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Development of push-pull osmotic tablets using chitosan-poly(acrylic acid) interpolymer complex as an osmopolymer
Wichan Ketjinda1, Nuttanan Sinchaipanid, Pichet Limsuwan
1Department of Industrial Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, 10400, Thailand.
AAPS Pharmscitech
|December 25, 2010
Summary
This study developed novel push-pull osmotic tablets (PPOT) for felodipine using chitosan-poly(acrylic acid) complexes. These tablets offer prolonged, zero-order drug release, controlled by osmotic extrusion and erosion mechanisms.
Area of Science:
- Pharmaceutical Technology
- Polymer Science
- Drug Delivery Systems
Background:
- Osmotic drug delivery systems offer controlled release profiles.
- Chitosan and poly(acrylic acid) can form interpolymer complexes with potential in drug formulations.
- Felodipine is a calcium channel blocker used for hypertension, requiring controlled release for efficacy.
Purpose of the Study:
- To prepare push-pull osmotic tablets (PPOT) of felodipine using a chitosan (CS) and poly(acrylic acid) (PAA) interpolymer complex as the osmopolymer.
- To investigate the drug release mechanisms and kinetics from these novel PPOT formulations.
- To evaluate the influence of formulation variables, such as polymer ratios and plasticizers, on felodipine release.
Main Methods:
- Preparation of CS-PAA interpolymer complexes at varying weight ratios.
- Fabrication of bilayered PPOT containing a felodipine-loaded drug layer and a polymeric expansion layer with the CS-PAA complex.
- In vitro drug release studies were conducted to assess the effects of polymer ratios, plasticizers (dibutyl sebacate, polyethylene glycol 400), and compression forces on release characteristics.
Main Results:
- Felodipine release from PPOT followed zero-order kinetics, with release duration extended up to 12 or 24 hours based on the plasticizer used.
- Dibutyl sebacate resulted in a longer lag time and slower release compared to polyethylene glycol 400.
- Increased CS proportion in the CS-PAA complex enhanced the drug release rate when using polyethylene glycol 400; compression force had no significant effect.
Conclusions:
- The developed PPOT formulation effectively provides sustained, zero-order release of felodipine.
- Drug release is governed by a dual mechanism involving osmotic extrusion of the drug layer followed by its erosion and dissolution.
- The CS-PAA interpolymer complex is a promising osmopolymer for developing advanced osmotic drug delivery systems.
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