Agglomerated Sucroferric Oxyhydroxide Micro-Tablet Ejection Marks
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Solution Overview
Problem
The existing sucroferric oxyhydroxide compositions used in micro-tableting lead to dark brown marks on the extremities of micro-tablets due to higher ejection forces, making it challenging to produce smaller tablets suitable for pediatric applications or patients with dysphagia.
Innovation Solution
Subjecting the sucroferric oxyhydroxide particles obtained by spray drying to agglomeration, resulting in a coarser particle size distribution with a higher fraction of particles above 90 μm and 125 μm, which allows for the manufacture of smaller tablets, such as micro- or mini-tablets, without the formation of marks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If spray-dried sucroferric oxyhydroxide particles are used in micro-tableting, then the tablets can be produced, but dark brown marks appear on the extremities due to high ejection forces
Solution Approach 1:
The patent changes the particle size distribution parameter by agglomerating spray-dried particles to achieve a coarser distribution (d10: 45-75 μm, d50: 90-150 μm, d90: 150-250 μm). This parameter change reduces ejection forces during micro-tableting, preventing dark brown marks on tablet extremities while maintaining manufacturability
Solution Approach 2:
The patent applies preliminary agglomeration treatment to the spray-dried particles before micro-tableting. This preliminary action modifies the particle characteristics in advance, ensuring that the particles have suitable size distribution and flow properties that prevent mark formation during the subsequent compression and ejection process
2Volume of moving object
If particle size is reduced for pediatric applications, then smaller tablets can be produced, but ejection forces increase causing manufacturing defects
Solution Approach 1:
The patent optimizes the particle size distribution parameters through agglomeration to achieve a coarser distribution than conventional spray-dried particles. This parameter optimization enables the production of smaller tablets (micro-tablets) with reduced ejection forces, solving the contradiction between tablet size reduction and ejection force increase
Solution Approach 2:
The patent creates agglomerated particle composites by combining multiple spray-dried particles into larger agglomerates with controlled size distribution. This composite structure maintains the beneficial properties of spray-dried particles while achieving the coarser size distribution needed for reduced ejection forces in micro-tablet production
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The agglomerated sucroferric oxyhydroxide particles enable the production of smaller tablets with reduced ejection forces, preventing dark brown marks and ensuring the tablets can be effectively compressed into micro- or mini-tablet form.
Implementation Method 1
when the known sucroferric oxyhydroxide particles obtained by spray drying were subjected to agglomeration leading to a decrease of smaller particles and an increase of bigger particles
Data Source
AI summary
The invention relates to particles of a mixture of iron(III)-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.