Orally Disintegrating Tablet Hardness and Disintegration Balance
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Solution Overview
Problem
Existing orally disintegrating tablets face challenges in achieving both sufficient hardness and rapid disintegration in the presence of water, as increased component firmness enhances hardness but reduces disintegrability, while reduced firmness leads to insufficient hardness and fragility.
Innovation Solution
The development of orally disintegrating tablets using pharmaceutically active ingredient-containing granules with specific particle-size distribution, particle distribution index, angle of repose, and aspect ratio, which are compression molded with a disintegrant, ensuring a minimum 25% granule content and a mean particle size not exceeding 300 µm, to balance hardness and disintegrability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the components of the tablet are firmly combined, then the hardness of the tablet increases, but the disintegrability of the tablet decreases
Solution Approach 1:
The tablet is segmented into multiple granules with specific physical properties (particle size, shape, density) that allow individual granules to separate from each other during disintegration. The granules are designed to break apart the tablet structure when exposed to water, enabling rapid disintegration while maintaining tablet hardness for handling stability.
Solution Approach 2:
The invention changes the physical parameters of the granule components, specifically controlling particle size distribution, shape factors, and density ratios. By optimizing these parameters, the granules exhibit different mechanical behaviors under compression (maintaining hardness) versus in water (rapid disintegration), thus resolving the contradiction between hardness and disintegrability.
2Duration of action of moving object
If the components of the tablet are weakly combined, then the disintegrability of the tablet increases, but the hardness of the tablet becomes insufficient
Solution Approach 1:
The granules act as intermediary elements between the binding requirements for hardness and the disintegration requirements. These granules have specific physical properties that allow them to provide structural integrity during handling while simultaneously serving as disintegration triggers when exposed to water, mediating between the two opposing requirements.
Solution Approach 2:
The tablet is constructed as a composite of granules with specifically controlled physical properties rather than a homogeneous mixture. The composite structure of granules with varying particle sizes, shapes, and densities creates a material that exhibits both hardness for handling stability and rapid disintegration in water.
Data Source
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AI summary
Disclosed are orally disintegrating tablet having advantageous physical strength and disintegrability, and their method for production. The orally disintegrating tablet is a compression molding product of a mixture comprising granules A that contains a pharmaceutically active ingredient, and at least a disintegrant, wherein (a) the mean particle size of granules A is not greater than 300 µm, (b) the particle distribution index for granules A is 3.0 or less, and (c) the angle of repose of granules A is not greater than 38 degrees.