Pharmaceutical Formulation Comprising Ezetimibe
Patent No. EP2965752 (titled "Pharmaceutical Formulation Comprising Ezetimibe") was filed by Assia Chemical Industries on Dec 9, 2008. The application was issued on Sep 3, 2025.
Patent Summary
A pharmaceutical composition for lipid-lowering use comprises 5–20 wt-% ezetimibe, 50–85 wt-% diluent, 3–25 wt-% disintegrant, 2–5 wt-% solubility enhancer, 1–10 wt-% binder, and 0.5–1 wt-% lubricant. The ezetimibe must have a particle size distribution (determined by laser diffraction "wet powder method") of d(0.9) between 9–20 µm and d(0.5) between 4–10 µm. This specific formulation achieves a dissolution profile where ≥90% of ezetimibe is released within 30 minutes, tested using a USP standard apparatus in 500 ml of 1% sodium lauryl sulfate in pH 4.5 phosphate buffer at 50 rpm. The composition may be manufactured using a corn starch paste (concentration >10 wt-% in water) for granulation prior to compression or encapsulation.
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Date
Description
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EP2965752
- Application Number
- EP15171262A
- Filing Date
- Dec 9, 2008
- Status
- Granted And Under Opposition
- Aug 1, 2025
- Publication Date
- Sep 3, 2025
- External Links
- Slate, Register , Google Patents