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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
PubMed

Insights

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.

Keywords:
biphasic drug releaseenhanced bioavailabilityfixed dose combinationhot-melt coextrusionmultilayer drug deliverysimvastatin

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