Rapid Disintegrating Tablet Composition Mannitol Xylitol
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Solution Overview
Problem
Conventional rapid disintegrating tablets in the oral cavity have limitations in terms of disintegration time and hardness, with existing compositions failing to achieve a balance between rapid disintegration and sufficient hardness.
Innovation Solution
A composition comprising mannitol, xylitol, an inorganic excipient, and a disintegrating agent in specific ratios, forming complex particles that enhance disintegration time and hardness, achieved through compression molding and spray-drying processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If conventional rapid disintegrating tablet compositions are used, then disintegration time is reduced, but tablet hardness is insufficient
Solution Approach 1:
The invention uses a composite particle system consisting of saccharide particles (mannitol and/or xylitol) with dispersed inorganic excipient particles and disintegrating agent particles. This composite structure allows the tablet to maintain hardness through the saccharide matrix while the dispersed disintegrating agent ensures rapid disintegration when exposed to oral cavity moisture, thus resolving the contradiction between hardness and disintegration speed.
Solution Approach 2:
The inorganic excipient and disintegrating agent are dispersed locally within the saccharide particles rather than being uniformly mixed. This local distribution ensures that the disintegrating agent is concentrated at strategic locations where it can rapidly act upon moisture exposure, while the saccharide provides the overall structural integrity and hardness of the tablet.
2Productivity
If spray-drying process is used to prepare granules, then productivity is improved, but manufacturing precision may be affected
Solution Approach 1:
The saccharide particles are prepared in advance with predetermined size ranges (0.5-5 μm for inorganic excipient, 1-20 μm for disintegrating agent) before the spray-drying process. This preliminary sizing and selection of materials ensures that the subsequent spray-drying operation produces uniform granules with consistent disintegration properties, maintaining manufacturing precision while achieving high productivity.
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 composition significantly shortens disintegration time in the oral cavity while maintaining sufficient hardness, achieving rapid disintegration within 20 seconds and excellent tablet-forming properties, with improved productivity and manufacturing efficiency.
Implementation Method 1
mannitol and xylitol form complex particles
Implementation Method 2
prepared by spray-drying a suspension
Implementation Method 3
compression molding
Data Source
AI summary
The present invention provides rapid disintegrating tablets in oral cavity having a shortened disintegration time in oral cavity as well as a sufficient hardness with compared to rapid disintegrating tablets of the prior art.The above objective is solved by a composition for rapid disintegrating tablets in oral cavity, wherein components (a) to (c) are contained in such manner that(a) saccharides consisting of a combination of mannitol and xylitol is 40 to 90 parts by weight;(b) the inorganic excipient is 1 to 30 parts by weight; and(c) the disintegrating agent is 5 to 40 parts by weight, provided that the total amount of (a), (b) and (c) is 100 parts by weight.