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Fixed Dose Combination Formulations: Multilayered Platforms Designed for the Management of Cardiovascular Disease
G P Andrews1, S Li1, A Almajaan1
1Pharmaceutical Engineering Group, School of Pharmacy , Queen's University , Belfast BT9 , U.K.
Molecular Pharmaceutics
|February 1, 2019
Summary
This study developed a novel bilayer drug delivery system for biphasic release of simvastatin and aspirin. The system successfully achieved delayed simvastatin release and immediate aspirin release, offering a new platform for fixed-dose combination therapies.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Cardiovascular Pharmacology
Background:
- Hyperlipidemia is a major risk factor for cardiovascular diseases (CVDs).
- Simvastatin, a common statin for hyperlipidemia, undergoes extensive metabolism by CYP450 3A4/3A5 enzymes.
- Co-administration of antihypertensives and anticoagulants is common in CVD management.
Purpose of the Study:
- To design and develop a bilayer drug delivery system for biphasic release of simvastatin and aspirin.
- To create a fixed-dose combination platform for managing cardiovascular risk factors.
Main Methods:
- Development of a delayed-release platform using anionic polymers and hot-melt extrusion for simvastatin.
- Formulation of an immediate-release layer with Kollidon VA64 for aspirin.
- Manufacturing of bilayer tablets and coextrudates, followed by dissolution testing.
Main Results:
- The optimized formulation successfully delayed the release of simvastatin.
- An immediate-release layer for aspirin was effectively developed.
- Bilayer systems demonstrated biphasic release profiles for both drugs.
Conclusions:
- The developed bilayer system provides a viable platform for biphasic drug delivery.
- This approach can be extended to fixed-dose combinations of various medications.
- The system offers potential for improved therapeutic outcomes in cardiovascular disease management.
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