Particles of a mixture of iron(III)-oxyhydroxide, sucrose and one or more starches, preferably of sucroferric oxyhydroxide

Agglomerated sucroferric oxyhydroxide particles with a specific particle size distribution address the issue of dark brown marks in micro-tablets, enabling the production of smaller tablets suitable for pediatric applications.

CA3163438CActive Publication Date: 2026-07-07VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD

Patent Information

Authority / Receiving Office
CA · CA
Patent Type
Patents
Current Assignee / Owner
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD
Filing Date
2021-01-14
Publication Date
2026-07-07

AI Technical Summary

Technical Problem

Existing sucroferric oxyhydroxide compositions used in micro-tableting processes result in unwanted dark brown marks on the extremities of the micro-tables, which are not desirable for pediatric applications, and the use of the said sucroferric oxyhydroxide compositions lead to dark brown marks on the extremities of the micro-tablets due to higher ejection forces in micro-tableting tools.

Method used

The use of agglomerated sucroferric oxyhydroxide particles, comprising iron(III)-oxyhydroxide, sucrose, and one or more starches, with a specific particle size distribution, reduces the fraction of smaller particles and increases the fraction of larger particles, allowing for the production of smaller tablets without dark brown marks.

Benefits of technology

The agglomerated particles enable the manufacture of suitable smaller tablets, such as micro- or mini-tablets, without the formation of dark brown marks, suitable for pediatric applications or patients with dysphagia.

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Abstract

The invention relates to particles of a mixture of iron(I I I)-oxyhydroxide, sucrose and one or more starches, preferably of sucroferric oxyhydroxide having a certain particle size distribution, a process for the manufacture thereof, the pharmaceutical composition comprising the same, in particular compressed tablets.
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