method for RI quantification.
- Analysis of drug release kinetics using the Ritger-Peppas model.
Main Results:
- Developed membranes showed good transparency and homogeneous drug distribution.
- FTIR and DSC indicated no significant drug/polymer interactions, only a plasticizer effect.
- Validated RP-HPLC method demonstrated linearity, reproducibility, and accuracy (LOD: 0.38 μg/mL, LOQ: 1.17 μg/mL).
- High drug loading efficiency and excellent drug stability were observed.
- Drug release kinetics followed the Ritger-Peppas model, indicating a complex transport mechanism (super case II transport).
Conclusions:
- The novel poly(VA-co-DOF) based TDDS for risedronate is a promising system for osteoporosis treatment.
- The system exhibits favorable characteristics including drug stability and controlled release.
- This TDDS could provide an effective alternative to oral administration, potentially minimizing adverse effects.
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