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Development and Evaluation of Lactose-Free Single-Unit and Multiple-Unit Preparations of a BCS Class II Drug,
Daniel Zakowiecki1, Peter Edinger1, Markos Papaioannou1
1Chemische Fabrik Budenheim KG, Rheinstrasse 27, 55257 Budenheim, Germany.
Pharmaceutics
|November 27, 2024
Summary
New lactose-free rivaroxaban formulations were developed to improve oral anticoagulant therapy for patients with lactose intolerance. These stable and effective rivaroxaban tablets offer a patient-friendly alternative.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Rivaroxaban, a BCS Class II drug, presents poor aqueous solubility, complicating oral anticoagulant formulation.
- Increasing prevalence of lactose intolerance necessitates development of lactose-free medications.
Purpose of the Study:
- To develop stable, lactose-free rivaroxaban formulations in both single-unit tablets and multiple-unit pellet systems (MUPS).
- To ensure these formulations meet stringent physical and performance standards for oral anticoagulation.
Main Methods:
- Utilized phosphate-based excipients for formulation development.
- Prepared traditional tablets and multiple-unit pellet systems (MUPS).
- Evaluated physical properties (hardness, friability) and chemical stability, alongside dissolution profiles.
Main Results:
- Developed rivaroxaban formulations exhibited excellent mechanical strength and chemical stability.
- Dissolution profiles aligned with the compendial monograph for Rivaroxaban Tablets.
- Performance was comparable to the reference product, Xarelto® film-coated tablets.
Conclusions:
- Successfully produced effective and stable lactose-free rivaroxaban formulations.
- These formulations provide patient-friendly alternatives for individuals with lactose intolerance or those preferring vegan options.
- Demonstrates potential for advanced drug delivery meeting modern patient needs.
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