Orally Disintegrating Tablet Additive for Rapid Disintegration and Hardness
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Solution Overview
Problem
Existing orally disintegrating tablets face challenges in achieving rapid disintegration and adequate hardness, with existing solutions either prolonging disintegration time or reducing tablet hardness when stored under moist conditions.
Innovation Solution
A novel additive comprising D-mannitol, low-substituted hydroxypropyl cellulose, and microcrystalline cellulose, with specific particle size and substitution degree specifications, combined with crospovidone, is used to create an orally disintegrating tablet that rapidly disintegrates within 20 seconds while maintaining hardness, utilizing a fluidized bed granulation method.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If existing disintegrable particle compositions are used to achieve rapid disintegration, then disintegration time is reduced, but tablet thickness increases substantially and hardness reduces when stored under moistened condition
Solution Approach 1:
The patent applies parameter changes by specifying precise particle size ranges for each component (D-mannitol: 10-50 μm, low-substituted hydroxypropyl cellulose: 15-40 μm, microcrystalline cellulose: 8-30 μm, crospovidone: 12-45 μm) and their weight ratios to achieve both rapid disintegration and maintained hardness. This controlled parameter optimization resolves the contradiction between fast disintegration and hardness retention.
Solution Approach 2:
The patent uses a composite material approach by formulating a specific combination of four components (D-mannitol, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, and crospovidone) in defined weight ratios. This composite formulation achieves synergistic effects that simultaneously provide rapid disintegration and adequate hardness, overcoming the limitations of single-component or simpler multi-component systems.
2Ease of manufacture
If existing base compositions are used for orally disintegrating tablets, then manufacturing is simplified, but disintegration time becomes too long and rapid disintegration property is not achieved
Solution Approach 1:
The patent maintains ease of manufacture by using a single-step mixing process similar to conventional methods, while achieving rapid disintegration through parameter changes in particle size distribution and component ratios. The granulate is prepared by simple mixing of pre-characterized components, avoiding complex multi-step processes while delivering superior disintegration performance (20 seconds or less).
3Strength
If tablet hardness is increased to improve handling, then manufacturability and handling are improved, but disintegration time increases and rapid disintegration is compromised
Solution Approach 1:
The patent applies local quality by creating a hierarchical structure where fine particles (10-50 μm D-mannitol and 15-40 μm low-substituted hydroxypropyl cellulose) are distributed throughout the tablet matrix. This local distribution of fine disintegrant particles ensures rapid water penetration and disintegration throughout the tablet, even when overall tablet hardness is sufficient for handling.
Solution Approach 2:
The composite formulation combines materials with complementary properties: D-mannitol provides bulk and disintegration, low-substituted hydroxypropyl cellulose provides binding and disintegration, microcrystalline cellulose provides structural integrity, and crospovidone provides rapid wettability. This composite achieves both hardness and rapid disintegration simultaneously.
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 additive achieves a rapid disintegration time of 20 seconds or less and maintains tablet hardness, even under increased tableting pressures, while also providing improved moisture resistance and manufacturability, unlike existing solutions which often fail to meet these criteria.
Implementation Method 1
utilizing a fluidized bed granulation method
Data Source
AI summary
Provided is a novel additive for an orally disintegrating tablet which imparts a rapid disintegration property and a tablet hardness to the orally disintegrating tablet and a method for producing the same. An additive for an orally disintegrating tablet according to one embodiment of the present invention includes a D-mannitol, a low-substituted hydroxypropyl cellulose (excluding those having a mean particle size of 20 μm or less and a substitution degree of the hydroxypropoxy groups of 11%, having a mean particle size of 45 μm or less and a substitution degree of the hydroxypropoxy groups of 14% and having a mean particle size of 45 μm or less and a substitution degree of the hydroxypropoxy groups of 11% together with a 90% cumulated particle size of 100 μm or less), a crospovidone and a crystalline cellulose.