Cellulose Composition with Cellooligosaccharides for Tablet Hardness
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Solution Overview
Problem
Existing cellulose powders used in pharmaceutical tableting face challenges in maintaining uniform active component content and tablet hardness, especially when mixing times are lengthened, leading to potential maldistribution and reduced tablet quality.
Innovation Solution
A cellulose composition incorporating cellooligosaccharides from trisaccharides to heptasaccharides, with a specific content range per 5 g of the composition, is used to enhance the binding properties between particles, thereby maintaining tablet hardness and uniformity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the raw material mixing time is lengthened to ensure uniformity of active component content, then the content uniformity is improved, but the tablet hardness is reduced
Solution Approach 1:
The invention changes the chemical composition parameters of the cellulose excipient by specifying a water-soluble substance content of 5.0 mg or more per 5 g and a cellooligosaccharide (3 to 7) content within 0.3 to 3.0 mg per 5 g. This parameter optimization allows for improved particle binding properties that maintain tablet hardness even with extended mixing times required for content uniformity.
Solution Approach 2:
The invention creates a composite cellulose composition with specific combinations of cellulose, water-soluble substances, and cellooligosaccharides (3 to 7). This composite structure provides both the flowability needed for mixing and the binding properties needed to maintain tablet hardness, resolving the contradiction between mixing time requirements and hardness preservation.
2Ease of manufacture
If conventional cellulose powder is used, then the manufacturing process is simple, but tableting failure occurs due to unfavorable binding properties
Solution Approach 1:
The invention optimizes specific compositional parameters of cellulose powder: water-soluble substance content (5.0 mg or more per 5 g) and cellooligosaccharide (3 to 7) content (0.3 to 3.0 mg per 5 g). These parameter changes enhance particle binding properties and suppress electrostatic charge, improving tableting reliability while maintaining manufacturing simplicity.
Solution Approach 2:
The cellooligosaccharides (3 to 7) act as an intermediary substance within the cellulose composition, mediating between particles to improve binding properties. This intermediary component enables reliable tableting without complicating the manufacturing process, as it is already present in the optimized cellulose composition.
3Manufacturing precision
If the mixing time is extended to prevent maldistribution of active component, then the content uniformity is improved, but the tablet hardness reduction becomes problematic
Solution Approach 1:
The invention changes the chemical composition parameters of the cellulose excipient to include water-soluble substances (5.0 mg or more per 5 g) and cellooligosaccharides (3 to 7) (0.3 to 3.0 mg per 5 g). These parameter optimizations improve particle binding properties, allowing extended mixing times to achieve content uniformity without the usual penalty of reduced tablet hardness.
Data Source
AI summary
A cellulose composition containing cellulose and cellooligosaccharides from trisaccharides to heptasaccharides, wherein the cellooligosaccharide content per 5 g of the cellulose composition is at least 1.5 mg but not more than 9.0 mg. A tablet contains the cellulose composition and at least one active component.